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| Name | Class |
|---|---|
| Kenya Medical Research Institute | OTHER |
| European and Developing Countries Clinical Trials Partnership (EDCTP) | OTHER_GOV |
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This is a clinical trial to evaluate the safety and immunogenicity of R21/MM in healthy Kenyan participants from the different age groups.Participants will receive 3 vaccinations 4 weeks apart.
The study includes three age groups:
Group 1: healthy adults (18-45 years) Group 2: young children (aged 1-5 years) Group 3: infants (aged 5- <12 months of age) Each group will receive 3 vaccine doses which will be 4-weeks apart. A booster dose will be administered at 9-25 months post 3rd dose.
The trial is funded by The European & Developing Countries Clinical Trials Partnership (EDCTP), European Union, ref: RIA2016V-1649 MMVC
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Group 1 adults (n=20) will be administered 10mcg R21/50mcg Matrix-M vaccine through intramuscular route (into the non-dominant arm). A booster dose will be administered at 9-25 months post 3rd dose. |
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| Group 2 | Experimental | Group 2A children 1-5 years (n=3) will be receiving 5mcg R21/25mcg Matrix-M vaccine through intramuscular route (into the left deltoid). Group 2B children 1-5 years (n=17) will be receiving 10mcg R21/50mcg Matrix-M vaccine through intramuscular route (into the left deltoid). A booster dose will be administered at 9-25 months post 3rd dose. |
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| Group 3 | Experimental | Group 3A infants 5-<12 months (n=3) will be receiving 5mcg R21/25mcg Matrix-M vaccine through intramuscular route (into the left deltoid). Group 3B infants 5-<12 months (n=3) will be receiving 10mcg R21/50mcg Matrix-M vaccine through intramuscular route (into the left deltoid). Group 3C infants 5-<12 months (n=15) will be receiving 5mcg R21/25mcg Matrix-M vaccine through intramuscular route (into the left deltoid). Group 3D infants 5-<12 months (n=15) will be receiving 10mcg R21/50mcg Matrix-M vaccine through intramuscular route (into the left deltoid). Group 3E infants 5-<12 months (n=15) will be receiving 5mcg R21/50mcg Matrix-M vaccine through intramuscular route (into the left deltoid). A booster dose will be administered at 9-25 months post 3rd dose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R21 in Matrix- M adjuvant vaccine | Biological | R21: Protein particle malaria vaccine candidate in Matrix-M: Saponin based vaccine adjuvant. |
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| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of R21 with adjuvant Matrix-M in healthy adults then children and finally infants. | Solicited and unsolicited adverse event data will be collected at each clinic visit from diary cards, clinical review, clinical examination (including observations) and laboratory results. This AE data will be tabulated and frequency, duration and severity of AEs compared between groups. The following parameters will be assessed for all study groups:
| up to 2 years following vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the cellular and humoral immunogenicity of R21 in humans with adjuvant Matrix- M in healthy adults, children and infants. | Comparison of immunogenicity (antibody responses) of the R21-Matrix-M1 - adjuvanted vaccination doses and the longevity of responses.
|
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Inclusion Criteria:
For female participants, we will ask them to attend with their family planning records for verification. Effective contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly, in accordance with the product label. Examples of these include: combined oral contraceptives; injectable progestogen; implants of etenogestrel or levonorgestrel; intrauterine device or intrauterine system; male partner sterilisation at least 6 months prior to the female subject's entry into the study, and the relationship is monogamous; male condom combined with a vaginal spermicide (foam, gel, film, cream or suppository); and male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or suppository)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrian Hill | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KEMRI/Wellcome Trust Programme, Centre for Geographic Medicine Research - Coast | Kilifi | PO Box 230, 80108 | Kenya |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41176969 | Derived | Mukhopadhyay ES, Bellamy DG, Tinto H, Hamaluba M, Truby A, Salman AM, Hill AVS. Naturally acquired immune responses to alpha-gal in malaria endemic settings and pre-clinical efficacy testing with R21/MM. Vaccine. 2025 Dec 5;68:127897. doi: 10.1016/j.vaccine.2025.127897. Epub 2025 Nov 1. | |
| 38813551 | Derived | Sang S, Datoo MS, Otieno E, Muiruri C, Bellamy D, Gathuri E, Ngoto O, Musembi J, Provstgaard-Morys S, Stockdale L, Aboagye J, Woods D, Lawrie A, Roberts R, Keter K, Kimani D, Ndungu F, Kapulu M, Njau I, Orindi B, Ewer KJ, Hill AVS, Bejon P, Hamaluba M. Safety and immunogenicity of varied doses of R21/Matrix-M vaccine at three years follow-up: A phase 1b age de-escalation, dose-escalation trial in adults, children, and infants in Kilifi-Kenya. Wellcome Open Res. 2023 Oct 12;8:450. doi: 10.12688/wellcomeopenres.19795.1. eCollection 2023. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 17, 2025 | |
| Reset | Mar 6, 2025 | |
| Release | Jul 23, 2025 | |
| Reset | Aug 11, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 17, 2025 | Mar 6, 2025 | |||
| Jul 23, 2025 |
| ID | Term |
|---|---|
| D016778 | Malaria, Falciparum |
| ID | Term |
|---|---|
| D008288 | Malaria |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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| up to 2 years following vaccination |
| Aug 11, 2025 |
| D000096724 |
| Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |