Safety, Immunogenicity, and Protective Efficacy of Radiation Attenuated Plasmodium Falciparum NF54 Sporozoites (PfSPZ Vaccine) During Malaria Transmission Season in Healthy African Adult Women of Childbearing Potential in Mali

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Jun 15, 2019

Keywords

ClinConnect Summary

Pregnant women are highly susceptible to Plasmodium falciparum malaria, leading to substantial maternal, perinatal, and infant mortality. While malaria vaccine development has made significant progress in recent years, no trials of malaria vaccines have ever been conducted in only women of child bearing potential (WOCBP) or in pregnant women.

PfSPZ Vaccine (Sanaria, Inc) is an advanced malaria candidate being developed for use in

pregnant women, owing in part to its highly favorable safety profile. The vaccine is comprised of aseptic, metabolically active, non-replicating, purified, cryop...

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• • 1. Females of child bearing potential aged greater than or equal to 18 and less than or equal to 38 years
• • 2. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
• • 3. In good general health and without clinically significant medical history
• • 4. Willing to have blood samples stored for future research
• • 5. Available for the duration of the study
• • 6. Must be willing to use reliable contraception (defined as: pharmacologic contraceptives \[parental delivery\] or pre-existing intrauterine or implantable device) from 21 days prior to study day 1 to 28 days after last vaccination
• • 7. Report being interested in becoming pregnant within the next 1-2 years
• EXCLUSION CRITERIA:
• • 1. Pregnancy at the time of enrollment/vaccination, as determined by a positive urine or serum human chorionic gonadotropin (beta-hCG) test
• • 2. Biologically unable to become pregnant secondary to: surgical sterilization, premature ovarian insufficiency (defined as no menses for greater than or equal to 12 months without an alternative medical cause)
• • 3. Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and comply with the study protocol
• • 4. Hemoglobin (Hgb), white blood cell count (WBC), absolute neutrophils, and platelets outside the local laboratory-defined limits of normal and greater than or equal to Grade 2 (subjects may be included at the investigators discretion for not clinically significant abnormal values)
• • 5. Alanine transaminase (ALT) or creatinine (Cr) level above the local laboratory-defined upper limit of normal and greater than or equal to Grade 2 (subjects may be included at the investigators discretion for not clinically significant abnormal values)
• • 6. Infected with human immunodeficiency virus (HIV)
• • 7. Known or documented sickle cell disease by history (Note: known sickle cell trait is NOT exclusionary)
• • 8. Clinically significant abnormal electrocardiogram (ECG) such as abnormal corrected QT interval (QTc).
• • 9. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, or renal disease by history, physical examination, and/or laboratory studies including urinalysis
• • 10. History of receiving any investigational product within the past 30 days
• • 11. Participation or planned participation in a clinical trial with an investigational product prior to completion of the follow-up visit 28 days following last vaccination OR planned participation in an investigational vaccine study until the last required protocol visit
• • 12. Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
• • 13. History of a severe allergic reaction (Grade 2 or higher or per PI discretion) or anaphylaxis
• • 14. Severe asthma (defined as asthma that is unstable or required emergent care, urgent care, hospitalization, or intubation during the past two years, or that has required the use of oral or parenteral corticosteroids at any time during the past two years)
• • 15. Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren s syndrome, or autoimmune thrombocytopenia
• • 16. Known immunodeficiency syndrome
• • 17. Known asplenia or functional asplenia
• • 18. Use of chronic (greater than or equal to 14 days) oral or IV corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e., prednisone greater than or equal to 20 mg/day) or immunosuppressive drugs within 30 days of vaccination
• • 19. Receipt of a live vaccine within the past four weeks or a killed vaccine within the past two weeks prior to Vaccination #1 and every subsequent vaccination day
• • 20. Receipt of immunoglobulins and/or blood products within the past six months
• • 21. Previous receipt of an investigational malaria vaccine in the last five years
• • 22. Known allergies or other contraindications against use of artemeter/lumefantrine
• • 23. Other condition(s) that, in the opinion of the investigator, would jeopardize the safety or rights of a participant participating in the trial, interfere with the evaluation of the study objectives, or would render the subject unable to comply with the protocol