Characterization and Durability of COVID-19 Vaccine Induced Immune Responses in Healthcare/Frontline Workers

Covid19 Clinical Trial

Official title:

Characterization and Durability of COVID-19 Vaccine Induced Immune Responses in Healthcare/Frontline Workers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05049187
• Other study ID #: 2021 007
• Status: Completed
• Start date: May 7, 2021
• Est. completion date: March 1, 2023

Study information

• Verified date: November 2023
• Source: Tuberculosis Research Centre, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Adults aged 18-60 years
• Should have been vaccinated with either Covaxin or Covishield
• Willing to provide written informed consent

Exclusion Criteria:

• Participants will be ineligible if they are not vaccinated for either Covaxin or Covishield vaccine
• Not willing to provide written informed consent

Related Conditions & MeSH terms

• COVID-19
• Covid19

Locations

Country	Name	City	State
India	National Institute for Research in Tuberculosis	Chennai	Tamilnadu

Sponsors (2)

Lead Sponsor	Collaborator
Tuberculosis Research Centre, India	National Institute of Epidemiology

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibody titers	IgM and IgG SARS-Cov2 specific antibody titres and IgA and IgE (total)	2 years
Primary	Ratio of immune biomarker production	The ratio of immune biomarkers production between pre and post COVID-19 vaccination	2 years