An open-label extension Phase 2 study, to evaluate the safety and immunogenicity of 10 mcg HXP-GPOVac vaccine boost in volunteers from study GPO NDV-HXP-S 202

Phase 2

• Conditions: Healthy male and female subjects

• Registration Number: TCTR20230213001
• Lead Sponsor: The Government Pharmaceutical Organization

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-13
• Study Completion: 2023-03-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: nknown
• Sex: All
• Target Recruitment: 280

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 entire duration of the study.
3. Be a Thai male or female 18-75 years of age from study NDV-HXP-S 202 who were previously vaccinated with two intramuscular doses of HXP-GPOVac or Pfizer-BioNTech with the same vaccine type of each dose and a minimum of 6 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 (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 at least the three months before enrollment to require hospitalization or significant changes in therapy.

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:
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 renowned 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 or found positive ATK at screening.
8. History of bleeding disorder (e.g. 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 underlying disease 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 alcohol dependence 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 considers would increase the risk of having an adverse outcome from participation in the trial.

Note 1) Investigators should use good clinical judgment in considering a participant is overall fitness for inclusion in the trial. Some participants may not be appropriate for the study, even if they meet all the eligibility criteria. In addition, the participants should reside within reasonable proximity to the study site, without plans to leave the area prior to the end of the study; 2) specific exclusion cr

Study & Design

• Study Type: Interventional
• Study Design: Not specified