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

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

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

Sponsors & Collaborators

• Universidad Nacional de San Martín (UNSAM)

  collaborator UNKNOWN

• National Council of Scientific and Technical Research, Argentina

  collaborator OTHER_GOV

• Laboratorio Pablo Cassará S.R.L.

  collaborator INDUSTRY

• Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

  lead OTHER

Principal Investigators

• Pablo Bonvehí, MD · Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

• Gustavo Yerino, MD · FP Clinical Pharma

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

99 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-02-06

Primary Completion

2023-08-22

Completion

2023-12-07

Countries

• Argentina

Study Locations