Sporozoite Challenge of Polyprotein Vaccinees

European Vaccine Initiative

Status and phase

Completed

Phase 2

Phase 1

Conditions

Malaria, Falciparum

Malaria

Treatments

Biological: MVA-PP (Modified Virus Ankara polyprotein)

Biological: FP9-PP (FP9 polyprotein)

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT00375128

VAC027.2

EMVI trial identifier: PP_2_04

EudraCT number: 2006-000629-67

Details and patient eligibility

About

This study examines the ability of two new malaria vaccines (FP9-PP and MVA-PP) to prevent the development of malaria infection after controlled exposure to the parasite. Volunteers for this trial will have received these vaccines in the preceding trial VAC027.1.

Full 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 the clinical efficacy of two candidate malaria vaccines (FP9-PP and MVA-PP). These live viral vector vaccines were administered in a 'prime boost' regime in the preceding trial VAC027.1.

Volunteers will now be exposed to 5 infective bites from mosquitoes carrying P. falciparum malaria.

This trial will:

Measure efficacy as the time in hours from malaria exposure to blood film positive for malaria parasites
Examine immunogenicity before and after malaria infection
Measure longer term vaccine efficacy by re-challenging any protected volunteers 6 - 12 months later

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy non-pregnant adults aged 18 to 50 years
The vaccinated group will be subjects who have received the vaccine regime described for group 6 or 7 in VAC027.1
Resident in or near Oxford, UK for the duration of the challenge study
For females only, willingness to practice effective contraception during the challenge study.
Agreement to refrain from blood donation during the course of the study
Written informed consent
Willingness to allow the investigators to access hospital and General Practitioner medical notes
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 (unless administered in VAC027.1)
Use of any investigational or non-registered drug, live 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 3 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
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 requiring ongoing specialist supervision
Chronic gastrointestinal disease requiring ongoing specialist supervision
History of > 2 hospitalisations for invasive bacterial infections (pneumonia, meningitis)
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
Acute disease at the time of enrolment
Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
Pregnant or lactating female
Female who is willing or intends to become pregnant during the study
History of severe reactions or allergy to mosquito bites
PI assessment of lack of willingness to participate and comply with all requirements of the protocol
History or clinical evidence of intravenous drug abuse
Any other finding which in the opinion of the investigator would significantly increase the risk of having an adverse outcome from participating in this protocol