NCT05656508

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

Phase 1 Study to Evaluate Safety, Tolerability and Immunogenicity of a New Recombinant Protein-based Vaccine (ARVAC CG) Against Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2), in a Population of Healthy Adult Volunteers Previously Vaccinated Against SARS-CoV-2 Virus.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Laboratorio Pablo Cassara S.R.L. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The objective of this clinical trial is to test a new vaccine against SARS-CoV-2 (ARVAC-CG) in healthy adult volunteers, previously vaccinated against the SARS-CoV-2 virus. The main questions it aims to answer are: * What is the safety and tolerability profile of the two-dose schedule of this new vaccine? * What is the immune response after each dose of vaccine Participants will receive two doses of the study vaccine 28 days apart. They will be required to complete a total of 7 safety and immunogenicity follow-up visits over a 1-year period.

Conditions

• COVID-19 Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	ARVAC-CG vaccine (recombinant protein vaccine against SARS-CoV-2)	2 doses of vaccine with an interval between doses of 28 days. Administration route: Intramuscular (IM) injection

Timeline

• Start date: 2022-04-20
• Primary completion: 2022-09-30
• Completion: 2023-10-29
• First posted: 2022-12-19
• Last updated: 2023-12-22

Locations

1 site across 1 country: Argentina