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A Phase 1/2b Study of an Investigational Malaria Vaccination Strategy in 5-17 Month Old Infants and Children in Burkina Faso

NCT01635647 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 730

Last updated 2016-02-15

No results posted yet for this study

Summary

Prime boost vaccination with ChAd63 ME-TRAP followed eight weeks later with MVA ME-TRAP shows efficacy against malaria infection when tested in UK volunteers using sporozoite challenge experiments. It is a leading candidate vaccination strategy against malaria. In the field, Phase I studies have been conducted in adults in Kenya and The Gambia and children and infants in The Gambia. The vaccination strategy appears safe and well tolerated in these populations, and also shows impressive immunogenicity, not significantly different to that seen in the UK trials where efficacy was shown. In particular, recent data from The Gambia shows excellent safety and immunogenicity in infants in malaria endemic areas, who would be the ones to benefit most from such a vaccine against malaria. With this clinical development as background, the investigators now propose to evaluate efficacy against natural malaria infection in this important target group for an effective malaria vaccine, that is, 5-17 month infants and children living in malaria endemic areas. The proposed study area, Banfora, Burkina Faso, is highly endemic for Plasmodium falciparum malaria.

Conditions

Interventions

BIOLOGICAL

ChAd63 ME-TRAP and MVA ME-TRAP

ChAd63 ME-TRAP: 5 x 10\^10vp MVA ME-TRAP: 1 x 10\^8 pfu heterologous prime-boost immunisation

BIOLOGICAL

Rabies vaccine

Two doses eight weeks apart into anterolateral thigh. 2 x 2.5IU Verorab

Sponsors & Collaborators

  • European and Developing Countries Clinical Trials Partnership (EDCTP)

    collaborator OTHER_GOV

  • University of Oxford

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Months
Max Age
17 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2014-08-31
Completion
2014-09-30

Countries

  • Burkina Faso

Study Locations

More Related Trials

Entities

Diseases

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 NCT01635647 on ClinicalTrials.gov