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

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.

Study Overview

• Status: Completed
• Conditions: Covid19

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 Type: Observational
• Enrollment (Actual): 132

Contacts and Locations

Study Locations

• India
  • Tamilnadu
    • Chennai, Tamilnadu, India, 600031
      • National Institute for Research in Tuberculosis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthcare/frontline workers working in the ICMR-NIRT and ICMR-NIE aged 18 to 60 years

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tuberculosis Research Centre, India
• Collaborators: National Institute of Epidemiology
• Investigators: Principal Investigator: PAVAN Kumar, PhD, National Institute for Research in Tuberculosis; Principal Investigator: BANUREKHA V V, MBBS, MPH, National Institute for Research in Tuberculosis

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2021
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: September 17, 2021
• First Submitted That Met QC Criteria: September 17, 2021
• First Posted (Actual): September 20, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 23, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2021 007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No