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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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CTRI |
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Last refreshed on:
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1 April 2024 |
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Main ID: |
CTRI/2023/09/057398 |
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Date of registration:
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11-09-2023 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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.
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Scientific title:
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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)
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Date of first enrolment:
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01-11-2023 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=91768 |
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Study type:
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Interventional |
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Study design:
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Randomized, Parallel Group, Active Controlled Trial Method of generating randomization sequence:Random Number Table Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label
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Phase:
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Phase 2
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Countries of recruitment
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India
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Contacts
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Name:
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Vikram Jadhav
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Address:
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Reliance Life Sciences Pvt. Ltd. (RLS), Dhirubhai Ambani Life Sciences Centre
(DALC)R-282, TTC Area of MIDC, Thane - Belapur Road, Rabale, Navi
Mumbai
400701
Thane, MAHARASHTRA
India |
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Telephone:
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9987885679 |
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Email:
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Sachin.Kagane@relbio.com |
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Affiliation:
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Reliance Life Sciences Pvt. Ltd. (RLS) |
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Name:
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Dr Sachin Kagane
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Address:
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Reliance Life Sciences Pvt. Ltd. (RLS), Dhirubhai Ambani Life Sciences Centre
(DALC)R-282, TTC Area of MIDC, Thane - Belapur Road, Rabale, Navi
Mumbai -
400701
Thane, MAHARASHTRA
India |
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Telephone:
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9987885679 |
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Email:
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Sachin.Kagane@relbio.com |
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Affiliation:
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Reliance Life Sciences Pvt. Ltd. (RLS) |
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Key inclusion & exclusion criteria
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Inclusion criteria: 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
Exclusion criteria: 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).
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Intervention(s)
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Intervention1: 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
Control Intervention1: 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
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Primary Outcome(s)
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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.Timepoint: From Day 0, Day 28, Day 56, Day 90
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Secondary Outcome(s)
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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 vaccinationTimepoint: From Day 0, Day 28, Day 56, Day 90
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Secondary ID(s)
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Protocol No:RLS/VAC/2023/01; Version:3.0, Dated: 30 Jun 2023
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Source(s) of Monetary Support
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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
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Ethics review
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Status: Approved
Approval date: 31/07/2023
Contact:
Penta-Med Ethics Committee Medipoint Hospitals Pvt.Ltd 241/1, New D.P.Road, Near Sai Heritage,Aundh Pune Pune Maharashtra - 411007 India
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Status: Approved
Approval date: 04/08/2023
Contact:
ORCHID SPECIALITY HOSPITAL ETHICS COMMITTEE Orchid Speciality Hospital, L-Square, Porwal Road Sr. No 282/3/3, Lohgaon, Pune Maharashtra - 411047 India
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Status: Approved
Approval date: 05/08/2023
Contact:
Ashirwad Ethics Committee Ashirwad Hospital and Research Centre Maratha Section, Near Jijamata Udyan Ulhasnagar Thane Thane Maharashtra - 421004 India
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Status: Approved
Approval date: 09/08/2023
Contact:
Ethics Committee Hira Mongi Navneet Hospital Mulund West Mumbai Valaji Ladha Road Mumbai Mumbai City Maharashtra - 400080 India
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Status: Approved
Approval date: 21/08/2023
Contact:
O & P institutional committee, Oyster & Pearl Hospital (Phadnis Clinic Pvt Ltd) 1671 -75, ganeshkhind road shivajinagar Pune, 411005, Maharashtra, India
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Status: Approved
Approval date: 24/08/2023
Contact:
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
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Status: Approved
Approval date: 04/09/2023
Contact:
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
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Status: Approved
Approval date: 13/09/2023
Contact:
Ethics Committee Dr. D.Y Patil Vidyapeeth, Dr. D.y Patil Medical college and hospital and Research centre, Sant Tukaram Nagar Pimpri,Pune 411018
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Status: Approved
Approval date: 26/09/2023
Contact:
Ethics Committee Inamdar Multispeciality Hospital
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Status: Approved
Approval date: 12/10/2023
Contact:
Institutional Ethics Committee - Human Research Lokmanya Tilak Municipal Medical College & General Hospital, Sion
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Status: Approved
Approval date: 12/10/2023
Contact:
Institutional Ethics Committee BVDU, Bharati Hospital & Research Centre, Bharati Hospital, Pune-Satara road, Dhankawadi, Pune - 411043, Maharashtra, India
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Status: Approved
Approval date: 14/10/2023
Contact:
KEM Hospital research centre ethics Committee, sardar moodliar road, rasta peth, pune 41101
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Status: Approved
Approval date: 25/10/2023
Contact:
IPGME&R Resaerch Oversight Committee,IPGME&R and SSKM Hospital ,244, AJC Bose Road,Bhowanipore,Kolkata- 700020
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Status: Not Applicable
Approval date:
Contact:
ETHICS COMMITTEE OF TRAUMA CARE HOSPITAL
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Status: Not Applicable
Approval date:
Contact:
IEC of New Health Care Nursing Home
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Status: Not Applicable
Approval date:
Contact:
Institutional Ethics Committee Masina Hospital Marg Byculla Mumbai
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Status: Not Applicable
Approval date:
Contact:
Shree Siddhivinayak Hospital Ethics Committee
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Status: Not Approved
Approval date:
Contact:
Institutional Ethics Committee D Y Patil Medical College
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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