CTRI/2023/09/057398 [Registered on: 11/09/2023] Trial Registered Prospectively
Last Modified On:
06/03/2024
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Vaccine
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A open label, active control, phase 2 clinical study to evaluate immunogenicity, safety and tolerability of single heterologous booster dose of Protein Subunit Vaccine against SARS-CoV-2 Virus.
Scientific Title of Study
Prospective, multi-center, randomized, open label, active control, phase 2 clinical study to evaluate immunogenicity, safety and tolerability of single heterologous booster dose of RelCoVax® (Protein Subunit Vaccine of Reliance Life Sciences against SARS-CoV-2 Virus) with Corbevax® (Protein Subunit Vaccine of Biological E Ltd. against SARS-CoV-2 Virus)
Trial Acronym
NA
Secondary IDs if Any
Secondary ID
Identifier
Protocol No:RLS/VAC/2023/01; Version:3.0, Dated: 30 Jun 2023
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Ajaykumar Yadav
Designation
Head - Clinical Research (overall Trial Coordinator)
Affiliation
Reliance Life Sciences Pvt. Ltd. (RLS)
Address
Reliance Life Sciences Pvt. Ltd. (RLS) Dhirubhai Ambani Life Sciences Centre (DALC) Plot R 282 TTC Area of MIDC Thane Belapur Road Rabale, Navi Mumbai
Thane MAHARASHTRA 400701 India
Phone
9820804218
Fax
Email
Ajaykumar2.Yadav@relbio.com
Details of Contact Person Scientific Query
Name
Dr Sachin Kagane
Designation
Medical Monitor
Affiliation
Reliance Life Sciences Pvt. Ltd. (RLS)
Address
Reliance Life Sciences Pvt. Ltd. (RLS), Dhirubhai Ambani Life Sciences Centre
(DALC)R-282, TTC Area of MIDC, Thane - Belapur Road, Rabale, Navi
Mumbai -
Thane MAHARASHTRA 400701 India
Phone
9987885679
Fax
Email
Sachin.Kagane@relbio.com
Details of Contact Person Public Query
Name
Vikram Jadhav
Designation
Project Manager
Affiliation
Reliance Life Sciences Pvt. Ltd. (RLS)
Address
Reliance Life Sciences Pvt. Ltd. (RLS), Dhirubhai Ambani Life Sciences Centre
(DALC)R-282, TTC Area of MIDC, Thane - Belapur Road, Rabale, Navi
Mumbai
Thane MAHARASHTRA 400701 India
Phone
9948664283
Fax
Email
Vikram.Jadhav@relbio.com
Source of Monetary or Material Support
Reliance Life Sciences Pvt. Ltd. (RLS), Dhirubhai Ambani Life
Sciences Centre(DALC), Plot R 282 TTC Area of MIDC, Thane Belapur Road Rabale, Navi Mumbai 400701, Maharashtra, India
Primary Sponsor
Name
Reliance Life Sciences Pvt Ltd RLS
Address
Dhirubhai Ambani Life Sciences Centre (DALC), Plot R 282 TTC Area ofMIDC, Thane Belapur Road Rabale, Navi Mumbai 400 701, Maharashtra,India
5th Floor, Department of pharmacology, Plot no. 2, Sector 5, Nerul, Navi Mumbai - 400706, Maharashtra, India Thane MAHARASHTRA
9930550009
deepak.langade@dypatil.edu
DrAkash Khobragade
Grant Government Medical College and Sir J.J. Group of Hospitals
2nd floor, Department of Pharmacology, Grant Government Medical College and Sir J.J. Group of Hospitals, JJ Marg, Nagpada, Mumbai – 400008, Maharashtra, India Mumbai MAHARASHTRA
9702658822
drakashk.research@gmail.com
Dr ShrikantVishnuDeshpande
Ashirwad Hospital and research Centre
3rd Floor, Department of Clinical research, Near JijamataUdyan, MarathaSection Ulhasnagar,420004
Thane
MAHARASHTRA Thane MAHARASHTRA
9822017445
writetoshrikant@rediffmail.com
DrPrachee Makashir
Bhrati Vidyapeeth (Deemed to be University) Medical College and Hospital
ground floor, Pediatric OPD Pune-Satara road, Pune - 4110577, Maharashtra, India
Pune MAHARASHTRA
9011073840
drprachee@gmail.com
Dr Swapnil Sakhala
Chopda Medicare & Research Center Pvt. Ltd: Magnum Heart Institude,
3rd floor, Department of clinical research, Laxman Rekha Apartment 3/5, Patil Lane No.1, Laxmi Nagar, Near K.B.H. Vidyalaya, Canada Corner,
Nashik - 4222005, Maharashtra India Nashik MAHARASHTRA
Ashirwad Ethics Committee Ashirwad Hospital and Research Centre Maratha Section, Near Jijamata Udyan Ulhasnagar Thane Thane Maharashtra - 421004 India
Approved
Ethics Committee Dr. D.Y Patil Vidyapeeth, Dr. D.y Patil Medical college and hospital and Research centre, Sant Tukaram Nagar Pimpri,Pune 411018
Approved
Ethics Committee Hira Mongi Navneet Hospital Mulund West Mumbai Valaji Ladha Road Mumbai Mumbai City Maharashtra - 400080 India
Approved
Ethics Committee Inamdar Multispeciality Hospital
Approved
ETHICS COMMITTEE OF TRAUMA CARE HOSPITAL
Not Applicable
IEC of New Health Care Nursing Home
Not Applicable
Institutional Ethics Committee - Human Research Lokmanya Tilak Municipal Medical College & General Hospital, Sion
Approved
Institutional Ethics Committee BVDU, Bharati Hospital & Research Centre, Bharati Hospital, Pune-Satara road, Dhankawadi, Pune - 411043, Maharashtra, India
Approved
Institutional Ethics Committee D Y Patil Medical College
Submittted/Under Review
Institutional Ethics Committee Masina Hospital Marg Byculla Mumbai
KEM Hospital research centre ethics Committee, sardar moodliar road, rasta peth, pune 41101
Approved
Magna-Care Ethica Committee, C/o Chopda medicare and research centre Pvt Lt; Magnum heart institute, Patil Lane no 1, Near K.B.H Vidyalaya, Canada Corner, Nashik-422005, Maharashtra India
Approved
O & P institutional committee, Oyster & Pearl Hospital (Phadnis Clinic Pvt Ltd) 1671 -75, ganeshkhind road shivajinagar Pune, 411005, Maharashtra, India
Approved
ORCHID SPECIALITY HOSPITAL ETHICS COMMITTEE Orchid Speciality Hospital, L-Square, Porwal Road Sr. No 282/3/3, Lohgaon, Pune Maharashtra - 411047 India
Approved
Penta-Med Ethics Committee Medipoint Hospitals Pvt.Ltd 241/1, New D.P.Road, Near Sai Heritage,Aundh Pune Pune Maharashtra - 411007 India
Approved
Rajarshree Chhatrapati Shahu Maharaj Govt. Medical College and Chhatrapati Pramila Raje Hospital, Kolhapur Institutional ethics Committee 2 (RCSMGMCIEC2).,Dasara Chowk, Bhausingji road, town hall, Kolhapur-416012 Maharashtra India
Approved
Shree Siddhivinayak Hospital Ethics Committee
Not Applicable
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Healthy Volunteers
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Biological E Ltd.’s (Corbevax®)
Subunit vaccine containing RBD protein adsorbed onto Aluminium Hydroxide. The formulation also contains CpG 1018 as adjuvant
Unit dose strength: 0.5 ml as a single booster dose at day 0
Dosage level:25 μg of RBD antigen of SARS-Cov-2
Route of administration: Intramuscular
Intervention
Reliance Life Sciences Pvt. Ltd.’s (RelCoVax®) (product code R-TPR-106)
Subunit vaccine containing RBD and Nucleocapsid proteins adsorbed onto Aluminum hydroxide. The formulation also contains CpG 1018 dinucleotide adjuvant
Unit dose strength: 0.5 ml as a single booster dose at day 0
Dosage level: 10 μg of RBD antigen of SARS-CoV-2 and 10 μg of NC antigen of SARS-CoV-2
Route of administration: Intramuscular
Inclusion Criteria
Age From
18.00 Year(s)
Age To
80.00 Year(s)
Gender
Both
Details
1. Male and female subjects who have received their primary vaccination series with either two doses of Covishield® or two doses of Covaxin® ≥ 6 months prior to enrolment, as confirmed by COVID- 19 certificate issued by CoWIN. 2. Age is ≥18 years to ≤ 80 years. 3. The subject voluntarily agreed to participate in the study, and signed an informed consent form and agrees to remain in study area for period of study and willing to comply with other protocol requirements. Subject of stable health as determined by investigator based on medical history, physical examination and laboratory examination at screening. 4. Body temperature is between 95.6 to 99.0 ºF. 5. Body mass index (BMI) at 18.0 to 35.0 kg/m2 (inclusive). 6. Willing to allow storage and future use of biological samples for future research 7. Male and Female subjects of childbearing potential must be using adequate birth control measures, as discussed with the study doctor and should agree to continue such precautions for 6 months after receiving the last injection of study medication. Menopausal females must have experienced their last period more than 12 months prior to study entry to be classified as not of childbearing potential. Note-Female subjects of child bearing potential must agree to use adequate contraception during the study and continue at least six months after the vaccine dose of study. For this study, acceptable and effective methods of contraception for females include: • Intrauterine device placed at least 3 months prior to the start of the study and remaining in place during the study period, • Two barrier methods used together (cervical cap, diaphragm, contraceptive sponge, or vaginal spermicide plus a male or female condom) or • Absolute sexual abstinence (no sexual intercourse or genital contact with a male partner).
For males, adequate birth control methods suggested and defined as double barrier contraception, i.e., condom + diaphragm, condom or diaphragm + spermicidal gel
ExclusionCriteria
Details
1. History of any of the following: a. Any product (investigational or off-label or which is approved by regulatory authority) for prevention of COVID-19 disease within 6 months prior to enrolment. b. History of receipt of any COVID Vaccine as a booster dose c. Receipt of any licensed vaccine within 28 days before enrolment in study or planned administration of any vaccine for until 28 days after study vaccination. 2. Individuals who report any medical condition as determined by investigator / clinician is not suitable to receive protein based subunit COVID -19 vaccines. 3. Seropositive for HIV 1 and 2, HBsAg and HCV. 4. Have a history of severe allergies such as: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis (Arthus reaction to any component of the research vaccine i.e. RLS Protein Subunit Vaccine against SARS-CoV-2 Virus (RelCoVax®) or Corbevax® or aluminium preparation. Subjects with any previous history of serious side effects of vaccines or drugs or history of allergic disease or reactions likely to be exacerbated by any component of the vaccines in study will also be excluded 5. Those with a history of confirmed SARS COVID-19 infection or current COVID-19 infection meeting any of the following: ➢ History of confirmed SARS-CoV 2 infection (Symptomatic or asymptomatic disease) in prior 6 months of enrollment as established by confirmed RTPCR test. ➢ RTPCR test which is positive within 72 hours prior to enrollment. 6. Have taken antipyretics or analgesics within 24 hours before the study enrollment or planned use of any investigational or non-registered product other than study vaccine during study period including three months prior to enrollment. 7. Current use or past history of alcohol abuse or consumption of drug of abuse. 8. Long term use (> 2 weeks) of oral or parenteral steroids (glucocorticoids) or high dose inhaled steroids (> 800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months. (Inhaled and topical steroids are allowed). 9. Any confirmed or suspected immunosuppressive or immunodeficient condition, due to underlying illness or treatment with immunosuppressive or cytotoxic or anticancer chemotherapy or radiation therapy within preceding 36 months. Any medical condition that in the judgment of the investigator would make study participation unsafe and / or can interfere with assessment or vaccine response. 10. Acute or chronic, uncontrolled and / or clinically significant systemic disorders such as cardiovascular, gastrointestinal, respiratory, neurologic, hepatic, renal, endocrine, hematological, psychiatric or immunological disorders. 11. Have received blood or blood-related products, including immunoglobulin within 3 months prior to enrollment; or plan to use it during the study. 12. Lactating women or pregnant women (as determined by serum beta HCG).
Method of Generating Random Sequence
Random Number Table
Method of Concealment
An Open list of random numbers
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To evaluate & compare the immunogenicity of single heterologous booster dose of RLS Protein Subunit Vaccine against SARS-CoV-2 Virus i.e. RelCoVax® & single heterologous booster dose of reference Protein Subunit Vaccine (Biological E Ltd.’s Corbevax®) after administration in subjects who have completed primary vaccination.
From Day 0, Day 28, Day 56, Day 90
Secondary Outcome
Outcome
TimePoints
To evaluate the safety & tolerability & additional immunogenicity of single heterologous booster dose of RLS Protein Subunit Vaccine against SARS-CoV-2 Virus i.e. RelCoVax® and single heterologous booster dose of reference Protein Subunit Vaccine (Biological E Ltd.’s Corbevax®) after administration in subjects who have completed primary vaccination
From Day 0, Day 28, Day 56, Day 90
Target Sample Size
Total Sample Size="200" Sample Size from India="200" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="200"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is Prospective, multi-center, randomized, open label,
active control, phase 2 clinical study to evaluate immunogenicity, safety and
tolerability of single heterologous booster dose of RelCoVax® (Protein Subunit
Vaccine of Reliance Life Sciences against SARS-CoV-2 Virus) with Corbevax®
(Protein Subunit Vaccine of Biological E Ltd. against SARS-CoV-2 Virus).
In this study we will only accept healthy Male and female
subjects who have received their primary vaccination series with either two
doses of Covishield® or two doses of Covaxin® ≥ 6 months prior to enrolment, as
confirmed by COVID- 19 certificate issued by Cowin by before randomization.
Subjects who have received COVID vaccine other than Covishield or Covaxin in
past would not be eligible for enrolment. Subjects will receive a single
booster dose of RLS SARS CoV-2 vaccine (RelCoVax®) or Corbevax® on day 0 as per
Randomization schedule. Subjects will be randomized in 1:1 ratio to receive
either RLS SARS CoV-2 vaccine RelCoVax® Or Corbevax®. Enrollment will be such
that 100 subjects will be those who have received primary vaccination with
Covishield®. These subjects will be
randomly assigned in equal proportion to either RelCoVax® group (50 subjects)
or Corbevax® group (50 subjects) and 100 enrolled subjects will be those who
have received Covaxin® as primary vaccination. These subjects will also be
randomly assigned in equal proportion to either RelCoVax® group (50 subjects)
or Corbevax® group (50 subjects).
It is proposed to enroll 200 subjects. (100 subjects in
RelCoVax® arm and 100 subjects in Corbevax® arm). 100 enrolled subjects will be
those who have received Covishield® as two doses of primary vaccination and 100
enrolled subjects will be those who have received Covaxin® as two doses of
primary vaccination.
Safety would be evaluated in all subjects till day 90 while
immunogenicity will be evaluated in a subpopulation at baseline (i.e. before
receipt of booster dose), at day 28 and day 56 as follows:
Anti RBD IgG, anti-NC IgG, neutralizing antibody (against
Omicron variant and additional variant) will be evaluated in at least 46
subjects in each group (i.e. total 92 subjects) at baseline and at day 28.
These evaluations will be conducted in 20 subjects in each group at day 56.
Interferon gamma, IL-4 and IL-17 will be evaluated in at
least 20 subjects in each group at baseline and at day 28 and at least 10
subjects in each group at day 56
CD4 and CD8 assessment would be conducted in at least 10
subjects in each group at baseline and day 28 and 56
For immunogenicity assessment following tests would be
conducted:
• Assessment of T cell response as determined by –
o Levels of Interferon γ and / or count of antigen activated
T cells secreting interferon γ (indicative of Th1 response)
o IL 4 (indicative of Th2 response) and
o IL 17 (Indicative of Th17 response)
o CD4 and CD8 counts
Timepoints for immunogenicity assessment are day 0, day 28
and day 56.
Safety of vaccine will be evaluated by reporting of adverse
events. Adverse events will be known by subject information, physical
examination, laboratory investigations, telephonic follow up with subjects.
Subjects would be provided with subject diary card to report the adverse
events. Total duration of follow up for safety is up to 90 days after
vaccination.