Age De-escalation Safety Trial of PfSPZ-LARC2 Vaccine in Burkina Faso

Launched by SANARIA INC. · Oct 21, 2024

Keywords

ClinConnect Summary

The Age De-escalation Safety Trial is a study aimed at testing a new malaria vaccine called PfSPZ-LARC2 in healthy adults and children in Burkina Faso. This vaccine is designed to help the body build immunity against malaria without causing the disease. Researchers will be looking at how safe the vaccine is, how well it is tolerated, and whether it can effectively stimulate the immune system. The trial is specifically recruiting healthy individuals aged between 1 and 50 years, who do not have any serious medical conditions and have not received any malaria vaccines in the past.

Participants in this trial can expect to receive either the vaccine or a placebo (a harmless substance with no active ingredients) through a direct injection into their veins. They will be monitored closely for any side effects, and researchers will check to see if any malaria infections occur after vaccination. It's important for potential participants to be aware that they need to agree to follow specific health guidelines and undergo certain tests, including for conditions like HIV and hepatitis, to ensure their safety during the study. This trial is an important step in developing a potentially effective malaria vaccine and understanding how it works across different age groups.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy males and females, based on clinical and laboratory findings
• • 2. From the age 1 to 50 years
• • 3. Adults with a Body Mass Index (BMI) 18 to 30 Kg/m2; or adolescents, and children with Z-score of the selected indicator (\[weight-for-height\], \[(height and BMI) for age\]) category within ±2SD.
• • 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 (subjects 21 years of age and older) or the parent / guardian signing the informed consent (for subjects \<21 years of age) is able to demonstrate their understanding of the study by responding correctly to 9 out of 10 true/false statements (in a maximum of two attempts for those who failed to respond correctly to all true/false statements in the first attempt)
• • 13. Signed written informed consent, in accordance with local practice, provided by adult volunteers, parents or legal representatives and relevant assent for children participants as applicable
• • 14. Has not been treated with any antimalarial medication for at least two weeks prior to the initial clearance treatment.
• • 15. Female volunteers aged 12 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 the study and safety follow-up period. Acceptable measures to not become pregnant include oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner during the entire study. 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. One additional inclusion criterion is 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 atovaquone-proguanil (AP), dihydroartemisinin-piperaquine (DHA-P), artemether-lumefantrine (AL), 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 would precede or coincide with vaccination through to 28 days after the last dose of vaccine.
• • 15. Anticipated use of medications known to cause drug interactions with DHAP (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 - see Section2.2.1.3) 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. One additional exclusion criterion is inability to take a course of malaria treatment prior to receipt of investigational product.