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
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 3
Healthy Volunteers: t
View:
• Age:
‣ Group 1: The child is 5-11 months of age at the time of randomization (i.e. up to the day before of their first birthday).
⁃ Group 2: The child is 12-23 months of age at the time of randomization (i.e. up to the day before of their second birthday).
⁃ Group 3: The child is 24-36 months of age at the time of randomization (i.e. up to the day of their third birthday).
⁃ Group 4: The child is 6-7 months of age at the time of randomization.
⁃ Group 5: The child is 6 weeks of age at the time of randomization and have not received any dose of the pentavalent vaccine, pneumococcal vaccine, rotavirus vaccine, IPV and only the first dose of the OPV.
⁃ Group 6: The child is aged 5-36 months at the time of their first vaccination
• Signed informed consent/thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child to join the trial.
• The investigator believes that the parents/guardians can and will comply with the requirements of the protocol if the child is enrolled in the study.
• The child is a permanent resident of the study area and likely to remain a resident for the duration of the trial.
Locations
Other Locations
Mali
Malaria Research & Training Center, Department of Epidemiology of Parasitic Diseases, Faculty of Medicine, Pharmacy and Dentistry, University of Sciences Techniques and Technologies of Bamako
Bamako
United Kingdom
CCVTM, University of Oxford
Oxford
Time Frame
Start Date:2022-05-14
Completion Date:2025-05-27
Participants
Target number of participants:593
Treatments
Experimental: Groups 1a, 2a and 3a
60 children, aged 5-36 months, who will receive 4 doses of 5µg R21/50µg Matrix-M as a two vial formulation. The first three doses will be given one month apart, followed by a booster vaccination 12 months after the third dose. The age range of 5-36 months has been split into three groups to ensure an even age spread across age groups. Group 1a is 20 children aged 5-11 months, group 2a is 20 children aged 12-23 months, and group 3a is 20 children aged 24-36 months.
Experimental: Group 1b, 2b and 3b
60 children, aged 5-36 months, who will receive 4 doses of 5µg R21/50µg Matrix-M as a single vial formulation. The first three doses will be given one month apart, followed by a booster vaccination 12 months after the third dose. The age range of 5-36 months has been split into three groups to ensure an even age spread across age groups. Group 1b is 20 children aged 5-11 months, group 2b is 20 children aged 12-23 months, and group 3b is 20 children aged 24-36 months.
Experimental: Group 4a
150 participants, aged 6-7 months at the time of randomisation (to ensure third vaccination is given at approximately 9 months), who will receive 3 doses of 5µg R21/50µg Matrix-M one month apart. At the time of the third dose they will receive their measles-rubella and yellow fever vaccinations at the same time as R21/Matrix-M.
Active_comparator: Group 4b
150 participants, aged 6-7 months at the time of randomisation, who will receive a measles-rubella and yellow fever vaccination 2 months after randomisation.
Experimental: Group 4c
Group 4c is 50 participants, aged 6-7 months at the time of randomisation, who will receive 3 doses of 5µg R21/50µg Matrix-M one month apart.
Experimental: Group 5a
30 children who will receive 3 doses of 5µg R21/50µg Matrix-M, pentavalent, rotavirus, pneumococcal and OPV vaccines at 6, 10 and 14 weeks of age. They will receive IPV two weeks following the third dose.
Active_comparator: Group 5b
30 children who will receive 3 doses of pentavalent, rotavirus, pneumococcal and OPV vaccines at 6, 10 and 14 weeks of age. They will receive IPV two weeks following the third dose.
Experimental: Group 6a
30 children, aged 5-36 months, who will receive 3 doses of 5µg R21/50µg Matrix-M. The first two doses one month apart and the third dose 6 months after the first dose.
Experimental: Group 6b
30 children, aged 5-36 months, who will receive 3 doses of 5µg R21/50µg Matrix-M. The first two doses one month apart and the third dose 12 months after the first dose.