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New treatment option for Malaria (Plasmodium Falciparum)
Official title Field Trial of PfSPZ-LARC2 Vaccine in Burkinabe Adults
ClinicalTrials.gov ID: NCT07385287
What this study is testing
What is Genetically attenuated PfSPZ Vaccine?
Genetically attenuated PfSPZ Vaccine is an investigational medicine, given as an once-daily injectable medicine, being studied as a potential treatment for malaria (plasmodium falciparum).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50. Healthy volunteers may be eligible.
You may be able to join if
- Healthy males and females, based on clinical and laboratory findings
- From the age 18 to 50 years
- Adults with a Body Mass Index (BMI) 18 to 30 Kg/m2.
- Residence in the study area for the duration of the study.
- Agreement to release medical information and to inform the study doctor concerning contraindications for participation in the study.
You likely can't join if
- Unable to provide informed consent including inability to pass the test of understanding.
- Receipt of a malaria vaccine in a prior clinical trial.
- History of a splenectomy or sickle cell disease.
- History of a neurologic disorder (including non-febrile seizures or complex febrile seizures) or formal history of migraine headache.
- Current use of systemic immunosuppressant pharmacotherapy.
- 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.
See the full eligibility criteria
- Healthy males and females, based on clinical and laboratory findings
- From the age 18 to 50 years
- Adults with a Body Mass Index (BMI) 18 to 30 Kg/m2.
- Residence in the study area for the duration of the study.
- Agreement to release medical information and to inform the study doctor concerning contraindications for participation in the study.
- Willingness to be attended to by a study clinician and take all necessary medications prescribed during study period.
- Agreement to provide contact information of a third party household member or close friend to study team.
- Agreement not to participate in another clinical trial during the study period.
- Agreement not to donate blood during the study period (until final clearance is completed)
- Able and willing to complete the study visit schedule over the study follow up period.
- Willingness to undergo HIV, hepatitis B (HBV), hepatitis C (HCV), and sickle cell anemia tests.
- 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...
- Signed written informed consent, in accordance with local practice.
- Has not been treated with any antimalarial medication for at least two weeks prior to the initial clearance treatment.
- 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...
- Demonstration of the ability to complete pre-vaccination drug clearance without significant untoward effects.
- Unable to provide informed consent including inability to pass the test of understanding.
- Receipt of a malaria vaccine in a prior clinical trial.
- History of a splenectomy or sickle cell disease.
- History of a neurologic disorder (including non-febrile seizures or complex febrile seizures) or formal history of migraine headache.
- Current use of systemic immunosuppressant pharmacotherapy.
- 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.
- Women who are breast-feeding, pregnant or planning to become pregnant during the study period.
- Known allergy to artemether-lumefantrine (AL), dihydroartemisinin-piperaquine (DHA-P), or any component of the investigational products.
- History of anaphylaxis or other life-threatening reaction to a vaccine.
- 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...
- Evidence of increased cardiovascular disease risk; defined as \>10% five-year risk by non-laboratory method (Gaziano, 2008).
- Plan to participate in another investigational vaccine/drug research during the study.
- Plan for major surgery between enrollment until last study visit.
- Use or planned use of any drug with anti-malarial activity that is not specified by the protocol.
- Anticipated use of medications known to cause drug interactions with DHA-P (antiarrhythmics, neuroleptics, macrolide antibiotics, fluoroquinolones, imidazole and triazole antifungal agents, quinine, halofantrine...
- Positive HIV, HBsAg or HCV serology.
- History of or evidence for other chronic disease conditions including cancer, diabetes, renal failure, hypertension, tuberculosis, etc.
- 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...
- Any clinically significant deviation from the normal range in biochemistry or hematology tests measured at screening and not resolving (grade 1 abnormalities are allowed).
- 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...
- Inability to complete a course of malaria treatment prior to receipt of investigational product.
The study team makes the final eligibility decision.
Where it's taking place
- Ouagadougou, Burkina Faso
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ouagadougou, Burkina Faso. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.