Malaria
Conditions
Interventions
P27A Alhydrogel 1a
P27A GLA-SE 1a
P27A Alhydrogel 1b
P27A 10µg GLA-SE 2.5µg 1b
P27A 50µg GLA-SE 2.5µg 1b
P27A 50µg GLA-SE 5µg 1b
Commercial control rabies vaccine Ib
Sponsors
Centre Hospitalier Universitaire Vaudois
Centre Hospitalier Universitaire Vaudois
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Phase Ia Inclusion criteria: 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Assessment of the humoral immune response to the vaccine antigen;Assessment of the cellular immune response to the vaccine antigen | — |
Countries
Switzerland, Tanzania
Contacts
Public ContactSamuel Roethlisberger
Outcome results
None listed