A Phase 1 interventional study of Normal Saline (Placebo) and PfSPZ-LARC2 Vaccine in Malaria Falciparum, sponsored by Sanaria Inc.. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Sanaria Inc. · Phase 1, Interventional, and Prevention
This is a randomized, double-blind, placebo-controlled Phase 1 trial of Plasmodium falciparum (Pf) sporozoite (SPZ) late-arresting replication-competent (LARC) malaria vaccine (PfSPZ-LARC2 Vaccine) administered to healthy, malaria-naive study participants in Germany by direct venous inoculation (DVI) to determine safety, tolerability, and vaccine efficacy (VE) against controlled human malaria infection (CHMI). PfSPZ-LARC2 Vaccine contains a deletion of two genes, the Mei2 and LINUP genes, and undergoes developmental arrest in the late liver stages without releasing merozoites into the blood stream (blood stage parasites).
The primary objective of the study is to assess the safety and tolerability of administration of PfSPZ-LARC2 Vaccine, with special attention to the adequacy of attenuation, in the intention-to-treat (ITT) population.
This is a randomized, double-blind, placebo-controlled, single-center Phase 1 clinical trial in two parts, with the performance and design of Part B conditional on the outcome of Part A. Each study part includes two staggered cohorts (-1, -2). CHMI in the second cohort will be initiated only after at least 14 days have elapsed since the CHMI of cohort 1 and after confirmation that no CHMI-related SAEs have occurred in cohort 1. According to the study schedule, this results in an approximately 2 week delay in the start of vaccination for cohort 2 relative to cohort 1.
In Part A-1, eligible healthy participants will receive a 3-dose immunization regimen with 2x10\^5 PfSPZ of PfSPZ-LARC2 Vaccine (n=10) or normal saline (n=2) administered on Days 1, 6 and 29. Participants will be followed up for parasitemia and adverse events after immunization. After immunizations on Day 1 (V1) and Day 6 (V2 = V1+5), qPCR and thick blood smears (TBS) will commence to monitor for P. falciparum blood stage infections. These will be done every other day from Day 7 (V1+6) to Day 23 (V1+22) and on Day 28 (V1+27), and then weekly thereafter until two weeks after the third immunization given at Day 29 (V1+28), noting that the chance of breakthrough1 should be much reduced after the first and second immunizations due to the development of immunity. Participants will be instructed to contact the clinical staff if they develop any signs or symptoms suggestive of malaria parasite infection.
Two weeks after the last Part A-1 study participant has received the first vaccination (V1), vaccinations in Part A-2 will begin using the same dose and regimen as in Part A-1. In Part A-2, 8 participants will receive PfSPZ-LARC2 Vaccine, and 1 participant will receive saline as placebo. The follow-up schedule will be identical to that in Part A-1.
Three weeks after the third immunization (V3), corresponding to 8 weeks after first immunization, at Day 50 (V1+49), the 12 participants of Part A-1 will undergo heterologous CHMI using DVI of 3.2x10\^3 PfSPZ Challenge (7G8). The follow-up for CHMI is described below. CHMI in the Part A-2 cohort will be initiated only after at least 14 days have elapsed since the last CHMI in Part A-1 and after confirmation that no CHMI-related SAEs have occurred in Part A-1.
Following Part A (Part A-1 and Part A-2), an unblinded interim analysis will be conducted. The goal is to achieve 100% protection against heterologous CHMI at 3 weeks after the third immunization. This parallels what 2x10\^5PfSPZ of PfSPZ-CVac (chloroquine) achieved against heterologous CHMI using the same dose of PfSPZ [1]. The outcome of CHMI will determine what is done for Part B.
If any vaccinee in Part A develops Pf parasitemia following CHMI, indicating that the PfSPZ-LARC2 Vaccine dose might not be sufficiently protective, and if the safety monitoring committee (SMC) and the ethics committee agree to continue with the study, the study will proceed to Part B in which the dose of PfSPZ-LARC2 Vaccine will be doubled to 4x10\^5 PfSPZ.
The rationale for Part B is that protection may be improved by using a higher dose for immunization. The dose of 4x 10\^5 PfSPZ is supported by previous clinical experience with comparable PfSPZ-based products. A dose of 4x10\^5 fully infectious, non-attenuated PfSPZ administered as PfSPZ-CVac has previously been evaluated in 158 African adults and was well tolerated. In addition, 4x10\^5 PfSPZ-LARC2 Vaccine has been administered to 12 adults in Burkina Faso (NCT06652737) without emerging safety concerns. Further clinical evaluation of PfSPZ-LARC2 Vaccine is ongoing in Burkina Faso, including Day 1 and Day 28 administrations of 4x10\^5 PfSPZ-LARC2 Vaccine as well as once a higher dose of 6x10\^5 PfSPZ-LARC2 Vaccine (NCT07385287); immunizations have been completed and the available safety experience to date is favourable. Moreover, doses of fully attenuated (irradiated) PfSPZ as high as 2.7x10\^6 - 6.75-fold higher than the 4x10\^5 PfSPZ dose proposed here - have been administered to both malaria-naive and malaria-exposed adults and were well tolerated. Taken together, the available clinical experience with PfSPZ-based vaccines supports the proposed dose increase, and no specific safety concern is anticipated from administration of 4x 105 PfSPZ-LARC2 Vaccine.
In comparison to and based on the results of Part A, Part B will be adapted in regards to the immunization schedule, and CHMI timing. Participants will receive 4x10\^5 PfSPZ-LARC2 Vaccine or placebo on Days 1, 29, and 57. After the first vaccination V1, breakthrough monitoring will start on Day 6 and will be performed every second day until Day 21 and Day 28. After the second (V2) and third vaccination (V3), breakthrough monitoring will be performed at 7, 14, 21 and 27 days following each vaccination. Monitoring will include clinical assessment and parasitological testing according to the protocol. Heterologous CHMI with PfSPZ Challenge (7G8) will be performed 12 weeks after the third immunization. The CHMI dose, challenge strain, route of administration, diagnostic monitoring, rescue treatment criteria, pausing rules, and SMC oversight remain unchanged. Beyond safety and tolerability, the aim of the adapted Part B schedule is to assess whether the same vaccine dose administered according to a monthly immunization regimen provides improved protective efficacy compared with the condensed schedule evaluated in Part A. The longer intervals between vaccinations also allow more time for the development of vaccine-induced immune responses, without presuming a specific underlying mechanism. The interval between the third vaccination and CHMI was extended to 12 weeks, consistent with the timing used in the majority of previous PfSPZ DVI CHMI studies and allowing assessment of protection at a later time point after completion of the vaccination regimen.
Additional safety evaluations: Although blood stage infection is a focus of the safety evaluation, local and systemic adverse events (AE) and laboratory abnormalities are equally important and will be recorded. Solicited local and systemic AEs will be followed after each immunization (for 7 days each) and unsolicited AEs will also be followed from the first vaccination until 28 days after the last immunization. In addition, laboratory testing (complete blood count, liver enzymes creatinine) will be done before each of the three immunizations and during the follow-up period to assess laboratory abnormalities. Finally, at the day of PfSPZ Challenge (7G8) administration for CHMI solicited local and systemic AEs will be followed for seven days as before, and unsolicited AEs will be monitored through day C+30 to assess the tolerability of any parasitemias that develop in challenged clinical trial participants. In addition, during the period of any antimalarial treatment, unsolicited adverse events will be monitored. Serious adverse events (SAEs) will be followed throughout the study.
CHMI and last study visit: The follow-up for CHMI (C) will be for 21 days, with daily qPCR performed from Day 56-63, 65, 67, 69, 71 post V1 (Part A) or Day 147-154, 156, 158, 160 post V1 (Part B) (corresponding to days C+6 to days C+13 and then every other day until day C+21). TBS will be done and read concurrently as described above. On days when blood is not sampled for qPCR, participants will be telephoned for a symptom check, and if symptomatic, qPCR and TBS will be performed on these unscheduled days. Those developing parasitemia by qPCR and TBS will be treated under direct observation with a three-day regimen of atovaquone/proguanil or artemether/lumefantrine. Any participant still negative on Day 71(Part A) or Day 162 (Part B) (day C+21) will be treated with atovaquone/proguanil under direct observation as a safety precaution on Day 71, Day 72, and Day 73 (Part A) and Day 162, Day 163, and Day 164 (Part B) (days C+21, +22, +23). If not achieved within 3 days of treatment, follow-up continues until two consecutive qPCR samples show declining parasitemia. All participants will have a last study visit (LSV) on day C+30 (Day 80 (Part A) or Day 171 (Part B)) with a physical examination, safety labs, AE and SAE review, and qPCR to confirm absence parasitemia and immunology sampling. Prior to treatment on day C+21, a thick blood smear (TBS) will be obtained for retrospective reading.
455 studies on the registry are indexed under Malaria, Falciparum; 37 are open to participants now.
This study's planned enrollment of 42 is below 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:
Anticipated use of medications known to:
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
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.
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.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
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.
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.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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.
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.
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.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
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.
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.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The verum group (n=10) will receive three doses of 2x10\^5 PfSPZ of PfSPZ-LARC2 Vaccine by DVI on Days 1, 6 and 29. Participants will be followed up for parasitemia and adverse events after immunization. After immunizations on Day 1 (V1) and Day 6 (V2 = V1+5), qPCR and thick blood smears (TBS) will commence to monitor for P. falciparum blood stage infections. These will be done every other day from Day 7 (V1+6) to Day 23 (V1+22) and on Day 28 (V1+27), and then weekly thereafter until two weeks after the third immunization given at Day 29 (V1+28). Three weeks after the third immunization (V3), the 12 participants of Part A-1 (10 from verum and 2 from placebo) will undergo heterologous CHMI using DVI of 3.2x10\^3 PfSPZ Challenge (7G8).
Biological: PfSPZ-LARC2 Vaccine · Biological: PfSPZ Challenge (7G8)
The blinded control group (n = 2) of the main cohort will receive normal saline as placebo, also by DVI. All of the participants in the main cohort will progress through a 3-dose immunization regimen of normal saline administered on Days 1, 6 and 29. Follow-up and CHMI will be same as A-1 Main Cohort verum group.
Other: Normal Saline (Placebo) · Biological: PfSPZ Challenge (7G8)
Two weeks after the last Part A-1 study participant has received the first vaccination (V1), vaccinations in Part A-2 (n=8, verum) will begin using the same dose and regimen as in Part A-1 main cohort verum group. The follow-up schedule will be identical to that in Part A-1 cohort. CHMI in the Part A-2 cohort will be initiated only after at least 14 days have elapsed since the last CHMI in Part A-1 and after confirmation that no CHMI-related SAEs have occurred in Part A-1. Heterologous CHMI dose via DVI will be the same as Part A-1 cohort.
Biological: PfSPZ-LARC2 Vaccine · Biological: PfSPZ Challenge (7G8)
The blinded control group (n = 1) of the main cohort will receive normal saline as placebo by DVI on Days 1, 6 and 29. The follow-up schedule will be identical to that in Part A-1 cohort. CHMI in the Part A-2 cohort will be initiated only after at least 14 days have elapsed since the last CHMI in Part A-1 and after confirmation that no CHMI-related SAEs have occurred in Part A-1. Heterologous CHMI dose via DVI will be the same as Part A-1 cohort.
Other: Normal Saline (Placebo)
If any vaccinee in Part A develops Pf parasitemia following CHMI, the study will proceed to Part B. The verum group in the main cohort (n = 10) will receive 4x10\^5 PfSPZ of PfSPZ-LARC2 Vaccine per immunization dose by DVI on Days 1, 29, and 57. After the first vaccination V1, breakthrough monitoring will start on Day 6 and will be performed every second day until Day 21 and Day 28. After the second (V2) and third vaccination (V3), breakthrough monitoring will be performed at 7, 14, 21 and 27 days following each vaccination. Twelve weeks after the third immunization dose, the main cohort participants will undergo heterologous CHMI using DVI of 3.2x10\^3 PfSPZ of PfSPZ Challenge (7G8).
Biological: PfSPZ-LARC2 Vaccine · Biological: PfSPZ Challenge (7G8)
The blinded control group (n = 2) of the main cohort will receive normal saline as placebo, also by DVI on Days 1, 29, and 57. Follow-up and CHMI will be same as B-1 Main Cohort verum group.
Other: Normal Saline (Placebo) · Biological: PfSPZ Challenge (7G8)
Two weeks after the last Part B-1 study participant has received the first vaccination (V1), vaccinations in Part B-2 (n=8, verum) will begin using the same dose and regimen as in Part B-1 main cohort verum group. The follow-up schedule will be identical to that in Part B-1 cohort. CHMI in the Part B-2 cohort will be initiated only after at least 14 days have elapsed since the last CHMI in Part B-1 and after confirmation that no CHMI-related SAEs have occurred in Part B-1. Heterologous CHMI dose via DVI will be the same as Part B-1 cohort.
Biological: PfSPZ-LARC2 Vaccine · Biological: PfSPZ Challenge (7G8)
The blinded control group (n = 1) of the main cohort will receive normal saline as placebo, also by DVI on Days 1, 29, and 57. Follow-up and CHMI will be same as B-1 Main Cohort verum group.
Other: Normal Saline (Placebo) · Biological: PfSPZ Challenge (7G8)
The blinded control group of the main cohorts will receive normal saline as placebo, also by DVI.
Plasmodium falciparum (Pf) sporozoite (SPZ) late-arresting replication-competent (LARC) malaria vaccine (PfSPZ-LARC2 Vaccine) contains a deletion of two genes, the Mei2 and LINUP genes, and undergoes developmental arrest in the late liver stages without releasing merozoites into the blood stream (blood stage parasites).
Main cohort participants (verum and placebo) will undergo heterologous CHMI using DVI of 3.2x10\^3 PfSPZ of PfSPZ Challenge (7G8), which are infectious cryopreserved Pf sporozoites.
Safety and tolerability of administration of PfSPZ-LARC2 Vaccine, with special attention to the adequacy of attenuation, in the intention-to-treat (ITT) population: infection
Number of trial participants with blood stage infection during the first 28 days after immunization.
Time frame: 28 days after immunization
Safety and tolerability of administration of PfSPZ-LARC2 Vaccine, with special attention to the adequacy of attenuation, in the intention-to-treat (ITT) population: related AEs
Incidence of at least possibly related grade 3 solicited adverse events (AE) and grade 3 abnormal laboratory values occurring in the 7 days after injection of PfSPZ-LARC2 Vaccine .
Time frame: 7 days after injection of PfSPZ-LARC2 Vaccine
Safety and tolerability of administration of PfSPZ-LARC2 Vaccine, with special attention to the adequacy of attenuation, in the intention-to-treat (ITT) population: related SAEs
Incidence of related serious adverse events (SAEs)
Time frame: Time of first immunization to the end of the study
Vaccine Efficacy (VE) (1 minus the risk ratio) against heterologous CHMI with PfSPZ Challenge (7G8) conducted 12 weeks after 3rd immunization in the modified ITT (mITT) population
Proportion of protected volunteers following CHMI. Protection is defined as the absence of parasitemia in the peripheral blood for +21 days following CHMI with PfSPZ Challenge (7G8) in volunteers who received PfSPZ-LARC2 Vaccine.
Time frame: 21 days following CHMI
Humoral immune responses to PfCSP and their relationship to VE.
Antibody responses as measured by PfCSP ELISA.
Time frame: The day before immunization until 21 days post CHMI
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Aug 2027, 17 months after the start.
Of 49 phase 1 interventional studies under Malaria, Falciparum, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 18. This study's planned 17 months is above that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 3, 2026: primary completion Sep 2026 → Aug 2027 and completion Dec 2026 → Dec 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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