Last reviewed · How we verify
NCT04318002
Safety and Immunogenicity of RH5.1/Matrix-M in Adults and Infants Living in Tanzania
Completed
Phase 1
Last updated 22 November 2024
What this trial tests
Phase 1 trial testing RH5.1/Matrix-M in Malaria,Falciparum in 60 participants. Completed in 27 August 2023.
Timeline
21 January 2021
Primary endpoint
27 August 2023
27 August 2023
27 August 2023
Quick facts
| Lead sponsor | University of Oxford |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 60 |
| Start date | 21 January 2021 |
| Primary completion | 27 August 2023 |
| Estimated completion | 27 August 2023 |
| Sites | 1 location across Tanzania |
Drugs / interventions tested
- RH5.1/Matrix-M — full drug profile →
Conditions studied
- Malaria,Falciparum — all drugs for Malaria,Falciparum →
Sponsor
University of Oxford
Who can join
Adults 5 Months to 45, any sex, with Malaria,Falciparum. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an age de-escalation, dose-escalation open label randomised trial studying the safety and immunogenicity of RH5.1/Matrix-M, administered intramuscularly in healthy adults, young children and infants in Tanzania
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Reduced blood-stage malaria growth and immune correlates in humans following RH5 vaccination.
Minassian AM, Silk SE, Barrett JR, Nielsen CM, et al · · 2021 · cited 117× · PMID 34223402 · DOI 10.1016/j.medj.2021.03.014 -
Blood-stage malaria vaccine candidate RH5.1/Matrix-M in healthy Tanzanian adults and children; an open-label, non-randomised, first-in-human, single-centre, phase 1b trial.
Silk SE, Kalinga WF, Salkeld J, Mtaka IM, et al · · 2024 · cited 34× · PMID 38880111 · DOI 10.1016/s1473-3099(24)00312-8 -
Vaccines and monoclonal antibodies: new tools for malaria control.
Miura K, Flores-Garcia Y, Long CA, Zavala F. · · 2024 · cited 24× · PMID 38656211 · DOI 10.1128/cmr.00071-23 -
Delayed boosting improves human antigen-specific Ig and B cell responses to the RH5.1/AS01B malaria vaccine.
Nielsen CM, Barrett JR, Davis C, Fallon JK, et al · · 2023 · cited 21× · PMID 36692019 · DOI 10.1172/jci.insight.163859 -
A Critical Review on Human Malaria and Schistosomiasis Vaccines: Current State, Recent Advancements, and Developments.
Siddiqui AJ, Bhardwaj J, Saxena J, Jahan S, et al · · 2023 · cited 16× · PMID 37112704 · DOI 10.3390/vaccines11040792 -
The Need for Novel Asexual Blood-Stage Malaria Vaccine Candidates for <i>Plasmodium falciparum</i>.
Takashima E, Otsuki H, Morita M, Ito D, et al · · 2024 · cited 15× · PMID 38254700 · DOI 10.3390/biom14010100 -
Recent clinical trials inform the future for malaria vaccines.
Kurtovic L, Reiling L, Opi DH, Beeson JG. · · 2021 · cited 13× · PMID 35602185 · DOI 10.1038/s43856-021-00030-2 -
Malaria therapeutics: are we close enough?
Tripathi H, Bhalerao P, Singh S, Arya H, et al · · 2023 · cited 12× · PMID 37060004 · DOI 10.1186/s13071-023-05755-8
Verify or expand the search:
- PubMed search for NCT04318002
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other University of Oxford trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04318002 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Oxford
- Last refreshed: 22 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04318002.
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