R21/MM Dosing, Presentations, and Preservatives
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 10μg R21/50μg Matrix-M, 5μg R21/50μg Matrix-M with adaptor preservative free, 5μg R21/50μg Matrix-M with 2PE preservative.
- Who it may be relevant to
- Registry conditions: Plasmodium Falciparum Malaria, Malaria, Vaccine Reaction. Basic parameters: 14 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Bangladesh
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Immunogenicity of a Fractional Adult Dose of the Malaria Vaccine R21/Matrix-M - A Noninferiority Trial
Overview
This is a single blind randomised controlled trial (Phase 3 trial). This study aims to assess whether a half-dose of the R21/Matrix-M malaria vaccine is as effective as the full dose in children and adults. The results will help optimize vaccine usage and improve malaria prevention strategies. All participants will receive the same number of injections and will be randomly assigned to 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 and liver size will be recorded if palpable. Pregnancy test (for female of child bearing potential) * Venous blood collection (Pre-vaccination) 3mL * Vaccination
Detailed description
This study was funded by Hanako Foundation. The grant reference number: 001/2026.
Interventions
- 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)
Primary outcome measures
- The concentration of antibodies against Plasmodium falciparum circumsporozoite (anti-NANP total IgG antibody) [Time frame: One month after the completion of the third dose (at M3), and one month after the booster dose (at M12).]
- The concentration of antibodies against Plasmodium falciparum circumsporozoite (anti C-Term, and full length R21 total IgG antibody), in addition to total IgG against Hepatitis B surface antigen [Time frame: One month after the completion of the third dose (at M3), and one month after the booster dose (at M12).]
Secondary outcome measures (2)
- Adverse event and severe adverse event reports for safety and tolerability assessment of the standard adult vaccine dose 10μg R21/50μg Matrix-M and a half of the standard adult dose 5μg R21/50μg Matrix-M [Time frame: At Month 1, Month 2, Month 3, Month 11 and Month 12]
- Adverse event and severe adverse event reports for safety and tolerability assessment a half of the standard adult dose 5μg R21/50μg Matrix-M with 2PE preservative vs, without 2PE preservative. [Time frame: At Month 1, Month 2, Month 3, Month 11 and Month 12]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Bangladesh · 2 centers
- Alikadam Upazila Health Complex — Bāndarban
- Lama Upazila Health Complex — Lāma
Identifiers
NCT: NCT07194668 · MAL25005