R21/MM Dosing, Presentations, and Preservatives
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age14-60
SponsorUniversity of Oxford
About this trial
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
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- 10μg R21/50μg Matrix-M
- 5μg R21/50μg Matrix-M with adaptor preservative free
- 5μg R21/50μg Matrix-M with 2PE preservative
Treatment groups
375 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov