A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants (ENSEMBLE)

• ClinicalTrials.gov Identifier: NCT04505722
• Recruitment Status: Completed
• First Posted: August 10, 2020
• Results First Posted: April 15, 2022
• Last Update Posted: May 6, 2023
• Sponsor: Janssen Vaccines & Prevention B.V.
• Information provided by (Responsible Party): Janssen Vaccines & Prevention B.V.

Study Description

Brief Summary:

The study will evaluate the efficacy of Ad26.COV2.S in the prevention of molecularly confirmed moderate to severe/critical COVID-19, as compared to placebo, in adult participants.

Condition or disease	Intervention/treatment	Phase
Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19 at Different Stages of the Protocol	Biological: Ad26.COV2.S; Other: Placebo	Phase 3

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 44325 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older
• Actual Study Start Date: September 7, 2020
• Actual Primary Completion Date: March 31, 2023
• Actual Study Completion Date: March 31, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ad26.COV2.S; Participants will receive intramuscular (IM) injection of Ad26.COV2.S at a dose level of 5*10^10 virus particles (vp) as single dose vaccine on Day 1. At Year 1 (booster visit), participants who previously received any coronavirus disease-2019 (COVID-19) vaccination (as primary regimen or additional dose) will be offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.	Biological: Ad26.COV2.S; Ad26.COV2.S will be administered at a single dose of 5*10^10 virus particles (vp) on Day 1 (or Month 6 for placebo recipients) and as a single booster dose at Year 1.; Other Names: JNJ-78436735; Ad26COVS1
Experimental: Placebo; Participants will receive IM injection of placebo on Day 1. At Month 6/unblinding visit, post Emergency Use Authorization (EUA), conditional licensure, or approval for the single dose regimen, participants initially receiving placebo will be offered to receive a single dose of Ad26.COV2.S vaccine IM at a dose level of 5*10^10 vp. At Year 1 (booster visit), participants who previously received any COVID-19 vaccination (as primary regimen or additional dose) will be offered a single booster dose of Ad26.COV2.S at the 5*10^10 vp dose level.	Biological: Ad26.COV2.S; Ad26.COV2.S will be administered at a single dose of 5*10^10 virus particles (vp) on Day 1 (or Month 6 for placebo recipients) and as a single booster dose at Year 1.; Other Names: JNJ-78436735; Ad26COVS1; Other: Placebo; Participants will receive Placebo.

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Main Study) [ Time Frame: 14 Days after double-blind vaccination (Day 15) ]
   Molecularly confirmed moderate to severe/critical COVID-19 was defined as a severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) positive reverse transcription-polymerase chain reaction (RT-PCR) or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute, oxygen saturation (SpO2) <= 93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
2. Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 With Seronegative Status (Main Study) [ Time Frame: 28 Days after double-blind vaccination (Day 29) ]
   Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate >=20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats/minute and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute, SpO2 less than or equal to (<=) 93 percent (%) on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the Intensive Care Unit (ICU), death defined as per Food and Drug Administration (FDA) guidance.
3. Number of Participants With Solicited Local Adverse Events (AEs) Up to 7 Days After Booster Vaccination (Open-label Booster Vaccination Phase) [ Time Frame: Up to Day 372 (7 Days after booster vaccination on Day 365 [Year 1]) ]
   Participants who receive the booster dose was asked to note in the e-Diary occurrences of injection site pain/tenderness, erythema, and swelling at the study vaccine injection site daily for 7 days post-booster vaccination (day of vaccination and the subsequent 7 days).
4. Number of Participants With Solicited Systemic AEs Up to 7 Days After Booster Vaccination (Open-label Booster Vaccination Phase) [ Time Frame: Up to Day 372 (7 Days after booster vaccination on Day 365 [Year 1]) ]
   Participants recorded the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement was made on any given day, the highest temperature of that day was recorded in the e-Diary. Fever was defined as endogenous elevation of body temperature >= 38.0 degree Celsius or >=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants also noted the signs and symptoms in the e-Diary on a daily basis for 7 days post-booster vaccination (day of vaccination and the subsequent 7 days), if feasible, for the following events: fatigue, headache, nausea, myalgia.
5. Number of Participants With Unsolicited AEs Up to 28 Days After Booster Vaccination (Open-label Booster Vaccination Phase) [ Time Frame: Up to Day 393 (28 Days after booster vaccination on Day 365 [Year 1]) ]
   Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
6. Number of Participants With Serious Adverse Events (SAEs) From Booster Vaccination Until End of the Study (Open-label Booster Vaccination Phase) [ Time Frame: From booster vaccination (Year 1) up to end of the study (up to 2 years 3 months) ]
   SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
7. Number of Participants With Adverse Events of Special Interest (AESI) From Booster Vaccination Until End of the Study (Open-label Booster Vaccination Phase) [ Time Frame: From booster vaccination (Year 1) up to end of the study (up to 2 years 3 months) ]
   Number of participants with AESIs were reported. AESIs are significant AEs that are judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, is considered to be an AESI in this study. A suspected TTS case is defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter.
8. Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Open-label Booster Vaccination Phase) [ Time Frame: 14 Days after unblinding visit to 1 year follow up of the last booster vaccination (up to Day 546) ]
   Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
9. Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Open-label Booster Vaccination Phase) [ Time Frame: 28 Days after unblinding visit to 1 year follow up of the last booster vaccination (up to Day 560) ]
   Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
10. Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Open-label Booster Vaccination Phase) [ Time Frame: 14 days after booster vaccination (Day 379) to end of study (up to 2 years and 3 month) ]
    Severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
11. Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical Coronavirus Disease (COVID-19) With Seronegative Status (Open-label Booster Vaccination Phase) [ Time Frame: 28 days after booster vaccination (Day 393) to end of study (up to 2 years and 3 month) ]
    Severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.

Secondary Outcome Measures :

1. Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical COVID-19 With Seronegative Status (Main Study) [ Time Frame: 14 Days after double-blind vaccination (Day 15) ]
   Severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
2. Number of Participants With First Occurrence of Molecularly Confirmed Severe/Critical COVID-19 With Seronegative Status (Main Study) [ Time Frame: 28 Days after double-blind vaccination (Day 29) ]
   Severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
3. Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Main Study) [ Time Frame: 1 Day after double-blind vaccination (Day 2) ]
   Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
4. Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Main Study) [ Time Frame: 14 days after double-blind vaccination (Day 15) ]
   Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
5. Number of Participants With First Occurrence of Molecularly Confirmed Moderate to Severe/Critical COVID-19 Regardless of Their Serostatus (Main Study) [ Time Frame: 28 days after double-blind vaccination (Day 29) ]
   Molecularly confirmed moderate to severe/critical COVID-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample. Moderate included one sign or symptom such as respiratory rate >= 20 breaths per minute and symptoms such as shortness of breath or two signs or symptoms such as heart rate >= 90 beats per minute (beats/minute) and symptoms such as cough from a list of signs and symptoms and severe/critical included one of the following signs and symptoms: respiratory rate >=30 breaths/minute, heart rate >=125 beats/minute,SpO2 <=93% on room air at sea level respiratory failure, evidence of shock, significant acute renal, hepatic, or neurologic dysfunction, admission to the ICU, death defined as per FDA guidance.
6. Number of Participants With First Occurrence of COVID-19 Requiring Medical Intervention (Main Study) [ Time Frame: 14 days after double-blind vaccination (Day 15) ]
   Number of participants with first occurrence of COVID-19 requiring medical intervention (such as a composite endpoint of hospitalization, ICU admission, mechanical ventilation, and extracorporeal membrane oxygenation [ECMO], linked to objective measures such as decreased oxygenation, X-ray or computed tomography [CT] findings) or linked to any molecularly confirmed, COVID-19 at least 14 days post vaccination were reported.
7. Number of Participants With First Occurrence of COVID-19 Requiring Medical Intervention (Main Study) [ Time Frame: 28 Days after double-blind vaccination (Day 29) ]
   Number of participants with first occurrence of COVID-19 requiring medical intervention (such as a composite endpoint of hospitalization, ICU admission, mechanical ventilation, and ECMO, linked to objective measures such as decreased oxygenation, X-ray or CT findings) or linked to any molecularly confirmed, COVID-19 at least 28 days post vaccination were reported.
8. SARS-CoV-2 Viral Load as Assessed by Quantitative Reverse-Transcriptase Polymerase Chain Reaction (RT-PCR) in Participants With Molecularly Confirmed, Moderate to Severe/Critical COVID-19 (Main Study) [ Time Frame: 14 Days after double-blind vaccination (Day 15) ]
   The viral load of SARS-CoV-2 was assessed in confirmed COVID-19 cases using RT-PCR. Nasal swabs were used to detect and/or quantify SARS-CoV-2.
9. Number of Participants With First Occurrence of Molecularly Confirmed Mild COVID-19 (Main Study) [ Time Frame: 14 Days after double-blind vaccination (Day 15) ]
   Molecularly confirmed mild Covid-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: fever (>=38°C or >=100.4°F), sore throat, malaise (loss of appetite, generally unwell, fatigue, physical weakness), headache, muscle pain (myalgia), gastrointestinal symptoms, cough, chest congestion, runny nose, wheezing, skin rash, eye irritation or discharge, chills, new or changing olfactory or taste disorders, red or bruised looking feet or toes, or shaking chills or rigors.
10. Number of Participants With First Occurrence of Molecularly Confirmed Mild COVID-19 (Main Study) [ Time Frame: 28 Days after double-blind vaccination (Day 29) ]
    Molecularly confirmed mild Covid-19 was defined as a SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample and one of the following signs and symptoms: fever (>=38°C or >=100.4°F), sore throat, malaise (loss of appetite, generally unwell, fatigue, physical weakness), headache, muscle pain (myalgia), gastrointestinal symptoms, cough, chest congestion, runny nose, wheezing, skin rash, eye irritation or discharge, chills, new or changing olfactory or taste disorders, red or bruised looking feet or toes, or shaking chills or rigors.
11. Number of Participants With First Occurrence of Molecularly Confirmed COVID-19 Defined by the US Food and Drug Administration (FDA) Harmonized Case Definition (Main Study) [ Time Frame: 14 Days after double-blind vaccination (Day 15) ]
    Molecularly confirmed COVID-19 was defined as a positive SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample; and COVID-19 symptoms consistent with those defined by the US FDA harmonized case Definition at the time of finalization of the study protocol: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea.
12. Number of Participants With First Occurrence of Molecularly Confirmed COVID-19 Defined by the US Food and Drug Administration (FDA) Harmonized Case Definition (Main Study) [ Time Frame: 28 Days after double-blind vaccination (Day 29) ]
    Molecularly confirmed COVID-19 was defined as a positive SARS-CoV-2 positive RT-PCR or molecular test result from any available respiratory tract sample (example, nasal swab sample, sputum sample, throat swab sample, saliva sample) or other sample; and COVID-19 symptoms consistent with those defined by the US FDA harmonized case Definition at the time of finalization of the study protocol: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea.
13. Number of Participants With Burden of Disease (BOD) Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 (Main Study) [ Time Frame: 14 Days after double-blind vaccination (Day 15) ]
    BOD is a weighted version of the mild, moderate, and severe/critical vaccine efficacies and was evaluated based on the first occurrence of molecularly confirmed COVID-19, including mild, moderate or severe/critical COVID-19 case.
14. Number of Participant With BOD Based on First Occurrence of Molecularly Confirmed Symptomatic COVID-19 (Main Study) [ Time Frame: 28 Days after double-blind vaccination (Day 29) ]
    BOD is a weighted version of the mild, moderate, and severe/critical vaccine efficacies and was evaluated based on the first occurrence of molecularly confirmed COVID-19, including mild, moderate or severe/critical COVID-19 case.
15. Number of Participants With SARS-CoV-2 Seroconversion Based on Antibodies to N Protein Using ELISA and/or SARS-CoV-2 Immunoglobulin Assay (Main Study) [ Time Frame: From Day 29 until end of double-blind phase (up to 284 days after first vaccination) ]
    Number of participants with SARS-CoV-2 seroconversion based on antibodies to nucleocapsid (N) protein using enzyme-linked immunosorbent assay (ELISA) and/or SARS-CoV- 2 immunoglobulin assay that is dependent on the SARS-CoV-2 N protein was reported.
16. Number of Participants With Asymptomatic Infection Detected by RT-PCR at the Time of the Month 6/Unblinding Visit (Main Study) [ Time Frame: Month 6 ]
    Number of participants with asymptomatic infection detected by RT-PCR at the time of the Month 6/unblinding visit were reported.
17. Number of Participants With First Occurrence of SARS-CoV-2 Infection (Serologically and/or Molecularly Confirmed) (Main Study) [ Time Frame: 28 Days after double-blind vaccination (Day 29) ]
    Number of participants with first occurrence of SARS-CoV-2 infection (serologically and/or molecularly confirmed) were reported.
18. Number of Participants With Serious Adverse Events (SAEs) (Main Study) [ Time Frame: Up to 35 weeks ]
    SAE is any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product.
19. Number of Participants With Adverse Events of Special Interest (AESI) (Main Study) [ Time Frame: Up to 35 weeks ]
    Number of participants with AESIs were reported. AESIs are significant AEs that are judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Thrombosis with Thrombocytopenia Syndrome (TTS), a syndrome characterized by a combination of both a thrombotic event and thrombocytopenia, is considered to be an AESI in this study. A suspected TTS case is defined as: Thrombotic events: suspected deep vessel venous or arterial thrombotic events; Thrombocytopenia, defined as platelet count below 150,000/micro liter.
20. Number of Participants With Medically-Attended Adverse Events (MAAEs) (Main Study) [ Time Frame: Up to 6 months after double-blind vaccination on Day 1 ]
    MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason.
21. Number of Participants With MAAEs Leading to Study Discontinuation (Main Study) [ Time Frame: Up to 35 weeks ]
    MAAEs were defined as AEs with medically-attended visits including hospital, emergency room, urgent care clinic, or other visits to or from medical personnel for any reason. Routine study visits were not considered medically-attended visits. New onset of chronic diseases was collected as part of the MAAEs.
22. Number of Participants With Solicited Local Adverse Events (AEs) During 7 Days Following Vaccination (Main Study) [ Time Frame: Up to Day 8 (7 Days after double-blind vaccination on Day 1) ]
    Participants who were enrolled in safety subset were asked to note in the e-Diary occurrences of injection site pain/tenderness, erythema, and swelling at the study vaccine injection site daily for 7 days post-vaccination (day of vaccination and the subsequent 7 days).
23. Number of Participants With Solicited Systemic AEs During 7 Days Following Vaccination (Main Study) [ Time Frame: Up to Day 8 (7 Days after double-blind vaccination on Day 1) ]
    Participants who were enrolled in safety subset were instructed on how to record daily temperature using a thermometer provided for home use. Participants recorded the temperature in the e-Diary in the evening of the day of vaccination, and then daily for the next 7 days approximately at the same time each day. If more than 1 measurement was made on any given day, the highest temperature of that day was recorded in the e-Diary. Fever was defined as endogenous elevation of body temperature >= 38.0 degree Celsius or >=100.4-degree Fahrenheit, as recorded in at least 1 measurement. Participants also noted the signs and symptoms in the e-Diary on a daily basis for 7 days post vaccination (day of vaccination and the subsequent 7 days), for the following events: fatigue, headache, nausea, myalgia.
24. Number of Participants With Unsolicited AEs During 28 Days Post-vaccination (Main Study) [ Time Frame: Up to Day 29 (28 Days after double-blind vaccination on Day 1) ]
    Unsolicited AEs were all AEs for which the participant is not specifically questioned in the participant diary.
25. Binding Antibodies to SARS-CoV-2 S Protein Assessed by ELISA (Main Study) [ Time Frame: Baseline (Day 1), Day 29, and Day 71 ]
    Binding antibodies to SARS-CoV-2 S protein as assessed by enzyme-linked immunosorbent assay (ELISA) to measure humoral immune response was reported. The lower limit of quantification (LLOQ) and upper limit of quantification (ULOQ) were 50.3 EU/mL and 58,158.10 EU/mL, respectively. A sample was considered positive if the value was strictly greater than the LLOQ (>LLOQ).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Contraceptive (birth control) use should be consistent with local regulations regarding the acceptable methods of contraception for those participating in clinical studies
• All participants of childbearing potential must: have a negative highly sensitive urine pregnancy test at screening; and have a negative highly sensitive urine pregnancy test immediately prior to each study vaccine administration
• Participant agrees to not donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine
• Must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
• Must be able to read, understand, and complete questionnaires in the electronic clinical outcome assessment (eCOA) (that is, the coronavirus disease-2019 [COVID 19] signs and symptoms surveillance question, the e-Diary, and the electronic patient-reported outcomes (ePROs). Note: Participants with visual impairment are eligible for study participation and may have caregiver assistance in completing the electronic clinical outcome assessment (eCOA) questionnaires

Exclusion Criteria:

• Participant has a clinically significant acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (>=) 38.0 degree Celsius (100.4-degree Fahrenheit) within 24 hours prior to the planned first dose of study vaccine; randomization at a later date is permitted at the discretion of the investigator and after consultation with the sponsor
• Participant received or plans to receive: (a) licensed live attenuated vaccines - within 28 days before or after planned administration of study vaccine ; and (b) other licensed (not live) vaccines - within 14 days before or after planned administration of study vaccine
• Participant previously received a coronavirus vaccine
• Participant received an investigational drug (including investigational drugs for prophylaxis of COVID-19) within 30 days or used an invasive investigational medical device within 30 days or received investigational immunoglobulin (Ig) or monoclonal antibodies within 3 months, or received convalescent serum for COVID-19 treatment within 4 months or received an investigational vaccine (including investigational Adenoviral-vectored vaccines) within 6 months before the planned administration of the first dose of study vaccine or is currently enrolled or plans to participate in another investigational study during the course of this study

Contacts and Locations

Locations

United States, Alabama

Synexus Clinical Research US, Inc

Birmingham, Alabama, United States, 35209

University of Alabama Birmingham

Birmingham, Alabama, United States, 35233

Alabama Vaccine Research Clinic at UAB

Birmingham, Alabama, United States, 35294

Optimal Research

Huntsville, Alabama, United States, 35802

United States, Arizona

Synexus Clinical Research US, Inc

Glendale, Arizona, United States, 85308

VA Medical Center

Phoenix, Arizona, United States, 85012

Central Phoenix Medical Clinic

Phoenix, Arizona, United States, 85020

Quality of Life Medical & Research Center, LLC

Tucson, Arizona, United States, 85712

Synexus Clinical Research US, Inc

Tucson, Arizona, United States, 85712

United States, Arkansas

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States, 72202

Central Arkansas Veterans Healthcare System

Little Rock, Arkansas, United States, 72205

United States, California

Anaheim Clinical Trials, LLC

Anaheim, California, United States, 92801

Ark Clinical Research

Long Beach, California, United States, 90806

Anthony Mills Medical, Inc

Los Angeles, California, United States, 90069

Stanford University Medical Center

Palo Alto, California, United States, 94304

UCSD Antiviral Research Center AVRC

San Diego, California, United States, 92103

Wr-McCr, Llc

San Diego, California, United States, 92108

VA Medical Center

San Francisco, California, United States, 94121-1545

United States, Colorado

Childrens Hospital Colorado

Aurora, Colorado, United States, 80045

Rocky Mountain Regional VA Medical Center

Denver, Colorado, United States, 80220

United States, Florida

Avail Clinical Research, LLC

DeLand, Florida, United States, 32720

North Florida South Georgia Veteran Health System

Gainesville, Florida, United States, 32608

Velocity Clinical Research, Hallandale Beach

Hallandale Beach, Florida, United States, 33009

Research Centers of America, LLC

Hollywood, Florida, United States, 33024

Suncoast Research Group

Miami, Florida, United States, 33135

University of Miami - Miller School of Medicine

Miami, Florida, United States, 33136

Orlando Immunology Center

Orlando, Florida, United States, 32803

Advent Health Orlando

Orlando, Florida, United States, 32804

Synexus Clinical Research US, Inc

Orlando, Florida, United States, 32806

Synexus Clinical Research US, Inc

Pinellas Park, Florida, United States, 33781

James A Haley VA Hospital GNS

Tampa, Florida, United States, 33612

Synexus Clinical Research US, Inc

The Villages, Florida, United States, 32162

United States, Georgia

Emory University of Medicine

Atlanta, Georgia, United States, 30322

The Hope Clinic at Emory University

Decatur, Georgia, United States, 30030-1705

Atlanta VA Medical Center

Decatur, Georgia, United States, 30033

United States, Illinois

Northwestern University

Chicago, Illinois, United States, 60611

Jesse Brown VAMC Department of Surgery

Chicago, Illinois, United States, 60612

Rush University Medical Center

Chicago, Illinois, United States, 60612

University of IL Chicago

Chicago, Illinois, United States, 60612

The University Of Chicago Medicine

Chicago, Illinois, United States, 60637

Optimal Research

Peoria, Illinois, United States, 61614

United States, Indiana

Buynak Clinical Research

Valparaiso, Indiana, United States, 46383

United States, Kansas

Johnson County Clin-Trials

Lenexa, Kansas, United States, 66219

United States, Kentucky

Central Kentucky Research Associates, Inc.

Lexington, Kentucky, United States, 40509

University of Kentucky

Lexington, Kentucky, United States, 40536

University of Louisville

Louisville, Kentucky, United States, 40202

United States, Louisiana

Benchmark Research

Metairie, Louisiana, United States, 70006

Clinical Trials Management, LLC

Metairie, Louisiana, United States, 70006

New Orleans Adolescent Trials Unit CRS

New Orleans, Louisiana, United States, 70118

Southeast Louisiana Veterans Health Care Center

New Orleans, Louisiana, United States, 70119

Ochsner Clinic Foundation

New Orleans, Louisiana, United States, 70121

United States, Maryland

Baltimore VA Medical Center

Baltimore, Maryland, United States, 21201

Optimal Research

Rockville, Maryland, United States, 20850

Meridian Clinical Research, LLC

Rockville, Maryland, United States, 20854

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

The Brigham and Women's Hospital, Inc.

Boston, Massachusetts, United States, 02115

United States, Michigan

University of Michigan Neuorsurgery A. Alfred Taubman Health Care Center

Ann Arbor, Michigan, United States, 48109-5000

Henry Ford Health System

Detroit, Michigan, United States, 48202

Cherry Street Services, Inc.

Grand Rapids, Michigan, United States, 49503

United States, Minnesota

Abbott Northwestern Hospital Clinic

Minneapolis, Minnesota, United States, 55407

United States, Mississippi

University of Mississippi Medical Center

Jackson, Mississippi, United States, 39216

MediSync Clinical Research

Petal, Mississippi, United States, 39465

United States, Missouri

The Center For Pharmaceutical Research

Kansas City, Missouri, United States, 64114

Saint Louis University

Saint Louis, Missouri, United States, 63106

Washington University School of Medicine

Saint Louis, Missouri, United States, 63110-1035

Synexus Clinical Research US, Inc

Saint Louis, Missouri, United States, 63141

United States, Nevada

Clinical Research Center of Nevada

Las Vegas, Nevada, United States, 89106

Clinical Research Consortium, an AMR company

Las Vegas, Nevada, United States, 89119

VA Sierra Nevada Health Care System

Reno, Nevada, United States, 89509

United States, New Jersey

Rutgers Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States, 08903

Saint Michaels Medical Center

Newark, New Jersey, United States, 07102

United States, New Mexico

Raymond G. Murphy VA Medical Center

Albuquerque, New Mexico, United States, 87108

United States, New York

Bronx Veterans Affairs Medical Center

Bronx, New York, United States, 10468

Meridian Clinical Research, LLC

Endwell, New York, United States, 13760

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Harlem Hospital Center

New York, New York, United States, 10037

New York Blood Center

New York, New York, United States, 10065

Rochester Clinical Research, Inc

Rochester, New York, United States, 14609

United States, North Carolina

Tryon Medical Group

Charlotte, North Carolina, United States, 28210

Carolina Institute for Clinical Research

Fayetteville, North Carolina, United States, 28304

Durham VAMC

Raleigh, North Carolina, United States, 27610

Wake Research Associates

Raleigh, North Carolina, United States, 27612

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States, 27157

United States, Ohio

Synexus Clinical Research US, Inc

Akron, Ohio, United States, 44311

CTI Clinical Trial and Consulting Services

Cincinnati, Ohio, United States, 45212

Synexus Clinical Research US, Inc

Cincinnati, Ohio, United States, 45236

Velocity Clinical Research

Cincinnati, Ohio, United States, 45242

Rapid Medical Research

Cleveland, Ohio, United States, 44122

Synexus Clinical Research US, Inc

Columbus, Ohio, United States, 43212

United States, Oregon

Corvallis Clinic PC

Corvallis, Oregon, United States, 97330

Clinical Research Institute of Southern Oregon, P.C.

Medford, Oregon, United States, 97504

Oregon Health & Science University

Portland, Oregon, United States, 97239

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Temple University Hospital

Philadelphia, Pennsylvania, United States, 19140

University of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15232

United States, South Carolina

Synexus Clinical Research US, Inc

Anderson, South Carolina, United States, 29621-2062

VA Medical Center

Columbia, South Carolina, United States, 29201

Coastal Carolina Research Center

Mount Pleasant, South Carolina, United States, 29464

PMG Research of Charleston, LLC

Mount Pleasant, South Carolina, United States, 29464

Spartanburg Medical Research

Spartanburg, South Carolina, United States, 29303

United States, Tennessee

St Jude Children's Research Hospital

Memphis, Tennessee, United States, 38105

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

United States, Texas

Benchmark Research

Austin, Texas, United States, 78705

Optimal Research, LLC

Austin, Texas, United States, 78705

AIDS Arms Incorporated Trinity Health and Wellness Center

Dallas, Texas, United States, 75208

Synexus Clinical Research US, Inc

Dallas, Texas, United States, 75234

Baylor Scott & White Research Institute

Dallas, Texas, United States, 75246

North Texas Infectious Diseases Consultants

Dallas, Texas, United States, 75246

The University of Texas Health Science Center at Houston

Houston, Texas, United States, 77030

Texas Center for Drug Development, Inc

Houston, Texas, United States, 77081

Gordon Crofoot, MD

Houston, Texas, United States, 77098

Clinical Trials of Texas, Inc

San Antonio, Texas, United States, 78229

Synexus Clinical Research US, Inc

San Antonio, Texas, United States, 78229

United States, Utah

Synexus Clinical Research US, Inc

Murray, Utah, United States, 84123

University of Utah

Salt Lake City, Utah, United States, 84132

Advanced Clinical Research

West Jordan, Utah, United States, 84088

United States, Washington

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, United States, 98101

Argentina

CIPREC

Buenos Aires, Argentina, C1119ACN

Helios Salud Sa

Buenos Aires, Argentina, C1141ACG

CEMEDIC

Buenos Aires, Argentina, C1440CFD

Centro Medico Viamonte SRL

Ciudad Autonoma Buenos Aires, Argentina, C1120AAC

Clinical Trials Division-Stamboulian Servicios de Salud

Ciudad Autonoma Buenos Aires, Argentina, C1425AWK

Clínica y Maternidad Suizo Argentina

Ciudad Autonoma de Buenos Aires, Argentina, 1118

Fundacion Huesped

Ciudad Autonoma De Buenos Aire, Argentina, C1202ABB

CEMIC Saavedra

Ciudad de Buenos Aires, Argentina, 1431

Hospital J. M. Ramos Mejía

Ciudad de Buenos Aires, Argentina, C1221Adc

Instituto Medico Platense

La Plata, Argentina, B1900AVG

Hospital Italiano de La Plata

La Plata, Argentina, B1900AXI

DIM Clinica Privada

Ramos Mejia, Argentina, B1704ETD

Brazil

Faculdade de Medicina Barretos FACISB

Barretos, Brazil, 14785-002

Universidade Federal De Minas Gerais - Hospital das Clínicas

Belo Horizonte, Brazil, 30130-100

Santa Casa de Misericordia de Belo Horizonte

Belo Horizonte, Brazil, 30150-221

L2IP - Instituto de Pesquisas Clínicas

Brasília, Brazil, 70200-730

Sociedade Campineira de Educacao e Instrucao - Hospital e Maternidade Celso Pierro

Campinas, Brazil, 13060-904

Fundação Universidade Federal de Mato Grosso do Sul

Campo Grande, Brazil, 778606-715

Sociedade Literaria e Caritativa Santo Agostinho - Hospital Sao Jose

Criciúma, Brazil, 88811-508

Oncovida - Centro de Onco-Hematologia de Mato Grosso

Cuiabá, Brazil, 78043-142

Hospital Nossa Senhora Das Gracas

Curitiba, Brazil, 80810-040

Centro de Estudos e Pesquisas em Moléstias Infecciosas

Natal, Brazil, 59025-050

Hospital das Clinicas de Porto Alegre

Porto Alegre, Brazil, 90035-903

Hospital Nossa Senhora da Conceicao S.A

Porto Alegre, Brazil, 91350-200

Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP

Ribeirao Preto, Brazil, 14040-900

Ministerio da Saude - Hospital dos Servidores do Estado - RJ

Rio de Janeiro, Brazil, 20221-160

Instituto Brasil de Pesquisa Clinica

Rio de Janeiro, Brazil, 20241-180

Fundacao Oswaldo Cruz

Rio de Janeiro, Brazil, 21040-900

Municipio de Nova Iguacu - Hospital Geral de Nova Iguacu

Rio de Janeiro, Brazil, 26030-380

Fundação Bahiana De Infectologia

Salvador, Brazil, 40110-060

Universidade Municipal de Sao Caetano do Sul

Sao Caetano do Sul, Brazil, 09521-160

Fundação Faculdade Regional de Medicina de São José do Rio Preto - Hospital de Base

Sao Jose do Rio Preto, Brazil, 15090-000

Instituto de infectologia Emilio Ribas

Sao Paulo, Brazil, 01246-900

Centro de Referencia E Treinamento Dst/Aids

Sao Paulo, Brazil, 02141-000

Hospital Das Clinicas Da Faculdade De Medicina Da USP

Sao Paulo, Brazil, 05403-000

CPQuali Pesquisa Clinica LTDA ME

São Paulo, Brazil, 01228-000

Sociedade Beneficente de Senhoras - Hospital Sírio Libanês

São Paulo, Brazil, 01308-901

Real e Benemérita Associação Portuguesa de Beneficência

São Paulo, Brazil, 01323-900

CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos

São Paulo, Brazil, 04266-010

Chile

Centro de Estudios Clínicos e Investigación Médica (CeCim)

Santiago, Chile, 8331143

Facultad de Medicina Universidad de Chile

Santiago, Chile, 8380453

Hospital Padre Hurtado

Santiago, Chile, 8880465

Centro de Investigacion del Maule

Talca, Chile, 3465586

Hospital Dr Hernan Henriquez Aravena

Temuco, Chile, 47811-51

Centro de Estudios Clínicos V Región Ltda

Viña del Mar, Chile, 2520997

Colombia

Clinica de la Costa

Barranquilla, Colombia, 080001

Centro de Reumatologia y Ortopedia

Barranquilla, Colombia, 080020

Hospital Universidad del Norte

Barranquilla, Colombia, 80020

Centro de Atencion e Investigacion Medica S.A. - CAIMED

Bogota, Colombia, 00000

Medplus Medicina Prepagada S.A.

Bogota, Colombia, 110111

Solano y Terront Servicios Médicos Ltda.

Bogota, Colombia, 110221

Centro de Investigaciones Clinicas S.A.S.

Cali, Colombia, 760001

Fundación Valle del Lili

Cali, Colombia, 760032

Fundación Cardiovascular de Colombia - Instituto del Corazón Floridablanca

Floridablanca, Colombia, 6810002

Fundacion Oftalmologica de Santander - FOSCAL

Floridablanca, Colombia, 681002

Programa de Estudio y Control de Enfermedades Tropicales

Medellin, Colombia, 00000

Fundacion Centro de Investigacion Clinica CIC

Medellin, Colombia

Hospital Pablo Tobon Uribe

Medellín, Colombia, 050034

Mexico

Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán

Ciudad de Mexico, Mexico, 14080

Instituto Nacional de Salud Publica

Cuernavaca, Mexico, 62100

Hospital Civil Fray Antonio Alcalde

Guadalajara, Mexico, 44280

Unidad de Atención Medica e Investigacion en Salud (UNAMIS)

Merida, Mexico, 97000

Centro Medico Nacional Siglo XXI IMSS

Mexico, Mexico, 06720

CAIMED Investigacion en salud S.A de C.V.

Mexico, Mexico, 06750

Instituto Nacional de Enfermedades Respiratorias

Mexico, Mexico, 14080

Hospital Universitario de Nuevo Leon 'Dr Jose Eleuterio Gonzalez'

Monterrey, Mexico, 64460

Infectolab

Tijuana, Mexico, CP 22010

Peru

Centro de Invetigaciones Medicas

Callao, Peru, 0000

Hospital Nacional Daniel Alcides Carrion

Callao, Peru, 02

Centro de Investigaciones Tecnologicas, Biomedica y medio ambientales (CITBM)

Callao, Peru, 07066

Asociacion Civil Selva Amazonica (ACSA)

Iquitos, Peru, 16001

Asociacion Civil Impacta Salud y Educacion - Barranco

Lima - Barranco, Peru, Barranco 15063

Hospital Nacional Edgardo Rebagliati Martins

Lima, Peru, 11

Hospital Nacional Arzobispo Loayza

Lima, Peru, 15082

Asociacion Civil Via Libre

Lima, Peru, LIMA 01

Instituto de Investigacion Nutricional

Lima, Peru, LIMA12

Asociacion Civil Impacta Salud y Educacion- San Miguel CRS

Lima, Peru, LIMA32

South Africa

Josha Research

Bloemfontein, South Africa, 9301

Synexus Helderberg Clinical Research Centre

Cape Town, South Africa, 7130

Family Clinical Research Unit FAM-CRU

Cape Town, South Africa, 7505

TASK Central

Cape Town, South Africa, 7530

Desmond Tutu HIV Foundation

Cape Town, South Africa, 7750

University of Cape Town IDM/CIDRI Research Site

Cape Town, South Africa, 7784

Desmond Tutu Hiv Foundation - University Of Cape Town

Cape Town, South Africa, 7925

Masiphumelele Research Centre

Cape Town, South Africa, 7975

Ndlovu Elandsdoorn Site

Dennilton, South Africa, 0485

SA Medical Research Council

Durban, South Africa, 3660

SA Medical Research Council

Durban, South Africa, 4400

CRISMO Bertha Gxowa Research Centre

Johannesburg, South Africa, 1401

Shandukani Research Centre

Johannesburg, South Africa, 2001

The Aurum Institute Klerksdorp Clinical Research Centre

Klerksdorp, South Africa, 2571

Qhakaza Mbokodo Research Centre

KwaZulu-Natal, South Africa, 4030

South African Medical Research Council Chatsworth Clinical Research Site

KwaZulu-Natal, South Africa, 4030

Centre for the AIDS Programme of Research in South Africa

KwaZulu-Natal, South Africa, 4110

Stanza Clinical Research Centre : Mamelodi

Mamelodi East, South Africa, 0122

Mzansi Ethical Research Centre

Middelburg, South Africa, 1055

Nelson Mandela Academic Clinical Research Unit 'NeMACRU'

Mthatha, South Africa, 5099

PHOENIX PHARMA (Pty) Ltd

Port Elizabeth, South Africa, 6001

MeCRU Clinical Research Unit

Pretoria, South Africa, 0204

Synexus Watermeyer

Pretoria, South Africa

The Aurum Institute Rustenburg Clinical Research Site

Rustenburg, South Africa, 300

Setshaba Research Centre

Soshanguve, South Africa, 152

Perinatal HIV Research Unit (PHRU), Kliptown

Soweto, South Africa, 1809

Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital

Soweto, South Africa, 2013

The Aurum Institute: Tembisa - Clinic 4

Tembisa, South Africa, 1632

CAPRISA Vulindlela Clinic

Vulindlela, South Africa, 4013

University of Witwatersrand - Helen Joseph Hospital - Themba Lethu Hiv Research Centre

Westdene Johannesburg Gauteng, South Africa, 2092

SATVI, Brewelskloof Hospital

Worcester, South Africa, 6850

Sponsors and Collaborators

Janssen Vaccines & Prevention B.V.

Investigators

• Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial; Janssen Vaccines & Prevention B.V.

  Study Documents (Full-Text)

Documents provided by Janssen Vaccines & Prevention B.V.:

Study Protocol  [PDF] September 4, 2021

Statistical Analysis Plan  [PDF] July 20, 2021

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sadoff J, Gray G, Vandebosch A, Cardenas V, Shukarev G, Grinsztejn B, Goepfert PA, Truyers C, Van Dromme I, Spiessens B, Vingerhoets J, Custers J, Scheper G, Robb ML, Treanor J, Ryser MF, Barouch DH, Swann E, Marovich MA, Neuzil KM, Corey L, Stoddard J, Hardt K, Ruiz-Guinazu J, Le Gars M, Schuitemaker H, Van Hoof J, Struyf F, Douoguih M; ENSEMBLE Study Group. Final Analysis of Efficacy and Safety of Single-Dose Ad26.COV2.S. N Engl J Med. 2022 Mar 3;386(9):847-860. doi: 10.1056/NEJMoa2117608. Epub 2022 Feb 9.

Sadoff J, Struyf F, Douoguih M. A plain language summary of how well the single-dose Janssen vaccine works and how safe it is. Future Virol. 2021 Nov;16(11):725-739. doi: 10.2217/fvl-2021-0199. Epub 2021 Nov 1.

Sadoff J, Gray G, Vandebosch A, Cardenas V, Shukarev G, Grinsztejn B, Goepfert PA, Truyers C, Fennema H, Spiessens B, Offergeld K, Scheper G, Taylor KL, Robb ML, Treanor J, Barouch DH, Stoddard J, Ryser MF, Marovich MA, Neuzil KM, Corey L, Cauwenberghs N, Tanner T, Hardt K, Ruiz-Guinazu J, Le Gars M, Schuitemaker H, Van Hoof J, Struyf F, Douoguih M; ENSEMBLE Study Group. Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19. N Engl J Med. 2021 Jun 10;384(23):2187-2201. doi: 10.1056/NEJMoa2101544. Epub 2021 Apr 21.

Williams TC, Burgers WA. SARS-CoV-2 evolution and vaccines: cause for concern? Lancet Respir Med. 2021 Apr;9(4):333-335. doi: 10.1016/S2213-2600(21)00075-8. Epub 2021 Jan 29. No abstract available.

• Responsible Party: Janssen Vaccines & Prevention B.V.
• ClinicalTrials.gov Identifier: NCT04505722
• Other Study ID Numbers: CR108876; VAC31518COV3001 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
• First Posted: August 10, 2020
• Results First Posted: April 15, 2022
• Last Update Posted: May 6, 2023
• Last Verified: May 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
• URL: https://www.janssen.com/clinical-trials/transparency

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Vaccines & Prevention B.V.:

Prevention; Vaccine

Additional relevant MeSH terms:

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases