Covid19NCT05049187
Characterization and Durability of COVID-19 Vaccine Induced Immune Responses in Healthcare/Frontline Workers
An observational study of Covid19, run by Tuberculosis Research Centre, India at 1 site in India.
Trial summary
Rationale: Early in the covid-19 pandemic, it was unclear whether and how individuals and populations would develop protective and enduring immunity against SARS-CoV-2, either after infection or vaccination. Read more about this study
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthcare/frontline workers working in the ICMR-NIRT and ICMR-NIE aged 18 to 60 years
Who may be able to join
- Adults aged 18-60 years
- Should have been vaccinated with either Covaxin or Covishield
- Willing to provide written informed consent
Who cannot join
- Participants will be ineligible if they are not vaccinated for either Covaxin or Covishield vaccine
- Not willing to provide written informed consent
Trial locations and contacts
1 site in 1 country.
India1 site
National Institute for Research in Tuberculosis
Chennai, Tamil Nadu, 600031
About this study
Rationale: Early in the covid-19 pandemic, it was unclear whether and how individuals and populations would develop protective and enduring immunity against SARS-CoV-2, either after infection or vaccination. It is still not clear what role might immune cellular responses play in the development of immunity to SARS-CoV-2 infection and what are the implications for vaccines? As T cells recognise and respond to viral antigens they produce many protective reactions and effector molecules. One such molecule is the cytokine interferon γ, secreted by CD4+ and CD8+ T cells and their memory cells. This can be measured means of documenting specific T cell responses to viral antigens. Published studies offered a strong evidence that T cell immune responses are sustained, even in the face of declining or undetectable antibodies, implying that some immunity persists. The evidence from new studies, interim results from phase III vaccine trials, and previous data from phase I and phase II trials support the notion that memory T cell responses to the vaccines, along with B cell antibody responses, should provide good and possibly enduring immunity to SARS-Cov-2. We propose to describe and characterize the humoral, innate and long-term adaptive immune responses and the neutralization potential generated by COVID-19 vaccination (Covaxin, Covishield) among healthcare and frontline workers.
Read the detailed description
Study objectives i. To estimate the neutralizing antibodies titre against SARS CoV-2 by vaccine type.
ii. To estimate the proportion of vaccine recipients developing effective antibody response for SARS-CoV-2 specific IgG, IgM, and total IgE and IgA antibodies pre- and post-COVID-19 vaccination on day zero, day 28, month 2, 3, 6, 12, 18 and 24 by vaccine type.
iii. To identify and characterize the immune biomarkers for long term innate and adaptive immune response by vaccine type.
iv. To estimate the ratio of immune biomarker levels between pre- and post- COVID-19 vaccination at days 28, month 2, 3, 6, 12, 18 and 24 by vaccine type
- Conditions
- Covid19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 COVISHIELD | Participants will receive one dose of COVID-19 vaccine (Covishield) at baseline and one second dose after 28 days (Window period of +3 days) intra muscularly. | |
| Group 2 COVAXIN | Participants will receive one dose of COVID-19 vaccine (Covaxin) at baseline and one second dose after 28 days (Window period of +3 days) intra muscularly. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody titers
IgM and IgG SARS-Cov2 specific antibody titres and IgA and IgE (total)
Measured: 2 years
Ratio of immune biomarker production
The ratio of immune biomarkers production between pre and post COVID-19 vaccination
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start7 May 2021
- Primary completion1 Mar 2023
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuberculosis Research Centre, India
- Sponsor type
- Other government
- Collaborators
- National Institute of Epidemiology
- Responsible party
- Sponsor
- Investigators
- PAVAN Kumar, PhD, Principal investigator, National Institute for Research in TuberculosisBANUREKHA V V, MBBS, MPH, Principal investigator, National Institute for Research in Tuberculosis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05049187
- Sponsor's protocol ID
- 2021 007
- Status last verified
- Nov 2023
- First submitted
- 17 Sep 2021
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization and Durability of COVID-19 Vaccine Induced Immune Responses in Healthcare/Frontline Workers
- ClinicalTrials.gov ID
- NCT05049187
- Acronym / sponsor ID
- 2021 007
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Tuberculosis Research Centre, IndiaOther government
- Collaborators
- National Institute of Epidemiology
- Study start
- 7 May 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 20 Sep 2021 (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.
Rationale: Early in the covid-19 pandemic, it was unclear whether and how individuals and populations would develop protective and enduring immunity against SARS-CoV-2, either after infection or vaccination. It is still not clear what role might immune cellular responses play in the development of immunity to SARS-CoV-2 infection and what are the implications for vaccines? As T cells recognise and respond to viral antigens they produce many protective reactions and effector molecules. One such molecule is the cytokine interferon γ, secreted by CD4+ and CD8+ T cells and their memory cells. This can be measured means of documenting specific T cell responses to viral antigens. Published studies offered a strong evidence that T cell immune responses are sustained, even in the face of declining or undetectable antibodies, implying that some immunity persists. The evidence from new studies, interim results from phase III vaccine trials, and previous data from phase I and phase II trials support the notion that memory T cell responses to the vaccines, along with B cell antibody responses, should provide good and possibly enduring immunity to SARS-Cov-2. We propose to describe and characterize the humoral, innate and long-term adaptive immune responses and the neutralization potential generated by COVID-19 vaccination (Covaxin, Covishield) among healthcare and frontline workers.
Detailed description
Study objectives i. To estimate the neutralizing antibodies titre against SARS CoV-2 by vaccine type.
ii. To estimate the proportion of vaccine recipients developing effective antibody response for SARS-CoV-2 specific IgG, IgM, and total IgE and IgA antibodies pre- and post-COVID-19 vaccination on day zero, day 28, month 2, 3, 6, 12, 18 and 24 by vaccine type.
iii. To identify and characterize the immune biomarkers for long term innate and adaptive immune response by vaccine type.
iv. To estimate the ratio of immune biomarker levels between pre- and post- COVID-19 vaccination at days 28, month 2, 3, 6, 12, 18 and 24 by vaccine type
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 COVISHIELD | – | –Participants will receive one dose of COVID-19 vaccine (Covishield) at baseline and one second dose after 28 days (Window period of +3 days) intra muscularly. |
| Group 2 COVAXIN | – | –Participants will receive one dose of COVID-19 vaccine (Covaxin) at baseline and one second dose after 28 days (Window period of +3 days) intra muscularly. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthcare/frontline workers working in the ICMR-NIRT and ICMR-NIE aged 18 to 60 years
Key inclusion criteria (3 listed)
- Adults aged 18-60 years
- Should have been vaccinated with either Covaxin or Covishield
- Willing to provide written informed consent
Key exclusion criteria (2 listed)
- Participants will be ineligible if they are not vaccinated for either Covaxin or Covishield vaccine
- Not willing to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Antibody titers
Time frame: 2 years
IgM and IgG SARS-Cov2 specific antibody titres and IgA and IgE (total)
Ratio of immune biomarker production
Time frame: 2 years
The ratio of immune biomarkers production between pre and post COVID-19 vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: No
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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.
PAVAN Kumar, PhD principal investigator
National Institute for Research in Tuberculosis
BANUREKHA V V, MBBS, MPH principal investigator
National Institute for Research in Tuberculosis
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 Covid19, run by Tuberculosis Research Centre, India at 1 site in India.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 29 Nov 2023. 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 India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Antibody titers (time frame: 2 years). The study lists 2 primary outcomes in all. 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 29 Nov 2023.