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.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- Osman ERGANIS, PhD, Prof
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Acute adverse events (AEs)
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
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.
Investigators
Osman ERGANIS, PhD, Prof
PhD, Prof
The Scientific and Technological Research Council of Turkey
Eligibility Criteria
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,
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,
Outcomes
Primary Outcomes
Acute adverse events (AEs)
Time Frame: 24 hours
Frequency of acute adverse events 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
Solicited local and systemic adverse events (AEs)
Time Frame: 15 days
Frequency of local and systemic AEs in all dosage groups
Secondary Outcomes
- Neutralizing antibody response(Before first dose administration, on Day 21-28-35 and Month 3 and Month 6 after first dose administration.)
- Cellular immune response(Before first dose administration, on Day 21-28-35 and Month 3 and Month 6 after first dose administration.)