- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04866069
Study of a Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Adjuvanted Inactivated Vaccine in Healthy Adults (COVID-19)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Ankara, Turkey, 06800
- Ankara City Hospital Phase I Drug Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
To be eligible for the study, each participant must satisfy all the following criteria:
- Healthy participants between 18-45 years of age,
- Sign an informed consent document,
- Negative immunoglobulin G (IgG) and immunoglobulin M (IgM) antibody for COVID-19,
- Negative quantitative polymerase chain reaction (qPCR) SARS-CoV-2 results of nasopharyngeal/sputum samples,
- Able to comply with the study protocol during the study period,
- Negative tests for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV),
- Body temperature <37.2 C and no signs of active infection,
- Body mass index 18-35 kg/m2,
- 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,
- Good general health (no known disease in the history and physical examination within 14 days prior to the enrolment),
- 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:
- History of seizure, encephalopathy, or psychosis,
- History of allergic reactions to any known vaccine or to any component of the study vaccine,
- Pregnant, breastfeeding, or positive pregnancy test or planning to conceive within 6 months,
- History of SARS-CoV-2 infection,
- Severe cardiovascular disorders (arrhythmia, conduction disorders, history of myocardial infarction, uncontrolled hypertension),
- Severe chronic disorders (asthma, diabetes mellitus, thyroid disorders…etc),
- Congenital or acquired angioedema,
- Diagnosis of immunodeficiency,
- Diagnosis of bleeding diathesis,
- Use of immunosuppressive treatment, anti-allergic treatment, cytotoxic treatment, inhaler corticosteroids (allergic rhinitis or topical steroid ointments are excluded),
- Those who received blood and blood product transfusions in the last 6 months,
- Those on any vaccine program or experimental medication within 1 month prior to the study,
- History of any vaccination against SARS-CoV-2 within 1 month prior to the study,
- Use of active tuberculosis treatment,
- History of addictive drug use,
- 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),
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
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Adjuvanted inactivated vaccine
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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
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Adjuvanted inactivated vaccine
|
Placebo Comparator: Placebo Group
10 participants will receive 1 ml of 0.9% sodium chloride (NaCl)
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0.9% NaCl
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Unsolicited local and systemic adverse events (AEs)
Time Frame: 28 days
|
Frequency of local and systemic AEs in all dosage groups
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28 days
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Acute adverse events (AEs)
Time Frame: 24 hours
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Frequency of acute adverse events in all dosage groups
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24 hours
|
Solicited local and systemic adverse events (AEs)
Time Frame: 15 days
|
Frequency of local and systemic AEs in all dosage groups
|
15 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Before first dose administration, on Day 21-28-35 and Month 3 and Month 6 after first dose administration.
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Cellular immune response
Time Frame: Before first dose administration, on Day 21-28-35 and Month 3 and Month 6 after first dose administration.
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Interferon-γ (IFN-γ) positive cell level (by ELISPOT)
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Before first dose administration, on Day 21-28-35 and Month 3 and Month 6 after first dose administration.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ISV2AOH3ODN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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