Safety and Immunogenicity of inactivated COVID-19 vaccine in Thai adults

Phase 4

Completed

• Conditions: Safety and Immunogenicity of inactivated COVID-19 vaccine in Thai adults; COVID-19, Vaccine, inactivated, adults

• Registration Number: TCTR20210308003
• Lead Sponsor: ational Reseach Council, Thailand

Brief Summary

The seroconversion rate of total antibodies against RBD after the first CoronaVac dose was 67% with a Geometric mean concentration (GMC) of 1.98 U/ml. Following CoronaVac dose 2, the seroconversion rate increased to 100% with a GMC of 92.9 U/ml. The seroconversion rates of IgG against N protein were 1% after dose 1 and 62.8% after dose 2.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-08
• Study Completion: 2021-06-23
• Results First Posted: 2021-11-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 182

Inclusion Criteria

1. Healthy Thai adults aged between 18-60 years
2. Willing to be immunized with COVID-19 vaccine
3. Intend to be available for follow-up visits and phone call through 12 months postvaccination

Exclusion Criteria

1. Subjects with history of COVID-19, asymptomatic SARS-CoV-2 infection or pre-existing antibodies to SARS-CoV-2
2.Previous severe reaction or allergy to any components in the COVID-19 vaccine
3.History of hospitalization within the past one month before injection.
4.Serious underlying medical condition (e.g., immunosuppressive disease or receiving immunosuppressive therapy, human immunodeficiency virus (HIV) infection)
5.Pregnant women, lactating women or women who are planning to become pregnant

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immunogenicity 3 months Antibodies against SARS-COV-2

Secondary Outcome Measures

Name	Time	Method
Safety 7 days Records of adverse events