Safety Evaluation of PfSPZ Vaccine in Pregnant Women in Mali (MalVIP1)

NCT05652504 | Suspended Phase 1 FDA Drug

• 2 other identifiers: 10001012001012-I
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Malaria is a disease that affects many people in Africa. It is caused by germs carried by some mosquitoes. A person bitten by an infected mosquito will get malaria. Most malaria infections cause only mild symptoms or none at all, but sometimes the disease can be deadly. Malaria can also harm pregnant women. They may lose their pregnancies or deliver too early, and the mother and newborn may die. An experimental malaria vaccine (PfSPZ) has shown some protection against malaria infection. It is not yet known if PfSPZ is safe for pregnant women. Objective: To test the PfSPZ vaccine in pregnant women. Eligibility: Healthy women aged 18 to 34 years at 14 to 32 weeks gestation with 1 fetus. Design: The study will be in Mali. Participants will have about 40 clinic visits over 20 months. They will be screened. They will have an ultrasound exam and a test of their heart function. They will have blood and urine tests. Participants will receive an injection through a needle into a vein on 3 visits over 1 month. Some will receive the PfSPZ vaccine; others will be injected with salt water. They will not know which injection they are getting. After the last injection, participants will visit the clinic every 2 weeks. They will have blood tests at each visit. After giving birth, participants and their infants will visit the clinic every 2 weeks for 4 months; then they will have visits each month until the infant is 1 year old. The infant will be examined and will have blood tests at each visit.

Conditions

Malaria

Keywords

Immunogenicity; Protective; Efficacy; Tolerability; Randomized

Outcome Measures

Primary Outcomes (1)

• Safety using a composite of adverse maternal and birth outcomes

  Composite endpoint of adverse maternal or birth outcomes defined as: preterm birth, miscarriage, stillbirth, early neonatal death, direct maternal death, low birth weight, small for gestational age (counts and proportions)

  One year

Secondary Outcomes (1)

• Safety and tolerability in pregnant women and their fetuses using solicited adverse events (AEs), unsolicited AEs, and laboratory abnormalities

  7 and 14 days post injection; 6 months after delivery

Study Arms (2)

Arm 1

EXPERIMENTAL

(n = 30) pregnant women will receive three doses of PfSPZ Vaccine (9x10\^5 PfSPZ) via direct venous inoculation (DVI) at 1, 8, 29 days

Biological: PfSPZ Vaccine; Other: PfSPZ Diluent

Arm 2

PLACEBO COMPARATOR

(n = 30) pregnant women will receive normal saline via DVI at 1, 8, 29 days

Drug: Normal Saline

Interventions

PfSPZ Vaccine BIOLOGICAL

PfSPZ Vaccine contains aseptic, purified, vialed, cryopreserved, radiation attenuated NF54 Pf sporozoites (PfSPZ) produced by Sanaria Inc. PfSPZ Vaccine is manufactured in compliance with Good Manufacturing Practice (GMP) regulations (21 Code of Federal Regulations \[CFR\] 21), that is described in detail in Investigational New Drug (IND) 13969. Manufacture of PfSPZ Vaccine is performed in Sanaria s Clinical Manufacturing Facility (CMF) in Rockville, Maryland, USA.

Arm 1

PfSPZ Diluent OTHER

The diluent for PfSPZ Vaccine is composed of phosphate-buffered saline (PBS) and human serum albumin (HSA) and is termed PfSPZ Diluent (or Diluent). The PfSPZ Diluent was manufactured in compliance with GMP by Sanaria, Inc. (9800 Medical Center Dr., Rockville, MD, USA), or Sanaria s contractor Emergent Biosolutions (https://www.emergentcdmo.com/). Each lot of PfSPZ Diluent is issued a Certificate of Analysis (CoA) and is also placed on a stability program. HSA used in PfSPZ Diluent is a licensed product which is approved for parenteral, IV administration to humans and is purchased by Sanaria, Inc. from CSL Behring, Bern, Switzerland.

Arm 1

Normal Saline DRUG

Sterile isotonic (0.9%) normal saline will be procured in the US and shipped to Mali at ambient temperature. Like the study product, normal saline is a clear liquid, making it indistinguishable from the study product when drawn up into a syringe. Normal saline will be used as a placebo, rather than a comparator vaccine being used, as currently there are no licensed vaccines available as IV formulations. The NS to be used in this trial will be an FDA-licensed product which is commercially available (sodium chloride for injection 10 mL by Pfizer). NS will be purchased by Sanaria and supplied to the clinical site.

Arm 2

Eligibility Criteria

• Age: Up to 34 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following
• criteria:
• Willing and able to provide consent for study participation for herself and for her infant prior to initiation of any study procedures
• Stated willingness to comply with all study procedures and availability of both mother and offspring for the duration of the study
• Healthy, pregnant women 18-34 years of age (inclusive)
• Singleton pregnancy (confirmed by ultrasound)
• Gestational weeks of pregnancy, confirmed by best obstetrical estimate, at minimum of 16 weeks 0 days and a maximum of 32 weeks 6 days of gestation at the time of the first dose of PfSPZ Vaccine and minimum 14 weeks 0 days and maximum of 32 week 0 days of gestation at the time of the first dose of IPTp
• Note: women may be screened prior to 16 0/7 weeks gestation for dating of pregnancy
• Documented first, second, or third trimester ultrasound with singleton gestation and no significant fetal anomalies or other abnormalities
• Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
• Identified antenatal care provider outside of the study team
• In good general health as evidenced by medical history
• Willing to have blood samples stored for future research

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this
• study:
• Medical, 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 laboratory defined limits of normal per trimester 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 (per trimester) upper limit of normal and \>= Grade 2 (participants may be included at the investigator s discretion for not clinically significant abnormal values)
• Infected with HIV, hepatitis B, hepatitis C, syphilis, toxoplasmosis, rubella as documented by testing at screening
• Sickle cell disease (HbSS or HbSC) or sickle trait (HbAS) by testing at screening
• Clinically significant abnormal ECG such as abnormal QTc
• History of receipt of the following:
• Investigational malaria vaccine in the last 5 years
• Immunoglobulins and/or blood products within 6 months of enrollment
• Investigational product within 3 months of enrollment
• Chronic (\>=14 days) oral or IV corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e., prednisone \>=20 mg/day or equivalent) or immunosuppressive drugs within 30 days of enrollment
• Live vaccine within 30 days of enrollment
• Non-live vaccine within 14 days of enrollment or planned receipt of a killed vaccine within 14 days of scheduled vaccination

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Ou(SqrRoot)(Copyright)less(SqrRoot)(Copyright)bougou, Health Research Center

Ou(SqrRoot)(Copyright)less(SqrRoot)(Copyright)bougou, Mali

Location

MeSH Terms

Conditions

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

• Patrick E Duffy, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: December 15, 2022
• Study Start (Estimated): April 21, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-01-16

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)