Mixing of the COVID-19 vaccines Covishield and Covaxin for safety assessment
| ISRCTN | ISRCTN98052401 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98052401 |
| ClinicalTrials.gov number | Nil KNown |
| Secondary identifying numbers | COVID-19-21;Version 1.0 ;dt :11 th August ,2021 |
- Submission date
- 30/12/2021
- Registration date
- 06/01/2022
- Last edited
- 20/12/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
Vaccination is protective against COVID-19 infection. Based on recent studies by ICMR study which included 18 patients and Com- COV study, Combi Vacs trial, It has been observed that combination vaccines elicit a better immune response. There are a few studies from India on combination vaccines. We aim to assess the safety of mixing vaccines in a large number of healthy volunteers.
Who can participate?
Healthy volunteers aged 18-65 years (inclusive of both) with no medical history or evidence of COVID-19 and not vaccinated for COVID-19/influenza
What does the study involve?
Participants will be divided into four groups. Two groups will be given homologous vaccines and two groups will be given heterologous vaccines (mix and match). Blood samples will be collected at 28 days after the 1st dose and 14 days after the 2nd dose for assessing antibody levels.. Participants will be closely monitored for any adverse effects for 3 months.
What are the possible benefits and risks of participating?
No adverse effects are reported from a combination of vaccines. The participants will have the benefit of a reduced risk of getting severe COVID-19.
Where is the study run from?
Asian Healthcare Foundation (India)
When is the study starting and how long is it expected to run for?
August 2021 to November 2021
Who is funding the study?
Asian Healthcare Foundation (India)
Who is the main contact?
Dr Bhanu Prakash Reddy Attunuru
drbhanu.prakash@aighospitals.com
Contact information
Principal Investigator
AIG Hospitals No 136, Plot No 2/3/4/5 Survey
1, Mindspace Rd
Gachibowli
Hyderabad Telangana
Hyderabad
500032
India
| Phone | +91 (0)9963355044 |
|---|---|
| drbhanu.prakash@aighospitals.com |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Studying the immunogenicity and safety of combination vaccines for COVID-19 |
| Study acronym | MIX-VAC |
| Study objectives | Mixing of the vaccines Covishield and Covaxin will elicit a better immune response. |
| Ethics approval(s) | Approved 25/08/2021, Institutional Ethics Committee, Asian Institute of Gastroenterology (lEC-AlG) (6-3-661, Somajiguda, Hyderabad - 500 082, India; +91 (0)40 23378888; iecaig2044@gmail.com), ref: AIG/IEC-CT 51/08.2021-01 |
| Health condition(s) or problem(s) studied | COVID-19 (SARS-CoV-2 infection) |
| Intervention | 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 randomisation. Two groups will be given homologous vaccines and two groups will be given heterologous vaccines (mix and match). Blood samples will be collected 28 days after the 1st dose and 14 days after the 2nd dose. Participants will be closely monitored for any adverse effects for 3 months. Blood samples will be used for assessing S1, S2, and RBD specific antibody titres. Group 1 received Covishield on day 0 and Covishield on day 28 Group 2 received Covaxin on day 0 and Covaxin on day 28 Group 3 received Covishield on day 0 and Covaxin on day 28 Group 4 received Covaxin on day 0 and Covishield on day 28 |
| Intervention type | Biological/Vaccine |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Covishield, Covaxin |
| Primary outcome measure | 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 | 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 |
| Overall study start date | 01/08/2021 |
| Completion date | 12/11/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 200 |
| Total final enrolment | 44 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 28/08/2021 |
| Date of final enrolment | 20/09/2021 |
Locations
Countries of recruitment
- India
Study participating centre
1, Mindspace Rd
Gachibowli
Hyderabad
500032
India
Sponsor information
Research organisation
No 136, Plot No 2/3/4/5 Survey
1, Mindspace Rd
Gachibowli
Telangana
Hyderabad
500032
India
| Phone | +91 (0)40 4244 4222 |
|---|---|
| research@aighospitals.com | |
| Website | https://ahf.aigindia.net/ |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 10/01/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in an international journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Bhanu Prakash Reddy Attunuru (drbhanu.prakash@aighospitals.com). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1.0 | 11/08/2021 | 31/12/2021 | No | No |
| Results article | 21/03/2022 | 20/12/2022 | Yes | No |
Additional files
Editorial Notes
20/12/2022: Publication reference added.
31/12/2021: Trial's existence confirmed by the Institutional Ethics Committee, Asian Institute of Gastroenterology (lEC-AlG).
