A Phase 1 interventional study of PfSPZ Vaccine and PfSPZ Diluent in Malaria, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Withdrawn at 1 site in Mali. Open to participants aged Up to 34 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Prevention
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.
Study Description:
A randomized double blind, placebo-controlled study to assess the safety, tolerability, immunogenicity and protective efficacy of a 1, 8, 29-day regimen of 9x105 PfSPZ of PfSPZ Vaccine or placebo (normal saline) in healthy pregnant women and their fetus/newborn. The first immunization is to be administered at 16 0/7 to 32 6/7 weeks of gestation and targeted to be completed prior to delivery. Offspring and post-partum women will be followed for 12 months post-delivery.
The study is composed of two cohorts (3rd trimester: Arms 1A, 2A, 2nd trimester: Arms 1B, 2B) with two arms (PfSPZ Vaccine, normal saline placebo) and associated offspring. Enrollment and vaccinations will be staggered for safety with only third trimester women (n=30; based on guidance provided by regulatory bodies) enrolling first in two separate subsets (n=10 [5 PfSPZ Vaccine/5 normal saline], n=20 [10 PfSPZ Vaccine/10 normal saline]) and receiving all three doses of vaccine in a staggered manner and undergoing safety reviews prior to further enrollments. Third trimester enrollment in this staggered manner is to account for any significant events occurring immediately post initial vaccinations with the smaller first subset of women (n=10; DSMB review). After all third trimester pregnancy outcomes are reviewed (by DSMB, FDA, Sponsor, EC/IRB), an additional cohort of women in their second trimester will be vaccinated in two separate subsets (n=10 [5 PfSPZ Vaccine/5 normal saline], n=20 [10 PfSPZ Vaccine/10 normal saline]) separated by at least six weeks. A longer time period of review will be conducted during the 2nd trimester out of additional safety measures to ensure no significant events of concern occur post receipt of a full vaccination series (n=10; DSMB review) before proceeding to the last subset of women (n=20).
Arm 1 (9x10\^5 PfSPZ Vaccine): (n = 30) pregnant women will receive three doses of PfSPZ Vaccine (9x10\^5 PfSPZ) via direct venous inoculation (DVI) at 1, 8, 29 days
Arm 2 (normal saline): (n = 30) pregnant women will receive normal saline via DVI at 1, 8, 29 days
All participants will receive intermittent preventive treatment in pregnancy (IPTp) with sulfadoxine-pyrimethamine (SP) as per standard of care in Mali. The study team will coordinate with the women s antenatal care (ANC) provider to time her IPTp prior to vaccine dose 1 (approximately 2 weeks prior) and between vaccine dose 2 and dose 3 (approximately 2 weeks prior to dose 3) within the protocol defined windows.
Pregnant women will be monitored closely for the duration of their pregnancy and for at least 12 months post-partum for safety, tolerability, immunogenicity, and malaria infection during the follow-up period.
Infants (n=up to 60) born to enrolled women will also be monitored closely for 12 months post-delivery for safety, immunogenicity, and malaria infection.
Objectives:
Primary Objectives:
-To describe the safety of PfSPZ Vaccine at 9x10\^5 PfSPZ at dosing schedule of 1, 8, 29 days in pregnant women and their fetuses using a composite measure of adverse maternal and birth outcomes
Secondary Objectives:
Exploratory Objectives:
Endpoints:
Primary Endpoints:
-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)
Secondary Endpoints:
Safety and tolerability in pregnant women and their fetuses
Safety in infants
Exploratory Endpoints:
Protective efficacy
1,184 studies on the registry are indexed under Malaria; 79 are open to participants now.
Browse Malaria studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
In order to be eligible to participate in this study, an individual must meet all of the following
criteria:
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
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this
study:
History of receipt of the following:
Known medical problems:
rheumatoid arthritis, multiple sclerosis, Sj(SqrRoot)(Delta)gren s syndrome, or autoimmune thrombocytopenia)
History of prior uterine surgery
Prior Cesarean section
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
(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
(n = 30) pregnant women will receive normal saline via DVI at 1, 8, 29 days
Drug: Normal Saline
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.
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.
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.
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)
Time frame: One year
Safety and tolerability in pregnant women and their fetuses using solicited adverse events (AEs), unsolicited AEs, and laboratory abnormalities
Solicited local and systemic AEs through 7 days post injection (counts and proportions) -Clinical laboratory parameters through 14 days post injection (counts and proportions) -All unsolicited AEs, medically attended AEs (MAEs), and serious AEs (SAEs) through delivery and six months thereafter (counts and proportions)
Time frame: 7 and 14 days post injection; 6 months after delivery
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Institute of Allergy and Infectious Diseases (NIAID) →