None listed
Conditions
Interventions
Intervention1: Covishield: vaccine
Control Intervention1: covaxin: vaccine
Sponsors
National Centre for Biological Science
Eligibility
Inclusion criteria
Inclusion criteria: - Permanent residents of the selected localities where community outreach is routine - Only one member from a household will be selected. - 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: - Participant failure to consent. - Pregnancy, diabetes, chronic infection such as HIV or tuberculosis and immunocompromised patients (all by history) - Acute febrile illness in the participant at the time of the survey. - Active cancers or bleeding disorders - Individuals with a history of severe COVID-19 that required ventilation or received either convalescent plasma or monoclonal antibody treatments. - Any medical condition in the participant, which, in the judgment of the investigator, would interfere with protocol adherence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Difference in titers and rate of increase of plasma neutralizing antibody/glycoprotein-specific antibodies post vaccination between individuals seropositive and seronegative at baseline - Magnitude of binding antibody titers (RBD/spike, nucleocapsid) post vaccination in individuals seropositive and seronegative at baseline - Seroconversion rate and duration of antibodies in individuals sero-negative at baseline Timepoint: day 42 90 180 270 | — |
Secondary
| Measure | Time frame |
|---|---|
| Difference in frequency of RBD/spike-reactive memory B cells post-vaccination between individuals seropositive and seronegative at baseline -Difference in positivity and magnitude of cytokine-producing T cells against spike peptides between individuals seropositive and seronegative at baselineTimepoint: day 42 90 180 270 | — |
Countries
India
Contacts
Public ContactDr Carolin Elizabeth George
Bangalore Baptist Hospital
Outcome results
None listed