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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
10μg R21/50μg Matrix-M
Biological/VaccineAdults and adolescents receiving the standard adult vaccine dose: 10μg R21/50μg Matrix-M (n=125)
5μg R21/50μg Matrix-M with adaptor preservative free
Biological/VaccineAdults 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)
5μg R21/50μg Matrix-M with 2PE preservative
Biological/VaccineAdults 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)
Treatment groups
375 Participants
are divided into 3 treatment groupsGroup A: The standard adult vaccine doseActive comparator 1 intervention
Group B: A half of the standard adult vaccine dose with adaptor Preservative FreeActive comparator 1 intervention
Group C: A half of the standard adult vaccine dose with 2PE PreservativeActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).2
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 outcomes
1
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 122
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 12Other outcomes
1
Prevalence and level of vaccine-induced antibodies.
Time frame
At Month 0, Month 3, Month 11 and Month 122
Prevalence and level of immunity to malaria and immunological responsiveness that may be relevant to prior malaria exposure and be used to predict vaccine immunogenicity.
Time frame
At Month 0, Month 3, Month 11 and Month 123
Prevalence and level of other factors affecting vaccine immunogenicity, such as antibodies against viral pathogens including cytomegalovirus.
Time frame
At Month 0, Month 3, Month 11 and Month 12Sponsors and contacts
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Source ClinicalTrials.gov
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