The goal of this open-label clinical trial is to evaluate the safety and immunogenicity of INAVAC (Vaksin Merah Putih - UNAIR SARS-CoV-2 (Vero Cell Inactivated)) Vaccine as Homologue Booster in Adult Subjects in Indonesia. The main question it aims to answer is: "To evaluate the humoral immunogenicity profile at 28 days following vaccination with INAVAC vaccine as homolog booster administered intramuscularly in healthy adults age 18 years and above". Participants will be administered one dose of vaccination for the third dose (booster vaccination) intramuscularly.
This is an open-label trial. There will be only one group in the study. This group will receive the INAVAC vaccine as a booster. The inclusion and exclusion criteria for the subjects are listed below. All subjects will be followed for 6 months. The vaccine will be administered intramuscularly. This study will have one interim and one full analysis report. A Data Safety Monitoring Board will be commissioned for this study to evaluate safety data over the study period and to review any events that meet a specific study pausing rule or any other safety issue that may arise. They will review the 7 and 28-day safety data following the vaccine, and then the 3 and 6-month safety data. The immunogenicity data will be evaluated for 6 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
400
1 dose of 0.5 ml containing inactivated SARS-CoV-2 virus (5 μg ), Tween 80, histidine, Polysorbate 80, Aluminium hydroxide gel, and sodium chloride
Dr. Soetomo General Hospital
Surabaya, East Java, Indonesia
RECRUITINGHumoral Immune Reponse
1. SARS-CoV-2 Neutralization: SARS-CoV-2 neutralizing titers in serum measured by a virus neutralization assay, at 28 days following vaccination with INAVAC vaccine as homologue booster administered intramuscularly in healthy adults age 18 year and above 2. IgG RBD SARS-CoV-2 antibodies measured by CLIA: analysis of antibodies binding to the SARS-CoV-2 S-protein, at 28 days following vaccination with INAVAC vaccine as homologue booster administered intramuscularly in healthy adults age 18 year and above
Time frame: 28 days following vaccination
Incidence of Adverse Events
1. Solicited - clinical (local and systemic) adverse events for 7 and 28 days, 3 and 6 month following vaccination with INAVAC vaccine as homologue booster administered intramuscularly in healthy adults age 18 year and above 2. Unsolicited adverse events for 7 and 28 days, 3 and 6 months following vaccination with INAVAC vaccine as homologue booster administered intramuscularly in healthy adults age 18 year and above 3. Serious adverse event (SAE) throughout the study
Time frame: 7 days, 28 days, 3 months and 6 months following vaccination
Humoral Immune Reponse
1. SARS-CoV-2 Neutralization: SARS-CoV-2 neutralizing titers in serum measured by a virus neutralization assay, for 3 and 6 months following vaccination with INAVAC vaccine as homolog booster administered intramuscularly in healthy adults age 18 years and above 2. IgG RBD SARS-CoV-2 antibodies measured by CLIA: analysis of antibodies binding to the SARS-CoV-2 S-protein, for 3 and 6 months following vaccination with INAVAC vaccine as homolog booster administered intramuscularly in healthy adults age 18 years and above
Time frame: 3 and 6 months following vaccination
Exploratory Endpoints
Whole genome sequencing (WGS) of S protein of SARS-CoV-2 virus from positive Covid-19 cases during the study
Time frame: Through study completion, an average of 6 months after the study product administration
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