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

Malaria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00374998
• Other study ID #: VAC027.1
• Secondary ID: EudraCT number:
• Status: Completed
• Phase: Phase 1
• First received: September 10, 2006
• Last updated: February 28, 2007
• Start date: April 2006
• Est. completion date: January 2007

Study information

• Verified date: February 2007
• Source: European Malaria Vaccine Initiative
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum

Intervention

Biological:
• FP9-PP (FP9 polyprotein)

• MVA-PP (Modified Virus Ankara polyprotein)

Locations

Country	Name	City	State
United Kingdom	Centre for Clinical Vaccinology & Tropical Medicine, University of Oxford	Oxford

Sponsors (3)

Lead Sponsor	Collaborator
European Malaria Vaccine Initiative	University of Oxford, Wellcome Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immediate reactogenicity
Primary	Adverse events occurring before the end of the trial
Primary	Biological safety (haematological and biochemical indices)
Secondary	T-cell immunogenicity (prime-boost groups)
Secondary	Humoral immunogenicity (prime-boost groups)
Secondary	Gene expression (prime-boost groups)