Testing the protection by a Plasmodium falciparum sporozoite Chemoprophylaxis Vaccine (PfSPZ-CVac), using a simplified regimen in healthy and malaria-naive adults in Germany

Phase 1

• Conditions: Immunization of healthy volunteers against P. falciparum infection; MedDRA version: 20.0Level: PTClassification code 10025487Term: MalariaSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Parasitic Diseases [C03]

• Registration Number: EUCTR2018-004523-36-DE
• Lead Sponsor: niversity Clinics Tübingen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-02
• Last Update Posted: 13 September 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Healthy volunteers, 18 to 45 years of age, with body mass index < 35.
Agreement to follow all study procedures, including administration of PfSPZ challenge and antimalarial drugs and contraperception in case of female participants.
Residence in the surrounding of the study center and availibility 24/7 during the period following immunization and CHMI.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 21
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified