ong-term Immunity after COVID vaccination in healthy adults

Phase 4

Registration Number: CTRI/2021/09/036258

Lead Sponsor: ational Centre for Biological Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Between the ages of 18 and 45, both inclusive

2.Permanent residents of the selected localities where community outreach is routine

3.Only one member from a household will be selected.

4.Either a) sero-negativity or b) sero-positivity to SARS-CoV-2 with or without a history of clinical illness suggestive of COVID-19 or confirmed COVID-19 in the past (either mild or moderate infection)

Exclusion Criteria

1.Participant failure to consent.

2.Acute febrile illness in the participant at the time of the recruitment.

3.Active cancers or bleeding disorders

4.Individuals with a history of severe COVID-19 that required ventilation or received either convalescent plasma or monoclonal antibody treatments.

5.Any medical condition in the participant, which, in the judgment of the investigator, would interfere with protocol adherence.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective 1: To determine effect of the COVID-19 vaccination on humoral immune responses over a period of nine months in individuals seropositive as well as seronegative for SARS-CoV-2 infection <br/ ><br>Outcome: <br/ ><br>a. Difference in titers of plasma neutralizing antibody/glycoprotein-specific antibodies post vaccination between individuals seropositive and seronegative at baseline <br/ ><br>b. Difference in titers of binding antibody titers (RBD/spike, nucleocapsid) post vaccination in individuals seropositive and seronegative at baseline <br/ ><br>c. Seroconversion rate and duration of antibodies in individuals sero-negative at baseline <br/ ><br>d. Difference in magnitude of saliva antibody responses post vaccination between individuals seropositive and seronegative at baseline <br/ ><br>Timepoint: COVISHIELD-Day 0, 28, 84 & 98 and Month 6 & 9 <br/ ><br>COVAXIN-Day 0, 28, 42, 84 and Month 6 & 9

Secondary Outcome Measures