CTRI Number |
CTRI/2020/08/027170 [Registered on: 15/08/2020] Trial Registered Prospectively |
Last Modified On: |
26/12/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Vaccine |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Study to check the safety and immune response of a COVID-19 vaccine in healthy Indian adults. |
Scientific Title of Study
|
A Phase 2/3, Observer-Blind, Randomized, Controlled Study to Determine the Safety and Immunogenicity of Covishield (COVID-19 Vaccine) in Healthy Indian Adults |
Trial Acronym |
ICMR/SII-COVISHIELD |
Secondary IDs if Any
Modification(s)
|
Secondary ID |
Identifier |
ICMR/SII-COVISHIELD Version 4.0 dated 14 Oct 2020 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
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Designation |
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Affiliation |
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Address |
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Phone |
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Fax |
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Email |
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Details of Contact Person Scientific Query
|
Name |
Dr Prasad Kulkarni |
Designation |
Medical Director |
Affiliation |
Serum Institute of India Private Limited |
Address |
Serum Institute of India Private Limited,
212/2, Hadapsar, Pune – 411 028, India
Pune MAHARASHTRA 411028 India |
Phone |
00912026602949 |
Fax |
00912026993945 |
Email |
drpsk@seruminstitute.com |
|
Details of Contact Person Public Query
|
Name |
Dr Prasad Kulkarni |
Designation |
Medical Director |
Affiliation |
Serum Institute of India Private Limited |
Address |
Serum Institute of India Private Limited,
212/2, Hadapsar, Pune – 411 028, India
Pune MAHARASHTRA 411028 India |
Phone |
00912026602949 |
Fax |
00912026993945 |
Email |
drpsk@seruminstitute.com |
|
Source of Monetary or Material Support
|
Indian Council of Medical Research (ICMR)
V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, INDIA |
Serum Institute of India Private Limited 212/2, Hadapsar, Pune – 411 028, India |
|
Primary Sponsor
|
Name |
Serum Institute of India Private Limited |
Address |
212/2, Off Soli Poonawalla Road, Hadapsar,
Pune – 411 028, India |
Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
|
Name |
Address |
Indian Council of Medical Research ICMR |
V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, INDIA |
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
No of Sites = 14 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr B Devi Madhavi |
Andhra Medical College, Visakhapatnam |
Department of Community Medicine
Andhra Medical College
Maharani Peta, Visakhapatnam, Andhra Pradesh 530002, India Visakhapatnam ANDHRA PRADESH |
918912712258
drdevimadhavi@rediffmail.com |
Dr Muralidhar Tambe |
B J Medical College and Sassoon General Hospital, Pune |
B J Medical College and Sassoon General Hospital,
Jai Prakash Narayan Road,
Pune Railway Station, Pune,
Maharashtra 411001, India Pune MAHARASHTRA |
912026128000
muralidhartambe@gmail.com |
Dr Sanjay Lalwani |
Bharati Vidyapeeth Deemed University Medical College and Hospital, Pune |
Department of Pediatrics Bharati Vidyapeeth Deemed University Medical College and Hospital, Dhankawadi, Pune- Satara Road, Pune- 411043, Maharashtra, India Pune MAHARASHTRA |
912024364308
researchpedpune@gmail.com |
Dr Sushant Meshram |
Government Medical College, Nagpur |
Department of Respiratory Medicine,
Government Medical College,
Near Hanuman Nagar,
Nagpur, Maharashtra 440009 Nagpur MAHARASHTRA |
917122744671
drsushant.in@gmail.com |
Dr T S Selvavinayagam |
Institute of Community Medicine, Madras |
Institute of Community Medicine, Madras Medical College, Old Central Jail Campus, Park Town, Chennai- 600 003, Tamil Nadu, India Chennai TAMIL NADU |
914425305000
drsvinayagam@gmail.com |
Dr Kiranjit Singh |
Jehangir Hospital, Pune |
Jehangir Clinical Development Center,
Jehangir Hospital premises,
32 Sassoon Road,
Pune 411 001,
Maharashtra, India Pune MAHARASHTRA |
912066819999
startup@jcdc.co.in |
Dr Praveen Kulkarni |
JSS Academy of Higher Education and Research, Mysore |
Department of Community Medicine,
JSS Academy of Higher Education and Research
Bannimantap Road, Sri Shivarathreeshwara Nagara, Bannimantap A Layout, Bannimantap, Mysore, Karnataka 570015, India Mysore KARNATAKA |
918212548416
prakulfi@gmail.com |
Dr Ashish Bavdekar |
KEM Hospital Research Centre, Vadu |
Department of Paediatrics, KEM Hospital Research Centre
Vadu Rural Health Program,
Vadu Budruk, Taluka Shirur, Pune - 412216, Maharashtra, India Pune MAHARASHTRA |
020-66037342
a.bavdekar@kemhrcpune.org |
Dr B S Garg |
Mahatma Gandhi Institute of Medical Sciences, Sewagram |
Department of Community Medicine,
Dr Sushila Nair School of Public Health
Mahatma Gandhi Institute of Medical Sciences,
Sewagram, Wardha, Maharashtra 442102 Wardha MAHARASHTRA |
917152284341
bsgarg@mgims.ac.in |
Dr Madhu Gupta |
Post Graduate Institute of Medical Education & Research (PGIMER) |
Department of Community Medicine and School of Public Health, Post Graduate Institute of Medical Education & Research (PGIMER), Sector -12, Chandigarh- 160012 Punjab, India Chandigarh CHANDIGARH |
911722755223
madhugupta21@gmail.com |
Dr Krishna Pandey |
Rajendra Memorial Research Institute of Medical Sciences, Patna |
Rajendra Memorial Research Institute of Medical Sciences
(Indian Council of Medical Research) Department of Health Research, Ministry of Health & Family Welfare, Govt of India, Agamkuan, Patna-800007, Bihar, India Patna BIHAR |
916122245744
drkrishnapandey@yahoo.com |
Dr Nithya Gogtay |
Seth G. S. Medical College and KEM Hospital, Mumbai |
Department of Clinical Pharmacology,
Seth G. S. Medical College and KEM Hospital Acharya Donde Marg, Parel East, Parel, Mumbai, Maharashtra 400012, India Mumbai MAHARASHTRA |
00912224133767
njgogtay@hotmail.com |
Dr Ramkrishnan |
Sri Ramchandra Institute of Higher Education and Research, Chennai |
Sri Ramchandra Institute of Higher Education and Research,
No. 1, Ramchandra Nagar,
Porur, Chennai, Tamil Nadu 600116 Chennai TAMIL NADU |
00914445928916
srmcclinicalresearch@gmail.com |
Dr Renuka Munshi |
TN Medical College & BYL Nair Hospital, Mumbai |
TN Medical College & BYL Nair Hospital, 5th floor, Department of Clinical Pharmacology,
TN Medical College & BYL Nair Hospital,
Dr. AL Nair Road, Mumbai Central, Mumbai, Maharashtra 400008 Mumbai MAHARASHTRA |
02223027000
renuka.munshi@gmail.com |
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Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 14 |
Name of Committee |
Approval Status |
Mahatma Gandhi Institute of Medical Sciences, Institutional Ethics Commitee, Sewagram |
Approved |
Ethics Committee Jehangir Clinical Development Center Pvt.Ltd, Pune |
Approved |
Ethics Committee Rajendra Memorial Research Institute of Medical Sciences, Patna |
Approved |
IEC King George Hospital, Visakhapatnam |
Approved |
Institutional Ethics Committee - TNGMSSH, Chennai |
Approved |
Institutional Ethics Committee of B. J. Government Medical College and Sassoon General Hospital, Pune |
Approved |
Institutional Ethics Committee Seth GS Medical College and KEM Hospital, Mumbai. |
Approved |
Institutional Ethics Committee Sri Ramachandra Institute of Higher Education and Research, Chennai |
Approved |
Institutional Ethics Committee, BVDU, Pune |
Approved |
Institutional Ethics Committee, Government Medical College, Nagpur |
Approved |
Institutional Ethics Committee, JSS Medical College, Mysore |
Approved |
Institutional Ethics Committee, PGIMER, Chandigarh |
Approved |
Institutional Ethics Committee, T N Medical College & BYL Nair Hospital, Mumbai |
Approved |
KEM Hospital Research Centre Ethics Committee, Pune |
Approved |
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Regulatory Clearance Status from DCGI
Modification(s)
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Prevention of COVID-19 infection |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Covishield (SII-ChAdOx1 nCoV-19) |
Covishield will be administered as 2 dose schedule on Days 1 and 29 as 0.5 ml dose intramuscularly. |
Comparator Agent |
Oxford/AZ-ChAdOx1 nCoV-19 vaccine |
Oxford/AZ-ChAdOx1 nCoV-19 vaccine will be administered as 2 dose schedule on Days 1 and 29 as 0.5 ml dose intramuscularly. |
Comparator Agent |
Placebo |
Placebo will be administered as 2 dose schedule on Days 1 and 29 as 0.5 ml dose intramuscularly. |
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Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
99.00 Year(s) |
Gender |
Both |
Details |
1. Healthy adults aged more than or equal to 18 years of either sex.
2. Written informed consent by participants.
3. The participant is resident of the study area and is willing to comply with study protocol requirements.
4. Healthy, as determined by medical history and physical examination.
5. Female participants of childbearing potential must have a negative urine pregnancy test within 24 hours prior to study vaccine administration. |
|
ExclusionCriteria |
Details |
1. Acute illness with or without fever at the time of study vaccine administration
2. History of laboratory confirmed COVID-19 disease in household contact or close workplace contact
3. IgG seropositivity to SARS-CoV-2
4. History or currently positive for SARS-CoV-2 by RT-PCR
5. History of severe allergic reactions after previous vaccinations or hypersensitivity to any component of study vaccines
6. Any confirmed or suspected condition with impaired/altered function of immune system |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Centralized |
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1. Occurrence of causally related SAEs throughout the study duration following vaccination
2. Ratio of GMTs
of anti-S IgG antibodies |
1. Throughout the study duration following vaccination
2. 28 days after the second
vaccination |
|
Secondary Outcome
|
Outcome |
TimePoints |
Occurrence of solicited local and/or systemic adverse events (AEs) |
7 days following each vaccination |
Occurrence of unsolicited adverse events |
28 days following each vaccination |
Occurrence of serious adverse events (SAEs) |
Throughout the study duration following vaccination |
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Target Sample Size
|
Total Sample Size="1600" Sample Size from India="1600"
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 2/ Phase 3 |
Date of First Enrollment (India)
|
24/08/2020 |
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="0" Months="7" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
This is a Phase 2/3, observer-blind, randomised, controlled study in healthy adults in India, for comparison of the safety of COVISHIELD with Oxford/AZ-ChAdOx1 nCoV-19 and Placebo, and immunogenicity with Oxford/AZ-ChAdOx1 nCoV-19 in prevention of SARS CoV-2 infection. A total of 1600 eligible participants of more than or equal to 18 years of age will be enrolled the study. Of these 400 participants will be part of immunogenicity cohort and will be randomly assigned in a 3:1 ratio to receive either COVISHIELD or Oxford/AZ-ChAdOx1 nCoV-19, respectively. The remaining 1200 participants from safety cohort will be randomly assigned in a 3:1 ratio to receive either COVISHIELD or Placebo, respectively. |