Immunization of healthy volunteers against P. falciparum infection MedDRA version: 20.0 Level: PT Classification code 10025487 Term: Malaria System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: aseptic, purified, cryopreserved Plasmodium falciparum (Pf) sporozoites (SPZ) NF54 (PfSPZ Challenge)
Product Code: PfSPZ Challenge NF54
Pharmaceutical Form: Injection
INN or Proposed INN
Sponsors
University Clinics Tübingen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy volunteers, 18 to 45 years of age, with body mass index =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Prior Plasmodium falciparum infection, or prior receipt of malaria vaccine. Planned travel to malaria endemic areas during the study or residence in malaria endemic areas for > 5 years. Recent administration of antimalarial (< 30 days), other investigational products (< 90 days), or immunglobulin or blood products (< 3 months) or more than 3 vaccinations (< 4 weeks) Confirmed or suspected immunosuppressive or deficiant state. Pregnancy or lactating women. Known infection of HIV, Hepatitis B or C. Cardiovascular risks, or abnormal cardiogram. Retinal abnormalities. Known or suspected porphyria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Establish an immunization regimen of three injections of intravenous PfSPZ Challenge (NF54) by DVI and oral CQ chemoprophylaxis administered on Days 0, 5 and 28, which is safe and well tolerated.;Secondary Objective: Establish an immunization regimen of PfSPZ Challenge (NF54) under CQ chemoprophylaxis, which provides protection against repeat CHMI with heterologous PfSPZ Challenge (7G8) in healthy adult subjects 10, 26 and 52 weeks following the last immunization.;Primary end point(s): Safety endpoints: Number or occurrence of at least possibly related Grade 3-4 AEs and SAEs from time of first CQ administration to the end of the follow-up period. Efficacy endpoint: Proportion of protected volunteers. Protection, defined as absence of parasites in peripheral blood, in contrast to parasitemia, defined as verified positive qPCR result or positive thick blood smear, for +28 days following CHMI with PfSPZ Challenge (7G8) in volunteers receiving PfSPZ-CVac. Statistical testing is done hierarchically: 1) protection against first CHMI, 2) protection against second CHMI, 3) protection against third CHMI.;Timepoint(s) of evaluation of this end point: Safety endpoint is evaluated until the end of the study. Efficacy endpoint is evaluated following each CHMI with PfSPZ Challenge (7G8), monitored through daily thick blood smears and qPCR between +6 and +21 days, and +28 days during the period following DVI for CHMI. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Exploratory endpoints: Time-to-parasitemia in volunteers who receive immunization using PfSPZ Challenge or placebo under chloroquine chemoprophylaxis and become parasitemic within +28 days following CHMI with PfSPZ Challenge (7G8). Statistical testing is done hierarchically: 1) time-to-parasitemia in first CHMI, 2) time-to-parasitemia in second CHMI and 3) time-to-parasitemia in third CHMI. Time-to-parasitemia in placebo recipients following second versus first CHMI and third versus second CHMI (carry-over effect). ;Timepoint(s) of evaluation of this end point: Time-to parasitemia is evaluated following each CHMI with PfSPZ Challenge (7G8), monitored through daily thick blood smears and qPCR between +6 and +21 days, and +28 days during the period following DVI for CHMI. | — |
Countries
Germany
Contacts
Public ContactClinical Trial Management
Universtity Clinics Tübingen, Institute for Tropical Medicine
Outcome results
None listed