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A Study of Ad26.COV2.S in Healthy Pregnant Participants (COVID-19) (HORIZON 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04765384
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : January 19, 2022
Sponsor:
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

Brief Summary:
The purpose of this study is to assess the safety and reactogenicity of Ad26.COV2.S administered intramuscularly (IM) as a 1-dose schedule at the standard dose level, or 2-dose schedule at a lower dose level, if applicable in adult participants during the second and/or third trimester of pregnancy and (potentially) post-partum; to assess the humoral immune response in peripheral blood of adult participants to Ad26.COV2.S administered IM as a 1-dose, or 2-dose schedule, if applicable, at a lower dose during the second and/or third trimester of pregnancy, 28 days after the first vaccination and 14 days after the second vaccination.

Condition or disease Intervention/treatment Phase
COVID-19 Prevention Biological: Ad26.COV2.S Phase 2

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

Detailed Description:
There is an increased risk of severe coronavirus disease-2019 (COVID-19) during pregnancy, as well as an increased risk of adverse birth outcomes. Therefore, the aim of this study is to assess the safety, reactogenicity and immunogenicity of Ad26.COV2.S in adult participants in the second and/or third trimester of pregnancy. Ad26.COV2.S (also known as Ad26COVS1) is a monovalent vaccine composed of a recombinant, replication incompetent adenovirus type 26 (Ad26) vector, constructed to encode the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) spike (S) protein. For each adult participant, the total study duration from screening until the last follow-up visit will be approximately 16 months. The study will consist of a screening phase (28 days), vaccination period (study period from first vaccination to pregnancy completion/termination) and a follow-up period (up to 12 months post pregnancy completion/termination). For neonates/infants born to the participants in the study will be followed for approximately 12 months postpartum. Safety assessments will include immunogenicity assessments, physical examination, vital signs, clinical safety laboratory assessments, medical, obstetric and delivery history, pregnancy outcome, neonate safety assessment, adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESI).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Open-label, Phase 2 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.COV2.S in Healthy Pregnant Participants
Actual Study Start Date : August 27, 2021
Estimated Primary Completion Date : January 16, 2023
Estimated Study Completion Date : September 18, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Groups 1-4: Ad26.COV2.S (One Dose)
Participants who are previously vaccinated (Groups 1-3) and vaccine naïve (Group 4) will receive single dose of Ad26.COV2.S vaccine at standard dose level on Day 1 (if safety profile of such dose is acceptable per independent data monitoring committee [IDMC] review). Participants from group 4 may receive single booster dose of Ad26.COV2.S vaccine at standard dose level.
Biological: Ad26.COV2.S
Participants will receive IM injection of Ad26.COV2.S.
Other Name: JNJ-78436735, Ad26COVS1

Experimental: Groups 1-4: Ad26.COV2.S (Two Dose)
Participants who are previously vaccinated (Groups 1-3) and vaccine naïve (Group 4) will receive 2 doses of Ad26.COV2.S at a lower dose level on Day 1 and 57 (if safety profile after 1 dose at standard dose level is not acceptable per IDMC review). Participants from group 4 may receive single booster dose of Ad26.COV2.S vaccine at standard dose level.
Biological: Ad26.COV2.S
Participants will receive IM injection of Ad26.COV2.S.
Other Name: JNJ-78436735, Ad26COVS1




Primary Outcome Measures :
  1. Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days After Each vaccination or Until Resolution [ Time Frame: 7 days after each vaccination or until resolution (Up to Day 64) ]
    Solicited local AEs are pre-defined local (at the injection site) AEs for which participants are specifically asked and which are noted by participants in their reactogenicity diary for 7 days post each vaccination or until resolution. Solicited local AEs are: injection site pain/tenderness, erythema, swelling at the vaccination site.

  2. Number of Participants with Solicited Systemic AEs for 7 Days After Each Vaccination or Until Resolution [ Time Frame: 7 days after each vaccination or until resolution (Up to Day 64) ]
    Participants will be instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) or until resolution for solicited systemic AEs. Solicited systemic events include fatigue, headache, nausea and myalgia.

  3. Number of Participants with Unsolicited AEs [ Time Frame: 28 days after each vaccination (Up to Day 85) ]
    Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's reactogenicity diary.

  4. Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 16 months ]
    SAE is any untoward medical occurrence that at any dose results in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.

  5. Number of Participants with Adverse Events of Special Interest (AESIs) [ Time Frame: Up to 16 months ]
    Number of participants with AESIs will be reported. Thrombosis with thrombocytopenia syndrome is considered to be an AESI.

  6. Number of Participants with Medically-attended Adverse Events (MAAEs) [ Time Frame: 6 months after last vaccination (Up to Day 240) ]
    MAAEs are 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 will not be considered medically-attended visits. New onset of chronic diseases will be collected as part of the MAAEs.

  7. Number of Participants with AEs leading to Discontinuation [ Time Frame: Up to 16 months ]
    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

  8. Serological Response to Vaccination as Measured by Enzyme-linked Immunosorbent Assay (ELISA) 28 Days After the First Vaccination [ Time Frame: 28 days after the first vaccination (Day 29) ]
    Serological response to vaccination as measured by enzyme-linked immunosorbent assay (S-ELISA, ELISA Units/milliliter [EU/mL]), 28 days after first vaccination will be reported.

  9. Serological Response to Vaccination as Measured by ELISA 14 Days After the Second Vaccination [ Time Frame: 14 days after the Second vaccination (Day 71) ]
    Serological response to vaccination as measured by enzyme-linked immunosorbent assay (S-ELISA, ELISA Units/milliliter [EU/mL]), 14 days after the second vaccination will be reported.


Secondary Outcome Measures :
  1. Group 4: Number of Adult Participants with Solicited Local AEs for 7 Days After Booster Vaccination or Until Resolution [ Time Frame: Up to 7 days after booster vaccination or until resolution (up to 16 months) ]
    Solicited local AEs are pre-defined local (at the injection site) AEs for which participants are specifically asked and which are noted by participants in their reactogenicity diary for 7 days post each vaccination or until resolution. Solicited local AEs are: injection site pain/tenderness, erythema, swelling at the vaccination site.

  2. Group 4: Number of Adult Participants with Solicited Systemic AEs for 7 Days After Booster Vaccination or Until Resolution [ Time Frame: Up to 7 days after booster vaccination or until resolution (up to 16 months) ]
    Participants will be instructed on how to note signs and symptoms in the diary on a daily basis for 7 days post-vaccination (Day of vaccination and the subsequent 7 days) or until resolution for solicited systemic AEs. Solicited systemic events include fatigue, headache, nausea and myalgia.

  3. Group 4: Number of Adult Participants with Unsolicited AEs For 28 Days After Booster Vaccination [ Time Frame: Up to 28 days after booster vaccination ]
    Unsolicited AEs are all AEs for which the participant is not specifically questioned in the participant's reactogenicity diary.

  4. Group 4: Number of Adult Participants with SAEs Throughout the Study (From First Booster Vaccination Until End of the Study [EOS]) [ Time Frame: Up to 16 months ]
    SAE is any untoward medical occurrence that at any dose results in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important.

  5. Group 4: Number of Adult Participants with AESIs Throughout the Study (From First Booster Vaccination Until EOS) [ Time Frame: Up to 16 months ]
    Number of adult participants with AESIs throughout the study (from first booster vaccination until EOS) will be reported. Thrombosis with thrombocytopenia syndrome is considered to be an AESI.

  6. Group 4: Number of Adult Participants with MAAEs Until 6 Months After the Last Booster Vaccination (If Applicable) [ Time Frame: 6 months after last booster vaccination ]
    MAAEs are 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 will not be considered medically-attended visits. New onset of chronic diseases will be collected as part of the MAAEs.

  7. Number of Adult Participants with AEs leading to Discontinuation (During the Entire Study) [ Time Frame: Up to 16 months ]
    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

  8. Number of Adult Participants with Pregnancy Outcomes [ Time Frame: Up to 6 months ]
    Number of adult participants with pregnancy outcomes (including, live term birth, live preterm birth, stillbirth, and abortion) (non-exhaustive) will be reported.

  9. Number of Adult Participants with Pregnancy Related AEs [ Time Frame: Up to 6 months ]
    Number of adult participants with pregnancy-related AEs including: gestational diabetes, gestational hypertension, premature rupture of membranes, premature labor, premature uterine contractions, poor or restricted fetal growth, pre-eclampsia, eclampsia, vaginal or intrauterine hemorrhage (non-exhaustive) will be reported.

  10. Serological Response to Vaccination as Measured by ELISA and/or Equivalent Assay, at all Blood Collection Timepoints in Adult Participants [ Time Frame: Up to 16 months ]
    Serological response to vaccination as measured by ELISA (S-ELISA, EU/mL) and/or equivalent assay, at all blood collection timepoints in adult participants will be reported.

  11. Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers 28 Days After the First Vaccination and 14 Days After the Second Vaccination in Adult Participants [ Time Frame: 28 days after the First vaccination (Day 29), 14 days after the second vaccination (Day 71) ]
    Serological response to vaccination as measured by VNA titers, 28 days after the first vaccination and 14 days after the second vaccination in adult participants will be reported.

  12. Group 4: Serological Response to Booster Vaccination Measured by Binding (S-ELISA and/or Equivalent Assay) in Adult Participants [ Time Frame: Up to 16 months ]
    Serological response to booster vaccination measured by binding (S-ELISA and/or equivalent assay) in adult participants will be reported.

  13. Group 4: Serological Response to Booster Vaccination Measured by Neutralizing (VNA) Antibody Titers in Adult Participants [ Time Frame: Up to 16 months ]
    Serological response to booster vaccination measured by neutralizing (VNA) antibody titers in adult participants will be reported

  14. Serological Response to Vaccination as Measured by ELISA and/or Equivalent Assay in Infants and Neonates [ Time Frame: From birth up to 2 months, 6 months, 12 months ]
    Serological response to vaccination as measured by ELISA (S-ELISA, EU/mL) and/or equivalent assay will be reported for neonates and infants (born to adult participants who received vaccination) at birth (in cord blood) and up to 2 months, 6 months, and 12 months of age.

  15. Serological Response to Vaccination as Measured by VNA Titers at Birth in Neonates and Infants [ Time Frame: At birth ]
    Serological response to vaccination as measured by VNA titers will be reported for neonates and infants (born to adult participants who received vaccination) at birth (in cord blood).

  16. Number of Neonates and Infants with SAEs [ Time Frame: From birth up to 12 months ]
    Number of neonates and infants (born to adult participants who received vaccination) with SAEs including multisystem inflammatory syndrome in children (MIS-C) from birth up to 12 months of age will be reported.

  17. Number of Neonates and Infants with AESIs [ Time Frame: From birth up to 12 months ]
    Number of neonates and infants with AESIs will be reported. Thrombosis with thrombocytopenia syndrome is considered to be an AESI.

  18. Number of Neonates and Infants with MAAEs [ Time Frame: From birth up to 6 months ]
    Number of neonates and infants (born to adult participants who received vaccination) with MAAEs from birth up to 6 months of age will be reported.

  19. Number of Neonates and Infants with AEs leading to Study Discontinuation [ Time Frame: From birth up to 12 months ]
    Number of neonates and infants (born to adult participants who received vaccination) with AEs leading to discontinuation from birth up to 12 months of age will be reported.

  20. Number of Neonates and Infants with any Complications, Anomalies and Deaths [ Time Frame: From birth up to 12 months ]
    Number of neonates and infants with any complication, anomalies and death will be reported. This will also includes normal neonate, term neonate with complications, preterm neonate with complications, neonatal infection, respiratory distress, congenital anomalies, neonatal death, low birth weight, and small for gestational age measured from birth up to 12 months of age (non exhaustive).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • If on medication for a condition, the medication dose must have been stable for at least 4 weeks preceding vaccination
  • Participant must be healthy as confirmed by medical history, physical examination, vital signs, and obstetric history performed at Screening. Participant may have underlying illnesses, as long as the symptoms and signs are medically controlled
  • Participant will be at second or third trimester of pregnancy, that is, Week 16 to Week 38 of gestation (inclusive), at the time of vaccination, based on ultrasound at the time of screening (or not longer than 10 days prior to vaccination if performed elsewhere)
  • 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
  • Participant must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study
  • Participant either received complete primary vaccination with an authorized/licensed COVID-19 vaccine (completed at least 6 months prior to first study vaccination) or is COVID 19 vaccine-naïve

Exclusion Criteria:

  • Participants with medical or obstetric histories that put them at higher risk for maternal or fetal complications (example, chronic pregnancy-related disorders, birth defects or genetic conditions during previous pregnancy)
  • Participant with abnormal pregnancy screening test (example, ultrasound fetal abnormalities, maternal blood screen)
  • Participant has a history of malignancy within 2 years before screening (exceptions are squamous, basal cell carcinomas of the skin, carcinoma in situ of the cervix, or malignancy, considered cured with minimal risk of recurrence)
  • Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine)
  • Participant has a history of any serious, chronic, or progressive neurological disorders or seizures including Guillain-Barre syndrome, with the exception of febrile seizures during childhood
  • Participant has a positive diagnostic test result (polymerase chain reaction [PCR] based viral ribonucleic acid [RNA] detection) severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection at screening or Day 1 (if more than 4 days in between)
  • Participant has a history of thrombosis with thrombocytopenia syndrome (TTS), including cerebral venous sinus thrombosis (CVST), or heparin-induced thrombocytopenia (HIT)
  • Participant has a history of capillary leak syndrome (CLS)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04765384


Contacts
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Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
Show Show 45 study locations
Sponsors and Collaborators
Janssen Vaccines & Prevention B.V.
Investigators
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Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial Janssen Vaccines & Prevention B.V.
Additional Information:
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Responsible Party: Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier: NCT04765384    
Other Study ID Numbers: CR108962
2020-005330-14 ( EudraCT Number )
VAC31518COV2004 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: January 19, 2022
Last Verified: January 2022
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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases