Malaria (Plasmodium Falciparum)Phase 2NCT07675785
PfSPZ-LARC2 Vaccine in Women of Child-bearing Potential (WOCBP) in Mali
A Phase 2 study testing PfSPZ-LARC2 Vaccine and Normal Saline in people with Malaria (Plasmodium Falciparum), run by Sanaria Inc. at 1 site in Mali.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Malaria (Plasmodium Falciparum)
- What is being tested?
- PfSPZ-LARC2 Vaccine and Normal Saline
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteMali
- Study dates
- 20 Jul 2026to Apr 2030
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
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- Known or documented sickle cell disease by history (Note: known sickle cell trait is NOT exclusionary)
- 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
- Known seizure disorder or history of seizures (exclusion: simple febrile seizure during childhood) or history of migraine headaches
- Laboratory evidence of hepatitis B or C
- Known asplenia or functional asplenia
- Use of chronic (≥14 days) oral or IV corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e., prednisone ≥20 mg/day) or immunosuppressive drugs within 30 days of vaccination
- Receipt of a live vaccine within the past four weeks or a killed vaccine within the past two weeks prior to Vaccination #1 and every subsequent vaccination day
- Receipt of immunoglobulins and/or blood products within the past six months
- Previous receipt of an investigational malaria vaccine in the last ten years
- Known allergies or other contraindications against use of artemether/lumefantrine
- Other condition(s) that, in the opinion of the investigator, would jeopardize the safety or rights of a participant participating in the trial, interfere with the evaluation of the study objectives, or would render the participant unable to comply with the protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mali1 site, 1 recruiting
- Recruiting
University of Sciences, Techniques and Technology, Bamako (USTTB)
Bamako
Halimatou Diawara, MD, MPH, +223-7248- 4849, hdiawara@icermali.org
Halimatou Diawara, MD MPH
About this study
Official title: Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety, Immunogenicity, & Protective Efficacy of Late Liver Stage-arresting, Replication-competent Plasmodium Falciparum Sporozoite Vaccine (Sanaria® PfSPZ-LARC2 Vaccine) in Healthy African Adult Women of Childbearing Potential in Mali
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.
Read more
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).
Read the detailed description
This study will enroll healthy Malian adult, non-pregnant WOCBP, who agree to be on birth control during the immunization period, between 18 and 38 years of age to participate in a randomized, double blind, placebo-controlled study to assess the safety, immunogenicity and protective efficacy of PfSPZ-LARC2 Vaccine during two years' of follow up, including at least two malaria transmission seasons. Participants will be immunized with a 3-dose series of 2x10^5 PfSPZ of PfSPZ-LARC2 Vaccine or normal saline (NS); placebo) at 1, 6, 29 days. Vaccinated subjects and controls will then be assessed for malaria infection during the ensuing two malaria transmission seasons and subsequent dry seasons, including following prospectively women who become pregnant during follow up and their offspring. Volunteers will be randomized into two arms at a 1:1 ratio to receive PfSPZ-LARC2 Vaccine (N=150) versus NS control (N=150).
If a woman becomes pregnant during follow-up, she will continue to be followed through the course of her pregnancy and for at least one year after delivery. Subsequent offspring born from pregnancies from this time period will also be followed for one year post birth.
Two study arms will be enrolled in this study, with two PfSPZ-LARC2 vaccination arms and one NS control arm.
Arm 1: (N=150) will receive 3 doses of PfSPZ-LARC2 Vaccine (2x10^5) via direct venous inoculation (DVI) at 1, 6, 29 days.
Arm 2: (N=150) will receive 3 doses of placebo NS injection via DVI at 1, 6, 29 days.
All injections will be administered by DVI. All participants will receive antimalarial treatment with artemether/lumefantrine (AL) approximately 2-4 weeks prior to the 1st and 3rd injections. Post 3rd injection, participants will be followed through the malaria transmission (rainy) season, approximately 6 months, and then the ensuing dry season for an additional 6 months. Participants will be monitored for safety, immunogenicity, and protective efficacy (malaria infection) during the follow-up period.
During the second year of follow-up, which will start immediately at the conclusion of the first year of follow-up, participants will be followed through the malaria transmission (rainy) season, approximately 6 months, and then the second dry season for an additional 6 months. Participants will be monitored for safety (unsolicited AEs), immunogenicity, and protective efficacy (malaria infection) during the second year of follow-up. No vaccine boost is planned at the end of the first year.
For any women who becomes pregnant during the trial, follow up will continue through the end of pregnancy, and any viable newborns/infants and their mothers will be followed through at least the first year of life.
If a woman becomes pregnant and has a pregnancy outcome and/or post-partum follow-up that completes prior to the end of Year 2 scheduled non-pregnant follow-up (~July/August 2026) she can resume being followed with non-pregnant women until the end of Year 2. A woman may be followed for multiple pregnancies during the course of her follow-up.
Safety monitoring: All solicited adverse events (AEs) will be recorded through Day 7 after each injection and graded for severity. Injection site reactions will also be assessed until Day 7 after injection (PfSPZ-LARC2 Vaccine or normal saline) or until resolved. After the periods specified above only unsolicited AEs, Serious AEs (SAEs), unanticipated problems (UPs), and new onset of chronic illness (NOCIs) will be recorded.
Any laboratory abnormalities (other than those specified as safety labs in the protocol as defined by the values in the toxicity table) will be reported as AEs if they require intervention. In pregnant women and neonates, safety monitoring involves assessing incidence of maternal obstetric outcomes (miscarriage/stillbirth, intrauterine growth restriction, hypertensive diseases in pregnancy, preterm delivery) and neonatal outcomes (neonatal death, low birth weight, small for gestational age, major malformations, and microcephaly).
- Conditions
- Malaria (Plasmodium Falciparum)
- Being tested
- PfSPZ-LARC2 Vaccine, Normal Saline
- Keywords
- PfSPZ-LARC2 Vaccine, malaria
- Medical subject headings
- Malaria, Falciparum, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PfSPZ-LARC2 VaccineBiological
PfSPZ-LARC2 Vaccine (2x105 PfSPZ) via direct venous inoculation (DVI)
Normal SalineOther
Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| PfSPZ-LARC2 Vaccine | Experimental | PfSPZ-LARC2 Vaccine 2x10^5 Receives: Biological: PfSPZ-LARC2 Vaccine |
| Normal Saline | Placebo comparator | Normal Saline controls Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
- 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).
Measured: Day 29 to 24 weeks
Secondary outcomes (13)
P. falciparum first clinical malaria from start of year 1 follow-up for 24 weeks
- falciparum first clinical malaria defined as first positive thick blood smear (detection of at least 1 P. falciparum asexual parasite by microscopic examination of 0.5 µL) plus: a) measured axillary temperature ≥ 37.5°C or history of fever in the last 24 hours; OR b) at least two of the following symptoms/symptom groups: headache; chills and/or rigors; malaise and/or fatigue; dizziness and/or light-headedness; myalgias and/or arthralgias; OR c) meeting criteria for severe malaria from the start of year 1 follow-up for 24 weeks.
Measured: 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.
- falciparum blood stage infection defined as time to first positive blood smear (detection of at least 1 P. falciparum asexual parasite by microscopic examination of 0.5 µL) from the start of year 2 follow-up for 24 weeks.
Measured: Start of year 2 follow-up for 24 weeks.
P.falciparum clinical malaria from start of year 2 follow-up for 24 weeks
- falciparum clinical malaria defined as first positive thick blood smear (detection of at least 1 P. falciparum asexual parasite by microscopic examination of 0.5 µL) plus: a) measured axillary temperature ≥ 37.5°C or history of fever in the last 24 hours; OR b) at least two of the following symptoms/symptom groups: headache; chills and/or rigors; malaise and/or fatigue; dizziness and/or light-headedness; myalgias and/or arthralgias; OR c) meeting criteria for severe malaria from the start of year 2 follow-up for 24 weeks.
Measured: Start of year 2 for 24 weeks
P. falciparum clinical malaria starting immediately after 3rd injection to the end of year 2.
- falciparum clinical malaria defined as first positive thick blood smear (detection of at least 1 P. falciparum asexual parasite by microscopic examination of 0.5 µL) plus: a) measured axillary temperature ≥ 37.5°C or history of fever in the last 24 hours; OR b) at least two of the following symptoms/symptom groups: headache; chills and/or rigors; malaise and/or fatigue; dizziness and/or light-headedness; myalgias and/or arthralgias; OR c) meeting criteria for severe malaria starting immediately after 3rd injection to the end of year 2.
Measured: 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.
- falciparum blood stage infection defined as time to first positive blood smear (detection of at least 1 P. falciparum asexual parasite by microscopic examination of 0.5 µL) starting immediately after 3rd injection to the end of year 2.
Measured: Starting immediately after 3rd injection to the end of year 2.
Time-to-first-conception post-vaccination in women who plan to become pregnant.
Time-to-first-conception post-vaccination in women who plan to become pregnant
Measured: start of study until the date of conception, assessed up to 45 months.
Incidence of maternal obstetric outcomes
Incidence of maternal obstetric outcomes (miscarriage/stillbirth, intrauterine growth restriction, hypertensive diseases in pregnancy, preterm delivery)
Measured: Start of study until date of delivery, assessed up to 45 months.
Incidence of neonatal outcomes (neonatal death, low birth weight, small for gestational age, major malformations, and microcephaly)
Incidence of neonatal outcomes (neonatal death, low birth weight, small for gestational age, major malformations, and microcephaly)
Measured: Start of study until date of delivery, assessed up to 45 months.
P. falciparum blood stage infection defined as time to first positive blood smear during pregnancy
- falciparum blood stage infection defined as time to first positive blood smear (detection of at least 1 P. falciparum asexual parasite by microscopic examination of 0.5 µL) during the pregnancy and starting immediately following 3rd injection.
Measured: Starting immediately following 3rd injection (Day 29) until end of pregnancy, assessed up to 12 months.
First clinical malaria during the pregnancy
First clinical malaria (as defined previously) during the pregnancy and starting immediately following 3rd injection.
Measured: Starting immediately following 3rd injection until end of pregnancy, assessed up to 12 months.
P. falciparum placental infection
- falciparum placental infection defined as any positive placental blood smear for P. falciparum
Measured: First day of pregnancy until date of delivery, assessed up to 36 months.
P. falciparum blood stage infection defined as time to first positive blood smear during follow up of children conceived within 2 years of maternal vaccination
- falciparum blood stage infection defined as time to first positive blood smear (detection of at least 1 P. falciparum asexual parasite by microscopic examination of 0.5 µL) during follow up of children conceived within 2 years of maternal vaccination
Measured: Time of delivery to 12 months post delivery date
Clinical malaria during follow up of children conceived within 2 years of maternal vaccination
Clinical malaria during follow up of children conceived within 2 years of maternal vaccination
Measured: time of delivery till 12 months post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start20 Jul 2026
- Primary completion15 Jul 2028 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria (Plasmodium Falciparum)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanaria Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), University of the Sciences, Techniques and Technologies of Bamako, Malaria Research and Training Center, Bamako, Mali
- Responsible party
- Sponsor
- Investigators
- Alassane Dicko, MD PhD, Study director, University of Sciences, Techniques and Technology, Bamako (USTTB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07675785
- Sponsor's protocol ID
- MLSPZL1
- Status last verified
- Jul 2026
- First submitted
- 17 Jun 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No