Study of a Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Adjuvanted Inactivated Vaccine in Healthy Adults (COVID-19)

• ClinicalTrials.gov Identifier: NCT04866069
• Recruitment Status: Terminated
• First Posted: April 29, 2021
• Last Update Posted: April 18, 2023
• Sponsor: Osman ERGANIS, PhD, Prof
• Collaborators: The Scientific and Technological Research Council of Turkey; VETAL Inc.; MonitorCRO
• Information provided by (Responsible Party): Osman ERGANIS, PhD, Prof, The Scientific and Technological Research Council of Turkey

Tracking Information

• First Submitted Date: April 26, 2021
• First Posted Date: April 29, 2021
• Last Update Posted Date: April 18, 2023
• Actual Study Start Date: April 25, 2021
• Actual Primary Completion Date: September 5, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 26, 2021)

• Acute adverse events (AEs) [ Time Frame: 24 hours ]
  Frequency of acute adverse events in all dosage groups
• Solicited local and systemic adverse events (AEs) [ Time Frame: 15 days ]
  Frequency of local and systemic AEs in all dosage groups
• Unsolicited local and systemic adverse events (AEs) [ Time Frame: 28 days ]
  Frequency of local and systemic AEs in all dosage groups

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 26, 2021)

• Neutralizing antibody response [ Time Frame: Before first dose administration, on Day 21-28-35 and Month 3 and Month 6 after first dose administration. ]
  Immunogenicity response by measuring neutralizing antibody titer (anti-spike and anti-RBD) developed against SARS-CoV-2 (by ELISA)
• Cellular immune response [ Time Frame: Before first dose administration, on Day 21-28-35 and Month 3 and Month 6 after first dose administration. ]
  Interferon-γ (IFN-γ) positive cell level (by ELISPOT)

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of a Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Adjuvanted Inactivated Vaccine in Healthy Adults
• Official Title: Phase I Study Evaluating the Safety and Efficacy of the Protective Adjuvanted Inactivated Vaccine Developed Against SARS-CoV-2 in Healthy Participants, Administered as Two Injections Subcutaneously in Two Different Dosages.
• Brief Summary: This phase I study is designed as double-blinded, randomised, placebo controlled, three-armed study composed of two different dose arms of protective adjuvanted inactivated vaccine against SARS-CoV-2 in dose escalations (first low dose group, followed by high dose group) and placebo arm.

Detailed Description

This phase I study is designed as double-blinded, randomised, placebo controlled, three-armed study composed of two different dose arms of protective adjuvanted inactivated vaccine against SARS-CoV-2 in dose escalations (first low dose group, followed by high dose group) and placebo arm. Each dose of vaccine will be defined as a cohort in itself, with vaccine administration to 20 participants and placebo administration to 5 participants. After completion of low-dose group, decision of switch to high-dose will be taken by the Independent Data Monitoring Committee and will continue accordingly.

In the study, 50 healthy participants of 18-45 years of age will be recruited.

All injections will be done subcutaneously.

Injections will be administered at 1 and 21 days.

The participants will be followed for 6 months and the study will be completed in 12 months.

• Study Type: Interventional
• Study Phase: Phase 1

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:

Double-blinded

Primary Purpose: Prevention

• Condition: Covid19

Intervention

• Biological: SARS-CoV-2 vaccine
  Adjuvanted inactivated vaccine
• Biological: Placebo
  0.9% NaCl

Study Arms

• Experimental: Low-Dose Group (Group A)
  20 participants will receive 10 µg-3M inactivated virus + 1 mg Al(OH)3 + 300 µg CpGODN adjuvanted vaccine
  Intervention: Biological: SARS-CoV-2 vaccine
• Experimental: High-Dose Group (Group B)
  20 participants will receive 20 µg-6M inactivated virus + 1 mg Al(OH)3 + 300 µg CpGODN adjuvanted vaccine
  Intervention: Biological: SARS-CoV-2 vaccine
• Placebo Comparator: Placebo Group
  10 participants will receive 1 ml of 0.9% sodium chloride (NaCl)
  Intervention: Biological: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: April 26, 2021): 50
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: September 5, 2021
• Actual Primary Completion Date: September 5, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

To be eligible for the study, each participant must satisfy all the following criteria:

1. Healthy participants between 18-45 years of age,
2. Sign an informed consent document,
3. Negative immunoglobulin G (IgG) and immunoglobulin M (IgM) antibody for COVID-19,
4. Negative quantitative polymerase chain reaction (qPCR) SARS-CoV-2 results of nasopharyngeal/sputum samples,
5. Able to comply with the study protocol during the study period,
6. Negative tests for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV),
7. Body temperature <37.2 C and no signs of active infection,
8. Body mass index 18-35 kg/m2,
9. Normal laboratory levels of whole blood count, alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin, urea, creatinine, and fasting blood glucose, or abnormal finding detected in any laboratory parameter which is not greater than Grade 1 according to the investigator's evaluation,
10. Good general health (no known disease in the history and physical examination within 14 days prior to the enrolment),
11. Female and male participants who will be able to have appropriate contraception methods within 30 days prior to vaccine injection and within 6 months after vaccination,

Exclusion Criteria:

Participants with any of the following criteria will be excluded:

1. History of seizure, encephalopathy, or psychosis,
2. History of allergic reactions to any known vaccine or to any component of the study vaccine,
3. Pregnant, breastfeeding, or positive pregnancy test or planning to conceive within 6 months,
4. History of SARS-CoV-2 infection,
5. Severe cardiovascular disorders (arrhythmia, conduction disorders, history of myocardial infarction, uncontrolled hypertension),
6. Severe chronic disorders (asthma, diabetes mellitus, thyroid disorders…etc),
7. Congenital or acquired angioedema,
8. Diagnosis of immunodeficiency,
9. Diagnosis of bleeding diathesis,
10. Use of immunosuppressive treatment, anti-allergic treatment, cytotoxic treatment, inhaler corticosteroids (allergic rhinitis or topical steroid ointments are excluded),
11. Those who received blood and blood product transfusions in the last 6 months,
12. Those on any vaccine program or experimental medication within 1 month prior to the study,
13. History of any vaccination against SARS-CoV-2 within 1 month prior to the study,
14. Use of active tuberculosis treatment,
15. History of addictive drug use,
16. History of alcohol abuse and/or history of alcohol intake more than 2 units per day or 10 units per week and/or positive breath alcohol test (one unit of alcohol equals to 250 mL beer, 125 mL wine or 25 mL whiskey),
17. According to the investigator's evaluation, those who have any condition (medical, psychological, social, etc.) that may impair the patient's compliance with the study will be excluded from the study.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT04866069
• Other Study ID Numbers: ISV2AOH3ODN
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Osman ERGANIS, PhD, Prof, The Scientific and Technological Research Council of Turkey
• Original Responsible Party: Same as current
• Current Study Sponsor: Osman ERGANIS, PhD, Prof
• Original Study Sponsor: Same as current

Collaborators

• The Scientific and Technological Research Council of Turkey
• VETAL Inc.
• MonitorCRO

Investigators

• Study Director: Oguz Akbas, MD; MonitorCRO

• PRS Account: The Scientific and Technological Research Council of Turkey
• Verification Date: April 2023