COVID-19 Pandemic, COVID-19 Vaccines
Conditions
Keywords
Inactivated COVID-1 9 Vaccine, Immunobridging Study, Immunogenicity, Safety, COVID-19, Indonesia
Brief summary
This is an open label trial. There will only be 1 group in the study. All subjects will receive INAVAC vaccine and be followed for 6 months. The vaccine will be administered intramuscularly. This study will be started after the interim analysis of the phase III INAVAC trial in adolescent. This study will have two interim and one full analysis reports.
Detailed description
This is an open label trial. There will only be 1 group in the study. All subjects will receive INAVAC vaccine and be followed for 6 months. The vaccine will be administered intramuscularly. This study will be started after the interim analysis of the phase III INAVAC trial in adolescent. This study will have two interim and one full analysis reports. 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 days safety data following the vaccine, and then the 3 and 6 months safety data. The immunogenicity data will be evaluated until 6 months.
Interventions
Dose : 1 dose 0.5 ml containing 5 μg inactivated SARS-CoV-2 virus, Tween 80, histidine, Polysorbate 80, Aluminium hydroxide gel, and sodium chloride.
Sponsors
Indonesia-MoH
Universitas Airlangga
PT Biotis Pharmaceuticals, Indonesia
Dr. Soetomo General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy males and females, adolescents age 12-17 years old. Healthy status will be determined by the investigator based on medical history, clinical laboratory results, vital sign measurements, and physical examination at screening. 2. Subjects already received 2 (two) doses of Coronavac (Sinovac) vaccines at least 3 months prior to this study. 3. Subjects and the parents or guardian have been informed properly regarding the study and signed the informed consent form 4. Subject and the parents or guardian will commit to comply with the instructions of the investigator and the schedule of the trial 5. Participants agree not to donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the vaccine. 6. Participants and the parents or guardian must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study.
Exclusion criteria
1. Subjects concomitantly enrolled or scheduled to be enrolled in another vaccine trial 2. Evolving mild, moderate, and severe illness, especially infectious diseases or fever (axillary temperature 37.5oC or more) concurrent or within 7 days prior to study vaccination. This includes respiratory or constitutional symptms consistent with SARS-CoV-2 (cough, sore throat, difficulty in breathing, etc) 3. Known history of allergy to any component of the vaccines 4. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection 5. Any autoimmune or immunodeficiency disease/condition 6. Subjects who have received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulin, blood derived products, long term corticosteroid - more than 2 weeks, and so on), OR anticipation of the need for immunosuppressive treatment within 6 months after last vaccination. The use of topical or nasal steroid will be permitted. Inhaled glucocorticoids are prohibited. 7. Unstable chronic disease, inclusive of uncontrolled hypertension, congestive heart failure, chronic obstructive pulmonary disease, asthma, chronic urticaria, diabetes requiring use of medicine. The final decision regarding this condition will be decided by the attending field clinicians or investigator. 8. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives 9. Subjects already immunized with any other vaccines within 4 weeks prior and expect to receive other vaccines within 60 days following the first dose 10. Individuals who have a previously ascertained Covid-19 in the period of 1 month (for mild, moderate, or asymptomatic people) or 3 months (for severe Covid-19) before the first recruit of this study, or in a close contact in the last 14 days with confirmed case of Covid-19. 11. Positive test for SARS-CoV-2 (Antigen or PCR) at screening prior to the vaccination. Testing may be repeated during the screening period if exposure to positive confirmed case of SARS-CoV-2 is suspected, at the discretion of investigator. 12. History of alcohol or substance abuse 13. HIV patients. 14. Malignancy patients within 3 years prior to study vaccination. 15. Any neurological disease or history of significant neurological disorder such as meningitis, encephalitis, Guillain-Barre Syndrome, multiple sclerosis, etc 16. Vital sign abnormalities and clinical laboratory abnormalities as decided by the investigators. Vital sign measurements and clinical laboratory testing may be repeated before the final decision. 17. Women who are pregnant or who plan to become pregnant during the study. 18. Participant has major psychiatric problem or illness 19. Participant cannot communicate reliably with the investigator 20. Participant has contraindication to intramuscular injection and blood draws, such as bleeding disorders or phobia. 21. Participant had major surgery within 12 weeks before vaccination which will not be fully recovered, or has major surgery planned during the time participant is expected to participate in the study or within 6 months after the vaccination. 22. Any condition that in the opinion of the investigators would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine or interpretation of the study results 23. Study team members. 24. Subject planning to move from the study area before the end of study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Humoral Immune Response (Neutralizing antibody) | 28 days after the booster vaccination | 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 heterologue booster in healthy adolescents age 12-17 years old. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events | 7 and 28 days, 3 and 6 months following vaccination with INAVAC vaccine as heterologue booster. | 1. Solicited - clinical (local and systemic) adverse events for 7 and 28 days, 3 and 6 months following vaccination with INAVAC vaccine as heterologue booster administered intramuscularly in healthy adolescents age 12-17 years old. 2. Unsolicited adverse events for 7 and 28 days, 3 and 6 months following vaccination with INAVAC vaccine as heterologue booster administered intramuscularly in healthy adolescents age 12-17 years old. 3. Serious adverse events (SAE) throughout the study. |
| Humoral Immune Response - The neutralizing antibody | 3 and 6 months following vaccination with INAVAC vaccine as heterologue booster | 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 heterologue booster administered intramuscularly in healthy Adolescent subjects. |
| Humoral Immune Response-IgG SARS-CoV-2 neutralizing titer by CLIA | 28 days, 3 and 6 months following vaccination with INAVAC vaccine as heterologue booster | IgG RBD SARS-CoV-2 (CLIA): analysis of IgG RBD SARS-CoV-2 antibodies for 3 and 6 months following vaccination with INAVAC vaccine as heterologue booster administered intramuscularly in healthy Adolescent subjects. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Exploratory Endpoints-Whole Genome Sequencing | Through study completion, an average of 6 months after the study product administration | Whole genome sequencing (WGS) of S protein of SARS-CoV-2 virus from positive Covid-19 cases |
Countries
Indonesia
Outcome results
None listed