Booster dose for Covid-19
- Registration Number
- CTRI/2022/02/040563
- Lead Sponsor
- Asian Healthcare Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Safety assessment by determining number of subjects with unsolicited adverse eventsTimepoint: Baseline, 4, 12, 24, 52 weeks
- Secondary Outcome Measures
Name Time Method 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. <br/ ><br> Immunological memory developed at 4,12,24,52 weeks would be considered as protection against SARS-CoV-2 infection post booster dose. <br/ ><br>Timepoint: Baseline, 4, 12, 24, 52 weeks