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Challenge Trial of PfSPZ-LARC2 Vaccine in Burkina Faso

NCT07730177 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2026-07-31

No results posted yet for this study

Summary

This is a randomized, double-blind, placebo-controlled, Phase 1 trial of Plasmodium falciparum (Pf) late liver stage-arresting replication-competent (LARC) sporozoite (SPZ) malaria vaccine (Sanaria® PfSPZ-LARC2 Vaccine) administered to healthy, malaria-exposed adults by direct venous inoculation (DVI) to determine safety, immunogenicity, and efficacy against controlled human malaria infection (CHMI).

The PfSPZ comprising PfSPZ-LARC2 Vaccine contain a double deletion of the genes encoding the Mei2 and LINUP proteins, both of which are required for transition from liver to blood stage malaria. As a result, mei2-/linup- parasites undergo developmental arrest in the late liver stages without releasing merozoites into the blood stream. No blood stage parasites are produced, either asexual or sexual, and the parasite life cycle does not progress.

CHMI will be performed using PfSPZ Challenge (NF54), composed of PfSPZ that are genetically intact and fully infectious. Because PfSPZ-LARC2 vaccine is also based on the Pf strain NF54, CHMI using PfSPZ Challenge (NF54) is considered homologous to the vaccine. It will be performed 6 weeks after the single administration of PfSPZ-LARC2 Vaccine or normal saline placebo (with an option to shorten the interval to 4 weeks if logistical issues arise, such as a risk that CHMI follow-up will overlap with the rainy season).

Conditions

  • Malaria (Plasmodium Falciparum)

Interventions

BIOLOGICAL

PfSPZ-LARC2 Vaccine

PfSPZ-LARC2 Vaccine is composed of aseptic, purified, vialed, cryopreserved, genetically altered PfNF54 sporozoites (SPZ) that are stored in liquid nitrogen vapor phase (LNVP).

BIOLOGICAL

PfSPZ Challenge

PfSPZ Challenge (NF54) is composed of PfSPZ that are genetically intact and fully infectious. The aseptic, purified, vialed, cryopreserved PfNF54 sporozoites (SPZ) are stored in liquid nitrogen vapor phase (LNVP).

OTHER

Normal Saline

saline control comparator

Sponsors & Collaborators

  • University of Maryland, Baltimore

    collaborator OTHER

  • Seattle Children's Hospital

    collaborator OTHER

  • University of California, Los Angeles

    collaborator OTHER

  • Groupe de Recherche Action en Sante

    collaborator OTHER

  • Sanaria Inc.

    lead INDUSTRY

Principal Investigators

  • Sodiomon B Sirima, MD PhD · Groupe de Recherche Action en Sante

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2027-03-31
Primary Completion
2027-12-31
Completion
2028-01-31
FDA Drug
Yes

Countries

  • Burkina Faso

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07730177 on ClinicalTrials.gov