A Phase 2 interventional study of PfSPZ-LARC2 Vaccine and Normal Saline in Malaria (Plasmodium Falciparum), sponsored by Sanaria Inc.. Recruiting at 1 site in Mali. Open to female participants aged 18 Years to 38 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by Sanaria Inc. · Phase 2, Interventional, and Prevention
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).
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).
455 studies on the registry are indexed under Malaria, Falciparum; 37 are open to participants now.
This study's planned enrollment of 300 is above the median of 126 across 376 interventional studies indexed under Malaria, Falciparum.
Browse Malaria, Falciparum studies →Sanaria Inc. is the lead sponsor of 29 studies on the registry; 4 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) 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.
Exclusion Criteria:
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
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.
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.
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 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 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.
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.
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 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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
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.
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.
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.
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.
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.
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.
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.
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.
PfSPZ-LARC2 Vaccine 2x10\^5
Biological: PfSPZ-LARC2 Vaccine
Normal Saline controls
Other: Normal Saline
PfSPZ-LARC2 Vaccine (2x105 PfSPZ) via direct venous inoculation (DVI)
Normal Saline
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
Time frame: 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
Time frame: 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).
Time frame: Day 29 to 24 weeks
P. falciparum first clinical malaria from start of year 1 follow-up for 24 weeks
P. 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.
Time frame: 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.
P. 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.
Time frame: Start of year 2 follow-up for 24 weeks.
P.falciparum clinical malaria from start of year 2 follow-up for 24 weeks
P. 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.
Time frame: Start of year 2 for 24 weeks
P. falciparum clinical malaria starting immediately after 3rd injection to the end of year 2.
P. 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.
Time frame: 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.
P. 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.
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
P. 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.
Time frame: 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.
Time frame: Starting immediately following 3rd injection until end of pregnancy, assessed up to 12 months.
P. falciparum placental infection
P. falciparum placental infection defined as any positive placental blood smear for P. falciparum
Time frame: 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
P. 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
Time frame: 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
Time frame: time of delivery till 12 months post delivery
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