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CTRI Number  CTRI/2022/04/041792 [Registered on: 11/04/2022] Trial Registered Prospectively
Last Modified On: 15/11/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Vaccine 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study to evaluate Immunogenicity and Safety of a Booster Dose of Sputnik Light Vector Vaccine for prevention of COVID-19 Indian Subjects. 
Scientific Title of Study   A Phase III, Randomized, Open label, Multicentre Clinical Study in Parallel Assignment to Evaluate Immunogenicity and Safety of a Booster Dose of Sputnik Light Vector Vaccine against COVID-19 in Adult Indian Subjects. 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
DRL-SLB-007, Version: 4.2 Dated 07 Jun 2022  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Piyush Agarwal 
Designation  Head Clinical Development, Global Clinical Management, IPDO 
Affiliation  Dr Reddy’s Laboratories Limited 
Address  Integrated Product Development, Innovation Plaza, Survey No 42, 45 & 46, Bachupally Village, Bachupally Mandal, Medchal-Malkajgiri District, Hyderabad – 500 090, Telangana, India.

Hyderabad
TELANGANA
500090
India 
Phone  9619097755  
Fax    
Email  piyushagarwal@drreddys.com  
 
Details of Contact Person
Scientific Query

Modification(s)  
Name  Dr Sonika Newar 
Designation  General Manager- Medical Monitoring and Safety 
Affiliation  JSS Medical Research Asia Pacific Pvt. Ltd. 
Address  Tower 2, 1st Floor, South Wing, L&T Business Park, Plot no 12/4 , Sector 27 D, Near Sarai Khawaja Metro Station, Delhi Mathura Road, Faridabad -121003, Haryana, India

Faridabad
HARYANA
121003
India 
Phone  8800799887  
Fax    
Email  sonika.newar@jssresearch.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jayashri Krishnan 
Designation  Director - Operations 
Affiliation  JSS Medical Research Asia Pacific Pvt. Ltd. 
Address  Tower 2, 1st Floor, South Wing, L&T Business Park, Plot no 12/4 , Sector 27 D, Near Sarai Khawaja Metro Station, Delhi Mathura Road, Faridabad -121003, Haryana, India

Faridabad
HARYANA
121003
India 
Phone  9771407484  
Fax    
Email  jayashri.krishnan@jssresearch.com  
 
Source of Monetary or Material Support  
Dr. Reddy’s Laboratories Limited, Integrated Product Development, Innovation Plaza, Survey No 42, 45 & 46, Bachupally Village, Bachupally Mandal, Medchal-Malkajgiri District, Hyderabad – 500 090, Telangana, India. 
 
Primary Sponsor  
Name  Dr Reddys Laboratories Limited 
Address  Integrated Product Development, Innovation Plaza, Survey No 42, 45 & 46, Bachupally Village, Bachupally Mandal, Medchal-Malkajgiri District, Hyderabad – 500 090, Telangana, India. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 8  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Himanshu Pophale  Ace Hospital & research centre  No. 32/2A, Gulwani Maharaj road, Erandwane, Pune 411004
Pune
MAHARASHTRA 
9503939461

himanshupophale@yahoo.co.in 
Dr S V Deshpande  Ashirwad Hospital & research centre  Maratha Section, Near Jijamata Udyan, Ulhasnagar – 421005, Thane. Maharashtra, India
Thane
MAHARASHTRA 
9822017445

writetoshrikant@rediffmail.com 
Dr Krishna Giri  Dhadiwal hospital In coalition with shreeji health care  Opp.New CBS (Thakkers Buzrr) Trimbak Road, Nashik-422002
Nashik
MAHARASHTRA 
9975753763

drkrigiri@gmail.com 
Dr Anil Kumar Pandey  ESIC Medical College & Hospital  NH-3, NIT Faridabad - 121001, Haryana, India
Faridabad
HARYANA 
7042918222

drpandeyak@yahoo.co.in 
Dr Viny Kantroo  Indraprastha Apollo Hospitals  Room No 1221,2 floor, DPD block, Indraprastha Apollo Hospitals, Sarita Vihar Mathura Road, New Delhi- 110076
New Delhi
DELHI 
9811120777

vinykantroo@gmail.com 
Dr Prathibha Pereira  JSS Hospital  Dept. of Geriatrics, 1st Floor, Room No. 1001, JSS Hospital, Mahatma Gandhi Road, Ramachandra Agrahara, Mysuru- 570004, Karnataka
Mysore
KARNATAKA 
9448282506

ppatt08@gmail.com 
Dr Manish Kumar Jain  Maharaja Agrasen Superspeciality Hospital  Room Number: 09, Basement, Main Building, Clinical Research Department, Maharaja Agrasen Superspeciality Hospital Central Spine, Agrasen Aspatal Marg Sector 7, Vidhyadhar Nagar, Jaipur, Rajasthan - 302039 India
Jaipur
RAJASTHAN 
9414414834

doctormanishjain2@gmail.com 
Dr Subhrojyoti Bhowmick  Peerless Hospitex Hospital and Research center Ltd  360, Panchasayar, Kolkata-700094, India.
Kolkata
WEST BENGAL 
9830204863

drsubhro@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 8  
Name of Committee  Approval Status 
AMAI Trust ACE Hospital IEC, Ace Hospital & Research Centre, No. 32/2A, Gulwani Maharaj road, Erandwane, Pune 411004  Approved 
Ashirwad Ethics Committee, Ashirwad Hospital & Research Centre, Maratha Section, Near Jijamata udyan, Ulhasnagar – 421005,Thane, Maharashtra, India.  Approved 
Clinical Research Ethics Committee, Peerless Hospitex Hospital and Research center Ltd. Peerless Hospitex Hospital and Research center Ltd, 360, Panchasayar, Kolkata-700094, India.  Approved 
IEC, Maharaja Agrasen Hospital, Maharaja Agrasen Superspecialty Hospital, Central Spine, Agrasen Aspatal Marg, Sector 7, Vidyadhar nagar, Jaipur - 302039  Approved 
Institutional Ethics Committee JSS Medical College, JSS Medical College and Hospital, Sri Shivarathreeshwara Nagar, Mysuru (Mysore), Karnataka - 570015 India  Approved 
Institutional Ethics Committee, ESIC Medical College & Hospital, NH-3, NIT Faridabad - 121001, Haryana, India  Approved 
Institutional Ethics Committee- Clinical Studies, Indraprastha Apollo Hospitals, Sarita Vihar, Mathura Road, New Delhi-110076  Approved 
Shree Institutional Ethics committee, Dhadiwal hospital In coalition with shreeji health care, Opp.New CBS (Thakkers Buzrr) Trimbak Road, Nashik-422002  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Prevention of SARS-CoV-2 Infection 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  COVAXIN  Whole Virion, Inactivated Coronavirus (SARS-CoV-2) Antigen (Strain: NIV-2020-770) ... 6 μg 
Comparator Agent  COVISHIELD  (ChAdOx1-S [recombinant]) 5 x 1010 viral particles (not less than 2.5 x 108 infectious units) 
Intervention  Sputnik-Light Vector Vaccine  Recombinant adenovirus serotype 26 particles containing the SARS-CoV-2 protein S gene, in the amount of (1.0±0.5) х 1011 particles per dose. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Subjects will be enrolled in the study if they meet all the following criteria.
1. Male and female aged ≥ 18 years
2. Subject who had recieved primary vaccination (both doses completed) with either
a. COVAXIN (Group 1) OR
b. COVISHIELD (Group 2)
Where last dose of primary vaccination was taken 6-7 months prior to the screening visit
3. Subjects who are determined by medical/surgical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study
4. If the subject had COVID-19 after primary vaccination, that subject should have passed 3 months after being asymptomatic or RT-PCR negative
5. Negative COVID-19 Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) test result at the screening visit
6. Consent for using effective methods of contraception during the entire trial and 3 months after its completion
7. No evidence of pronounced vaccine-induced reactions or complications after receiving immunobiological products in medical history
8. No acute infectious and/or respiratory diseases within at least 14 days before the enrollment
 
 
ExclusionCriteria 
Details  Subjects will be entered into the study only if they meet none of the following criteria.
1. Prior receipt of any COVID-19 vaccine in less than 6 months of duration
2. Currently receiving or have received (in last 4 weeks) medication intended to prevent COVID-19 except for multi-vitamin supplements
3. Receipt of steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products within 30 days prior to enrollment
4. Pregnancy or breast-feeding
5. Tuberculosis, chronic systemic infections associated with immunocompromised subjects in medical history
6. History of severe allergic reaction to drug or vaccine (anaphylactic shock, or other life-threatening allergic reactions), acute exacerbation of allergic diseases on screening and randomization day
7. Chronic immune disease or systemic collagenosis in medical history
8. Subjects who received transplantation and on immunosuppressive therapy
9. Other immunosuppressive therapy (other than steroids) that completed less than three months prior to randomization into the study
10. Splenectomy in the past medical history
11. Subjects with oncological disease within 5 years prior to inclusion into the study
12. Neutropenia (absolute number of neutrophils less than <1000/mm2), agranulocytosis, severe anemia (hemoglobin < 8 g/l)
13. Significant loss of blood, Immunodeficiency in the medical history within 6 months before the enrolment
14. Active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis B, or C
15. Acute Kidney injury or dialysis
16. Anorexia or Malnutrition
17. Tattoos or scars at the injection site (deltoid muscle area), which in the medical opinion of the investigator does not allow assessing the local response to the study vaccine administration
18. Alcohol or Drug addiction in medical history
19. Participation in other interventional clinical trial within the previous 90 days prior to enrolment and over duration of the trial
20. Any other condition that the study physician considers as a barrier to the trial completion as per the protocol 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To show the non-inferiority between Sputnik Light Booster vs Covaxin and Covishield as booster in terms of:
• Proportion of subjects achieving ≥2-fold increase in neutralizing antibodies at Day 28 from baseline 
Day 28 from baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To show the non-inferiority between Sputnik Light Booster vs Covaxin and Covishield as booster in terms of:
• GMT and GMFR for SARS-CoV-2 glycoprotein specific antibody on days 28, 90 and 180
• GMT and GMFR for SARS-CoV-2 Virus neutralizing antibody on days 28, 90 and 180 
Day 28, 90 and 180 
• Proportion of subjects achieving ≥2-fold increase in SARS-CoV-2 glycoprotein specific antibodies at Day 28 from baseline
• CD4/CD8 lymphoproliferation after RBD stimulation on day 28
• Interferon gamma induction after RBD stimulation on day 28 
Day 28 from baseline 
 
Target Sample Size   Total Sample Size="580"
Sample Size from India="580" 
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)   17/04/2022 
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="0"
Months="6"
Days="7" 
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 III study to evaluate the immunogenicity and safety of a booster dose of Sputnik Light Vector Vaccine. The study participants will be adult subjects (including those at high risk or with comorbid conditions) who are fully vaccinated against COVID-19 with either Covaxin or Covishield and received last dose of primary vaccination 6 - 7 months prior to screening.

Approximately 580 subjects will be enrolled and the enrolment will be competitive: 290 subjects with Covaxin as primary vaccination and 290 subjects with Covishield as primary vaccination. Subjects in each primary vaccination group will be randomized in 1:1 ratio to receive a booster dose with Sputnik light vector vaccine (heterologous booster) or homologous boosting with their respective primary vaccine.

Thus, Sputnik light Booster Group will include 290 subjects who would have received Covaxin (n=145) or Covishield (n=145) as primary vaccination (both doses).

Whereas Homologous booster Group will include 290 subjects; of which 145

would be Covaxin primed and receive Covaxin as booster and remaining 145

would be Covishield primed and would receive Covishield as booster.

All study subjects will receive 1 booster dose of respective vaccine as per their randomization arm on Day 1. 
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