NCT00408668

Brief Summary

The purpose of this study is to test three candidate malaria vaccines in new combinations to assess their efficacy at preventing malaria infection and triggering immune responses against malaria.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2005

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2006

Completed
Last Updated

December 7, 2006

Status Verified

October 1, 2006

First QC Date

December 5, 2006

Last Update Submit

December 5, 2006

Conditions

MalariaMalaria, Falciparum

Keywords

Malaria Vaccine

Outcome Measures

Primary Outcomes (1)

  • Vaccine efficacy: The primary outcome is protection against malaria infection in a P. falciparum sporozoite challenge model.

Secondary Outcomes (2)

  • Immunogenicity - Vaccine immunogenicity assessed by IFN-γ ELISPOT and ELISA for vaccine specific antibodies

  • Safety - Vaccine safety assessed by collection of local and systemic adverse events.

Interventions

PEV3ABIOLOGICAL
FP9 ME-TRAPBIOLOGICAL
MVA ME-TRAPBIOLOGICAL

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults aged 18 to 50 years
  • Written informed consent
  • Resident in or near Oxford for the duration of the vaccination study
  • For women only, willingness to practice continuous effective contraception during the study and (if participating) during the subsequent challenge study.
  • Agreement to refrain from blood donation during the course of the study
  • Willingness to undergo an HIV test

You may not qualify if:

  • Any deviation from the protocol defined normal range in biochemistry or haematology blood tests or in urine analysis
  • Prior receipt of an investigational malaria vaccine
  • Use of any investigational or non-registered drug, vaccine or medical device other than the study vaccine within 30 days preceding dosing of study vaccine, or planned use during the study period
  • Administration of chronic immunosuppressive drugs or other immune modifying drugs within six months of vaccination.
  • History of malaria chemoprophylaxis with chloroquine within 5 months prior to the planned challenge, with Lariam within 6 weeks prior to the challenge, and Riamet® within 2 weeks prior to the challenge
  • Any history of malaria
  • Travel to a malaria endemic area within the previous 6 months
  • Planned travel to malarious areas during the study period
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection and asplenia
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products
  • History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
  • History of haemoglobinopathies
  • History of diabetes mellitus
  • Chronic or active neurological disease
  • History of \> 2 hospitalisations for invasive bacterial infections
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Clinical Vaccinology and Tropical Medicine

Oxford, Oxfordshire, OX3 7LJ, United Kingdom

Location

Related Publications (1)

  • Thompson FM, Porter DW, Okitsu SL, Westerfeld N, Vogel D, Todryk S, Poulton I, Correa S, Hutchings C, Berthoud T, Dunachie S, Andrews L, Williams JL, Sinden R, Gilbert SC, Pluschke G, Zurbriggen R, Hill AV. Evidence of blood stage efficacy with a virosomal malaria vaccine in a phase IIa clinical trial. PLoS One. 2008 Jan 30;3(1):e1493. doi: 10.1371/journal.pone.0001493.

    PMID: 18231580DERIVED

MeSH Terms

Conditions

MalariaMalaria, Falciparum

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Adrian VS Hill, MA, BM BCh, DPhil, DM

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 5, 2006

First Posted

December 7, 2006

Study Start

August 1, 2005

Study Completion

February 1, 2006

Last Updated

December 7, 2006

Record last verified: 2006-10

Locations

GB(1)