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

Tracking Information
First Submitted Date ICMJE	September 10, 2006
First Posted Date ICMJE	September 12, 2006
Last Update Posted Date	March 1, 2007
Study Start Date ICMJE	April 2006
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: September 10, 2006)	Immediate reactogenicity; Adverse events occurring before the end of the trial; Biological safety (haematological and biochemical indices)
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00374998 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: September 10, 2006)	T-cell immunogenicity (prime-boost groups); Humoral immunogenicity (prime-boost groups); Gene expression (prime-boost groups)
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Safety and Immunogenicity Study of the Malaria Vaccines FP9 PP and MVA PP
Official Title ICMJE	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
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)
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Prevention
Condition ICMJE	Malaria, Falciparum; Malaria
Intervention ICMJE	Biological: FP9-PP (FP9 polyprotein); Biological: MVA-PP (Modified Virus Ankara polyprotein)
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE; (submitted: September 10, 2006)	35
Original Enrollment ICMJE	Same as current
Study Completion Date	January 2007
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 50 Years (Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United Kingdom
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00374998
Other Study ID Numbers ICMJE	VAC027.1; EudraCT number: 2004-002424-17; EMVI trial identifier: PP_1_04
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	European Malaria Vaccine Initiative
Collaborators ICMJE	University of Oxford; Wellcome Trust
Investigators ICMJE	Principal Investigator: Adrian VS Hill, MA, BM BCh, DPhil, DM University of Oxford
PRS Account	European Malaria Vaccine Initiative
Verification Date	February 2007
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP