None listed
Conditions
Interventions
Intervention1: COVISHIELD and COVAXIN in Seropositive and Seronegative individuals: COVISHIELD and COVAXIN will be administered to participants as per their choice under COVID National Immunisation Pr
Sponsors
National Centre for Biological Sciences
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Outcome: a. Difference in titers of plasma neutralizing antibody/glycoprotein-specific antibodies post vaccination between individuals seropositive and seronegative at baseline b. Difference in titers of binding antibody titers (RBD/spike, nucleocapsid) post vaccination in individuals seropositive and seronegative at baseline c. Seroconversion rate and duration of antibodies in individuals sero-negative at baseline d. Difference in magnitude of saliva antibody responses post vaccination between individuals seropositive and seronegative at baseline Timepoint: COVISHIELD-Day 0, 28, 84 & 98 and Month 6 & 9 COVAXIN-Day 0, 28, 42, 84 and Month 6 & 9 | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective 2: To determine effect of the COVID-19 vaccination on cellular immune responses over a period of nine months in individuals seropositive as well as seronegative for SARS-CoV-2 infection Outcome: a. Difference in frequency of RBD/spike-reactive memory B cells post-vaccination between individuals seropositive and seronegative at baseline b. Difference in positivity and magnitude of cytokine-producing T cells against spike peptides between individuals seropositive and seronegative at baseline Timepoint: COVISHIELD-Day 0, 98, Month 6 & 9 and post COVID infection (if collected) COVAXIN-Day 0, 42, 84, Month 9 & post COVID infection (if collected);Objective 3: To understand role of innate immunity, microbiome and micronutrient biomarkers on immune response to COVID-19 vaccination Outcome: a. Difference in levels of innate immune markers pre- and post- vaccination between individuals seropositive and seronegative at baseline b. Composition of skin and oral microbiome pre- and nine months post-vaccination c. Ex-vivo antimicrobial activity of skin scrubs pre- and nine months post-vaccination d. Levels of vitamins A, C, D and B12 and minerals zinc and iron pre vaccination Timepoint: COVISHIELD-Day 0, 28, 84 & 98 and Month 6 & 9 COVAXIN-Day 0, 28, 42, 84 and Month 6 & 9 | — |
Countries
India
Contacts
Public ContactDr Mangaiarkarasi Asokan
KEM Hospital Research Centre
Outcome results
None listed