Adults 18 to 50, any sex, with Malaria. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Safety and Tolerability of Administration of R21 With and Without the Adjuvant Matrix-M1 Assessed by the Occurrence of Solicited Local and Systemic Adverse Events.Primary· Assessment of solicited AEs in the first 7 days post vaccination.
Occurrence of solicited local and systemic adverse events (i.e: pain, redness, swelling and pruritus at injection site and temperature, feverishness, myalgia, arthralgia, malaise, headache and nausea).
Group
Value
95% CI
Group 1
103
Group 2
21
Group 3
94
Group 4
21
Safety and Tolerability of R21 With and Without the Adjuvant Matrix-M1 Assessed by the Occurrence of Unsolicited Adverse Events.Primary· Unsolicited AEs to be assessed up to 28 days post vaccination.
Occurrence of unsolicited local and systemic adverse events.
Group
Value
95% CI
Group 1
11
Group 2
4
Group 3
10
Group 4
6
Safety and Tolerability of R21 With and Without the Adjuvant Matrix-M1 Assessed by the Occurrence of Serious Adverse Events.Primary· 6 months
Occurrence of serious adverse events collected from enrolment until the end of the follow-up period.
Group
Value
95% CI
Group 1
1
Group 2
0
Group 3
0
Group 4
1
Safety and Tolerability of R21 With and Without the Adjuvant Matrix-M1 Assessed by the Occurrence of Laboratory Adverse Events.Primary· At Day 0 (baseline), day 7 and day 28 post vaccination
Occurrence of laboratory adverse events defined as clinically significant changes from baseline. Haematology (Full Blood Count) and Biochemistry (Kidney and Liver Function Tests) will be assessed.
Group
Value
95% CI
Group 1
11
Group 2
4
Group 3
10
Group 4
6
Adverse events — posted to ClinicalTrials.gov
Time frame: Solicited adverse events will be recorded daily for 7 days post-vaccination Unsolicited AEs of all severities will be recorded from receipt of vaccination through 28 days post-vaccination. After study Day 28, only SAEs or new chronic medical conditions that require ongoing medical management will be recorded through to the last study visit..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This is a clinical trial in which healthy volunteers will be administered one or two experimental malaria vaccines. The vaccine R21 will either be administered alone or in combination with the adjuvant vaccine Matrix-M1.
All vaccinations will be administered intramuscularly. Each volunteer will receive three vaccinations in total.
There are three different vaccine schedules:
Group 1 will receive 10µg of R21 mixed with 50µg of Matrix-M1 on days 0, 28, and 56.
Group 2 will receive 50µg of R21 on days 0, 28, and 56. .
Group 3 will receive 50µg of R21 mixed with 50µg of Matrix-M1 on days 0, 28, and 56.
The study will assess the safety of the vaccines, and the immune responses to the vaccinations. Immune responses are measured by tests on blood samples.
Healthy adult volunteers will be recruited in Oxford and London, England.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06507605 — Dose-Escalating Study of Pfs230D1 in Combination With R21 in Matrix-M in African Adults
· Phase 1
· completed
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Trials by the same sponsor.
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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: 12 November 2019
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/NCT02572388.