Phase II Study to Assess the Safety, Efficacy, and Immunogenicity of Authentic SARS-CoV-2 or Alpha Variant Spike Containing VLP Vaccines and Their Combination for the Prevention of COVID-19 in Healthy Adult Volunteers (SAVE STUDY)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- Ihsan GURSEL, PhD, Prof.
- Enrollment
- 349
- Locations
- 3
- Primary Endpoint
- Specific antibody (IgG) response
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a randomized, parallel dose assigned, double blind, multi center, Phase II study assessing the efficacy, safety, and immunogenicity of VLP vaccine (Authentic and Alpha variants) in adults between 18 and 59 years who are healthy or have medically stable chronic diseases and who have no known history of SARS-CoV-2 infection
Detailed Description
The primary objective of the study is to evaluate the humoral and cellular immune response of VLP vaccine candidates (harboring M, N, E, and HexaPro S antigens of the virus), as an efficacy criteria. Approximately 330 subjects will be randomized in a 1:1:1 ratio to receive two doses of 40 mcg VLP vaccine for Wuhan (n=110) or 40 mcg VLP vaccine for Alpha (British) variant (n=110) or 40 mcg VLP vaccine for Wuhan+Alpha variant (n=110) 21 days apart. The study will be completed in 14 months. All injections will be done subcutaneously.
Investigators
Ihsan GURSEL, PhD, Prof.
Co- Principal Investigator
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:
- •Female and/or male participant who is informed and about his/her participation and who agrees to give his/her written informed consent.
- •Aged between 18 and 59 years.
- •Negative Immunoglobulin G (IgG)/Immunoglobulin M (IgM) antibody for COVID-
- •Negative COVID-19 quantitative polymerase chain reaction (qPCR) test result.
- •Able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.
- •Negative blood test for hepatitis B (HBV), hepatitis C (HCV) and human immunodeficiency virus (HIV) at screening period.
- •Body temperature \< 37.2°C.
- •Body Mass Index (BMI) ranged between 18-35 kg/m
- •Clinical laboratory test results within the reference range of the laboratory or clinically non-significant (complete blood count (CBC), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, urea, creatinine, and fasting glucose) or any laboratory parameters defined in the study protocol.
Exclusion Criteria
- •Participants with any of the following criteria will be excluded:
- •History of laboratory-confirmed SARS-COV-2 infection.
- •History of seizures, encephalopathy, or psychosis.
- •Known or suspected allergy or history of anaphylaxis or other serious adverse reactions to any vaccine or study vaccine and/or any other excipients of the vaccine.
- •Pregnant, breastfeeding or planning to become pregnant within 6 months after the study vaccine administration.
- •Suspected active infection or other acute illness, including fever \> 37.2°C.
- •Any presence of clinical relevance of cardiovascular disease (including but not limited to arrythmia, myocardial infarction, uncontrolled hypertension, coronary artery disease, or congestive heart failure).
- •Any presence of clinical relevance of serious chronic disease \[asthma, diabetes, thyroid diseases etc.).
- •Any presence of clinical relevance of congenital or acquired angioedema.
- •Diagnosis of immunodeficiency.
Outcomes
Primary Outcomes
Specific antibody (IgG) response
Time Frame: On Day 28 after booster dose administration
SARS-CoV-2 Spike/S1 or RBD antibody titers
Comparison of efficacy
Time Frame: On Day 28 after booster dose administration
Comparison of antibody responses of participants to a cohort of standard convalescent serum samples obtained from World Health Organization (WHO).
Neutralizing antibody response
Time Frame: On Day 28 after booster dose administration
Neutralizing antibody titer against anti-Spike protein by virus neutralization method developed against SARS-CoV-2
Cellular immune response
Time Frame: Before first dose administration, on Day 14 after booster dose administration
ELISPOT: Interferon-γ (IFN-γ) positive level of T-cells
Secondary Outcomes
- Adverse events (AEs)(Until Month 12 after booster dose administration)
- Specific antibody (IgG) response(Before first and booster dose administration, at Month 3, Month 6, Month 9 and Month 12 after booster dose)
- Serious adverse events (SAEs)(Until Month 12 after booster dose administration)