| CTRI Number |
CTRI/2021/08/035648 [Registered on: 13/08/2021] Trial Registered Prospectively |
| Last Modified On: |
12/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Mixing of COVID vaccines study |
|
Scientific Title of Study
|
Comparison of reactogenicity and immunogenicity of heterologous prime-boost and heterologous boost of ChAdOx1 nCoV-19 (Covishield), BBV 152 (Covaxin), and other COVID vaccines with homologous administration of Covishield and Covaxin |
| Trial Acronym |
MnM study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| File No: BIO/CT/21/000092; CT No.: CT- 24/2021 |
DCGI |
| Mixing of COVID vaccines study, Version: 1.0 Date: 10thJuly |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Winsley Rose |
| Designation |
Professor |
| Affiliation |
Christian Medical College |
| Address |
Department of Child Health-Unit III and Pediatric Infectious Diseases, Christian Medical College, Ida Scudder Road, Vellore
Vellore
TAMIL NADU
632004
India |
| Phone |
9698884466 |
| Fax |
|
| Email |
winsleyrose@cmcvellore.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Winsley Rose |
| Designation |
Professor |
| Affiliation |
Christian Medical College |
| Address |
Department of Child Health-Unit III and Pediatric Infectious Diseases, Christian Medical College, Ida Scudder Road, Vellore
TAMIL NADU
632004
India |
| Phone |
9698884466 |
| Fax |
|
| Email |
winsleyrose@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Winsley Rose |
| Designation |
Professor |
| Affiliation |
Christian Medical College |
| Address |
Department of Child Health-Unit III and Pediatric Infectious Diseases, Christian Medical College, Ida Scudder Road, Vellore
TAMIL NADU
632004
India |
| Phone |
9698884466 |
| Fax |
|
| Email |
winsleyrose@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| Azim Premji University, Survey No 66, Burugunte Village, Bikkanahalli Main Road, Sarjapura, Bengaluru,-562125 |
|
|
Primary Sponsor
|
| Name |
Christian Medical College |
| Address |
Christian Medical College, Ida Scudder Road, Vellore |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Winsley Rose |
Christian Medical College |
Department of Paediatrics Unit 3,
Christian Medical College, Ida Scudder Road, Vellore- 632004
Vellore
TAMIL NADU |
9698884466
winsleyrose@cmcvellore.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Review Board, Christian Medical College, Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy adults more than 18 years of age will be involved in the study |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Covaxin booster to already Covaxin vaccinated with 2 doses |
0.5 ml Intramuscular |
| Intervention |
Covaxin booster to already Covishield vaccinated with 2 doses |
0.5 ml Intramuscular |
| Intervention |
Covaxin followed by Covishield followed by booster Covaxin |
0.5 ml Intramuscular |
| Intervention |
Covaxin followed by Covishield followed by booster Covishield |
0.5ml Intramuscular |
| Intervention |
Covishield booster to already Covaxin vaccinated with 2 doses |
0.5 ml Intramuscular |
| Comparator Agent |
Covishield booster to already Covishield vaccinated with 2 doses |
0.5 ml Intramuscular |
| Intervention |
Covishield followed by Covaxin followed by booster Covaxin |
0.5 ml Intramuscular |
| Intervention |
Covishield followed by Covaxin followed by booster Covishield |
0.5 ml Intramuscular |
| Comparator Agent |
Homologous Covaxin 2 primary doses followed by booster Covaxin |
0.5 ml Intramuscular |
| Comparator Agent |
Homologous Covaxin 2 primary doses followed by booster Covishield |
0.5 ml Intramuscular |
| Comparator Agent |
Homologous Covishield 2 primary doses followed by booster Covaxin |
0.5 ml Intramuscular |
| Comparator Agent |
Homologous Covishield 2 primary doses followed by booster Covishield |
0.5 ml Intramuscular |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Males and females aged 18+ years
2. No known immunodeficiency
3. History of no contact with COVID-2019 persons within at least 14 days before the enrolment (according to subjects)
4. No evident vaccine-induced reactions or complications after receiving immunobiological products in the medical history
5. No acute infectious and/or respiratory diseases within at least 14 days before the enrolment.
|
|
| ExclusionCriteria |
| Details |
1. Previous receipt of any COVID vaccine (only for those who are in the prime and boost part of the study)
2. Any vaccination/immunization within 30 days before the enrolment
3. Steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrolment
4. Immunosuppressors therapy finished within 3 months before the enrolment
5. Pregnancy or breast-feeding
6. Acute coronary syndrome or stroke suffered less than one year before the enrolment
7. Tuberculosis, chronic systemic infections
8. Drug allergy – history of anaphylaxis, hypersensitivity or allergic reaction to immunobiological products, known allergic reactions to study product components, acute exacerbation of allergic diseases on the enrolment day
9. Subjects who are on drugs that could have potential drug interactions with the vaccines:
A.drugs for multiple sclerosis (dimethyl fumarate, fingolimod, ozanimod, etc.),
B. monoclonal antibodies, corticosteroids, corticotropin,
C. antineoplastic drugs, cytostatic agents (platinum-based drugs, bleomycin, taxanes, methotrexate, melphalan, capecitabine, carmustine, vincristine, vinblastine, cyclophosphamide, cyclosporine, docetaxel, doxorubicin, daunorubicin, fluorouracil, etc.) and target drugs (dasatinib, lenalidomide, nilotinib, pemetrexed, everolimus, sirolimus, asparaginase, bortezomib, etc.),
D. immunoglobulins, interleukins, X-ray contrast agents
10. Medical history of malignancy
11. Donated blood or plasma (450+ mL) within 2 months before the enrolment
12. Splenectomy in the medical history
13. Neutropenia (absolute neutrophil count <1000 mm3, agranulocytosis, significant blood loss, severe anaemia (haemoglobin <80g/l) immunodeficiency including autoimmune disorders in the medical history within 6 months before the enrolment
14. Known HIV positive
15. Local inflammation at injection site (deltoid muscle area), which does not allow assessing the local response to the vaccine administration
16. Alcohol or drug addiction in the medical history
17. Participation in any other interventional clinical trial within 1 month prior to the screening
17. Any other medical condition that would limit the participation of the subject as per Investigator’s discretion
18. Subjects contraindicated for vaccination
Temporary exclusion criteria:
If at visit 1 screening/ vaccination the volunteer has any of the following, they will not be enrolled that day.
1. Acute respiratory illness (moderate or severe illness with or without fever)
2. Fever (oral temperature greater than 37.8°C)
They may be considered for enrolment later in the trial; if they recover in sufficient time.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Immunogenicity measured by anti spike immunoglobulins for SARS CoV 2 |
Boost Only - Day 28 after the booster dose
Prime/boost - Day 28 after the second dose of the 2 primary vaccine doses |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Serious adverse events and adverse events of special interest |
Throughout the study period |
Neutralizing antibodies against SARS CoV 2, antinucleocapsid immunoglobulins, pseudoneutralising antibodies, cellular T cell and B cell immune responses.
|
D1, D14, D28, D56, D84, D208, D365 |
|
|
Target Sample Size
|
Total Sample Size="1100"
Sample Size from India="1100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
21/08/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
India is in the midst of a pandemic due to COVID 19 reporting over 28 million cases and 300,000 deaths so far due to COVID 19. Vaccination has been shown to be the most important strategy in containing the pandemic and reducing the number of deaths. India introduced vaccines in a phased manner beginning on 16th January, 2021. Two vaccines- Covishield (ChAdOx1 nCoV-19 ) and Covaxin (BBV 152) were initially approved for use by the DCGI with the third vaccine Sputnik V approved in April 2021. Each vaccine uses different homologous schedules and there is a considerable shortage in the availability of these vaccines. There would be significant advantages to having flexible immunisation programmes where the second vaccine dose is not necessarily the same as the first dose and the intervals between the doses are similar. Accordingly, this study will determine the safety as well as the immune responses to mixed administration of Covishield following Covaxin and vice-versa given at an interval of 56+/- 7 days and make comparisons with the same 2 dose administration of these two vaccines. Safety and immune responses will also be determined following the mixed booster dose administration of available vaccines (after an interval of 3-6 months after the 2nd dose) including Covishield and Covaxin following same and mixed prime vaccination with Covishield or Covaxin |