Health Trials

A Study to Assess the Experimental Malaria Vaccines R78C and RH5.1 Combined With R21/Matrix-M (a "Multi-stage" Malaria Vaccine)

ConditionMalaria,Falciparum
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age5-35
SponsorUniversity of Oxford

About this trial

This is a Phase Ib age de-escalation, dose escalation, open-label study to assess the safety and immunogenicity of the multi-stage malaria vaccine candidate R21 plus RH5.1 and/or R78C in Matrix-M in adults aged 18-35 years and children aged 5-17 months in Burkina Faso.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Group 1: Healthy adult aged 18-35 years at the time of first study vaccination

Group 2-6: Healthy child aged 5-17 months at the time of first study vaccination

Group 1: Female participants must be non-pregnant (as demonstrated by a negative urine pregnancy .

Participant or parent/guardian provides signed/thumb-printed informed consent

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.

History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).

Children with weight-for-age Z score of less than -3 or other clinical signs of malnutrition.

Trial design

Design model

Parallel

Treatments tested in this trial

  • R21

    Biological/Vaccine

    A protein particle comprising recombinant HBsAg fused to the central repeat and the C-terminus of the circumsporozoite protein

  • RH5.1

    Biological/Vaccine

    A soluble protein vaccine against the RH5 antigen

  • R78C

    Biological/Vaccine

    A soluble RIPR EGF-CyRPA fusion protein vaccine

  • Matrix-M™

    Biological/Vaccine

    A saponin-based vaccine adjuvant

Treatment groups

56 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Group 1(n=8) adults (18-35years)Experimental treatment 4 interventions
Group B: Group 2 (n=8) Children aged between 5-17monthsExperimental treatment 3 interventions
Group C: Group 3 (n=8) children aged between 5-17 monthsExperimental treatment 3 interventions
Group D: Group 4 (n=8) Children aged between 5-17 monthsExperimental treatment 4 interventions
Group E: Group 5 (n=8) children aged 5-17 monthsExperimental treatment 2 interventions
Group F: Group 6 ( n=16) Children 5-17 monthsExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Safety: To assess the safety and reactogenicity of R21, RH5.1 and R78C in Matrix-M™ when used in different combinations in healthy adults and children living in a malaria-endemic area.

The specific endpoints for safety and reactogenicity will be actively and passively collected data on adverse events. The following parameters will be assessed: * Occurrence of solicited local reactogenicity signs and symptoms for 7 days following each vaccination (day of vaccination and 6 subsequent days) * Occurrence of solicited systemic reactogenicity signs and symptoms for 7 days following each vaccination (day of vaccination and 6 subsequent days) * Occurrence of unsolicited adverse events for 28 days following the vaccination (day of vaccination and 27 subsequent days) * Clinically significant change from baseline for safety laboratory measures throughout the study * Occurrence of serious adverse events during the whole study duration.

Time frame
Solicited AEs will be assessed at Day 0, Days 1-6, 28, days 29-34, 182 and days 187. Unsolicited AEs on Day 0, Days 1-6, 14, 28, Days 29-34, 42, 56, 182, Days 183-187 and 196. All SAEs will be assessed throughout the study follow up period upto Day 365

Secondary outcomes

1

Immunogenicity: To assess the humoral immunogenicity of R21, RH5.1 and R78C in Matrix-M™ when used in different combinations in healthy adults and children living in a malaria-endemic area.

Immunogenicity will be assessed by a variety of immunological assays. The following measures will be assessed: * Serum response: o Quantitative antigen-specific IgG antibody levels (µg/mL readout) over time - analysis of peak responses and longevity; * In vitro GIA against 3D7 clone P. falciparum parasites using purified total IgG and a single-cycle pLDH readout assay

Time frame
Immunology blood samples will be collected at screening, day of vaccination, at Days 42, 56, 182, 196, 210, 240, and 365.

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

European Vaccine Initiative

Collaborator

Bundesministerium für Forschung, Technologie und Raumfahrt (BMFTR)

Collaborator

Source ClinicalTrials.gov
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