COVID-19 (SARS-CoV-2 infection) Infections and Infestations
Conditions
Interventions
200 healthy volunteers will be recruited according to the inclusion and exclusion criteria as mentioned below. After taking informed consent they will be divided into four groups by computer-generated
Sponsors
Asian Healthcare Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult male or female human volunteer aged 18-65 years (inclusive of both) and not vaccinated for COVID-19/influenza, willing and able to provide written, signed and dated informed consent 2. Negative immunoglobulin M (IgM) SARS-CoV-2 antibodies through enzyme immunoassay test result 3. Negative COVID-2019 Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) test result at the screening visit 4. No medical history or evidence of COVID-19 5. No acute infections and/or respiratory diseases within 14 days before enrollment 6. No evidence of vaccine-induced reactions or complications after receiving immunobiological products in the past medical history 7. Willing to give consent to use effective contraception methods during the study 8. Negative urine pregnancy test at the screening visit (for childbearing aged women) 9. Negative human immunodeficiency virus (HIV 1 & 2), syphilis, hepatitis B and C test results
Exclusion criteria
Exclusion criteria: 1. Aged <18 years of age 2. Any vaccination/immunization within 30 days before enrollment 3. Any treatment with steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products within 30 days before enrollment 4. Any treatment with immunosuppressive therapy within 3 months before enrollment 5. Any drug allergy (anaphylactic shock, Quincke's edema, polymorphic exudative eczema, atopy, serum disease), hypersensitivity or allergic reaction to immunobiological products, known allergic reactions to study drug components, acute exacerbation of allergic diseases on enrollment day 6. Any neoplasms in the past medical history 7. Donated blood or plasma within 3 months before enrollment 8. Any history or evidence of splenectomy 9. Any immunodeficiency state 10. Any history or evidence of anorexia or protein deficiency of any origin 11. Alcohol or drug addiction in the past medical history 12. Participation in any other interventional clinical trial within 3 months 13. Any other condition that the study physician considers as a barrier to the trial completion as per the protocol 14. Pregnancy or breastfeeding 15. Subjects who test positive for Coronavirus disease through RT-PCR SARS CoV-2 Test and positive anti-COVID antibodies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immunogenicity: neutralising antibody titres against S1/S2 and RBD measured by electrochemiluminescence at baseline, 28 days and 45 days after complete vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| The safety of different vaccine combinations assessed on day 28 (4 weeks after 1st dose), day 45 (2weeks after 2nd dose) and day 60 using patient records, blood tests, and questionnaire: 1. Major adverse events 2. Laboratory parameters complete blood analysis, renal function tests, and liver function tests. 3. Clinical monitoring through a simple questionnaire | — |
Countries
India
Outcome results
None listed