Field Trial of PfSPZ-LARC2 Vaccine in Burkinabe Adults

Randomized, Double-Blind, Placebo-Controlled Trial to Assess Safety, Immunogenicity, and Protective Efficacy Against Naturally Transmitted Plasmodium Falciparum Malaria of One and Two Dose Regimens of a Late Liver Stage-arresting, Replication-competent Plasmodium Falciparum Sporozoite Vaccine (Sanaria® PfSPZ-LARC2 Vaccine) in Healthy Malaria-Exposed Adults in Burkina Faso

Field Trial of PfSPZ-LARC2 Vaccine in Burkinabe Adults (NCT07385287) is a Phase 2 interventional studying Malaria (Plasmodium Falciparum), sponsored by Sanaria Inc.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

This is a phase 2 clinical trial of a Plasmodium falciparum (Pf) late liver stage-arresting replication-competent (LARC) sporozoite (SPZ) vaccine (Sanaria® PfSPZ-LARC2 Vaccine) that will assess field efficacy in Africa. The PfSPZ comprising PfSPZ-LARC2 Vaccine contain a double deletion of the genes encoding the Mei2 and LINUP proteins, both of which are required for transition from liver to blood stage malaria. As a result, mei2-/linup- parasites undergo developmental arrest in the late liver stages without releasing merozoites into the blood stream. No blood stage parasites are produced, either asexual or sexual, and the parasite life cycle does not progress. Because Pf parasites with the LARC phenotype replicate in the liver before disintegrating, they amplify and diversify parasite protein expression and are expected to be a potent immunogen to induce anti-malarial immunity, equaling or exceeding the potency and efficacy of the replication-competent chemo-attenuated Sanaria® PfSPZ-CVac (chloroquine) vaccine approach. Because the parasites are intrinsically attenuated, they are expected to be safe and well tolerated, similar to radiation-attenuated Sanaria® PfSPZ Vaccine, to the replication deficient, early arresting PfSPZ-GA1 Vaccine, and to the single-gene(mei2)-deleted GA2 (LARC1) parasites tested at the Leiden University Medical Center that provided 90% protection against CHMI after a single dose. The active treatments to be assessed for efficacy are one immunization of 6.0x10\^5 PfSPZ or two immunizations with 4.0x10\^5 PfSPZ of PfSPZ-LARC2 Vaccine four weeks apart, timed so that the immunization of the one dose regimen coincides with the second immunization of the two dose regimen. The alternative treatment is immunization with normal saline (placebo group), which is indistinguishable from the test article. The primary variable of interest is whether and when trial participants develop Pf malaria parasitemia during surveillance. Malaria parasitemia will be detected by thick blood smear (TBS), which will be performed every two weeks starting two weeks after the second vaccination (to allow time for the vaccine to work) and extending to week 26 after the second vaccination (24-week surveillance period). Surveillance will continue for 40 weeks but the primary outcome will be determined at 24 weeks of surveillance so the data are comparable to other studies of PfSPZ vaccines.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Malaria (Plasmodium Falciparum) and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 180 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Malaria (Plasmodium Falciparum) subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Healthy males and females, based on clinical and laboratory findings 2. From the age 18 to 50 years 3. Adults with a Body Mass Index (BMI) 18 to 30 Kg/m2. 4. Residence in the study area for the duration of the study. 5. Agreement to release medical information and to inform the study doctor concerning contraindications for participation in the study. 6. Willingness to be attended to by a study clinician and take all necessary medications prescribed during study period. 7. Agreement to provide contact information of a third party household member or close friend to study team. 8. Agreement not to participate in another clinical trial during the study period. 9. Agreement not to donate blood during the study period (until final clearance is completed) 10. Able and willing to complete the study visit schedule over the study follow up period. 11. Willingness to undergo HIV, hepatitis B (HBV), hepatitis C (HCV), and sickle cell anemia tests. 12. Volunteer participant can demonstrate their understanding of the study by responding correctly to 18 out of 20 true/false statements (in a maximum of two repeat attempts for those who failed to pass in the first attempt). 13. Signed written willing to sign a consent form, in accordance with local practice. 14. Has not been treated with any antimalarial medication for at least two weeks prior to the initial clearance treatment. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Healthy males and females, based on clinical and laboratory findings 2. From the age 18 to 50 years 3. Adults with a Body Mass Index (BMI) 18 to 30 Kg/m2. 4. Residence in the study area for the duration of the study. 5. Agreement to release medical information and to inform the study doctor concerning contraindications for participation in the study. 6. Willingness to be attended to by a study clinician and take all necessary medications prescribed during study period. 7. Agreement to provide contact information of a third party household member or close friend to study team. 8. Agreement not to participate in another clinical trial during the study period. 9. Agreement not to donate blood during the study period (until final clearance is completed) 10. Able and willing to complete the study visit schedule over the study follow up period. 11. Willingness to undergo HIV, hepatitis B (HBV), hepatitis C (HCV), and sickle cell anemia tests. 12. Volunteer participant can demonstrate their understanding of the study by responding correctly to 18 out of 20 true/false statements (in a maximum of two repeat attempts for those who failed to pass in the first attempt). 13. Signed written informed consent, in accordance with local practice. 14. Has not been treated with any antimalarial medication for at least two weeks prior to the initial clearance treatment. 15. Female volunteers aged 18 years and above must be non-pregnant (as demonstrated by a negative urine pregnancy test), and provide consent / assent of their willingness to take protocol-defined measures not to become pregnant during pre-treatment and immunization period and until 28 days after the second immunization. Acceptable measures to not become pregnant include oral or implanted contraceptives, IUD, abstinence, sterilization or sterile sexual partner. Women with a history of surgical or chemical sterilization (e.g., tubal ligation, hysterectomy, other) must provide written documentation of the procedure from a health care provider. 16. Demonstration of the ability to complete pre-vaccination drug clearance without significant untoward effects. Exclusion Criteria: 1. Unable to provide informed consent including inability to pass the test of understanding. 2. Receipt of a malaria vaccine in a prior clinical trial. 3. History of a splenectomy or sickle cell disease. 4. History of a neurologic disorder (including non-febrile seizures or complex febrile seizures) or formal history of migraine headache. 5. Current use of systemic immunosuppressant pharmacotherapy. 6. Receipt of a live vaccine within 4 weeks of ﬁrst immunization or of 3 or more non-live vaccines within 2 weeks of ﬁrst immunization. 7. Women who are breast-feeding, pregnant or planning to become pregnant during the study period. 8. Known allergy to artemether-lumefantrine (AL), dihydroartemisinin-piperaquine (DHA-P), or any component of the investigational products. 9. History of anaphylaxis or other life-threatening reaction to a vaccine. 10. Participation in any study involving investigational vaccine or drug within 4 weeks prior to enrollment that in the estimation of the site PI might adversely aﬀect the individual's safety or the quality of data to be collected. 11. Evidence of increased cardiovascular disease risk; deﬁned as \>10% ﬁve-year risk by non-laboratory method (Gaziano, 2008). 12. Plan to participate in another investigational vaccine/drug research during the study. 13. Plan for major surgery between enrollment until last study visit. 14. Use or planned use of any drug with anti-malarial activity that is not speciﬁed by the protocol. 15. Anticipated use of medications known to cause drug interactions with DHA-P (antiarrhythmics, neuroleptics, macrolide antibiotics, fluoroquinolones, imidazole and triazole antifungal agents, quinine, halofantrine, pentamidine and saquinavir, certain non-sedating antihistamines, all of which can aﬀect QT intervals ) or AL (the same list of drugs aﬀecting QT intervals plus rifampin, carbamazepine, phenytoin, St. John's wort and antiretroviral drugs). 16. Positive HIV, HBsAg or HCV serology. 17. History of or evidence for other chronic disease conditions including cancer, diabetes, renal failure, hypertension, tuberculosis, etc. 18. History of arrythmias or cardiac disease, or an abnormal electrocardiogram, deﬁned as one showing prolonged QT interval, pathologic Q waves and signiﬁcant ST-T wave changes; left ventricular hypertrophy; any non-sinus rhythm including isolated premature ventricular contractions, but excluding isolated premature atrial contractions; right or left bundle branch block; or advanced (secondary or tertiary) A-V heart block; or other clinically signiﬁcant abnormalities on the electrocardiogram. 19. Any clinically signiﬁcant deviation from the normal range in biochemistry or hematology tests measured at screening and not resolving (grade 1 abnormalities are allowed). 20. Any medical, psychiatric, social, behavioral or occupational condition or situation (including active alcohol or drug abuse aﬀecting social function) that, in the judgment of the site PI, impairs the participant's ability to give informed consent, increases the risk to the participant of participation in the study, aﬀects the ability of the participant to participate fully in the study, or might negatively impact the quality, consistency, integrity or interpretation of data derived from their participation in the study. 21. Inability to complete a course of malaria treatment prior to receipt of investigational product.

Treatments Being Tested

BIOLOGICAL

Genetically attenuated PfSPZ Vaccine

PfSPZ-LARC2 Vaccine is composed of aseptic, purified, vialed, cryopreserved, genetically altered PfNF54 sporozoites (SPZ).

OTHER

Normal Saline (0.9% Sodium Chloride)

The placebo control is normal saline solution (0.9% sodium chloride) and is also administered by DVI.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Groupe de Recherche Action en Santé (GRAS), Unité de Recherche Clinique de Banfora 06 BP 10248

Ouagadougou, Burkina Faso

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07385287), the sponsor (Sanaria Inc.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07385287 clinical trial studying?

Who can participate in NCT07385287?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07385287?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07385287. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07385287. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.