| CTRI Number |
CTRI/2022/06/043365 [Registered on: 20/06/2022] Trial Registered Prospectively |
| Last Modified On: |
17/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Vaccine |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Trial to evaluate single
booster dose of ZyCoV-D of M/s Zydus
Lifesciences Limited in adult subjects already
vaccinated with 2 doses of Covaxin or Covishield |
|
Scientific Title of Study
|
A prospective, randomized, open label, active
controlled, multicenter, phase III clinical study to
evaluate the immunogenicity and safety of single
booster dose of ZyCoV-D of M/s Zydus
Lifesciences Limited in adult subjects already
vaccinated with 2 doses of Covaxin or Covishield |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 22-04, Version no. 01, Date: 30/05/2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravindra Mittal |
| Designation |
Medical Advisor & Head - Regulatory Affairs |
| Affiliation |
Zydus Lifesciences Limited (Formerly Known as Cadila Healthcare Limited) |
| Address |
Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj
(Gandhinagar), Nr. Vaishnodevi Circle, S.G. Highway, Ahmedabad
Ahmadabad
Ahmadabad
GUJARAT
382481
India |
| Phone |
079-48041430 |
| Fax |
|
| Email |
r.mittal@zyduslife.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayesh Sanmukhani |
| Designation |
Deputy General Manager - New Product Development |
| Affiliation |
Zydus Lifesciences Limited (Formerly Known as Cadila Healthcare Limited) |
| Address |
Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj
(Gandhinagar), Nr. Vaishnodevi Circle, S.G. Highway, Ahmedabad
Ahmadabad
Ahmadabad
GUJARAT
382481
India |
| Phone |
7600012192 |
| Fax |
|
| Email |
jayeshsanmukhani@zyduslife.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayesh Sanmukhani |
| Designation |
Deputy General Manager - New Product Development |
| Affiliation |
Zydus Lifesciences Limited (Formerly Known as Cadila Healthcare Limited) |
| Address |
Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj
(Gandhinagar), Nr. Vaishnodevi Circle, S.G. Highway, Ahmedabad
Ahmadabad
GUJARAT
382481
India |
| Phone |
7600012192 |
| Fax |
|
| Email |
jayeshsanmukhani@zyduslife.com |
|
|
Source of Monetary or Material Support
|
| Zydus Lifesciences Limited (Formerly Known as Cadila Healthcare
Limited),Zydus Corporate Park, Scheme No. 63, Survey
No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi
Circle, S.G. Highway, Ahmedabad – 382481,
Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Zydus Lifesciences Limited |
| Address |
Zydus Lifesciences Limited (Formerly Known as Cadila Healthcare
Limited),Zydus Corporate Park, Scheme No. 63, Survey
No. 536, Khoraj (Gandhinagar), Nr. Vaishnodevi
Circle, S.G. Highway, Ahmedabad – 382481,
Gujarat, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chintan Patel |
Aatman Hospital |
Basement, Research
Room, Aatman
Hospital, 5, Anveshan
Row House, Opp
Umiya Mata Mandir,
Bopal-Ghuma Road,
Bopal, Ahmedabad -
380058
Ahmadabad
GUJARAT |
9825182251
cr.aatman@gmail.com |
| Dr Chandramani Singh |
All India Institute of Medical Science |
All India Institute of Medical Science, Patna, Bihar – 801507
Patna
BIHAR |
7906261455
info@cmsclinical.com |
| Dr Sunil Naik |
Government Medical College & Govt. General Hospital (Old RIMSGGH) |
Government Medical College &
Govt. General Hospital (Old RIMSGGH),
Srikakulam-532001, Andhra Pradesh, India
Srikakulam
ANDHRA PRADESH |
8942279033
rimsresearch@gmail.com |
| Dr Suresh G Bhate |
Jeevan Rekha Hospital |
Clinical Research
Department, Second
Floor, Jeevan Rekha
Hospital, Dr. B.R.
Ambedkar Road Opp
Civil Hospital Belagavi
(Belgaum)
Belgaum
KARNATAKA |
9866330090
jrhclinicalresearch@gmail.com |
| Dr Manish Kumar Jain |
Maharaja Agrasen Superspeciality Hospital |
Research
Room, Basement, Maharaja
Agrasen Hospital
Superspeciality
Hospital, Central Spine,
Agrasen Aspatal Marg,
Sector 7, Vidyadhar
Nagar, Jaipur - 302039
Jaipur
RAJASTHAN |
9414414834
doctormanishjain2@gmail.com |
| DR ABHISHEK KARMALKAR |
Vedant Multispecialty Hospital |
Vedant Multispecialty Hospital, GP 83.Opp. to Rotary Club, Sambhaji Nagar
MIDC Chinchwad, Pune-411019.
Pune
MAHARASHTRA |
9970004295
drkarmalkar.vedant@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Vedant Multispeciality Hospital |
Approved |
| Institutional Ethics Committee, Aatman Hospital, 5, Anveshan Row House, Opp Umiya Mata Mandir, Bopal-Ghuma Road, Bopal, Ahmedabad - 380058, Gujarat |
Approved |
| Institutional Ethics Committee, All India Institute of Medical Sciences, Phulwarisharif, Patna - 801507, Bihar |
Approved |
| Institutional Ethics Committee, Government Medical College & Government General Hospital (Old RIMSGGH) |
Approved |
| Institutional Ethics Committee, Jeevan Rekha Hospital, Dr. B.R. Ambedkar Road, Opp. Civil Hospital, Veer Chambers, Belagavi – 590002, Karnataka |
Approved |
| Institutional Ethics Committee, Maharaja Agrasen Hospital Superspeciality Hospital, Central Spine, Agrasen Aspatal Marg, Sector 7, Vidyadhar Nagar, Jaipur - 302039, Rajasthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Covaxin of M/s Bharat Biotech
Bharat Biotech International Ltd. |
Subjects will receive
0.5ml dose of Covaxin by intramuscular route in upper arm. Subjects will be given one dose only during the study. |
| Comparator Agent |
Covishield of M/s Serum Institute of
India Pvt. Ltd. |
Subjects will receive 0.5ml dose of Covishield by intramuscular route in upper arm. Subjects will be given one dose only during the study |
| Intervention |
ZyCoV-D - Novel Corona Virus-2019-nCov vaccine of M/s. Zydus Lifesciences Limited |
Subject will be administered single dose of 3mg once during the study. 3mg dose of ZyCoVD consists of 3 shots of 0.1ml each via intradermal route using Pharmajet Tropis device at three different sites on the upper arm (2 shots on one arm (recommended distance between two shots is at least 5 cms) and 1 shot on other arm) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects (healthy / high risk) of either gender ≥18 years of age
2. Subjects who have received 2 doses on Covaxin or Covishield with last dose 6 (+1)
months prior to screening date
3. Informed consent from subjects
4. Subjects literate enough to fill the diary card
5. Females of childbearing potential, must agree to use one of the approved contraception methods (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization), from screening until completion of the followup visit and males who agree to use contraception |
|
| ExclusionCriteria |
| Details |
1. Febrile illness (temperature ≥ 38°C or 100.4°F) or any acute illness or infection within
4 weeks of enrolment
2. History or laboratory evidence of confirmed SARS-CoV-2 infection after primary
vaccination or RTPCR positive for COVID-19 at the time of screening
3. Subjects who have received one or two doses of any approved or experimental
COVID-19 vaccine other than Covaxin or Covishield in past.
4. History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days
5. History of SARS/ MERS infection
6. Past history of hypersensitivity reaction or any serious adverse event after any
vaccination
7. Subjects with known history of thrombocytopenia or any coagulation disorder, or
subjects on anticoagulation therapy
8. Subjects with confirmed or suspected immunosuppressive or immunodeficiency
disorder; or subjects on any immunosuppressive or immunostimulant therapy
9. Clinically significant (uncontrolled) systemic disorder such as cardiovascular,
respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, haematological,
psychiatric or immunological disorder
10. Subjects administered blood, blood containing products or immunoglobulins within the
last 3 months or planned administration during the study
11. Any other vaccine administration within the last 30 days or planned to be administered
during 8 weeks after enrolment (upto day 56 of study)
12. Participation in another clinical trial in the past 3 months
13. Pregnant and lactating women
14. History of drug / alcohol abuse |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To establish non-inferiority of single 3mg booster dose of ZyCoV-D as compared to
Homologous booster (Covaxin) in terms of seroconversion rate (IgG by ELISA and
NAB) in subjects who have received Covaxin as primary vaccination
2. To establish non-inferiority of single 3mg booster dose of ZyCoV-D as compared to
Homologous booster (Covishield) in terms of seroconversion rate (IgG by ELISA and
NAB) in subjects who have received Covishield as primary vaccination |
Day 0, Day 28 and Day 168 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To establish non-inferiority of single 3mg booster dose of ZyCoV-D as compared to
homologous booster (Covaxin / Covishield) in terms of GMTs of IgG by ELISA and
NAB
2. To compare the long term persistence of IgG antibodies against S1 antigen (by ELISA)
at and Neutralizing antibodies 24 weeks after booster dose (Seroconversion rate and
GMTs) with ZyCoV-D and homologous booster (Covaxin / Covishield)
3. To compare cellular response after booster dose with ZyCoV-D and homologous
booster (Covaxin / Covishield)
|
Day 0, Day 28 and Day 168 |
1. Adverse events (solicited, unsolicited and SAEs) reported during the study ZyCoV-D
and homologous booster (Covaxin / Covishield) |
Throughout the Study |
|
|
Target Sample Size
|
Total Sample Size="576"
Sample Size from India="576"
Final Enrollment numbers achieved (Total)= "576"
Final Enrollment numbers achieved (India)="576" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
23/06/2022 |
| Date of Study Completion (India) |
13/01/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The current study is being planned To establish non-inferiority of single 3mg booster dose of ZyCoV-D against homologous booster dose of Covaxin / Covishield in terms of immunogenicity (IgG ELISA and Neutralization antibodies) in subjects who have already received 2 doses of Covaxin / Covishield. subjects who have already received 2 doses of Covaxin or Covishield will be randomized in this clinical trial to receive either ZyCoV-D or Homologous
Booster (Covaxin / Covishield) in 1:1 ratio. enrolled subjects will be divided in to 2 groups based on the vaccine received by them earlier, Covaxin or Covishield. Equal number of subjects will be enrolled in each of
these 2 groups. Subjects will be followed for 168 days after vaccination. Blood samples will be taken at Day 0, 28 and 168 for immunogenicity analysis.
|