Testing a malaria vaccine in different age groups in Burkina Faso

Age De-escalation Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of a Late Liver Stage-arresting, Replication-competent Plasmodium Falciparum Sporozoite Vaccine (Sanaria® PfSPZ-LARC2 Vaccine) Administered by Direct Venous Inoculation to Malaria-exposed Adults and Children in Burkina Faso

This study is testing a new malaria vaccine in different age groups in Burkina Faso to see if it can safely help people build immunity against the disease.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 1 Year to 50 Years
• Sex: All
• Sponsor: Sanaria Inc. (industry)
• Drugs / interventions: radiation
• Locations: 1 site (Ouagadougou)
• Trial ID: NCT06652737 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety, tolerability, and immunogenicity of the PfSPZ-LARC2 malaria vaccine in healthy adults and children in Burkina Faso. It is a randomized, double-blind, placebo-controlled study that administers the vaccine via direct venous inoculation. Participants are divided into cohorts based on age, with varying doses of the vaccine being tested to assess immune response and safety. The trial aims to determine if the vaccine can effectively induce immunity against malaria without causing adverse effects.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy males and females aged 1 to 50 years who reside in the study area.

Not a fit: Patients with serious health conditions or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could provide a new and effective means of preventing malaria in vulnerable populations.

How similar studies have performed: Previous studies have shown promising results with similar malaria vaccine approaches, indicating potential for success.

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.

Where this trial is running

Ouagadougou

• Groupe de Recherche Action en Santé (GRAS) / Unité de Recherche Clinique de Sabou — Ouagadougou, Burkina Faso (RECRUITING)

Study contacts

• Study coordinator: Sodiomon B Professor Sodiomon Bienvenu Sirima, MD PhD

Conditions: Malaria Falciparum, Malaria Infection, malaria, PfSPZ-LARC2 Vaccine, falciparum