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Safety and Immunogenicity of Recombinant COVID-19 Variant Vaccine (Sf9 Cell) as a Booster Following Primary Vaccination of Either Inactivated or mRNA or Viral Vector COVID-19 Vaccines
This is a randomized, phase Ⅱ, single-blind, randomized, parallel-group controlled clinical trial. The study plans to enroll subjects who have completed homologous primary vaccination with either inactivated or mRNA or Viral Vector COVID-19 vaccines (one or two doses) and have not been infected with COVID-19. All subjects will be evaluated for safety and immunogenicity after a single dose booster immunization with Recombinant COVID-19 variant Vaccine (Sf9 Cell) or inactivated COVID-19 vaccine (Vero cell) or mRNA vaccine or Viral Vector vaccine.
Details
| Lead sponsor | WestVac Biopharma Co., Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | WITHDRAWN |
| Start date | 2023-07-07 |
| Completion | 2024-12 |
Conditions
- COVID-19
- SARS-CoV-2 Infection
Interventions
- Recombinant COVID-19 variant Vaccine (Sf9 Cell)
- COVID-19 Vaccine (Vero Cell), Inactivated
- mRNA COVID-19 vaccine (Moderna)
- Viral Vector COVID-19 vaccine (AstraZeneca)
Primary outcomes
- Incidence of adverse drug reactions (ADRs) — Day 0-28 post-boost dose
- GMT and SCR of specific neutralizing antibody (virus or pseudovirus) against SARS-CoV-2 — Day 14 post-boost dose
Countries
Mexico