| CTRI Number |
CTRI/2022/04/042017 [Registered on: 21/04/2022] Trial Registered Prospectively |
| Last Modified On: |
30/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to check the effect of Covovax vaccine when administered as booster dose in adults in India who have already received two doses of COVID-19 vaccines |
|
Scientific Title of Study
|
A phase 3, observer-blind, randomized, controlled study to evaluate the safety and immunogenicity of a booster dose of COVOVAX in Indian adults who have received primary vaccination against COVID-19 |
| Trial Acronym |
COVOVAX-Booster |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| COVOVAX-Booster Version No. 4.0 Dated 21 April 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasad Kulkarni |
| Designation |
Executive Director |
| Affiliation |
Serum Institute of India Private Limited |
| Address |
Serum Institute of India Private Limited
212/2, Hadapsar, Pune – 411028, India
Pune
MAHARASHTRA
411028
India |
| Phone |
00912071946820 |
| Fax |
00912026993945 |
| Email |
drpsk@seruminstitute.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasad Kulkarni |
| Designation |
Executive Director |
| Affiliation |
Serum Institute of India Private Limited |
| Address |
Serum Institute of India Private Limited
212/2, Hadapsar, Pune – 411028, India
Pune
MAHARASHTRA
411028
India |
| Phone |
00912071946820 |
| Fax |
00912026993945 |
| Email |
drpsk@seruminstitute.com |
|
|
Source of Monetary or Material Support
|
| Serum Institute of India Private Limited, Pune |
|
|
Primary Sponsor
|
| Name |
Serum Institute of India Private Limited Pune |
| Address |
Serum Institute of India Private Limited
212/2, Hadapsar, Pune – 411028, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hira Lal Bhalla |
All India Institute of Medical Sciences, Gorakhpur |
Department of
Pharmacology, All India
Institute of Medical
Sciences, Department
of Pharmacology,
Gorakhpur, Uttar
Pradesh - 273008
Gorakhpur
UTTAR PRADESH |
05512205572
hirabhalla@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
Satara
MAHARASHTRA |
00912024364308
researchpedpune@gmail.com |
| Dr Srikanth Tripathy |
Dr. D. Y. Patil Medical college, Hospital And Research Centre, Pune |
Medical Research Department,
Dr. D. Y. Patil Medical College, Hospital And Research Centre,
Sant Tukaram Nagar, Pimpri, Pune, Maharashtra-411018, India
Pune
MAHARASHTRA |
020-27805100
srikanthtripathy@gmail.com |
| Dr Sunil Kohli |
Hamdard Institute of Medical Sciences and Research, New Delhi |
Department of Medicine, Room No110, Block B, Hamdard Institute of Medical Sciences and Research with Centre for health Research and Development(CHRD),Society for Apllied Studies(SAS), Guru Ravidas Marg, Hamdard Nagar, New Delhi-110062
New Delhi
DELHI |
01126059688
drskohli.himsr@gmail.com |
| Dr Praveen Kulkarni |
JSS Academy of Higher Education and Research, Mysore |
Department of Community Medicine,
JSS Medical College, JSS Hospital, Mahatma Gandhi Road, Mysuru – 570004
Karnataka, India
Mysore
KARNATAKA |
08212335555
prakulfi@gmail.com |
| Dr Sonali Kar |
Kalinga Institute of Medical Sciences, Bhubaneswar |
Department of Community Medicine, Kalinga Institute of Medical Sciences, Kushabhadra Campus, KIIT Campus, 5, KIIT Road, Patia, Bhubaneswar, Odisha 751024
Khordha
ORISSA |
0674-2725708
sonsam72@yahoo.co.uk |
| Dr Aditi Apte |
KEM Hospital Research Centre Manchar |
KEM Hospital Research Centre-Community Health Research Unit
Third Floor, Shrivinayak Hospital, Mulewadi Road
P.O Manchar, Taluka Ambegaon
District- Pune. 410503, Maharashtra, India
Pune
MAHARASHTRA |
020-26065603
dr.aditiapte@gmail.com |
| Dr S K Raut |
Noble Hospitals Pvt. Ltd., Pune |
Noble Hospital Pvt. Ltd.,
153/A, Magarpatta City Road,
Hadapsar, Pune 411013, Maharashtra, India
Pune
MAHARASHTRA |
02066285120
skraut01@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| Ethics Committee, Dr. D. Y. Patil Vidyapeeth, Pune |
Submittted/Under Review |
| Institutional Ethics Committee Bharati Vidyapeeth Deemed University, Pune |
Submittted/Under Review |
| Institutional Ethics Committee, HIMSR and Associated HAH Centenary Hospital, New Delhi |
Submittted/Under Review |
| Institutional Ethics Committee, JSS Medical College, Mysore |
Submittted/Under Review |
| Institutional Ethics Committee, Kalinga Institute of Medical Sciences, Bhubneswar |
Approved |
| Institutional Human Ethics Committee All India Institute Of Medical Sciences, Gorakhpur |
Submittted/Under Review |
| KEM Hospital and Research center ethics committee |
Approved |
| Noble Hospital Institutional Ethics Committee, Pune |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Prevention of COVID-19 infection |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
COVAXIN |
COVAXIN (Whole Virion Inactivated Coronavirus (SARS-CoV-2) Vaccine) is a white to off white, opalescent suspension free from
extraneous particles containing 6 μg of Whole Virion, Inactivated
(SARS-CoV-2) Antigen (strain NIV-2020-770).
Manufacturer- Bharat Biotech International Limited
Dose: 0.5 mL
Frequency: Single dose
Route of administration: Intramuscular |
| Comparator Agent |
COVISHIELD |
COVISHIELD (ChAdOx1 nCoV-19 Corona Virus Vaccine (Recombinant))
One dose (0.5 ml) contains:
ChAdOx1 nCoV- 19 Corona Virus Vaccine (Recombinant) 5 × 1010
virus particles (vp)
Recombinant, replication-deficient chimpanzee adenovirus vector encoding
the SARS-CoV-2 Spike (S) glycoprotein. Produced in genetically modified
human embryonic kidney (HEK) 293 cells.
Manufacturer- Serum Institute of India Pvt. Ltd.
Dose: 0.5 mL Frequency: Single dose Route of administration: Intramuscular |
| Intervention |
COVOVAX [SARS-CoV-2 recombinant spike protein nanoparticle vaccine
(SARS-CoV-2 rS) with Matrix-M1™ adjuvant] |
Single dose of 0.5 mL contains 5 μg antigen and 50 μg Matrix-M1 adjuvant.
Dose: 0.5 mL
Frequency: Single dose
Route of administration: Intramuscular |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged more than or equal to 18 years of either sex
2. Written informed consent by participants
3. Those who have completed primary COVID-19 vaccination schedule with at least 6 months ago
4. 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 at the time of screening
2. History of laboratory confirmed COVID-19
3. History of allergic reactions after previous vaccinations including primary vaccination for COVID-19
4. Have any bleeding disorder which is considered as a contraindication to intramuscular injection or blood draw
5. Suspected or known current alcohol or drug dependence
6. Chronic administration of immunosuppressant or other immune-modifying drugs within three months prior to the study vaccination or planned use throughout the study period
7. Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months or planned use throughout the study period
8. Administration of any vaccine within 28 days prior to enrolment in the study or planned administration of any vaccine for until 28 days after study vaccination
9. Prior receipt of a booster dose of COVID-19 vaccine
10. Pregnant or breast-feeding
11. Acute or chronic, clinically significant systemic disorders
12. Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the participant in the study or make it unlikely that the participant could complete the protocol |
|
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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 |
| Anti-S IgG and Neutralizing antibodies |
28 days after vaccination |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Occurrence of solicited local and systemic adverse events (AEs) for 7 days post-vaccination |
7 days post-vaccination |
| Occurrence of unsolicited AEs for 28 days post-vaccination |
28 days post-vaccination |
| Occurrence of SAEs, and adverse events of special interest (AESI) throughout the study duration following vaccination |
180 Days Post Vaccination |
| Anti-S IgG and Neutralizing antibodies |
at Day 91 and Day 181 |
|
|
Target Sample Size
|
Total Sample Size="372"
Sample Size from India="372"
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 3 |
|
Date of First Enrollment (India)
|
25/04/2022 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
NA |
|
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 3, observer-blinded, randomised, active controlled study in adults of more than or equal to 18 years of age in India who have already received primary vaccination against COVID-19 at least 6 months ago (6 months or 180 days from the second dose), to evaluate the immunogenicity and safety of the COVOVAX booster dose in comparison with the control vaccine. A total of 372 eligible participants of ≥ 18 years of age who have completed primary 2 dose schedule of COVID-19 vaccination at least 6 months ago will be enrolled in this study in 2 cohorts of 186 participants each with 1:1 allocation to COVOVAX or control vaccine. Two cohorts of 186 participants each will be as below: 1. COVISHIELD Prime cohort: Primary vaccination with two doses of COVISHIELD 2. COVAXIN Prime cohort: Primary vaccination with two doses of COVAXIN |