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

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

Interventions

BIOLOGICAL

PfSPZ Vaccine

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.

OTHER

PfSPZ Diluent

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.

DRUG

Normal Saline

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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  lead NIH

Principal Investigators

• Patrick E Duffy, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Max Age

34 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-27

Primary Completion

2026-11-30

Completion

2026-11-30

FDA Drug

Yes

Countries

• Mali