PfSPZ Challenge

Phase 2Biologic

Merck & Co.

PfSPZ Challenge is one of 51 biologic programs targeting Efficacy. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

EfficacyNot yet recruiting

Malaria (plasmodium Falciparum)Not yet recruiting

EfficacyPhase 2

Not yet recruiting

Malaria (plasmodium Falciparum)Phase 1

Not yet recruiting

Competition

Competitive Landscape

139 competitors in Efficacy

#DrugCompanyPhaseTrials

Rayos

RRoxane Laboratories

Phase 3

5 2

Paraplatin

AAvyxa

Phase 3

4 3

Cytoxan

BBaxter Healthcare Corporation

Phase 3

3 4

Alimta

SShawn Eagle

Phase 3

3 5

Pifeltro

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Phase 3

1 6

Veracept

SSebela Women's Health Inc.

Phase 3

1 7

Levocept

SSebela Women's Health Inc.

Phase 3

1 8

Aralen

Sanofi

Preclinical

2 9

Primaquine

Sanofi

Preclinical

2 10

Proamatine

Takeda

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Not yet recruiting

Malaria (plasmodium Falciparum)

NCT07558122

Q4 2027

Phase 1Recruiting

Malaria

NCT06862453

Q1 2028

Phase 1Not yet recruiting

Malaria (plasmodium Falciparum)

NCT07730177

Clinical

Trials by Indication[1]

Malaria11 trials

Controlled Human Malaria Infection (CHMI) After Immunization With Cryopreserved Plasmodium Falciparum Sporozoites Under Chloroquine Prophylaxis

Completed·SSanaria Inc.·Phase 1·NCT01728701·30 enrolled

Controlled Human Malaria Infection Transmission Model - Phase A

Suspended·UUniversity of Oxford·Phase 1/2·NCT04280692·44 enrolled

Safety, Tolerability, Immunogenicity and Protective Efficacy of PfSPZ Vaccine and PfSPZ-CVac in Indonesian Adults Against Naturally-Transmitted Malaria

Completed·SSanaria Inc.·Phase 2·NCT03503058·345 enrolled

Show 8 more trials

Optimization of Controlled Human Malarial Infection by Injection of P. Falciparum Sporozoites in Non-Immune Adults

Completed·SSanaria Inc.·Phase 1·NCT01771848·36 enrolled

Controlled Human Malaria Infection by Intradermal Injection of Plasmodium Falciparum Sporozoites in Tanzanian Adults

Completed·SSanaria Inc.·Phase 1·NCT01540903·30 enrolled

Safety, Tolerability and Efficacy of PfSPZ Vaccine Against Heterologous CHMI in US Malaria naïve Adults

Completed·SSanaria Inc.·Phase 1·NCT04966871·54 enrolled

PfSPZ Challenge in Healthy Malaria-Naïve Adults in the United States

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT02773979·28 enrolled

Experimental Human Malaria Infection by PfSPZ

Completed·SSanaria Inc.·Phase 1·NCT01086917·18 enrolled

Controlled Human Malarial Infection by Intravenous Injection of Plasmodium Falciparum Sporozoites in Non-Immune Adults

Completed·SSanaria Inc.·Phase 1·NCT01624961·30 enrolled

Safety, Tolerability and Efficacy Against Controlled Human Malaria Infection of PfSPZ-LARC2 Vaccine in Malaria-naïve Adults

Recruiting·SSanaria Inc.·Phase 1·NCT06862453·42 enrolled

A Randomized, Double-Blind, Placebo-Controlled Phase 1 Trial to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of Sanaria(R) PfSPZ-LARC2 Vaccine, a Late-Arresting, Replication-Competent, Genetically Attenuated Plasmodium Falciparum Vaccine by Controlled Human Malaria Infection in Malaria-Naïve Healthy Adults

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT06735209·22 enrolled

Immunogenicity3 trials

Safety, Tolerability and Immunogenicity of PfSPZ Vaccine in an Age De-escalation Trial in Equatorial Guinea.

Completed·SSanaria Inc.·Phase 1·NCT02859350·135 enrolled

Safety and Immunogenicity in Age De-Escalation of PfSPZ Vaccine in Tanzanian Adults, Children, and Infants

Completed·SSanaria Inc.·Phase 1·NCT02613520·105 enrolled

Study to Evaluate Safety, Immunogenicity and Efficacy of PfSPZ Vaccine in HIV Negative and HIV Positive Tanzanian Adults

Completed·SSanaria Inc.·Phase 1·NCT03420053·21 enrolled

Acute Lymphoblastic Leukemia2 trials

Safety, Tolerability and Chemoprotective Activity of P218 in PfSPZ Challenge Model

Completed· Medicines for Malaria Venture logo

Medicines for Malaria Venture·Phase 1·NCT03707041·32 enrolled

Chemoprophylactic Activity of M5717 in PfSPZ Challenge Model

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT04250363·39 enrolled

Plasmodium Falciparum2 trials

Effect of Plasmodium Falciparum Exposure and Sickle Cell Trait on Infection Rates and Kinetics After IV Administration of PfSPZ Challenge

Completed·SSanaria Inc.·Phase 1·NCT02237586·25 enrolled

Safety and Protective Efficacy of Intravenous Immunization With Cryopreserved Plasmodium Falciparum Sporozoites Under Chemoprophylaxis

Completed·SSanaria Inc.·Phase 1·NCT02115516·67 enrolled

Vaccine2 trials

Sequential Optimization of Dose and Schedule of PfSPZ Vaccine

Completed·SSanaria Inc.·Phase 1·NCT02704533·45 enrolled

Regimen Optimization Trial of PfSPZ Vaccine in Equatorial Guinea

Completed·SSanaria Inc.·Phase 1·NCT03590340·104 enrolled

7 more indications

Efficacy2 trials

Comparing Safety and Protective Efficacy of Vaccine Candidate PfSPZ-CVac and MVA ME-TRAP/ ChAd63 ME-TRAP in Adults

Not yet recruiting·UUniversity Hospital Tuebingen·Phase 1/2·NCT05441410·30 enrolled

A Phase 1 Trial of PfSPZ Vaccine in Healthy Adults to Determine Safety, Tolerability and Efficacy Against Heterologous CHMI

Terminated·SSanaria Inc.·Phase 1·NCT05604521·31 enrolled

Malaria (Plasmodium Falciparum)2 trials

Phase I, Double-blind, Randomized Study of Physiological Parameters Biosensor Detection Device(s) Diagnosis of P. Falciparum NF54 Strain Malaria Following Controlled Human Malaria Infection and Post-hoc Analysis of Wearable Biosensor Device Detection

Not yet recruiting·UUniversity of Maryland, Baltimore·Phase 1·NCT07558122·32 enrolled

A Phase 1 Controlled Human Malaria Infection (CHMI) Study to Evaluate the Safety, Immunogenicity, and Efficacy of a Late Liver Stage-arresting, Replication-competent Plasmodium Falciparum Sporozoite Vaccine (Sanaria® PfSPZ-LARC2 Vaccine) Administered as a Single Dose to Malaria-exposed Adults in Burkina Faso

Not yet recruiting·SSanaria Inc.·Phase 1·NCT07730177·45 enrolled

Randomized Controlled Trial1 trial

Dose Escalation, Randomized Controlled Trial to Evaluate the Safety, Immunogenicity and Efficacy of Intravenously Administered Attenuated Plasmodium Falciparum Sporozoite Vaccine (PfSPZ Vaccine) in Tanzanian Adults

Completed·SSanaria Inc.·Phase 1·NCT02132299·67 enrolled

Immunization1 trial

Safety and Protective Efficacy of IV Immunization With Cryopreserved PfSPZ Under A/P Chemoprophylaxis

Completed·UUniversity Hospital Tuebingen·Phase 1·NCT02858817·30 enrolled

Sources

References

[1]
ClinicalTrials.gov — 29 trial records for PfSPZ Challenge. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — PfSPZ Challenge compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for PfSPZ Challenge. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Merck & Co. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Biologic[2]
Highest Phase: Phase 2[1]
Company: Merck & Co.

PfSPZ Challenge

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Q1 2028

Trials by Indication[1]

Malaria11 trials

Immunogenicity3 trials

Acute Lymphoblastic Leukemia2 trials

Plasmodium Falciparum2 trials

Vaccine2 trials

Efficacy2 trials

Malaria (Plasmodium Falciparum)2 trials

Randomized Controlled Trial1 trial

Immunization1 trial

Safety and Efficacy1 trial

Immune1 trial

Vaccination1 trial

References

Drug Info

Quick Facts

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