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.: PACTR202306533302513 Date of Approval: 06/06/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A comparison of the safety and immune response profiles between the new Pfizer-BioNTech Omicron adapted COVID-19 vaccine and the original Pfizer-BioNTech COVID-19 vaccine in previously unvaccinated adults in East Africa.
Official scientific title A randomised, controlled clinical trial to assess and compare the immunogenicity, safety and reactogenicity of the bivalent-Omicron BA.4/BA.5-adapted, and the original-Wuhan-Hu-1-strain-monovalent, BNT162b2 COVID-19 vaccine formulations in healthy unvaccinated East African adults.
Brief summary describing the background and objectives of the trial Coronavirus disease 2019 (COVID-19) cases continue to be reported from most regions around the world, including Africa. Thus, waves of increased transmission of the causal Coronavirus (COVID-19 virus), which are often characterised by high levels of hospitalisations with severe disease and deaths will remain a major risk for now, and in the future. COVID-19 virus also continues to evolve, with the Omicron variant now being the dominant strain globally. Sequential changes (over time) in the virus makeup are associated with structural modifications that increase its transmissibility, and in the case of Omicron, immune escape from vaccine induced immunity. Because the currently available COVID-19 vaccines were optimized for protection against the originally described (ancestral) COVID-19 virus strain, it is likely that they will be rendered less effective against COVID-19 associated with Omicron and other future variants. Furthermore, the vaccine induced protection also wanes with time, necessitating the administrations of additional vaccine doses to fully vaccinated people to extend the protection afforded by the primary immunisation series. One way to overcome the challenges of waning vaccine efficacy, owing to the introduction of new COVID-19 virus variants and passage of time, is to add components of the Omicron variant to the original vaccines, so that the new generation of “bivalent” vaccines are also optimised to protect against the more recently evolved COVID-19 virus variants. Vaccine manufacturers are now making these bivalent vaccines, and the one from Pfizer-BioNTech is already under emergency use authorisation in some countries, and already in the market for COVID-19 control. Until now, this vaccine has only been tested in previously COVID-19 vaccinated individuals, as additional booster vaccine doses. We would now like to compare the performance and safety profiles of the Pfizer-BioNTech Omicron-adapted bivalent COVID-19 vaccine, with that of the corresponding original Pfizer-BioNTech vaccine in previously COVID-19 unvaccinated adults in East African adults, to determine whether it induces a bigger immune response, while retaining a similar safety profile
Type of trial RCT
Acronym (If the trial has an acronym then please provide) BiMVaC01
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied COVID-19
Purpose of the trial Prevention: Vaccines
Anticipated trial start date 17/04/2023
Actual trial start date 01/05/2023
Anticipated date of last follow up 30/04/2024
Actual Last follow-up date 31/05/2024
Anticipated target sample size (number of participants) 580
Actual target sample size (number of participants) 580
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 Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Bivalent BNT162b2 Dose 1-total 30 µg Dose 2 after 28 days-total 30 µg Dose 1 at enrolment. Dose 2 after 28days Bivalent BNT162b2 COVID-19 vaccine containing Omicron BA.4 and BA.5 and Wuhan-Hu-1 strains 290
Control Group Comirnaty Dose1-total 30 µg Dose 2 after 28 days-total 30 µg Dose 1-At enrollment Dose 2-Given after 28 days. An RNA-LNP vaccine utilizing modRNA and encoding the P2 S of the ancestral Wuhan-Hu-1 strain of SAR-CoV-2. 290 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1) Adult (18 years of age) males, or non-pregnant females. 2) Able and willing to comply with trial requirements. 3) For females only, a negative pregnancy test within 24 hours prior to administration of each of the two vaccine doses and willing to take contraception till 28 days after the second vaccine dose. 4) Provide written informed consent. 1) Documented history of any COVID-19 vaccination. 2) Prior receipt of an investigational, or licensed vaccine within the last 30 days. 3) Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the first vaccine dose. 4) Any confirmed, or suspected immunosuppressive, or immunodeficient state, including HIV infection; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting <14 days). 5) History of allergic disease, or reactions that could be exacerbated by any component of study vaccine. 6) Any history of angioedema or anaphylaxis. 7) Any history of myocarditis and pericarditis. 8) Pregnancy or lactation at the time of screening. 9) Bleeding disorders, or other conditions that in the opinion of the investigator contraindicate intramuscular injection. 10) Any other conditions that in the opinion of the investigator may jeopardise participant safety and / or interfere with study outcomes 11) Participating, or planned participation in another concurrent interventional research study. 12) Acute febrile, or other significant, illness that may affect the conduct of the trial as judged by the study clinician (e.g., diarrhoeal illness). Adult: 19 Year-44 Year 18 Year(s) 100 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 06/04/2023 National Health Research Ethics Review Committe
Ethics Committee Address
Street address City Postal code Country
9653 Dar es Salaam, Tanzania 11101 Tanzania
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 06/04/2023 KEMRI SCIENTIFIC ETHICS REVIEW UNIT
Ethics Committee Address
Street address City Postal code Country
54840 Nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To determine superiority of the immune response against the Omicron BA.4/BA.5 sub lineage of SARS-CoV-2, measured as day 28 neutralising antibodies (Nabs) GMT in previously COVID-19 unvaccinated healthy East African adults following vaccinations with two doses of the Omicron BA.4/BA.5 adapted Bivalent BNT162b2 COVID-19 vaccine (28 days apart), versus two doses of the Original BNT162b2 COVID-19 vaccine. At 28 days after dosing
Secondary Outcome To assess and compare the safety and reactogenicity between the two trial vaccination arms following each of two successive doses of the Bivalent BNT162b2 and the Original BNT162b2vaccines in previously COVID-19 unvaccinated adults At 28 days after dosing
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kilifi CGMRC 230 Kilifi 80108 Kenya
Ifakara Health Insititute Ifakara Street Dar es Salaam United Republic of Tanzania
FUNDING SOURCES
Name of source Street address City Postal code Country
Coalition for Epidemic Preparedness Gibbs building, 215 Euston Rd, Bloomsbury, London NW1 2BE, UK Norway 1030 United Kingdom
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor OXFORD Oxford OX3 7BN Headington Oxford United Kingdom University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Francis Ndungu FNdungu@kemri-welocme.org 0715279268 230
City Postal code Country Position/Affiliation
Kilifi 80108 Kenya Project Lead
Role Name Email Phone Street address
Scientific Enquiries Kimani Makobu KMakobu@kemri-wellcome.org 0722258102 230
City Postal code Country Position/Affiliation
kilifi 80108 Kenya Investigator
Role Name Email Phone Street address
Public Enquiries Stella Mwakio SMwakio@kemri-wellcome.org +254724832853 230
City Postal code Country Position/Affiliation
Kilifi 80108 Kenya Project Manager
Role Name Email Phone Street address
Principal Investigator Said Jongo sjongo@ihi.or.tz +255714939631 Ifakara Street, Plot 463 Mikocheni
City Postal code Country Position/Affiliation
Dar es Salaam United Republic of Tanzania Site Principal Investigators
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be shared after deidentification. The data will be open access and held in the Oxford data repository. Data access will be granted upon reasonable request after the primary analyses of the trial, as specified, are published. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol After the primary analyses of the trial, as specified, are published. Available immediately following the last publication, no end date. Data access will be granted upon reasonable request. Reasonable request is defined as: - The requestor has a disclosed hypothesis and research question that can be answered using the trial data and is affiliated with a reputable research organisation, which has capacity to store and analyse the data according to good clinical practice /good data management practice In the short-term, each request will be evaluated by 3 or more current/former project team members with an understanding of the data (an external expert may also be invited to join where appropriate). This group can decide to approve access, request further information, or deny access. In the unlikely event that these people are no longer available, (e.g. they've moved onto other roles), responsibility for evaluation would transfer to the Research Governance Committee.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information