R21/MM Dosing, Presentations, and Preservatives

Phase 4Not Yet RecruitingNCT07194668

University of Oxford375 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

375

Conditions

Plasmodium Falciparum Malaria

Interventions

10μg R21/50μg Matrix-MBIOLOGICAL

Adults and adolescents receiving the standard adult vaccine dose: 10μg R21/50μg Matrix-M (n=125)

5μg R21/50μg Matrix-M with adaptor preservative freeBIOLOGICAL

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)

5μg R21/50μg Matrix-M with 2PE preservativeBIOLOGICAL

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)

Eligibility

Sex: ALLMin age: 14 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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 Outcomes

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.