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.
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.
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.
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
(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"
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.