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A Study to Evaluate Safety, Tolerability, and Reactogenicity of an RBD-Fc-based Vaccine to Prevent COVID-19

NCT04953078 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-01-12

No results posted yet for this study

Summary

This study is a phase 1, open-label, randomized, first-in-human clinical trial to evaluate the safety, tolerability and reactogenicity of escalating doses of Baiya SARS-CoV-2 VAX1 vaccine in participants aged 18-60 for adult groups and 61-75 for elderly groups. Each group will consist of three cohorts to evaluate different doses (low, medium, high) of Baiya SARS-CoV-2 VAX vaccine. Participants will be injected with two doses of the investigational product with a 21-day interval.

Conditions

  • Coronavirus

Interventions

BIOLOGICAL

Baiya SARS-CoV-2 Vax 1

Intramuscular injection in the deltoid region of 0.5 mL/dose of Baiya SARS-CoV-2 Vax 1 (recombinant SARS-CoV-2 receptor-binding domain fused with FC region of human IgG1 vaccine)

Sponsors & Collaborators

  • National Vaccine Institute, Thailand

    collaborator OTHER

  • Baiya Phytopharm Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2021-09-11
Primary Completion
2021-12-02
Completion
2022-11-04

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 NCT04953078 on ClinicalTrials.gov