R21/MM Dosing, Presentations, and Preservatives
- Conditions
- Plasmodium Falciparum MalariaMalariaVaccine Reaction
- Interventions
- Biological: 10μg R21/50μg Matrix-MBiological: 5μg R21/50μg Matrix-M with adaptor preservative freeBiological: 5μg R21/50μg Matrix-M with 2PE preservative
- Registration Number
- NCT07194668
- Lead Sponsor
- University of Oxford
- Brief Summary
This is a single blind randomised controlled 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 child 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:
1. The standard dose (10μg R21/50μg Matrix-M) of the malaria vaccine is administered in three doses over a two-month period (at Month 0, 1, and 2), followed by a booster dose at Month 11 (n=125).
or
2. A half dose (5μg R21/50μg Matrix-M) of the malaria vaccine is administered in three doses over a two-month period (at Month 0, 1, and 2), followed by a booster dose at Month 11.
If participant receive the half dose, it will come from one of two types of vaccine:
2a. 10 dose vials with adaptor Preservative Free (n=125) 2b. 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
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 375
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description The standard adult vaccine dose 10μg R21/50μg Matrix-M Adults and adolescents receiving the standard adult vaccine dose A half of the standard adult vaccine dose with adaptor Preservative Free 5μg R21/50μg Matrix-M with adaptor preservative free Adults and adolescents receiving a half of the standard adult vaccine dose with adaptor Preservative Free (n=125) A half of the standard adult vaccine dose with 2PE Preservative 5μg R21/50μg Matrix-M with 2PE preservative Adults and adolescents receiving a half of the standard adult vaccine dose with 2PE Preservative (n=125)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
Alikadam Upazila Health Complex
🇧🇩Bāndarban, Bāndarban, Bangladesh
Lama Upazila Health Complex
🇧🇩Lāma, Lama, Bangladesh
Alikadam Upazila Health Complex🇧🇩Bāndarban, Bāndarban, BangladeshMohammad Abul FaizContact+008801613008857drmafaiz@gmail.com