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

Primary Purpose

Malaria, Falciparum, Malaria

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
FP9-PP (FP9 polyprotein)
MVA-PP (Modified Virus Ankara polyprotein)
Sponsored by
European Vaccine Initiative
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malaria, Falciparum focused on measuring Malaria, Vaccine, Prime-boost

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centre for Clinical Vaccinology & Tropical Medicine, University of Oxford

Outcomes

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)

Full Information

First Posted
September 10, 2006
Last Updated
February 28, 2007
Sponsor
European Vaccine Initiative
Collaborators
University of Oxford, Wellcome Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00374998
Brief Title
Safety and Immunogenicity Study of the Malaria Vaccines FP9 PP and MVA PP
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
European Vaccine Initiative
Collaborators
University of Oxford, Wellcome Trust

4. Oversight

5. Study Description

Brief Summary
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.
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: Examine safety Examine immunogenicity Provide a subgroup of vaccinated volunteers to test clinical efficacy in the following malaria challenge study (VAC027.2)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria, Falciparum, Malaria
Keywords
Malaria, Vaccine, Prime-boost

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
FP9-PP (FP9 polyprotein)
Intervention Type
Biological
Intervention Name(s)
MVA-PP (Modified Virus Ankara polyprotein)
Primary Outcome Measure Information:
Title
Immediate reactogenicity
Title
Adverse events occurring before the end of the trial
Title
Biological safety (haematological and biochemical indices)
Secondary Outcome Measure Information:
Title
T-cell immunogenicity (prime-boost groups)
Title
Humoral immunogenicity (prime-boost groups)
Title
Gene expression (prime-boost groups)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian VS Hill, MA, BM BCh, DPhil, DM
Organizational Affiliation
University of Oxford
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Clinical Vaccinology & Tropical Medicine, University of Oxford
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom

12. IPD Sharing Statement

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

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