Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202307772264605 Date of Approval: 24/07/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Prospective, multi-center, randomized, open label, active controlled, seamless phase 2/phase3 clinical study to evaluate immunogenicity, safety and tolerability of RelCoVax® (Protein Subunit Vaccine of Reliance Life Sciences Pvt Ltd. against SARS-CoV-2 Virus) and Corbevax® (Protein Subunit Vaccine of Biological E Ltd. against SARS-CoV-2 Virus) administered as primary vaccination.
Official scientific title Prospective, multi-center, randomized, open label, active controlled, seamless phase 2/phase3 clinical study to evaluate immunogenicity, safety and tolerability of RelCoVax® (Protein Subunit Vaccine of Reliance Life Sciences Pvt Ltd. against SARS-CoV-2 Virus) and Corbevax® (Protein Subunit Vaccine of Biological E Ltd. against SARS-CoV-2 Virus) administered as primary vaccination.
Brief summary describing the background and objectives of the trial The SARS-CoV-2 pandemic presented an extraordinary challenge to global health. With rapid development of vaccines, the pandemic that started in December 2020 has now been brought under control and it is observed that occurrence of new cases by this time of December 2022 has greatly reduced.The disease epidemiology further becomes complex as new variants of SARS-CoV-2 emerge. The vaccination therefore is the most important tool so that some degree of protection is available against emerging variants. To evaluate and compare the immunogenicity of RLS Protein Subunit Vaccine against SARS-CoV-2 Virus i.e. RelCoVax® and reference Protein Subunit Vaccine (Biological E Ltd.’s Corbevax®). Secondary Objective(s) To evaluate the safety and tolerability and additional immunogenicity parameters of RLS Protein Subunit Vaccine against SARS-CoV-2 Virus i.e. RelCoVax® and reference protein Subunit Vaccine (Biological E Ltd.’s Corbevax®).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RelCoVax
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied SARS-CoV-2
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 01/08/2023
Actual trial start date 15/08/2023
Anticipated date of last follow up 30/03/2024
Actual Last follow-up date 31/05/2024
Anticipated target sample size (number of participants) 1550
Actual target sample size (number of participants) 1500
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Corbevax 0.5 ml as two dose schedule. First dose at day 0 and second dose at day 28 56 days Subunit vaccine containing RBD protein adsorbed onto Aluminium Hydroxide. The formulation also contains CpG 1018 as adjuvant 300 Dose Comparison
Experimental Group RelCoVax 0.5 ml as two dose schedule. First dose at day 0 and second dose at day 28 56 days Subunit vaccine containing RBD and Nucleocapsid proteins adsorbed onto Aluminum hydroxide. The formulation also contains CpG 1018 dinucleotide adjuvant 1200
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Male and female subjects in age group ≥18 years to ≤ 80 years. The subjects voluntarily agreed to participate in the study, and signed an informed consent form. Agree 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. Axillary Body temperature of between 35.5ºC to 37.2ºC or equivalent depending on location of temperature taking. Body mass index (BMI) at 18.0 to 35.0 kg/m2 (inclusive). Willing to allow storage and future use of biological samples for future research 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. History of any of the following: • Any investigational vaccine or a COVID-19 vaccine that has got emergency use authorization or • Any product (investigational or off-label) for prevention of COVID-19 disease • Inoculated with any subunit vaccine and inactivated vaccine within 14 days before the first dose of study vaccination, • Inoculated with live attenuated vaccine within 30 days. • Received influenza vaccination within 14 days prior to first study vaccination Have an acute illness or acute exacerbation of a chronic illness, as determined by the site Principal Investigator (PI) or sub-investigator, within 72 hours prior to study vaccination which is likely to impact interpretation of study results. Seropositive for HIV 1 and 2, HBsAg and HCV Have a history of severe allergies to any component of the research vaccine i.e. RLS Protein Subunit Vaccine against SARS-CoV-2 Virus, including aluminium preparations, such as: anaphylactic shock, allergic laryngeal oedema, allergic purpura, thrombocytopenic purpura, local 80 and over: 80+ Year,Adolescent: 13 Year-18 Year 18 Year(s) 80 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 16/06/2023 Jaramogi Oginga Odinga Teaching and Referral Hospital Institutional Scientific Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Kakamega Road KISUMU 40100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Percentage Seroconversion at day 56 w.r.t. neutralizing antibody against SARS-CoV-2. Note: Seroconversion is defined as ≥ 2 fold rise in neutralizing antibody against SARS-CoV-2 compared to baseline titres. (neutralization will be evaluated in assay using SARS-CoV-2 virus wild strain) at day 56
Secondary Outcome Percentage Seroconversion, Geometric Mean Titres (GMT), Geometric Mean Titre Ratio (GMTR), Geometric Mean Fold Ratio (GMFR) of neutralizing antibodies at day 0, day 28 and day 56 as assessed by PRNT /Microneutralization Tests / Pseudo Neutralization test. Neutralization against two strains (wild strain and additional variant of concern) will be evaluated.Percentage Seroconversion, Geometric Mean Titres (GMT), Geometric Mean Titre Ratio (GMTR), Geometric Mean Fold Ratio (GMFR) of neutralizing antibodies at day 0, day 28, day 56, day 90 and day 180 as assessed by PRNT /Microneutralization Tests / Pseudo Neutralization test. Neutralization against two strains (wild strain and additional variant of concern) will be evaluated at day 0, day 28, day 56, day 90 and day 180
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Victoria Biomedical Research Institute Kisumu County Referral Hospital Kisumu 40100 Kenya
KARGENO RESEARCH AND POLICY HUB Karume Road KISUMU 40123 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Reliance Life Sciences Thane Belapur Road MUMBAI India
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor RELIANCE LIFE SCIENCE Thane Belapur Road, Mumbai India research-driven organization developing business opportunities in bio-therapeutics
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Maricianah Onono maricianah@gmail.com +254734919191 Karume Rd
City Postal code Country Position/Affiliation
KISUMU Kenya PRINCIPAL INVESTIGATOR
Role Name Email Phone Street address
Scientific Enquiries Mary Atieno Onyango medsuptnpgh@yahoo.com +254736662522 Kakamega Road
City Postal code Country Position/Affiliation
KISUMU 40100 Kenya Ethics committe Chair
Role Name Email Phone Street address
Public Enquiries Maricianah Onono maricianah@gmail.com +254734919191 Karume Road
City Postal code Country Position/Affiliation
KISUMU 40123 Kenya Principal investigator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained from subjects taking part in this study will remain confidential. All information which is collected from subjects for the purposes of medical, or regulatory activities related to the study or to analyze the study data will be identified only by the subject number and/or a link to the subject number; this information will not be shared outside of the study team unless necessary for safety purposes. They are not allowed to share any personal information. All files will be kept in locked cabinets or rooms with restricted access when they are not in use. The subject’s data may be reviewed only by: • Representatives of the Scientific and Ethics Review Committees. • Representatives of ACE Research and the sponsor. • Representatives of the Country Drug Regulatory Authority (such as, PPB). • Representatives of the Ministry of Health. Study Protocol DURING THE STUDY All information disclosed to the Investigator by the sponsor or persons assigned by the sponsor shall be treated by the Investigator as strictly confidential. The Investigator shall only use such information for the purpose of conducting the clinical trial described in this protocol and agrees not to disclose such information to any third party except those of his/her colleagues and employees who are assisting in the conduct of the study and who are bound by the obligations of confidentiality. Information concerning the study vaccine, patent applications, processes, unpublished scientific data, the IB and other pertinent information is confidential and remains the property of the sponsor. Details should be disclosed only to the persons involved in the approval or conduct of the study. The Investigator may use this information for the purpose of the study only. It is understood by the Investigator that the sponsor will use the information obtained during the clinical study in connection with the development of the drug and therefore may disclose it as required to other clinical Investigators or to regulatory agencies. In order to allow for the use of the information derived from this clinical study, the Investigator understands that he has an obligation to provide the sponsor with all data obtained during the study
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information