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

February 12, 2022 updated by: Lahore General Hospital

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

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)

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 57000
        • Lahore general hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study will include participants who have received two doses of sinopharm or sinovac and six months have passed after the second dose.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IgG RBD levels
Time Frame: after 3 weeks of booster vaccine dose
to see the effect of booster vaccine after 3 weeks in terms of IgG RBD
after 3 weeks of booster vaccine dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lahore General Hospital

Investigators

  • Principal Investigator: Amina Asif, M.Phil, Lahore general hospital
  • Principal Investigator: Muhammad Irfan Malik, FRCP, Lahore general hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

February 28, 2022

Study Completion (Anticipated)

March 15, 2022

Study Registration Dates

First Submitted

January 16, 2022

First Submitted That Met QC Criteria

January 16, 2022

First Posted (Actual)

January 28, 2022

Study Record Updates

Last Update Posted (Actual)

March 2, 2022

Last Update Submitted That Met QC Criteria

February 12, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • LGH010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

will be available on request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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