A Phase 2b Multicenter Randomized, Placebo-Controlled, Double-Blind, Study to Evaluate the Safety, Immunogenicity and Efficacy of R21/Matrix-M Malaria Vaccine in African Infants With Different Immunization Schedules

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The aim of this study is to identify an optimal infant vaccine schedule for a malaria vaccine which is better aligned with the timing of other vaccine interventions.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 1 month
Healthy Volunteers: t
View:

• Signed informed consent or thumb-printed and witnessed informed consent obtained from the parent/legal guardian of the infant.

• Infants must have been born full-term (at ≥37 weeks of gestation) and \> 2500 grams at birth.

• Immunization schedule Cohorts 1, 2, and 3: : Male and female infants 42-49 days (inclusive) of age at time of enrollment. For infants in Cohort 1, randomization to receive vaccine dose 1 (Groups 1 and 2 of R21/MM or placebo, respectively) will occur at 42-49 days of age. For infants in Cohort 2, randomization to receive vaccine dose 1 (Groups 3 and 4 of R21/MM or placebo, respectively) will occur at 2 months (56-63 days of age). For infants in Cohort 3, randomization to receive vaccine dose 1 (Groups 5 and 6 of R21/MM or placebo, respectively) will occur at 3 months (84-91 days of age).

• The participant's parent/guardian must be willing to avoid travel, particularly in the 28 days after each study vaccination, must confirm willingness to contact the study team in the event of unexpected/unavoidable travel and, for the safety cohort, must confirm availability for the home visits to be conducted by a field worker to collect solicited AEs over the 7 days (day of vaccination and 6 subsequent days) following each study vaccine.

• The participant's parent/guardian must confirm willingness to bring their child to the study clinic / local health care clinic, and capacity to contact the study team in the event the subject has any illnesses or other health concerns during the study.

• Participants who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol (e.g. return for follow-up visits) may be enrolled in the study.

Locations
Other Locations
Burkina Faso
Institut de Recherche en Science de la Santé (IRSS)
RECRUITING
Bobo-dioulasso
Groupe de Recherche Action en Santé (GRAS)
RECRUITING
Ouagadougou
Contact Information
Primary
Michael Thigpen, MD
mthigpen@path.org
+1 202 822 0033
Time Frame
Start Date: 2025-05-30
Estimated Completion Date: 2028-03-22
Participants
Target number of participants: 1200
Treatments
Experimental: Compressed 6-10-14 Week Schedule: R21/MM Malaria Vaccine
Participants will receive R21/MM malaria vaccination at 6, 10, and 14 weeks of age, co-administered with hexavalent vaccine, pneumococcal conjugate vaccine (PCV), and oral rotavirus vaccine (RV). At 9 months of age participants will receive measles-rubella (MR) vaccine, yellow fever (YF) vaccine, and typhoid conjugate vaccine (TCV).~Participants will receive a booster dose of R21/MM malaria vaccine at 15 months of age co-administered with the 2nd dose of measles-rubella vaccine and meningococcal A conjugate vaccine (MenA).
Placebo_comparator: Compressed 6-10-14 Week Schedule: Placebo
Participants will receive placebo at 6, 10, and 14 weeks of age, co-administered with hexavalent vaccine, PCV, and oral RV. At 9 months of age participants will receive MR and YF vaccines, and TCV.~Participants will receive a booster dose of placebo at 15 months of age co-administered with the 2nd dose of MR vaccine and MenA vaccine.~Participants will receive R21/MM malaria vaccination at 27, 28, and 29 months of age (after completion of the study).
Experimental: Relaxed 2-4-6 Month Schedule: R21/MM Malaria Vaccine
Participants will receive R21/MM malaria vaccination at 2, 4, and 6 months of age co-administered with hexavalent vaccine, PCV, and oral RV. At 9 months of age participants will receive MR and YF vaccines and TCV.~Participants will receive a booster dose of R21/MM malaria vaccine at 15 months of age co-administered with the 2nd dose of MR vaccine and MenA vaccine.
Placebo_comparator: Relaxed 2-4-6 Month Schedule: Placebo
Participants will receive placebo at 2, 4, and 6 months of age co-administered with hexavalent vaccine, PCV, and oral RV. At 9 months of age participants will receive MR and YF vaccines, and TCV.~Participants will receive a booster dose of placebo at 15 months of age co-administered with the 2nd dose of MR vaccine and MenA vaccine.~Participants will receive R21/MM malaria vaccination at 27, 28, and 29 months of age (after completion of the study).
Experimental: Relaxed 3-6-9 Month Schedule: R21/MM Malaria Vaccine
Participants will receive R21/MM malaria vaccination at 3, 6, and 9 months of age. Participants will receive the hexavalent vaccine, PCV, and oral RV at 6 weeks, 10 weeks, and 3 months of age. At 9 months of age participants will receive MR and YF vaccines and TCV.~Participants will receive a booster dose of R21/MM malaria vaccine at 15 months of age co-administered with the 2nd dose of MR vaccine and the MenA vaccine.
Placebo_comparator: Relaxed 3-6-9 Month Schedule: Placebo
Participants will receive placebo at 3, 6, and 9 months of age. Participants will receive the hexavalent vaccine, PCV, and oral RV at 6 weeks, 10 weeks, and 3 months of age. At 9 months of age participants will receive MR and YF vaccines and TCV.~Participants will receive a booster dose of placebo at 15 months of age co-administered with the 2nd dose of MR vaccine and the MenA vaccine.~Participants will receive R21/MM malaria vaccination at 27, 28, and 29 months of age (after completion of the study).
Sponsors
Collaborators: Pharmassist Ltd, Serum Institute of India PVT LTD (SII), Agilis, Cytespace, MCT-CRO
Leads: PATH

This content was sourced from clinicaltrials.gov