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

NCT05049187 | Completed DMC

• 1 other identifier: 2021 007
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tuberculosis Research Centre, India: lead
• National Institute of Epidemiology: collaborator

Study Sites (1)

National Institute for Research in Tuberculosis

Chennai, Tamil Nadu, 600031, India

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• PAVAN Kumar, PhD

  National Institute for Research in Tuberculosis

  PRINCIPAL INVESTIGATOR

• BANUREKHA V V, MBBS, MPH

  National Institute for Research in Tuberculosis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: September 20, 2021
• Study Start: May 7, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)