PfSPZ-LARC2 Vaccine in Women of Child-bearing Potential (WOCBP) in Mali

NCT07675785 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: MLSPZL1
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized double blind, placebo-controlled study to assess the safety, tolerability, immunogenicity, and protective efficacy of 1, 6, 29-day PfSPZ-LARC2 Vaccine regimen given at a dose of 2 x10\^5 PfSPZ or placebo in healthy WOCBP, who are on pregnancy prevention during vaccination, but report plans to become pregnant in the near future. Participants will be randomized into two arms. Arm 1: (n= 150) will receive 3 doses of PfSPZ-LARC2 Vaccine (2x10\^5 PfSPZ) via direct venous inoculation (DVI) at 1, 6, 29 days. Arm 2: (n= 150) will receive 3 doses of normal saline (placebo) injection via DVI at 1, 6, 29 days. All volunteers will receive antimalarial treatment with artemether/lumefantrine (AL) \~2 to 4 weeks prior to 1st (study day -14 to -28) and \~2 weeks prior to 3rd injection (study day 44). Participants will be monitored for safety, tolerability, immunogenicity, and malaria infection during the follow-up period. Participants will also be monitored closely for pregnancy as well post 3rd injection through the entire planned study duration (2 years post dose 1). If pregnant, women will be followed during the course of their pregnancy and for at least 1 year post-delivery (as well as their offspring) for safety and malaria infection. Malaria infections in participants and their offspring will be classified as asymptomatic or symptomatic (clinical cases).

Conditions

Malaria (Plasmodium Falciparum)

Keywords

PfSPZ-LARC2 Vaccine; malaria

Outcome Measures

Primary Outcomes (3)

• Incidence of local AEs

  Incidence of local adverse events (AEs) graded by severity occurring within 7 days after each vaccine administration on day 1, 6, and 29

  Day 1 to Day 35

• Incidence of systemic adverse events

  Incidence of systemic adverse events (AEs) graded by severity occurring within 7 days after each vaccine administration on day 1, 6, and 29

  Day 1 to Day 35

• P.falciparum blood stage infection defined as time to first positive P.falciparum blood smear following 3rd injection to over 24 weeks

  P. falciparum blood stage infection defined as time to first positive blood smear (detection of at least 1 P. falciparum asexual parasites by microscopic examination of 0.5 µL) starting immediately following 3rd injection over 24 weeks (first malaria transmission season).

  Day 29 to 24 weeks

Secondary Outcomes (13)

• P. falciparum first clinical malaria from start of year 1 follow-up for 24 weeks

  Start of year 1 upto 24 weeks later

• P. falciparum blood stage infection defined as time to first positive blood smear from the start of year 2 follow-up for 24 weeks.

  Start of year 2 follow-up for 24 weeks.

• P.falciparum clinical malaria from start of year 2 follow-up for 24 weeks

  Start of year 2 for 24 weeks

• P. falciparum clinical malaria starting immediately after 3rd injection to the end of year 2.

  Starting immediately after 3rd injection (Day 29) to the end of year 2.

• P. falciparum blood stage infection defined as time to first positive blood smear starting immediately after 3rd injection to the end of year 2.

  Starting immediately after 3rd injection to the end of year 2.

Study Arms (2)

PfSPZ-LARC2 Vaccine

EXPERIMENTAL

PfSPZ-LARC2 Vaccine 2x10\^5

Biological: PfSPZ-LARC2 Vaccine

Normal Saline

PLACEBO COMPARATOR

Normal Saline controls

Other: Normal Saline

Interventions

PfSPZ-LARC2 Vaccine BIOLOGICAL

PfSPZ-LARC2 Vaccine (2x105 PfSPZ) via direct venous inoculation (DVI)

PfSPZ-LARC2 Vaccine

Normal Saline OTHER

Normal Saline

Normal Saline

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Females of childbearing potential aged ≥ 18 and ≤ 38 years
• Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
• In good general health and without clinically significant medical history
• Willing to have blood samples stored for future research
• Available for the duration of the study
• Must be willing to use reliable contraception (defined as: pharmacologic contraceptives \[parental delivery\] or pre-existing intrauterine or implantable device) from 21 days prior to first vaccination (study day 1) to 28 days after last vaccination (study day 57)
• Willingness to undergo HIV testing
• Report being interested in becoming pregnant within the next 1 year

You may not qualify if:

• Pregnancy at the time of enrollment/vaccination, as determined by a positive urine or serum human chorionic gonadotropin (β-hCG) test
• Biologically unable to become pregnant secondary to: surgical sterilization, premature ovarian insufficiency (defined as no menses for ≥12 months without an alternative medical cause)
• Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and comply with the study protocol
• Hemoglobin (Hgb), WBC, absolute neutrophils, and platelets outside the local laboratorydefined limits of normal and ≥ Grade 2 (participants may be included at the investigator's discretion for 'not clinically significant' abnormal values)
• Alanine transaminase (ALT) or creatinine (Cr) level above the local laboratory-defined upper limit of normal and ≥ Grade 2 (participants may be included at the investigator's discretion for 'not clinically significant' abnormal values)
• Infected with human immunodeficiency virus (HIV)
• Clinically significant abnormal electrocardiogram (ECG) such as abnormal QTc.
• Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, or renal disease by history, physical examination, and/or laboratory studies including urinalysis
• History of receiving any investigational product within the past 30 days
• Participation or planned participation in a clinical trial with an investigational product prior to completion of the follow-up visit 28 days following last vaccination OR planned participation in an investigational vaccine study until the last required protocol visit
• Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
• History of a severe allergic reaction (Grade 2 or higher or per PI discretion) or anaphylaxis
• Severe asthma (defined as asthma that is unstable or required emergent care, urgent care, hospitalization, or intubation during the past two years, or that has required the use of oral or parenteral corticosteroids at any time during the past two years)
• Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren's syndrome, or autoimmune thrombocytopenia
• Known immunodeficiency syndrome

Sponsors & Collaborators

• Malaria Research and Training Center, Bamako, Mali: collaborator
• University of the Sciences, Techniques and Technologies of Bamako: collaborator
• Sanaria Inc.: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

University of Sciences, Techniques and Technology, Bamako (USTTB)

Bamako, Mali

RECRUITING

MeSH Terms

Conditions

Malaria, Falciparum; Malaria

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Alassane Dicko, MD PhD

  University of Sciences, Techniques and Technology, Bamako (USTTB)

  STUDY DIRECTOR

Central Study Contacts

Halimatou Diawara, MD, MPH

CONTACT

+223-7248- 4849; hdiawara@icermali.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: During the study, the list linking randomization numbers to study product (PfSPZ-LARC2 Vaccine or control) will be made available only to the study statistician and associated team members, pharmacy team/syringe preparers (at the start of the study), independent safety monitor (if needed to review), and SMC chair (if needed for closed session unblinded review). On vaccination days, the vaccines associated with each randomization number will be obtained from the pharmacist.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 30, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): July 15, 2028
• Study Completion (Estimated): April 1, 2030
• Last Updated: July 23, 2026

Record last verified: 2026-07

Locations

MA (1)