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.: PACTR202307828402450 Date of Registration: 26/07/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Impact of a combination of the RTS,S/AS01E Malaria Vaccibe and Perennial Malaria Chemoprevention in Ghanaian Children
Official scientific title The Impact of a combination of the RTS,S/AS01E Malaria Vaccibe and Perennial Malaria Chemoprevention in Ghanaian Children
Brief summary describing the background and objectives of the trial Intermittent preventive treatment of malaria with sulfadoxine/pyrimethamine (SP) in infants (IPTi) was recommended for deployment in countries with a high burden of malaria in infants, and a low prevalence of SP resistance by the World Health Organization (WHO) in 2010. Recently, the IPTi regimen was renamed perennial malaria chemoprevention (PMC) and now focuses on flexible dosing regimens and age groups extending beyond infancy and allows for utilization of treatments other than SP. Over ten countries are currently implementing or planning to implement PMC as a malaria control intervention. Combining RTS,S/AS01 E with PMC, and extending the period of administration of the latter into the second year of life, could have a strong synergistic effect. Many countries are currently, or will shortly consider, deploying PMC-SP and/or the RTS,S/AS01 E intervention, but there is no empirical evidence to inform whether these interventions should be combined. Evidence generation on the effectiveness of PMC-SP is ongoing in current pilot studies. SPAQ is likely a more effective chemoprevention regimen, especially in countries where SP resistance is high. Therefore, this study sets out to investigate the efficacy of adding PMC-SP or PMC-SPAQ to RTS,S/AS01 E administered through the expanded programme on immunization (EPI) delivery system in Ghana. The primary objective is to determine the efficacy of the combination of RTS,S/AS01 E and PMC with sulphadoxine/pyrimethamine (PMC SP) or RTS,S/AS01 E and PMC with SP and amodiaquine (PMC-SPAQ) against clinical malaria among children up to 24 months of age compared with RTS,S/AS01 E vaccine administered alone.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) MalVac PMC Trial
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied Malaria
Purpose of the trial Determination of the efficacy of combining interventions against clinical malaria among children up to 24 months of age
Anticipated trial start date 14/08/2023
Actual trial start date 15/08/2023
Anticipated date of last follow up 14/06/2026
Actual Last follow-up date 31/12/2026
Anticipated target sample size (number of participants) 2310
Actual target sample size (number of participants) 2310
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 Permuted block randomization 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 Sulphadoxine Pyrimethamine plus Amodiaquine and Malaria RTS.S Vaccine 1.a Sulphadoxine/Pyrimethamine+Amodiaquine(250/12.5/75mg) 1.b Sulphadoxine/Pyrimethamine+Amodiaquine(500/25/150mg) 1.c Malaria RTS.S Vaccine 1.a Sulphadoxine/Pyrimethamine+Amodiaquine(250/12.5/75mg) : Sulphadoxine(250mg) plus Pyrimethamine(12.5mg) and Amodiaquine 75mg tablet on Day 1 and Amodiaquine(75mg) tablets on days 2 and 3 at months 3,6,7, and 9 months 1.b Sulphadoxine/Pyrimethamine+Amodiaquine(500/25/150mg) : Sulphadoxine(500mg) plus Pyrimethamine(25mg) and Amodiaquine 150mg tablet on Day 1 and Amodiaquine(150mg) tablets on days 2 and 3 at months 12, 15, 18 and 21 months 1.c Malaria RTS.S Vaccine(0.5ml) at months 6, 7,9 months and 18. 1.a Sulphadoxine/Pyrimethamine+Amodiaquine(250/12.5/75mg) 1.b Sulphadoxine/Pyrimethamine+Amodiaquine(500/25/150mg) 1.c Malaria RTS.S Vaccine 770
Experimental Group Sulphadoxine Pyrimethamine plus Placebo Tablets 1. Sulphadoxine/Pyrimethamine(500/25mg) plus Placebo at 3,6,7, and 9 months 2. Sulphadoxine/Pyrimethamine(250/12.5mg) plus placebo at 12, 15, 18 and 21 months 3. Malaria RTS.S Vaccine(0.5ml) at months 6,7, 9 and 18. 1.Sulphadoxine/Pyrimethamine(250/12.5mg) tablet on Day 1 and placebo tablets on days 2 and 3 at 3,6,7, and 9 months 2.Sulphadoxine/Pyrimethamine(500/25mg) tablet on Day 1 and placebo tablets on days 2 and 3 at 12, 15, 18 and 21 months 3. Malaria RTS.S Vaccine at months 6,7,9 and 18. 1.Sulphadoxine/Pyrimethamine(250/12.5mg) plus placebo tablets 2.Sulphadoxine/Pyrimethamine(500/25mg) plus placebo tablets 3. Malaria RTS.S Vaccine 770
Control Group Placebo tablets plus Malaria RTS.S Vaccine 1. Placebo Tablets to be given at months 3,6,7, 9, 12, 15, 18 and 21. 2. Malaria RTS.S Vaccine to be given at months 3,6,7 and 18 months. 1. Placebo Tablets: 2 tablets to be given on Day 1 at at months 3,6,7, 9, 12, 15, 18 and 21 and One placebo tablet to be given at 3,6,7, 9, 12, 15, 18 and 21 months. 2. Malaria RTS.S Vaccine(0.5ml) to be given at months 6,7,9 and 18 months 1. Sulphadoxine/Pyrimethamine + Amodiaquine Placebo Tablets 2. Malaria RTS.S Vaccine 770 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Provision of a signed and dated informed consent form by a parent or guardian. 2. A statement by the parent or guardian of a willingness to comply with all study procedures and of their availability for the duration of the study. 3. Aged 14 - 18 weeks at enrollment. 4. The infant is in good general health as evidenced by their medical history and by a physical examination. 5. The infant is able to take oral medication. 1. Current use of a disallowed concomitant medications. 2. Current participation in another intervention trial. 3. Prior administration of a malaria vaccine. 4. Known allergic reactions to components of SP, AQ or to RTSS/AS01 E . 5. Any other condition(s) or diagnosis, or physical examination finding that precludes participation as assessed by a study clinician. Infant: 13 Month(s)-24 Month(s) 14 Week(s) 18 Week(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 14/04/2023 GHANA HEALTH SERVICE ETHICAL REVIEW COMMITTEE
Ethics Committee Address
Street address City Postal code Country
Adabraka, Castle Rd, Accra Accra 00233 Ghana
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 15/03/2023 FOOD AND DRUGS AUTHORITY OF GHANA
Ethics Committee Address
Street address City Postal code Country
GA-237-7316 Accra 00233 Ghana
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 05/04/2023 London School of Hygiene and Tropical Medicine Ethics
Ethics Committee Address
Street address City Postal code Country
Keppel Street, London WC1E 7HT United Kingdom London 0044 United Kingdom
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 08/03/2023 Kintampo Health Research Institutional Ethics Committee
Ethics Committee Address
Street address City Postal code Country
No 2 Health Loop, Kintampo. Ghana Kintampo 00233 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The incidence of Clinical Malaria This will be measured at 24 months
Secondary Outcome Incidence of severe malaria 24 months
Secondary Outcome Incidence of all-cause hospital admissions or deaths, excluding external causes and elective surgical conditions. 24 months
Secondary Outcome Prevalence of under nutrition (any level of underweight and stunting) 12, 18 and 24 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
ATEBUBU AMANTIN MUNICIPALITY ATEBUBU-AMANTIN ATEBUBU AMANTIN 00233 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
PATH 2201 Westlake Avenue, Suite 200 Seattle, WA 98121, USA Seattle United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor PATH Seattle 2201 Westlake Avenue, Suite 200 Seattle, WA 98121 USA Seattle 001 United States of America Non-Profit Global Health Organization
COLLABORATORS
Name Street address City Postal code Country
Prof Daniel Chandramohan Room 414 LSHTM Keppel Street London WC1E 7HT United Kingdom London United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Kwaku Poku Asante kwakupoku.asante@kintampo-hrc.org +233208956598 No 2 Health Loop, P.O Box 200, Kintampo, Bono East Region. Ghana
City Postal code Country Position/Affiliation
Kintampo 00233 Ghana Director Kintampo Health Research Centre
Role Name Email Phone Street address
Public Enquiries Samuel Harrison samuel.harrison@kintampo-hrc.org +233243029493 No 2 Health Loop, P.O Box 200, Kintampo, Bono East Region, Ghana
City Postal code Country Position/Affiliation
Kintampo 00233 Ghana Clinical Research Fellow Kintampo Health Research Centre
Role Name Email Phone Street address
Scientific Enquiries Samuel Harrison samuel.harriso@kintampo-hrc.org +233243029493 No 2 Health Loop, P.O box 200, Kintampo, Bono East Region. Ghana
City Postal code Country Position/Affiliation
Kintampo 00233 Ghana Clinical Research Fellow Kintampo Health Research Centre
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Deidentified Individual participant data will be made available after 12 months of the study completion date. The study data will be shared to researchers who provide a written request to the principal investigators with a methodologically sound proposal that has been approved by an independent review board 12 months after results from the study has been published. Informed Consent Form,Study Protocol This will be shared within 12 months of study completion This will be open access
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