NCT00375128

Brief Summary

This study examines the ability of two new malaria vaccines (FP9-PP and MVA-PP) to prevent the development of malaria infection after controlled exposure to the parasite. Volunteers for this trial will have received these vaccines in the preceding trial VAC027.1.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

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

September 1, 2006

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2006

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

October 19, 2007

Status Verified

October 1, 2007

First QC Date

September 10, 2006

Last Update Submit

October 18, 2007

Conditions

Malaria, FalciparumMalaria

Keywords

MalariaVaccinePrime-boostChallenge

Outcome Measures

Primary Outcomes (1)

  • Efficacy (time in hours to parasitaemia)

Secondary Outcomes (1)

  • Immunogenicity

Interventions

FP9-PP (FP9 polyprotein)BIOLOGICAL
MVA-PP (Modified Virus Ankara polyprotein)BIOLOGICAL

Eligibility Criteria

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

You may qualify if:

  • Healthy non-pregnant adults aged 18 to 50 years
  • The vaccinated group will be subjects who have received the vaccine regime described for group 6 or 7 in VAC027.1
  • Resident in or near Oxford, UK for the duration of the challenge study
  • For females only, willingness to practice effective contraception during the challenge study.
  • Agreement to refrain from blood donation during the course of the study
  • Written informed consent
  • Willingness to allow the investigators to access hospital and General Practitioner medical notes
  • 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 (unless administered in VAC027.1)
  • Use of any investigational or non-registered drug, live 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 country within the previous 3 months prior to the planned challenge
  • 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
  • Evidence of cardiovascular disease
  • 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 requiring ongoing specialist supervision
  • Chronic gastrointestinal disease requiring ongoing specialist supervision
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Imperial College, University of London

London, SW7 2AZ, United Kingdom

Location

Centre for Clinical Vaccinology & Tropical Medicine, University of Oxford

Oxford, OX3 7LJ, United Kingdom

Location

MeSH Terms

Conditions

Malaria, FalciparumMalaria

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

September 10, 2006

First Posted

September 12, 2006

Study Start

September 1, 2006

Study Completion

April 1, 2007

Last Updated

October 19, 2007

Record last verified: 2007-10

Locations

GB(2)