Malaria, Plasmodium Falciparum Malaria, Vaccine Reaction
Conditions
Keywords
Plasmodium Falciparum Malaria, Malaria Vaccine
Brief summary
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
BIOLOGICAL10μg R21/50μg Matrix-M
Adults and adolescents receiving the standard adult vaccine dose: 10μg R21/50μg Matrix-M (n=125)
BIOLOGICAL5μg 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)
BIOLOGICAL5μg 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)
Sponsors
University of Oxford
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
14 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The concentration of antibodies against Plasmodium falciparum circumsporozoite (anti-NANP total IgG antibody) | 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 | One month after the completion of the third dose (at M3), and one month after the booster dose (at M12). |
Secondary
| Measure | Time frame |
|---|---|
| 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 | 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. | At Month 1, Month 2, Month 3, Month 11 and Month 12 |
Countries
Bangladesh
Contacts
CONTACTLorenz von Seidlein
CONTACTRupam Tripura
Outcome results
None listed