Mixing of the COVID-19 vaccines Covishield and Covaxin for safety assessment

Not Applicable

Completed

• Conditions: COVID-19 (SARS-CoV-2 infection); Infections and Infestations

• Registration Number: ISRCTN98052401
• Lead Sponsor: Asian Healthcare Foundation

Brief Summary

2022 Results article in https://www.walshmedicalmedia.com/open-access/safety-and-immunogenicity-of-mixmatch-of-vaccines-covishield-and-covaxin-a-pilot-study-110892.html (added 20/12/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-11-12
• Study Start: 2022-01-06
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 44

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Immunogenicity: neutralising antibody titres against S1/S2 and RBD measured by electrochemiluminescence at baseline, 28 days and 45 days after complete vaccination

Secondary Outcome Measures

Name	Time	Method
<br> 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:<br> 1. Major adverse events<br> 2. Laboratory parameters complete blood analysis, renal function tests, and liver function tests.<br> 3. Clinical monitoring through a simple questionnaire<br>