None listed
Conditions
Interventions
Intervention1: Corbevax vaccine: Dose:0.5ml
route of administration: intramuscular
duration of therapy: single dose
Control Intervention1: none: NA
Sponsors
Asian Healthcare Foundation
Eligibility
Inclusion criteria
Inclusion criteria: 1. Determined by medical history, targeted physical examination and clinical judgement of the investigator to be in good health. Note: Heathy volunteers with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrolment, can be included. 2. Subject is willing to provide a written informed consent for voluntary participation in the study. 3. Subject agrees to refrain from blood donation during the course of the study. 4. Subject have completed at least 6 months duration after second dose of vaccination
Exclusion criteria
Exclusion criteria: 1. Pregnant women, nursing women or women of childbearing potential who are not actively avoiding pregnancy during the study. 2. Subjects with known current or chronic history of any of the following conditions, likely to affect participation in the study: any bleeding disorder 3. Subjects requiring chronic administration (defined as more than 14 days in total) of immunosuppressant (e.g., corticosteroids, cytotoxic drugs or antimetabolites, etc.) or other immune-modifying drugs (e.g., interferons). 4. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). 5. Any medical condition that in the judgment of the investigator would make study participation unsafe.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety assessment by determining number of subjects with unsolicited adverse eventsTimepoint: Baseline, 4, 12, 24, 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| RBD specific antibody titre and S1/S2 neutralizing antibody titre at base line (base line), 4,12,24,52 weeks (1-12 months) post booster administration. Immunological memory developed at 4,12,24,52 weeks would be considered as protection against SARS-CoV-2 infection post booster dose. Timepoint: Baseline, 4, 12, 24, 52 weeks | — |
Countries
India
Contacts
Public ContactMohammad Jabeen Ruksana
AIG Hospitals
Outcome results
None listed