Health Trials

Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults

ConditionMalaria Falciparum
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorSanaria Inc.

About this trial

This is a randomized, double-blind, placebo-controlled Phase 1 trial of Plasmodium falciparum (Pf) sporozoite (SPZ) late-arresting replication-competent (LARC) malaria vaccine (PfSPZ-LARC2 Vaccine) administered to healthy, malaria-naive study participants in Germany by direct venous inoculation (DVI) to determine safety, tolerability, and vaccine efficacy (VE) against controlled human malaria infection (CHMI). PfSPZ-LARC2 Vaccine contains a deletion of two genes, the Mei2 and LINUP genes, and undergoes developmental arrest in the late liver stages without releasing merozoites into the blood stream (blood stage parasites).

The primary objective of the study is to assess the safety and tolerability of administration of PfSPZ-LARC2 Vaccine, with special attention to the adequacy of attenuation, in the intention-to-treat (ITT) population.

Eligibility criteria

Qualifiers

Healthy adults (male or non-pregnant female) 18 to 45 years of age.

Able and willing to participate for the duration of the study.

Able and willing to provide written informed consent.

Physical examination and laboratory results without clinically significant findings.

Disqualifiers

Unable to provide informed consent including inability to pass the test of understanding.

Receipt of a malaria vaccine in a prior clinical trial.

History of a splenectomy or sickle cell disease.

History of a neurologic disorder (including non-febrile seizures or complex febrile seizures) or formal history of migraine headache.

Trial design

Treatments tested in this trial

  • Normal Saline (Placebo)
  • PfSPZ-LARC2 Vaccine
  • PfSPZ Challenge (NF54)

Treatment groups

58 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Sponsors and collaborators

Sanaria Inc.

Lead sponsor

Universitätsklinikum Tübingen, Institut für Tropenmedizin Wilhelmstrasse

Collaborator

UCLA David Geffen School of Medicine and Fielding School of Public Health

Collaborator

Stanford University

Collaborator

Leiden University

Collaborator

Source ClinicalTrials.gov