NCT05752201

ARVAC-A New Recombinant Coronavirus Disease 2019 (COVID-19) Vaccine

Phase 2/3 Study to Evaluate Safety, Tolerability and Immunogenicity of a Recombinant Protein-based Vaccine Against SARS-CoV-2, in a Population of Adult Volunteers Previously Vaccinated Against SARS-CoV-2 Virus.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 2,014 (actual)
• Sponsor: Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

Summary

The goals of this clinical trial are: 1. Phase 2: to test a gamma adapted recombinant vaccine against SARS-CoV-2 in healthy adult volunteers, previously vaccinated against the SARS-CoV-2 virus. 2. Phase 3 (first volunteer enrollement on March 25, 2023): to test a recombinant vaccine against SARS-CoV-2 comparing three different versions (Gamma Variant RBD-based ARVAC-CG vaccine, Omicron Variant RBD-based ARVAC-CG vaccine, Bivariant Gamma/Omicron RBD-based ARVAC-CG vaccine), in adult volunteers previously vaccinated against the SARS-CoV-2 virus The main questions to be answered are: 1. Phase 2: 1. What si the immune response after one dose of vaccine? 2. What is the safety and tolerability profile of this vaccine? 2. Phase 3 : 1. What is the immune response triggered by each vaccine formulation against Wuhan, gamma, and omicron variants. 2. What is the safety and tolerability profile of this vaccine? In phase 2, participants will receive one dose of the study vaccine and one dose of placebo 28 days apart, in a cross-over design. In phase 3 (not yet recruitment), participants will be randomized to receive one of the three possible types of vaccines and all of them will receive one dose of the corresponding vaccine and 1 dose of placebo 28 days apart, in a cross over design.

Conditions

• COVID-19 Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	Gamma Variant RBD-based ARVAC-CG vaccine	Vaccine containing 50 µg of antigen + Alum. Schedule: One booster dose of vaccine Administration route: intramuscular (IM) injection
BIOLOGICAL	Omicron Variant RBD-based ARVAC-CG vaccine	Vaccine containing 50 µg of antigen + Alum. Schedule: One booster dose of vaccine Administration route: intramuscular (IM) injection
BIOLOGICAL	Bivalent RBD-based ARVAC-CG vaccine	Vaccine containing 25 µg of gamma antigen + 25 µg of omicron antigen + Alum Schedule: One booster dose of vaccine Administration route: intramuscular (IM) injection
OTHER	Placebo (Alum)	Schedule: One dose of placebo in a crossover design Administration route: intramuscular (IM) injection

Timeline

• Start date: 2023-02-06
• Primary completion: 2023-08-22
• Completion: 2023-12-07
• First posted: 2023-03-02
• Last updated: 2023-12-22

Locations

11 sites across 1 country: Argentina