Safety and Immunogenicity Study of the Malaria Vaccines FP9 PP and MVA PP

This study has been completed.
Sponsor:
Collaborators:
University of Oxford
Wellcome Trust
Information provided by:
European Malaria Vaccine Initiative
ClinicalTrials.gov Identifier:
NCT00374998
First received: September 10, 2006
Last updated: February 28, 2007
Last verified: February 2007
  Purpose

This study examines two new malaria vaccines (FP9-PP and MVA-PP) in healthy human volunteers to determine their safety and ability to induce a measurable immune response against malaria.


Condition Intervention Phase
Malaria, Falciparum
Malaria
Biological: FP9-PP (FP9 polyprotein)
Biological: MVA-PP (Modified Virus Ankara polyprotein)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase I Study to Assess the Safety and Immunogenicity of the Polyprotein Malaria Vaccine Candidates FP9 PP and MVA PP in Healthy Adults Using a Prime-Boost Delivery Schedule

Resource links provided by NLM:


Further study details as provided by European Malaria Vaccine Initiative:

Primary Outcome Measures:
  • Immediate reactogenicity
  • Adverse events occurring before the end of the trial
  • Biological safety (haematological and biochemical indices)

Secondary Outcome Measures:
  • T-cell immunogenicity (prime-boost groups)
  • Humoral immunogenicity (prime-boost groups)
  • Gene expression (prime-boost groups)

Estimated Enrollment: 35
Study Start Date: April 2006
Estimated Study Completion Date: January 2007
Detailed Description:

Malaria infection kills over 2 million people each year. It is a major problem for those who live in endemic areas and for travellers. There is clearly a great need for a safe effective malaria vaccine.

The purpose of this study is to test two candidate malaria vaccines (FP9-PP and MVA-PP) in different concentrations and combinations. These live viral vectors encode a ’polyprotein’ of six fused malaria antigens expressed at liver and blood stages of the malaria parasite lifecycle. MVA-PP uses the Modified Virus Ankara vector, a weakened form of the smallpox vaccine, vaccinia. FP9-PP uses a highly attenuated avian pox virus (FP9) as the vector instead. The two vaccines will be used in combination in a ’prime boost’ strategy to enhance the response of the cellular immune system.

This study will:

  1. Examine safety
  2. Examine immunogenicity
  3. Provide a subgroup of vaccinated volunteers to test clinical efficacy in the following malaria challenge study (VAC027.2)
  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
  • Resident in or near Oxford, UK for the duration of the vaccination study
  • Willingness to allow the investigators to access hospital and General Practitioner medical notes
  • For females 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
  • Written informed consent
  • 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 country within the previous 6 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
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products
  • 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
  • Chronic gastrointestinal disease
  • History of more than 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 other on-going chronic illness requiring hospital specialist supervision
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00374998

Locations
United Kingdom
Centre for Clinical Vaccinology & Tropical Medicine, University of Oxford
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
European Malaria Vaccine Initiative
University of Oxford
Wellcome Trust
Investigators
Principal Investigator: Adrian VS Hill, MA, BM BCh, DPhil, DM University of Oxford
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00374998     History of Changes
Other Study ID Numbers: VAC027.1, EudraCT number: 2004-002424-17, EMVI trial identifier: PP_1_04
Study First Received: September 10, 2006
Last Updated: February 28, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by European Malaria Vaccine Initiative:
Malaria
Vaccine
Prime-boost

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on April 16, 2014