Safety and Efficacy of Sanaria's PfSPZ-CVac in Malian Adults

• Status: Completed
• Trial end date: 2018-06-22
• Target enrollment: 0
• Participant gender: All

Summary

Single site, double-blinded, randomized, placebo-controlled clinical trial of PfSPZ-CVac safety, tolerability, immunogenicity and efficacy against naturally occurring malaria in malaria-exposed Malian adults. The overall goal of the study is to evaluate if a regimen of PfSPZ-CVac (PfSPZ Challenge under chemoprophylaxis) is safe, well-tolerated, and provides sterile protection against naturally-occurring malaria in malaria-experienced adults. The study population includes 62 healthy, malaria-experienced adults aged 18-45 years, inclusive, residing in Bougoula Hameau and surrounding villages, Mali. The primary objective of this study is to assess the safety and tolerability of PfSPZ Challenge compared to placebo among malaria-experienced adults taking chloroquine prophylaxis (PfSPZ-CVac)

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Artesunate; Chloroquine; Chloroquine diphosphate

Criteria

Inclusion Criteria:

1. A male or non-pregnant female aged 18-45 years inclusive at the time of screening.

2. For women of childbearing potential, willingness not to become pregnant or breastfeed until one month after the last CQ dose*.

*Pre-menopausal female participants will be referred to the local family planning clinic, which offers several means of contraception that are approved and recommended by the Mali Ministry of Health. Contraception (male or female condoms, diaphragm or cervical cap with spermicide, intrauterine device, or hormone-based contraceptive) should be started 30 days before the first vaccination and continue until 30 days after last vaccination.

3. Written informed consent obtained from the participant before screening.

4. Available and willing to participate in follow-up for the duration of study.

5. Residing in Bougoula Hameau region and environs.

6. In general good health based on clinical and laboratory investigation.

Exclusion Criteria:

1. Previous vaccination with an investigational malaria vaccine.

2. Use of an investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days before the first study vaccination, or planned use up to 30 days after last vaccination.

3. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months before the first vaccination*.

*This includes any dose level of oral steroids, but not inhaled steroids or topical steroids.

4. Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before the first study vaccination with the exception of tetanus toxoid.

5. Confirmed or suspected immunosuppressive or immunodeficient condition.

6. Confirmed or suspected autoimmune disease.

7. History of allergic reactions or anaphylaxis to chloroquine, 4-aminoquinolone derivatives, artesunate and artemisinin derivatives, vaccinations or to any vaccine component.

8. History of serious allergic reactions to any substance, requiring hospitalization or emergent medical care.

9. History of allergy to any component of the PfSPZ Challenge product, including human serum albumin.

10. Use or planned use of any drug with anti-malarial activity during the course of the study except for antimalarial medication administered by study clinicians.

11. History of splenectomy.

12. Confirmed pregnancy.

13. Laboratory evidence of liver disease (ALT > upper limit of normal).

14. Laboratory evidence of renal disease (serum or plasma creatinine > upper limit of normal).

15. Laboratory evidence of hematologic disease (platelet count <114,000/mm^3 for males and <144,000/mm^3 for females, or hemoglobin <11.2 g/dL for males and <9.5 g/dL for females).

16. Seropositive for hepatitis B surface antigen or hepatitis C virus (hepatitis C antibody).

17. Seropositive for HIV.

18. Sickle cell trait carriage or sickle cell disease.

19. Administration of immunoglobulin and/or any blood products within the three months preceding the first study. vaccination or planned administration during the study period.

20. Simultaneous participation in any other interventional clinical trial.

21. Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurological condition, severe malnutrition, or any other clinical findings that may increase the risk of participating in the study*.

*As determined by the PI.

22. Has evidence of increased cardiovascular disease risk (defined as > 10 percent, 5 year risk) as determined by the method of Gaziano*.

*Risk factors include sex, age (years), systolic blood pressure (mm Hg), smoking status, body mass index (BMI, kg/mm^2), reported diabetes status, and blood pressure.

23. Abnormal screening ECG*.

*Pathologic Q wave and significant ST-T wave changes, left ventricular hypertrophy, non-sinus rhythm except isolated premature atrial or ventricular contractions, right or left bundle branch block, advanced A-V heart block (secondary or tertiary), QT/QTc interval >450 ms.

24. Other condition that in the opinion of the PI would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol.

25. Documented history of non-febrile seizures or atypical (complex) febrile seizures.