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NCT05213455 Clinical Trial

Booster Effect of mRNA Vaccine on Antibody Response for SARS-CoV-2 After Complete Vaccination With Sinos

Vaccine Reaction Clinical Trial

Official title:
Booster Effect of mRNA Vaccine After Complete Vaccination With Sinos: an Observational Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05213455
Other study ID # LGH010
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date March 15, 2022

Study information
Verified date February 2022
Source Lahore General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

In most parts of the world, mRNA vaccines were used to provide protection to population against COVID 19. However, in some countries, including Pakistan, traditional viral vaccines named as Sinovac and Sinopharm were used for mass level immunization. Though these vaccines were approved by WHO, their efficacy had been questioned. Now after recommendation of booster doses, we aim to see the effect of mRNA vaccine as a booster dose after Sinovac and Sinopharm in terms of antibody response. (IgG RBD SARS CoV2)

Description:

In most parts of the world, mRNA vaccines were used to provide protection to population against COVID 19. However, in some countries, including Pakistan, traditional viral vaccines named as Sinovac and Sinopharm were used for mass level immunization. Though these vaccines were approved by WHO, their efficacy had been questioned. Now after recommendation of booster doses, we aim to see the effect of mRNA vaccine (BNT162b2, pfizer) as a booster dose after Sinovac and Sinopharm in terms of antibody response. (IgG RBD SARS CoV2). The antobody IgG RBD levels will be checked before the booster dose and then after 3 weeks of the booster.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 150
Est. completion date March 15, 2022
Est. primary completion date February 28, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - people who have received two doses of sinopharm or sinovac and six months have passed after the second dose Exclusion Criteria: - people getting one shot of sinopharm or sinovac or got vaccine other than sinopharm and sinovac.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• booster vaccine for COVID 19
The effect of Booster vaccine will be seen in participants in terms of antibody response IgG

Locations
Country Name City State
Pakistan Lahore General Hospital Lahore Punjab

Sponsors (1)
Lead Sponsor Collaborator
Lahore General Hospital

Country where clinical trial is conducted

Pakistan, 

Outcome
Type Measure Description Time frame Safety issue
Primary IgG RBD levels to see the effect of booster vaccine after 3 weeks in terms of IgG RBD after 3 weeks of booster vaccine dose
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