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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

2,014

Participants

Timeline

Start Date

February 6, 2023

Primary Completion Date

August 22, 2023

Study Completion Date

December 7, 2023

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

Trial Locations (11)

1202

Fundación Huesped, Buenos Aires

1425

Centro de Investigaciones Clínicas Belgrano (CICB), Buenos Aires

FP Clinical Pharma, Buenos Aires

Centro Médico Dra. Laura Maffei - Investigación Clínica Aplicada, Ciudad de Buenos Aires

1428

Vacunar S.A., Buenos Aires

1431

"Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno - CEMIC", Argentina

1900

Instituto Medico Platense, Buenos Aires

4400

ICSAL Salta, Salta

5000

Clinica Privada del Sol, Córdoba

7600

Instituto de Investigaciones Clínicas de Mar del Plata, Buenos Aires

7606

Centro Clínica del Niño y la Familia, Buenos Aires

All Listed Sponsors
collaborator

Universidad Nacional de San Martín (UNSAM)

UNKNOWN

collaborator

National Council of Scientific and Technical Research, Argentina

OTHER_GOV

collaborator

Laboratorio Pablo Cassará S.R.L.

INDUSTRY

lead

Centro de Educación Medica e Investigaciones Clínicas Norberto Quirno

OTHER