Phase 3 study, to evaluate the safety and immunogenicity of 10 mcg HXP-GPOVac COVID-19 vaccine boost in comparison to a viral vector-based COVID-19 vaccines
- Conditions
- Healthy male and female subjects
- Registration Number
- TCTR20221026004
- Lead Sponsor
- The Government Pharmaceutical Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Enrolling by invitation
- Sex
- All
- Target Recruitment
- 4000
1. Willingness to provide a signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for entire duration of the study.
3. Be a Thai male or female 18 years of age or older who were previously vaccinated with two intramuscular doses of Pfizer-BioNTech or AstraZeneca or Sinovac vaccine with a minimum of 4 months from their second dose vaccination.
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 complete vaccination. 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 (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.
1. Prior or planned administration of a non-study vaccine (licensed or investigational) within 30 days before and after vaccination.
2. History of allergic reactions or anaphylaxis to any previous immunizations.
3. History of allergies to eggs, chicken, or any components of the study vaccine.
4. Fever (greater than or equal to 38.0 Celsius) within the past 24 hours.
5. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the study vaccine.
6. Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban).
7. History of COVID-19 infection within the three months preceding the planned administration of the study vaccine.
8. History of bleeding disorder (exempli gratia: factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following intramuscular (IM) injections or venipuncture.
9. History of cerebral venous sinus thrombosis, antiphospholipid syndrome or heparin induced thrombocytopenia and thrombosis (HITT or HIT type 2).
10. Any other significant disease, disorder or finding which in the opinion of the investigator may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study or impair interpretation of the study data.
11. Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well controlled comorbidities are allowed).
12. Being pregnant (i.e. a positive urine pregnancy test) or lactating during the immunization phase of the study.
13. Planning to become pregnant or planning to discontinue contraceptive precautions during the vaccination phase through two months after vaccination.
14. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination (for corticosteroids, this means prednisone or equivalent, greater than or equal to 0.5 mg/kg/day; inhaled and topical steroids are allowed).
15 Compromised immune system diseases including cancer (except basal cell carcinoma), congenital or acquired immune deficiencies and uncontrolled autoimmune diseases, as per case history and/or physical examination.
16. Indications of drug abuse or excessive use of alcohol as deemed by the investigator to confound safety assessments or render the participant unable or unlikely to adhere to protocol requirements or provide accurate safety reports.
17. History of asplenia.
18. Unavailable for the entire trial period.
19. Any other findings the investigator feels would increase the risk of having an adverse outcome from participation in the trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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