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

NCT00374998 | Completed Phase 1

• 3 other identifiers: VAC027.1EudraCT number: 2004-002424-17EMVI trial identifier: PP_1_04
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria, Falciparum; Malaria

Keywords

Malaria; Vaccine; Prime-boost

Outcome Measures

Primary Outcomes (3)

• Immediate reactogenicity

• Adverse events occurring before the end of the trial

• Biological safety (haematological and biochemical indices)

Secondary Outcomes (3)

• T-cell immunogenicity (prime-boost groups)

• Humoral immunogenicity (prime-boost groups)

• Gene expression (prime-boost groups)

Interventions

FP9-PP (FP9 polyprotein) BIOLOGICAL

MVA-PP (Modified Virus Ankara polyprotein) BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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
• 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

Sponsors & Collaborators

• European Vaccine Initiative: lead
• University of Oxford: collaborator
• Wellcome Trust: collaborator

Study Sites (1)

Centre for Clinical Vaccinology & Tropical Medicine, University of Oxford

Oxford, OX3 7LJ, United Kingdom

Location

MeSH Terms

Conditions

Malaria, Falciparum; Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector 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: April 1, 2006
• Study Completion: January 1, 2007
• Last Updated: March 1, 2007

Record last verified: 2007-02

Locations

GB (1)