Drugs / R21
R21
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT06958198 | Sep 2025 → Oct 2026 expected | Plasmodium falciparum malaria | University of Oxford | Recruiting | No outcome recorded |
| Phase 1 | NCT06507605 | Aug 2024 → Jan 2026 | malaria | Serum Institute of India Pvt. Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT06320535 | Mar 2024 → Jun 2026 overdue | Plasmodium falciparum malaria | University of Oxford | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05357560 | Jul 2023 → Dec 2025 | Plasmodium falciparum malaria | University of Oxford | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT03970993 | Jun 2019 → Aug 2021 | malaria | University of Oxford | Completed | No outcome recorded |
| Phase 1/2 | NCT03896724 | May 2019 → Jul 2023 | Plasmodium falciparum malaria | University of Oxford | Completed | No outcome recorded |
| Phase 1/2 | NCT03580824 | Apr 2019 → Jun 2022 | Plasmodium falciparum malaria | University of Oxford | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT07183371 | Dec 2025 → Dec 2026 expected | Plasmodium falciparum malaria | University of Oxford | Active not recruiting | No outcome recorded |
| Phase 2 | NCT07147400 | Aug 2025 → Nov 2027 expected | malaria | Serum Institute of India Pvt. Ltd. | Active not recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06578572 | May → Dec 2024 overdue | malaria | London School of Hygiene and Tropical Medicine | Recruiting | No outcome recorded |
| Comparator or background therapy6 trials | ||||||
| Phase 1 | NCT02600975 Comparator | Dec 2015 → Jan 2017 | malaria | University of Oxford | Completed | No outcome recorded |
| Phase 1 | NCT02572388 Comparator | Oct 2015 → Aug 2017 | malaria | University of Oxford | Completed | No outcome recorded |
| Phase 1/2 | NCT02925403 Comparator | Aug 2016 → Feb 2017 | malaria | University of Oxford | Completed | No outcome recorded |
| Phase 1/2 | NCT02905019 Comparator | Aug 2016 → Dec 2017 | malaria | University of Oxford | Completed | No outcome recorded |
| Phase 2 | NCT06080243 Comparator | Mar 2025 → Sep 2027 expected | — | University of Oxford | Active not recruiting | No outcome recorded |
| Phase 4 | NCT07194668 Comparator | Apr → Dec 2026 expected | Plasmodium falciparum malaria, vaccinia | University of Oxford | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2024-02-01 | Serum Institute of India Pvt. Ltd. | Results New Phase 3 Trial Data Confirm the Uniquely High Efficacy and Good Safety Profile of the R21/Matrix-M™ Malaria Vaccine in African Children seruminstitute.com ↗
Efficacy over this period was broadly similar across sites and in different transmission settings. |
| 2023-10-02 | Serum Institute of India Pvt. Ltd. | Regulatory Oxford R21/Matrix-M™ malaria vaccine receives WHO recommendation for use paving the way for global roll-out seruminstitute.com ↗
R21/Matrix-M™ malaria vaccine has been recommended for use by the World Health Organization’s Strategic Advisory Group of Experts (SAGE) and the Malaria Policy Advisory Group (MPAG) |
| 2023-04-13 | Serum Institute of India Pvt. Ltd. | Regulatory R21/Matrix-M™ malaria vaccine developed by University of Oxford receives regulatory clearance for use in Ghana seruminstitute.com ↗
The R21/Matrix-M™ malaria vaccine, developed by the University of Oxford, leveraging an adjuvant technology from Novavax, and manufactured and scaled up by the SIIPL, has been granted full national licensure for use in Ghana by the country’s Food and Drugs Authority (FDA Ghana). |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-05-20 | Serum Institute of India Pvt. Ltd. | Serum Institute of India ships its first set of R21/Matrix-M™ Malaria Vaccine doses to Africa seruminstitute.com ↗ |
| 2024-02-01 | Serum Institute of India Pvt. Ltd. | New Phase 3 Trial Data Confirm the Uniquely High Efficacy and Good Safety Profile of the R21/Matrix-M™ Malaria Vaccine in African Children seruminstitute.com ↗ |
| 2023-10-02 | Serum Institute of India Pvt. Ltd. | Oxford R21/Matrix-M™ malaria vaccine receives WHO recommendation for use paving the way for global roll-out seruminstitute.com ↗ |
| 2023-04-13 | Serum Institute of India Pvt. Ltd. | R21/Matrix-M™ malaria vaccine developed by University of Oxford receives regulatory clearance for use in Ghana seruminstitute.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | R21 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02925403 ↗ |
| Known as | R21 Malaria Vaccine (Recombinant) | “R21 Malaria Vaccine (Recombinant) For Bedside Mixing” NCT07147400 ↗ |
| Known as | R21/Matrix-M | “Safety and immunogenicity of varied doses of R21/Matrix-M™ vaccine at three years follow-up” PMID 38813551 ↗ Oct 2023 |
| Known as | R21/MM | “Adjuvanted R21(R21/MM) in Adults, Young Children and Infants in Kilifi, Kenya” NCT03580824 ↗ |
| Modality | Vaccine | “R21 is a malaria vaccine comprising nanoparticles” PMID 39805302 ↗ Jan 2025 |
| Route | Intramuscular | “All vaccinations will be administered intramuscularly.” NCT02600975 ↗ |