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

NCT05656508 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-12-22

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Universidad Nacional de San Martín (UNSAM)

    collaborator UNKNOWN

  • National Council of Scientific and Technical Research, Argentina

    collaborator OTHER_GOV

  • Laboratorio Pablo Cassara S.R.L.

    lead INDUSTRY

Principal Investigators

  • Gustavo A YERINO, MD. · Unidad de Investigación Clínica Farmacocinética FP Clinical Pharma en Clínica CIAREC

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-04-20
Primary Completion
2022-09-30
Completion
2023-10-29

Countries

  • Argentina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05656508 on ClinicalTrials.gov