What is R21/Matrix-M studying for malaria prevention in infants?

This study is evaluating how different schedules for giving the R21/Matrix-M malaria vaccine affect immune responses in infants. Researchers want to find the best timing of vaccine doses that aligns with routine immunizations and improves protection in young children. The study is sponsored by PATH and focuses on infants in areas with moderate to high malaria risk.

Who may be eligible for this malaria vaccine clinical trial?

Infants aged 42 to 49 days who were born full-term and weighed more than 2500 grams at birth may be eligible. Both male and female infants can participate. Infants should not have received certain routine vaccines before enrollment and must be generally healthy without moderate or severe illness. Please review eligibility criteria for more details.

Is there any cost to participate in this malaria vaccine clinical trial?

Study-related care, including the vaccine and all trial visits, is provided at no cost. However, personal travel expenses to the study sites may vary and are not guaranteed to be covered. Participants and families should plan accordingly.

Actively Recruiting

Phase 2

Age: 42Days - 49Days

All Genders

Healthy Volunteers

ID06879327

Phase 2b Study to Test Safety and Immune Response of R21Matrix-M Malaria Vaccine in African Infants Using Different Vaccine Schedules

Led by PATH · Updated on 2026-05-15

964

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating the best timing for giving the R21Matrix-M R21MM malaria vaccine to infants to better align with other routine vaccinations. This vaccine, recommended by the World Health Organization, targets the malaria parasites early stage and aims to generate protective antibodies. The study focuses on infants in areas with moderate to high malaria transmission and compares different vaccine schedules to find the most effective one. Infants aged 6 to 7 weeks are randomly assigned to one of three vaccination schedules a compressed schedule at 6, 10, and 14 weeks a relaxed schedule at 2, 4, and 6 months or a relaxed schedule at 3, 6, and 9 months. Some infants receive the R21MM vaccine, while others receive a placebo in the compressed schedule group. All infants receive routine vaccines at recommended ages alongside the malaria vaccine. A booster dose of R21MM is given at 15 months in all groups. Participants will have blood samples taken at baseline and after the third and fourth doses to measure antibody levels against malaria. The study also monitors side effects and adverse events following each vaccination. Parents will bring their infants to clinic visits and may have home visits for safety monitoring. The trial includes careful follow-up to assess immune responses and vaccine safety over time, with participation lasting through the booster dose at 15 months of age.

CONDITIONS

Brief Title

Infant Malaria Vaccine Schedule Optimization

Who Can Participate

Age: 42Days - 49Days

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Signed informed consent or thumb-printed and witnessed consent from parent or legal guardian
Infants born full-term (at least 37 weeks of gestation) and weighing over 2500 grams at birth
Male or female infants aged 42 to 49 days at enrollment
Willingness of parent/guardian to avoid travel for 28 days after each vaccination and to participate in home visits for safety monitoring
Willingness and ability of parent/guardian to bring child to clinic visits and contact study team as needed
Investigator believes parent/guardian can comply with study requirements

You will not qualify if you...

Acute moderate or severe illness at enrollment (minor illnesses without fever allowed)
Significant pulmonary, cardiovascular, gastrointestinal, endocrine, neurological, skin, liver, or kidney abnormalities as judged by investigator
Prior receipt of hexavalent/pentavalent, pneumococcal, rotavirus, IPV vaccines or more than one dose of oral polio or hepatitis B vaccine
Weight-for-length/height Z score less than -3 or signs of malnutrition
Major congenital defects
Anemia with symptoms or hemoglobin 5.0 g/dL or lower
History of allergies to vaccine components
Known or suspected immunosuppressive or immunodeficient conditions including maternal HIV infection
Receipt of immunoglobulins or blood transfusions since birth
Prior vaccination of participant or mother with a malaria vaccine
Participation in another investigational product study
Any condition increasing risk or affecting study results as judged by investigator

Research Team

Michael Thigpen, MD

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Phase 2b Study to Test Safety and Immune Response of R21Matrix-M Malaria Vaccine in African Infants Using Different Vaccine Schedules

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria