Safety And Immunogenicity Of Novel Candidate Blood-Stage Malaria Vaccine P27A : Phase Ia/Ib

Recruitment & Eligibility

Status: Other

Sex: All

Target Recruitment: 56

Inclusion Criteria

Phase Ia
Healthy volunteers aged 18-45 years
General good health based on history and clinical examinationWritten informed consent obtained before any study procedure
Female volunteers practicing contraception before and up to 13 weeks after the last immunisation
Available to participate in follow-up for the duration of study (34 weeks)
Reachable by phone during the whole study period

Phase Ib inclusion criteria
Healthy male volunteers aged 18-45 years
General good health based on history and clinical examination
Written informed consent obtained before any study procedure
Available to participate in follow-up for the duration of study (34 weeks)
Reachable by phone during the whole study period
Having always lived in an area of low malaria transmission

Exclusion Criteria

Previous participation in any malaria vaccine trial
Symptoms, physical signs or laboratory values suggestive of systemic disorders which could interfere with the interpretation of the trial results or compromise the health of the volunteers
Any clinically significant laboratory abnormalities on screened blood samples
Enrolment in any other clinical trial during the whole trial period
Intake of chronic medication, especially immunosuppressive agents during the 13 weeks preceding the screening visit or during the trial period except topical and inhaled steroids
Volunteers unable to be closely followed for social, geographic or psychological reasons
Previous history of drug or alcohol abuse interfering with normal social function during a period of one year prior to enrolment in the study
Known hypersensitivity to any of the vaccine components
Vaccination or infusion of gammaglobulin from 4 weeks prior to the first vaccination and up to 6 weeks after the third vaccination

Additional Phase Ia exclusion criteria
Positive pregnancy test for females
Actively breast feeding females
Any history of malaria
History of living in a malaria endemic area for more than five (5) years OR living in a malaria endemic area in early childhood.
Known exposure to malaria in the previous six (6) months
P27A ELISA positive OR parasite ELISA antibody positive AND Known exposure to malaria in a malaria endemic area
P27A ELISA positive AND parasite ELISA antibody positive (with or without history of stay in a malaria endemic area)
Intention to travel to malaria endemic countries during the study period
Positive HIV, HBV or HCV tests

Additional Phase Ib exclusion criteria
Previous vaccination with the control vaccine
Positive HIV, HCV test or HBVsAg positive
Malaria parasite positivity by microscopy and/or RDT
Having had a history of confirmed malaria episode in the last five year

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the safety of P27A with Alhydrogel or GLA-SE as adjuvant, in healthy European adults not previously exposed to the parasite Plasmodium falciparum and in healthy African adults previously exposed to the parasite. The safety profile will be assessed on the basis of immediate local and systemic reactogenicity measured from Day 0 to Day 28 after each vaccination.

Secondary Outcome Measures

Name	Time	Method
Assessment of the humoral immune response to the vaccine antigen;Assessment of the cellular immune response to the vaccine antigen

Related Trials