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A Phase I/IIa Study of the Safety, Immunogenicity and Efficacy of FMP2.1/AS01B, an Asexual Blood-Stage Vaccine for Plasmodium Falciparum Malaria

NCT02044198 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-01-09

No results posted yet for this study

Summary

The purpose of this study is to evaluate an experimental malaria vaccine for its ability to prevent malaria infection or disease in a blood-stage challenge model (when volunteers are infected with malaria parasites using malaria-infected red blood cells). The vaccine being testing is a protein called FMP2.1, which is given with an adjuvant (a substance to improve the body's response to a vaccination) called AS01B.

The aim is to use this protein and adjuvant to help the body make an immune response against parts of the malaria parasite. This study will enable assessment of:

1. The ability of the vaccine to prevent malaria infection.
2. The safety of the vaccine in healthy participants.
3. The response of the human immune system to the vaccine.

This will be done by giving participants three vaccinations and then exposing them to malaria infection by transfusing a small number of red blood cells infected with malaria under carefully regulated conditions. Participants will be followed closely to observe if and when they develop malaria. If the vaccine provides some protection against malaria, participants will take longer to develop malaria than usual or will not develop malaria at all.

The study will enrol 15 participants to be vaccinated and then challenged with malaria in addition to recruit 15 individuals to be control subjects.

Conditions

  • Plasmodium Falciparum Malaria

Interventions

BIOLOGICAL

FMP2.1/AS01B

50 µg FMP2.1 in 0.5 mL of the adjuvant AS01B (containing 50 mcg MPL + 50 mcg QS21) is administered via intramuscular (IM) injection in the deltoid region of the non-dominant arm

Sponsors & Collaborators

  • The PATH Malaria Vaccine Initiative (MVI)

    collaborator OTHER

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • University of Oxford

    lead OTHER

Principal Investigators

  • Simon J Draper · University of Oxford

  • Saul N Faust · University of Southampton

  • Graham S Cooke · Imperial College London

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02044198 on ClinicalTrials.gov