NCT05155579

Assessment of Safety and Immunogenicity of a Single Vial Presentation of R21/Matrix-M and Co-Administration With EPI Vaccines

A Phase Ib Trial to Evaluate the Safety and Immunogenicity of R21/Matrix-M in a Single and Two Vial Presentation, With Different Immunisation Schedules, and When Co-Administered With EPI Vaccines in African Children

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 594 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 6 Weeks – 36 Months
• Healthy volunteers: Accepted

Summary

This is a Phase Ib trial conducted in Bougouni, Mali to evaluate the safety and immunogenicity of R21/Matrix-M in a single and two vial presentation, with different immunisation schedules, and when co-administered with EPI vaccines in African children.

Detailed description

This trial has six groups. This will be a double-blind, individually randomised trial, with 1:1 randomisation with the single or two vial presentation of R21/Matrix-M malaria vaccine for study groups 1, 2 and 3. Groups 1, 2 and 3 are to assess the safety and immunogenicity of R21/Matrix-M as a single vial formulation compared with a two-vial formulation, in children aged 5- 36 months, in a malaria endemic area. The age range of 5-36 months has been split into three groups to ensure an even age spread across age groups. For groups 4 and 5, this is a randomised, open-label study to assess the safety and immunogenicity of R21/Matrix-M when co-administrated with various EPI vaccines at the relevant ages, in a malaria endemic area. Group 6 is a randomised, open-label study to assess safety and immunogenicity of a delayed, third dose of R21/Matrix-M in 5-36 month old children, in a malaria endemic area. For groups 1, 2, 3, 5 and 6, participants will be randomised 1:1. For group 4, participants will be randomised 3:3:1. Approximately 590 children will be recruited across these six study groups. The primary study objectives are: Safety * To assess the safety and reactogenicity of R21/Matrix-M, as a single- vial formulation in 5-36-month old African children. * To assess the safety and reactogenicity of co-administration of R21/Matrix-M with the EPI vaccines given at 9 months, measles-rubella and yellow fever vaccines, in African children. * To assess the safety and reactogenicity of co-administration of R21/Matrix-M with the EPI vaccines given at 6, 10 and 14 weeks of age, pentavalent and oral polio vaccine (OPV), in African children. Immunogenicity * To assess the immunogenicity of R21/Matrix-M, as a single- vial formulation in 5-36-month-old African children, compared with the two-vial formulation. * To assess the immunogenicity of EPI vaccines given at 9 months, measles-rubella and yellow fever vaccines, when given with and without R21/Matrix-M * To assess the immunogenicity of EPI vaccines given at 6, 10 and 14 weeks of age, pentavalent and oral polio vaccines, given as part of EPI at 6, 10 and 14 weeks of age, when given with and without R21/Matrix-M. The secondary study objectives are: * To assess the safety and reactogenicity of R21/Matrix-M, as a single- vial formulation in African children compared with the two-vial formulation. * To assess the safety and reactogenicity of a delayed third dose of R21/Matrix-M in 5-36-month-old African children. * To assess the immunogenicity of a delayed third dose of R21/Matrix-M in 5-36-month-old African children. This trial is funded by the Serum Institute of India.

Conditions

• Malaria

Interventions

Type	Name	Description
BIOLOGICAL	R21/Matrix-M - single vial formulation	Adjuvanted malaria vaccine in a single vial formulation
BIOLOGICAL	R21/Matrix-M - two vial formulation	Adjuvanted malaria vaccine in a double vial formulation
BIOLOGICAL	Licensed vaccine - Measles-rubella	Licensed vaccine part of the EPI vaccination schedule
BIOLOGICAL	Licensed vaccine - Yellow fever	Licensed vaccine part of the EPI vaccination schedule
BIOLOGICAL	Licensed vaccine - Pentavalent (diphtheria, tetanus, pertussis, hepatitis B and Hib)	Licensed vaccine part of the EPI vaccination schedule
BIOLOGICAL	Licensed vaccine - Oral Polio Vaccine (OPV)	Licensed vaccine part of the EPI vaccination schedule
BIOLOGICAL	Licensed vaccine - Rotavirus	Licensed vaccine part of the EPI vaccination schedule
BIOLOGICAL	Licensed vaccine - Pneumococcal vaccine	Licensed vaccine part of the EPI vaccination schedule
BIOLOGICAL	Licensed vaccine - Inactivated Polio Vaccine (IPV)	Licensed vaccine part of the EPI vaccination schedule

Timeline

• Start date: 2022-05-14
• Primary completion: 2025-05-27
• Completion: 2025-05-27
• First posted: 2021-12-13
• Last updated: 2026-04-08

Locations

2 sites across 2 countries: Mali, United Kingdom