Safety and Immunogenicity of Sanaria's Irradiated Sporozoite Vaccine (PfSPZ Vaccine) in Malaria-Experienced Adults in Burkina Faso

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02663700
• Date of registration: 21/01/2016
• Prospective Registration: Yes
• Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Public title: Safety and Immunogenicity of Sanaria's Irradiated Sporozoite Vaccine (PfSPZ Vaccine) in Malaria-Experienced Adults in Burkina Faso
• Scientific title: Dose Escalation Study of Sanaria's Irradiated Sporozoite Vaccine (PFSPZ Vaccine), Followed by a Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of PfSPZ Vaccine in Malaria-Experienced Adults in Burkina Faso
• Date of first enrolment: April 7, 2016
• Target sample size: 112
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02663700
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

Burkina Faso

Key inclusion & exclusion criteria

Inclusion Criteria:

1. A male or non-pregnant female aged 21-40 years inclusive at the time of screening.

2. For women, willingness not to become pregnant until 1 month after the last
vaccination*.

*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 Burkina Faso 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 Sapone region and environs.

6. Appear to be in generally 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 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 vaccine formulation, 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 or suspected pregnancy or current breastfeeding.

13. Laboratory evidence of liver disease (ALT > / = 1.25 x 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 <115,000/mm^3, 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. 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. 23. Documented history of non-febrile
seizures or atypical (complex) febrile seizures.



Age minimum: 21 Years
Age maximum: 40 Years
Gender: All

Health Condition(s) or Problem(s) studied

Plasmodium Falciparum Infection

Intervention(s)

Drug: Artesunate

Biological: PfSPZ Vaccine

Other: Placebo

Primary Outcome(s)

Occurrence of Grade 3 unsolicited adverse events (AEs) considered related to vaccination [Time Frame: Day 1 through Day 28]

Occurrence of Grade 3 unsolicited adverse events (AEs) considered related to vaccination [Time Frame: Day 57 through Day 83]

Occurrence of solicited reactions [Time Frame: Day 1 through Day 8]

Occurrence of serious adverse events (SAEs) at any point during the study period [Time Frame: Day 1 through Day 645]

Occurrence of serious adverse events (SAEs) considered related to vaccination [Time Frame: Day 1 through Day 28]

Occurrence of serious adverse events (SAEs) considered related to vaccination [Time Frame: Day 57 through Day 83]

Occurrence of solicited reactions [Time Frame: Day 57 through Day 64]

Secondary Outcome(s)

Antibody titers against P. falciparum circumsporozoite protein (CSP) at serology time points [Time Frame: Day 1 through Day 127]

Secondary ID(s)

15-0001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors