Immunogenicity of the third COVID-19 vaccine booster dose in adults with completed 2 doses as recommended by the ministry of public health

Phase 4

Completed

• Conditions: Healthy Thai individuals aged 18 years and above; immunogenicity, COVID-19. vaccine, booster

• Registration Number: TCTR20211120002
• Lead Sponsor: ational Research Council of Thailand (NRCT)

Brief Summary

After booster, a significant increase in binding antibodies and neutralizing activities toward delta and omicron variants was observed. Neutralization to omicron BA.1 and BA.2 were comparable, showing the highest titers after boosted mRNA-1273 followed by BNT162b2 and AZD1222. In addition, individuals boosted with messenger RNA (mRNA) vaccines develop a T-cell response to spike protein, whereas those boosted with AZD1222 did not. Reactogenicity was mild to moderate without serious adverse events.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-20
• Study Completion: 2022-04-22
• Results First Posted: 2022-08-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Healthy Thai individuals above 18 years of age
2. Not previously infected with COVID-19
3. Provide informed consent

Exclusion Criteria

1. Previously infected with COVID-19
2. Immunocompromised individuals

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
immunogenicity day 14 and 28 post booster anti- receptor-binding domain of SARS-CoV-2

Secondary Outcome Measures

Name	Time	Method
neutralizing activities against variants day 14 and 28 post booster sVNT,T cell response dat 14 and day 28 post boost Quantiferon SARS-CoV-2