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

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ClinicalTrials.gov Identifier: NCT04866069
Recruitment Status : Recruiting
First Posted : April 29, 2021
Last Update Posted : May 6, 2021
Sponsor:
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  ICMJE April 26, 2021
First Posted Date  ICMJE April 29, 2021
Last Update Posted Date May 6, 2021
Actual Study Start Date  ICMJE April 25, 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of a Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Adjuvanted Inactivated Vaccine in Healthy Adults
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Double-blinded
Primary Purpose: Prevention
Condition  ICMJE Covid19
Intervention  ICMJE
  • Biological: SARS-CoV-2 vaccine
    Adjuvanted inactivated vaccine
  • Biological: Placebo
    0.9% NaCl
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 26, 2021)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Osman ERGANIS, PhD, Prof +905324333478 erganis@selcuk.edu.tr
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04866069
Other Study ID Numbers  ICMJE 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  ICMJE
Plan to Share IPD: No
Responsible Party Osman ERGANIS, PhD, Prof, The Scientific and Technological Research Council of Turkey
Study Sponsor  ICMJE Osman ERGANIS, PhD, Prof
Collaborators  ICMJE
  • The Scientific and Technological Research Council of Turkey
  • VETAL Inc.
  • MonitorCRO
Investigators  ICMJE Not Provided
PRS Account The Scientific and Technological Research Council of Turkey
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP