This is a single blind randomised controlled trial (Phase 3 trial). This study aims toassess whether a half-dose of the R21/Matrix-M malaria vaccine is as effective as thefull dose in children and adults. The results will help optimize vaccine usage andimprove malaria prevention strategies.All participants will receive the same number of injections and will be randomly assignedto receive one of the followings: - Group 1: Adults and adolescents receiving the standard adult vaccine dose: 10μg R21/50μg Matrix-M (n=125). - Group 2: Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21/50μg Matrix-M: 10 dose vials with adaptor Preservative Free (n=125) - Group 3: Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21/50μg Matrix-M: 10 dose vials with 2PE Preservative (n=125)Clinical procedure for participants: - Standardized symptom questionnaire - Physical examination:Weight, height, pulse, blood pressure, respiratory rate, tympanic temperature. Spleen andliver size will be recorded if palpable. Pregnancy test (for female of child bearingpotential) - Venous blood collection (Pre-vaccination) 3mL - Vaccination
This study was funded by Hanako Foundation. The grant reference number: 001/2026.
Biological: 10μg R21/50μg Matrix-M
Adults and adolescents receiving the standard adult vaccine dose: 10μg R21/50μg Matrix-M
(n=125)
Biological: 5μg R21/50μg Matrix-M with adaptor preservative free
Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21/50μg
Matrix-M using two presentations: 10 dose vials with adaptor Preservative Free (n=125)
Biological: 5μg R21/50μg Matrix-M with 2PE preservative
Adults and adolescents receiving a half of the standard adult vaccine dose: 5μg R21/50μg
Matrix-M using two presentations: 10 dose vials with 2PE Preservative (n=125)
Inclusion Criteria:
- Residence in a study village for the study period, i.e. 12 months.
- Age 14 years to 60 years.
- Written informed consent/assent provided by participants (or a parent/guardian in
case the participant is under 18 years old).
Exclusion Criteria:
- Pregnancy, plan to get pregnant within one month of vaccination, or breastfeeding.
- Acute illness requiring intervention.
- A history of an adverse reaction to study vaccine.
- Prior receipt of any other malaria vaccine.
- Enrolment in another intervention trial in the last month.
- Planned enrolment in another intervention trial in the coming 12 months.
- Regular use of Immunomodulating drugs e.g, Steroid, Methotrexate, Immunotherapy etc.
in the past month and/or planned for the coming 12 months.
Lama Upazila Health Complex
Lāma, Lama, Bangladesh
Alikadam Upazila Health Complex
Bāndarban, Bangladesh
Lorenz von Seidlein
+66926486322
Lorenz@tropmedres.ac
Rupam Tripura
+8801572288558
Rupam@tropmedres.ac
Not Provided