Efficacy of Combined PEV3A Virosomal Vaccine and FP9-MVA ME-TRAP Prime Boost Regimen - Full Text View

Sponsors and Collaborators:	University of Oxford Medical Research Council Pevion Biotech Ltd Swiss Tropical Institute Walter Reed Army Institute of Research (WRAIR)
Information provided by:	University of Oxford
ClinicalTrials.gov Identifier:	NCT00408668

Purpose

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.

Condition	Intervention	Phase
Malaria Malaria, Falciparum	Biological: PEV3A Biological: FP9 ME-TRAP Biological: MVA ME-TRAP	Phase I Phase II

MedlinePlus related topics: Malaria

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Assessment of Protection Against Malaria by Sporozoite Challenge of Healthy Adults Vaccinated With the Virosomal Vaccine PEV3A and FP9-MVA ME-TRAP. A Phase I / IIa Controlled Challenge Trial

Further study details as provided by University of Oxford:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Estimated Enrollment:	30
Study Start Date:	August 2005
Estimated Study Completion Date:	February 2006

Detailed Description:

Two of the vaccines (‘FP9 ME-TRAP’ and ‘MVA ME-TRAP’) have been designed at the University of Oxford. The other vaccine (PEV3A) has been designed jointly between the Swiss Tropical Institute and a Swiss company called Pevion Biotech Ltd. These are new vaccines that have been given to only a limited number of people before.

We aim to test these vaccines by:

assessing their ability to prevent malaria infection
determining how good they are at triggering a detectable immune response against malaria
studying their safety further

Volunteers will be given up to six vaccinations over three months and will then be exposed to malaria infection. We do this by allowing mosquitoes infected with malaria to bite them under closely regulated conditions and observing if and when they develop blood stage malaria. If the vaccines provide some protection from malaria infection then either they will not develop malaria after the bites or the time taken to develop malaria will be longer. If not all volunteers are protected then we will be able to try and improve our vaccines by comparing the immune responses of volunteers who are protected to those not protected.

The information we get from this study may help to prevent malaria infection and disease in those who live in endemic areas and in travellers. The results of this study will be published in scientific journals and may be presented at professional meetings.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week
Seropositive for hepatitis B surface antigen (HBsAg)
Seropositive for hepatitis C virus (antibodies to HCV)
Hepatomegaly, right upper quadrant abdominal pain or tenderness
Evidence of serious psychiatric condition
Any on-going chronic illness requiring hospital specialist supervision
Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
Pregnant or lactating woman
Any woman who is willing or intends to become pregnant during the study
Any history of anaphylaxis in reaction to vaccination
Principal Investigator assessment of lack of willingness to participate and comply with all requirements of the protocol
History or clinical evidence of intravenous drug abuse
Any other finding which in the opinion of the investigator would significantly increase the risk of having an adverse outcome from participating in this protocol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00408668

Locations

United Kingdom, Oxfordshire
Centre for Clinical Vaccinology and Tropical Medicine
Oxford, Oxfordshire, United Kingdom, OX3 7LJ

Sponsors and Collaborators

University of Oxford

Medical Research Council

Pevion Biotech Ltd

Swiss Tropical Institute

Walter Reed Army Institute of Research (WRAIR)

Investigators

Principal Investigator:

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

University of Oxford

More Information

No publications provided by University of Oxford

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	VAC030, MRC agreement ID 74636
Study First Received:	December 5, 2006
Last Updated:	December 5, 2006
ClinicalTrials.gov Identifier:	NCT00408668 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Oxford:

Malaria Vaccine

Study placed in the following topic categories:

Protozoan Infections
Parasitic Diseases
Malaria
Healthy
Malaria, Falciparum

Additional relevant MeSH terms:

Protozoan Infections
Coccidiosis
Parasitic Diseases
Malaria
Malaria, Falciparum

ClinicalTrials.gov processed this record on May 07, 2009