Vaccine ReactionNCT05213455
Booster Effect of mRNA Vaccine on Antibody Response for SARS-CoV-2 After Complete Vaccination With Sinos
An observational study of Vaccine Reaction, run by Lahore General Hospital at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vaccine Reaction
- What is being tested?
- booster vaccine for COVID 19
- Type of treatment
- Vaccines
- How many people
- 150 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2022to 15 Mar 2022
- How long will I take part?
- 3 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- people who have received two doses of sinopharm or sinovac and six months have passed after the second dose
Who cannot join
- people getting one shot of sinopharm or sinovac or got vaccine other than sinopharm and sinovac.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
Read the 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.
- Conditions
- Vaccine Reaction
- Being tested
- booster vaccine for COVID 19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
booster vaccine for COVID 19Biological
The effect of Booster vaccine will be seen in participants in terms of antibody response IgG
What is being measured
The primary outcome is the main question the study is designed to answer.
IgG RBD levels
to see the effect of booster vaccine after 3 weeks in terms of IgG RBD
Measured: after 3 weeks of booster vaccine dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start1 Jan 2022
- Primary completion28 Feb 2022 (estimated)
- Study completion15 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine ReactionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 3 Weeks
Sponsor and investigators
- Lead sponsor
- Lahore General Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Amina Asif, M.Phil, Principal investigator, Lahore General HospitalMuhammad Irfan Malik, FRCP, Principal investigator, Lahore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05213455
- Sponsor's protocol ID
- LGH010
- Status last verified
- Feb 2022
- First submitted
- 16 Jan 2022
- Last updated
- 2 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: will be available on request
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Booster Effect of mRNA Vaccine After Complete Vaccination With Sinos: an Observational Study
- ClinicalTrials.gov ID
- NCT05213455
- Acronym / sponsor ID
- LGH010
- Conditions
- Vaccine Reaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Lahore General HospitalOther government
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 28 Feb 2022 (estimated)
- Study completion
- 15 Mar 2022 (estimated)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Weeks
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- people who have received two doses of sinopharm or sinovac and six months have passed after the second dose
Key exclusion criteria (1 listed)
- people getting one shot of sinopharm or sinovac or got vaccine other than sinopharm and sinovac.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| booster vaccine for COVID 19The effect of Booster vaccine will be seen in participants in terms of antibody response IgG | Biological | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: Undecided. will be available on request
Related trials for Vaccine Reaction
RecruitingEarly Phase 1
Intradermal Influenza Vaccination
Vaccine Reaction
Active, not recruitingPhase 4
Understanding Poor Vaccine Responses to Hepatitis B Vaccination
Vaccine Reaction
RecruitingPhase 1
Phase 1b Ascending Dose Study of PanChol in Healthy Volunteers
Cholera Vaccination Reaction
Not yet recruitingPhase 4
R21/MM Dosing, Presentations, and Preservatives
Plasmodium Falciparum Malaria, Malaria
RecruitingObservational study
Reduced Vaccine Response to HZ/su in SLE
Vaccine Reaction, Zoster
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amina Asif, M.Phil principal investigator
Lahore General Hospital
Muhammad Irfan Malik, FRCP principal investigator
Lahore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaccine Reaction, run by Lahore General Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IgG RBD levels (time frame: after 3 weeks of booster vaccine dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.