A Phase 2b, Randomized, Double-blind, Active-controlled Study of Single Dose CVXGA Intranasal COVID-19 Vaccine in Adults
brief summary
The purpose of this trial is to assess the safety and relative efficacy of CVXGA (CVXGA50), a KP.2 containing vaccine, compared to COMIRNATY® (COVID-19 Vaccine, mRNA; 2024-2025 Formula), a currently approved COVID-19 vaccine in the prevention of symptomatic, RT-PCR-confirmed SARS-CoV-2 infection. The trial will enroll up to 434 healthy participants.
detailed description
This is a double-blind, active comparator-controlled Phase 2b study to evaluate the efficacy, immunogenicity, and safety study in which eligible adult participants will be randomized 1:1 to receive CVXGA (CVXGA50) or COMIRNATY.
Number of Participants:
The proposed enrollment for this study is approximately 434 participants, that includes 16 participants enrolled in Sentinel Cohort 1 and Sentinel Cohort 2 (8 participants in each cohort).
Treatment Assignment:
Participants in Sentinel Cohort 1 and Sentinel Cohort 2 will be assigned to receive a single dose of CVXGA (CVXGA50) intranasally and will not receive an IM placebo.
All other participants in the study will be randomized 1:1 to receive a single dose of CVXGA (CVXGA50) intranasally (plus a single dose of IM placebo), or a single dose of IM COMIRNATY (plus a single dose of intranasal placebo).
Study visits: Participants will be asked to complete approximately 6-7 clinic visits, over a period of approximately 12 months duration per participant.
official title
A Phase 2b, Randomized, Double-blind, Active-controlled Study of Single Dose CVXGA (CVXGA50) Intranasal COVID-19 Vaccine in Adults