| CTRI Number |
CTRI/2022/06/043447 [Registered on: 23/06/2022] Trial Registered Prospectively |
| Last Modified On: |
22/06/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Covid-19 vaccine interchangeability study |
|
Scientific Title of Study
|
Safety, immunogenicity and efficacy after interchangeability of Covid-19 vaccines [Covishield, Covaxin and Sputnik V] among adults in North India: A Randomized Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICMR/PGIMER-Covishield/Covaxin_Version 3.0 _24_05_2022. |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MADHU GUPTA |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Community Medicine and School of Public Health, Ground Floor, Room No. 126, Sector 12, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7009769629 |
| Fax |
|
| Email |
madhugupta21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MADHU GUPTA |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Community Medicine and School of Public Health, Ground Floor, Room No. 126, Sector 12, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7009769629 |
| Fax |
|
| Email |
madhugupta21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhu Gupta |
| Designation |
Professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Community Medicine and School of Public Health, Ground Floor, Room No. 126, Sector 12, PGIMER
Chandigarh
CHANDIGARH
160012
India |
| Phone |
7009769629 |
| Fax |
|
| Email |
madhugupta21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India
Ph: 91-11-26588895 / 91-11-26588980, 91-11-26589794 / 91-11-26589336, 91-11-26588707
Fax: 91-11-26588662
Email:icmrhqds[at]sansad[dot]nic[dot]in |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Bikash Medhi Professor Department of Pharmacology PGIMER Chandigarh |
Department of Pharmacology, PGIMER, Chandigarh-160012
Email: drbikashmedhi@gmail.com
Ph: 7087008510 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Madhu Gupta |
POSTGRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH |
Department of Community Medicine and School of Public Health
PGIMER, sector 12, Chandigarh, 160012
Chandigarh
CHANDIGARH |
7009769629
madhugupta21@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Research, Chandigarh India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cohort 2: Covishield and Sputnik V |
In Cohort 2 a total sample size of 257 will be taken. A first dose of Covishield will be given on day 1 followed by a dose of sputnik V at 28 days. |
| Intervention |
Cohort 3: Covaxin and Sputnik V |
In Cohort 3 a total sample size of 257 will be taken. A first dose of Covaxin will be given on day 1 followed by a dose of Sputnik at 28 days. |
| Comparator Agent |
Cohort 4: Covishield and Covishield |
In Cohort 4 a total sample size of 257 will be taken. A first dose of Covishield will be given on day 1 followed by a second dose of Covishield at 84 days |
| Comparator Agent |
Cohort 5: Covaxin and Covaxin |
In Cohort 5 a total sample size of 257 will be taken. A first dose of Covaxin will be given on day 1 followed by a second dose of Covaxin at 28 days |
| Comparator Agent |
Cohort 6: Sputnik V and Sputnik V |
In Cohort 2 a total sample size of 257 will be taken. A first dose of Sputnik V will be given on day 1 followed by a second dose of sputnik V at 28 days. |
| Intervention |
Trial Cohorts/heterologous arms
Cohort 1: Covishield and Covaxin
|
In Cohort 1 a total sample size of 257 will be taken. A first dose of Covishield will be given on day 1 followed by a dose of Covaxin at 28 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
healthy |
|
| ExclusionCriteria |
| Details |
children less than 18 years |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Antibody titers against Spike protein after interchangeability of the study vaccines at baseline, 28 days of first and second dose, 6 months and 1 year.
2. Incidence of mild, moderate and serious adverse events rate of the Covid-19 vaccines after interchangeability
3. Breakthrough infection rate of the Covid-19 vaccines (Covishield/Covaxin/Sputnik V) after interchangeability. |
At at baseline, 28 days of first and second dose, 6 months and 1 year. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Neutralizing antibody and celle mediated immune response after interchangeability of covid-19 vaccines |
at baseline, 28 days of first and second dose, 6 months and 1 year. |
|
|
Target Sample Size
|
Total Sample Size="1542"
Sample Size from India="1542"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/08/2022 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background In India, currently, Covishield, Covaxin and Sputnik V are being administered to the eligible candidates as homologous prime/boost vaccines. The Center for Disease Control and National Advisory Committee on Immunization have proposed the interchangeability of vaccines to boost immune response and protect the people. However, there is limited evidence that interchangeability of the vaccines will be as effective and safe as the homologous vaccination schedules in India. Novelty This study will generate new evidence on the safety, immunogenicity and efficacy of interchangeability vaccine schedules for the vaccines available in India. Objectives To ascertain the safety, immunogenicity and efficacy of the Covid-19 vaccines (Covishield/Covaxin/Sputnik V) after interchangeability among adults in North India. Methods It will be a multicentric open label parallel non-inferiority randomised control trial to determine safety, efficacy and immunogenicity of heterologous prime/boost COVID-19 vaccine schedules [Covishield:Covaxin; Covishield:Sputnik V; Covaxin:Sputnik V] as compared with homologous schedules [Covishield:Covishield; Covaxin:Covaxin; Sputnik V:Sputnik V]. 1537 volunteers will be randomly allocated into any of the six arms [three heterologous arms and three homologous control arms] i.e, 257 per arm in 1:1 ratio. Adverse events, covid-19 infection rate, and antibody titres against spike protein, neutralizing antibody titres and cell mediated immunity will be assessed at various intervals up to 365 days. Expected outcomes: Incidence of breakthrough infection rate, adverse events following immunization, and proportion of individuals with reactive antibody titres against spike protein, neutralizing antibodies and lymphocyte proliferation/raised cytokine levels after heterologous prime/boost COVID-19 vaccine schedules as compared with the homologous group. 1. Keywords: COVID-19 vaccines, Interchangeability, Randomized Controlled Trial, Heterologous prime/boost, Homologous prime/boost, Immunogenicity |