NCT06742281

A Phase 2b, Randomized, Double-blind, Active-controlled Study of Single Dose CVXGA Intranasal COVID-19 Vaccine in Adults

A Phase 2b, Randomized, Double-blind, Active-controlled Study of Single Dose CVXGA (CVXGA50) Intranasal COVID-19 Vaccine in Adults

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 432 (actual)
• Sponsor: CyanVac LLC · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	CVXGA (CVXGA50)	CVXGA is a recombinant parainfluenza virus type 5 (PIV5) engineered to express SARS-CoV-2 S gene from the KP.2 strain.
BIOLOGICAL	COMIRNATY®	COMIRNATY® (COVID-19 vaccine, mRNA) suspension for injection, for intramuscular use, 2024-2025 Formula (BioNTech Manufacturing GmbH \[Mainz, Germany\] and Pfizer Inc. \[New York, NY\]) will be used as the comparator vaccine for this study.

Timeline

• Start date: 2024-12-05
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2024-12-19
• Last updated: 2025-11-05

Locations

55 sites across 1 country: United States

Regulatory

• FDA-regulated drug study