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A Phase 1/2 Safety and Immunogenicity Trial of COVID-19 Vaccine COVIVAC (Phase 1)

NCT04830800 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-02-13

Study results available
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Summary

This prospective, single-center, randomized, placebo-controlled, observer-blind Phase 1/2 study includes two separate parts.

Part 1 is a first-in-human, Phase 1 study designed to evaluate the safety, tolerability and immunogenicity of the COVIVAC vaccine at three different dose levels (1, 3, and 10 µg) without adjuvant, and at one dose level (1 µg) with the adjuvant CpG 1018, in a total of 120 subjects aged 18-59 years. (Part 2 will be registered in a separate record)

Conditions

  • COVID-19 Disease
  • SARS Pneumonia
  • Pneumonia, Viral
  • COVID-19 Vaccine

Interventions

BIOLOGICAL

COVIVAC

COVIVAC vaccine, manufactured by IVAC with or without adjuvant CpG1018 for prevention of COVID-19

BIOLOGICAL

Phosphate-buffered saline

Phosphate buffer solution (pH 7.2), manufactured by IVAC

Sponsors & Collaborators

  • National Institute of Hygiene and Epidemiology, Vietnam

    collaborator OTHER

  • Hanoi Medical University

    collaborator OTHER

  • Institute of Vaccines and Medical Biologicals, Vietnam

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-03-10
Primary Completion
2021-06-06
Completion
2021-10-31

Countries

  • Vietnam

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 NCT04830800 on ClinicalTrials.gov