Health Trials

A Study to Test Experimental Blood Stage Malaria Vaccine in Burkina Faso.

ConditionMalaria,Falciparum
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age5-17
SponsorUniversity of Oxford

About this trial

This is a Phase IIb randomised controlled trial of the safety, immunogenicity and efficacy of the blood-stage malaria vaccine candidates RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in infants aged 5-17 months in Burkina Faso

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy infant aged 5-17 months at the time of first study vaccination

Parent/guardian provides signed/thumb-printed informed consent

Infant and parent/guardian resident in the study area villages and anticipated to be available for vaccination and follow-up for 12 months following last dose of vaccination.

Disqualifiers

Clinically significant congenital abnormalities as judged by the PI or other delegated individual.

Clinically significant skin disorder (psoriasis, contact dermatitis etc.), cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness as judged by the PI or other delegated individual.

Weight-for-age Z score of less than -3 or other clinical signs of malnutrition.

History of allergic reaction, significant IgE-mediated event, or anaphylaxis to immunization.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rabies vaccine

    Biological/Vaccine

    Vaccine

  • RH5.1 10μg adjuvated with 50μg Matrix-M

    Biological/Vaccine

    Vaccine

  • RH5.2 5μg adjuvated with 50μg Matrix-M

    Biological/Vaccine

    Vaccine

Treatment groups

480 Participants
are divided into 5 treatment groups
Group A: Group 1 (Control group)Placebo comparator 1 intervention
Group B: Group 2Experimental treatment 1 intervention
Group C: Group 3 (Control Group)Placebo comparator 1 intervention
Group D: Group 4Experimental treatment 1 intervention
Group E: Group 5Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To assess the protective efficacy against clinical malaria of RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in 5-17 months old children living in a malaria-endemic area for 6 months after the last vaccination.

Time to first episode of clinical malaria (defined as the presence of axillary temperature higher than 37.5 degree celsius and P. Falciparum parasite density \>5000 asexual forms/µL)

Time frame
From 14 days after the third study vaccination until 6 months after the third study vaccination.
2

To assess the safety and reactogenicity of RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in 5-17 months old children living in a malaria-endemic area.

Occurrence of solicited systemic reactogenicity signs and symptoms via clinic and home visits

Time frame
The month following each vaccination and at 6 and 12 months after administration of the final dose of vaccine.

Secondary outcomes

1

To assess the humoral immunogenicity of RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in 5-17 months old children living in a malaria-endemic area.

The following measures will be assessed * Serum ELISA response: 1\. Quantitative antigen-specific IgG antibody levels (µg/mL readout) over time - analysis of peak responses and longevity; 2. Antigen-specific antibody subclass/isotype measurement; 3. Antigen-specific antibody avidity measurement; In vitro GIA against 3D7 clone P. falciparum parasites using purified total IgG and a single-cycle pLDH readout assay * Purified IgG ELISA versus GIA titration "Quality Analysis"

Time frame
Immunology blood samples will be collected at screening, day of vaccination (V) 1, 14 & 28 days post V2, day of V3, 14 days post V3, 2, 6 and 12 months post V3.
2

To assess the protective efficacy against clinical malaria of RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in 5-17 months old children living in a malaria-endemic area for 3 months after the last vaccination.

Time to first episode of clinical malaria (defined as the presence of axillary temperature ≥37.5°C and P. falciparum parasite density \>5000 asexual forms/µL).

Time frame
From 14 days after the third study vaccination until 3 months after the third study vaccination
3

To assess the protective efficacy against clinical malaria of RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in 5-17 months old children living in a malaria-endemic area

Occurrence of solicited local reactogenicity signs and symptoms via clinic and home visits

Time frame
For 12 months after the last vaccination
4

To assess the protective efficacy against asymptomatic P. falciparum infection of RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in 5-17 months old children living in a malaria-endemic area, by qPCR.

Efficacy tested by conducting qPCR analysis

Time frame
At 6 and 12 months after administration of the final dose of vaccine.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Oxford

Lead sponsor

Institut de Recherche en Sciences de la Sante, Burkina Faso

Collaborator

European and Developing Countries Clinical Trials Partnership (EDCTP)

Collaborator

Wellcome Trust

Collaborator

Source ClinicalTrials.gov
Apply now