Healthy male and female subjects Healthy male and female subjects
Conditions
Interventions
GPO Vaccine, approved AZD1222 comparator vaccine
Experimental Other,Active Comparator Other
Sponsors
The Government Pharmaceutical Organization
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: To be eligible to participate in this study, an individual must meet all of the following criteria 1.Willingness to provide a signed and dated informed consent form. 2.Stated willingness to comply with all study procedures and availability for the duration of the study. 3.Be a Thai male or female 18 years of age or older. 4.For females- Be of non-childbearing potential or willing to use appropriate contraceptive measures for 30 days prior to vaccination through two months after completion of the vaccine series. Non-childbearing potential means being surgically sterilized or at least one year post-menopausal. Appropriate measures to prevent pregnancy include abstinence or adequate contraceptive precautions (i.e. intrauterine or implantable contraceptive device, oral contraceptives-diaphragm or condom in combination with contraceptive jelly, cream or foam). 5.For healthy participants with pre-existing medical conditions-Be in stable condition that has not worsened over the three months before enrollment to require hospitalization or significant changes in therapy.
Exclusion criteria
Exclusion criteria: An individual who meets any of the following criteria will be excluded from participation in this study 1. Self-reported history of COVID-19 disease or history of laboratory-confirmed COVID-19 (RT-PCR positive to SARS-CoV-2). 2.Prior receipt of a COVID-19 vaccine. 3. Prior or planned administration of a non-study vaccine within 30 days before the first dose of study vaccine or 30 days after the second vaccination, respectively. 4. History of allergic reactions or anaphylaxis to any previous immunizations. 5. History of allergies to eggs, chicken, or any components of the study vaccine. 6. Fever (More than 38.0 celsius) within the past 24 hours. 7. Administration of immunoglobulins and,or any blood products within the three months preceding the planned administration of the study vaccine. 8. History of bleeding disorder (example factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following intramuscular (IM) injections or venipuncture.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GMT ratio of humural immune response, seroconversion rate of humural immune response meameasured at baseline and 14 days after the second vaccination in a subset of participants.sured at baseline and 14 days after the second vaccination in a subset of participants. Pseudovirus neutralization assay | — |
Secondary
| Measure | Time frame |
|---|---|
| GMT ration of humual immune response ,Anti-S IgG GMT, S protein-specific T cell response 14 days and 3, 6, and 12 months after second vaccination in a subset of participants ELISA, Pseudovirus neutralization assay and ELISpot | — |
Countries
Thailand
Contacts
Public ContactDr. Kriengkrai Prasert
Nakhon Phanom Provincial Hospital
Outcome results
None listed