NCT05213455

Brief 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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2022

Enrollment Period

2 months

First QC Date

January 16, 2022

Last Update Submit

February 12, 2022

Conditions

Vaccine Reaction

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

booster vaccine for COVID 19BIOLOGICAL

The effect of Booster vaccine will be seen in participants in terms of antibody response IgG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • people who have received two doses of sinopharm or sinovac and six months have passed after the second dose

You may not qualify if:

  • people getting one shot of sinopharm or sinovac or got vaccine other than sinopharm and sinovac.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lahore General Hospital

Lahore, Punjab Province, 57000, Pakistan

Location

Study Officials

  • Amina Asif, M.Phil

    Lahore General Hospital

    PRINCIPAL INVESTIGATOR

  • Muhammad Irfan Malik, FRCP

    Lahore General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Weeks
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2022

First Posted

January 28, 2022

Study Start

January 1, 2022

Primary Completion

February 28, 2022

Study Completion

March 15, 2022

Last Updated

March 2, 2022

Record last verified: 2022-02

Locations

PA(1)