NCT03970993

VAC 072-An Efficacy Study of R21/MM in Different Dose Schedules

A Phase I/IIa Sporozoite Challenge Study to Assess the Safety, Immunogenicity and Protective Efficacy of Adjuvanted R21, Administered in Different Dose Schedules in Healthy UK Volunteers

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

An open label, partially blinded clinical trial in which healthy volunteers will be administered experimental malaria vaccines. There will be seven experimental groups of volunteers, of which five receive vaccination with the novel malaria vaccine candidate, R21, in combination with the vaccine adjuvant, Matrix M. The study will assess the safety \& immune responses to vaccination, and the efficacy of the vaccine.

Detailed description

Arms 1a \& 1b receive vaccines at 3 vaccinations at 4 week intervals and a booster vaccination approximately 12 months after the first vaccination. Arms 2a \& 2b receive 3 vaccinations at 0, 4 and 24 weeks. The protected volunteers in 2a from the first malaria challenge, VAC072A, will receive a booster vaccination 28 days before the rechallenge, VAC072B. Arms 3a and 3b receive 3 vaccinations at 0, 4 and 8 weeks. The protected volunteers in 3a from the first malaria challenge, VAC072A, will receive a booster vaccination 28 days before the rechallenge, VAC072B. Arms 4a and 4b will receive 3 vaccinations at 0, 4 and 24 weeks. The third dose is fractional. Volunteers then have the option to be challenged 28 days after final vaccination. Group 5 will receive 3 vaccinations at 0, 4 and 24 weeks. The third dose is fractional. Volunteers then have the option to be challenged 28 days after final vaccination. Groups 6 \& 7 are control groups and will receive controlled human malaria infection (CHMI) Healthy volunteers will be recruited in England across four research sites in Oxford, London, and Southampton.

Conditions

• Malaria

Interventions

Type	Name	Description
BIOLOGICAL	R21 Matrix-M vaccination	Three dose vaccination of 2μg, 10μg or 50μg of R21 and 50ug Matrix-M delivered intramuscularly
BIOLOGICAL	R21 Matrix-M vaccination and CHMI	Three dose vaccination of 2μg, 10μg or 50μg of R21 and 50ug Matrix-M delivered intramuscularly. Volunteers then have the option to be challenged with malaria by mosquito bite
BIOLOGICAL	R21 Matrix-M vaccination booster	Optional R21 Matrix-M vaccination booster following a three dose vaccination schedule

Timeline

• Start date: 2019-06-17
• Primary completion: 2021-08-24
• Completion: 2021-08-24
• First posted: 2019-06-03
• Last updated: 2021-10-13

Locations

4 sites across 1 country: United Kingdom