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ChulaCov19 Vaccine in Healthy Adults

NCT04566276 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2023-02-09

No results posted yet for this study

Summary

This study will be conducted in 2 phases. Phase 1 of this study will be a single-centre, open label, dose escalation first in human (FIH) study conducted in 2 groups of healthy participants. Group 1 will enrol adults aged 18-55 years (inclusive); Group 2 will enroll elderly adults (elderly) aged 56-75 years (inclusive).

Phase 2 of this study will be a single centre, the proposed design will be observer-blind, placebo-controlled study to assess the safety, reactogenicity, and immunogenicity of ChulaCov19 vaccine in healthy adults (18-75 years of age inclusive).

Conditions

  • COVID-19 Vaccine
  • Safety Issues

Interventions

BIOLOGICAL

ChulaCov19 vaccine

SARS-Cov2 Wild-type S-spike mRNA/ lipid nanoparticle (LNP) vaccine

OTHER

Placebo

Saline

Sponsors & Collaborators

  • Chula Vaccine Research Center (ChulaVRC), Bangkok, Thailand

    collaborator UNKNOWN

  • Center of Excellence in Vaccine Research and Development, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand

    collaborator UNKNOWN

  • Chula Clinical Research Center (Chula CRC), King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand

    collaborator UNKNOWN

  • King Chulalongkorn Memorial Hospital (KCMH), Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand

    collaborator UNKNOWN

  • Mahidol University

    collaborator OTHER

  • National Vaccine Institute, Thailand

    collaborator OTHER

  • Chulalongkorn University

    lead OTHER

Principal Investigators

  • Kiat Ruxrungtham, MD · Center of Excellence in Vaccine Research and Development, Faculty of Medicine, Chulalongkorn University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2021-05-03
Primary Completion
2022-10-01
Completion
2022-12-06

Countries

  • Thailand

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 NCT04566276 on ClinicalTrials.gov