Phase I Study of AMA1-C1/Alhydrogel® (Registered Trademark) + CPG 7909 Malaria Vaccine

This is an interventional prevention trial for Malaria focused on measuring Blood Stage, Investigational, Vaccine, Malaria, Healthy Volunteer, HV Read More

• INCLUSION CRITERIA:

Age between 18 and 50 years, inclusive.

Good general health as determined by review of medical history and/or clinical tests at screening.

Available for the duration of the trial (30 weeks).

Willingness to participate in the study as evidenced by signing the informed consent document.

EXCLUSION CRITERIA:

1. Pregnancy as determined by a positive urine beta-hCG at any time during the study (if female).
2. Participant unwilling to use reliable contraception methods for at least 2 weeks prior to vaccination and for the duration of the trial. Reliable methods of birth control include: pharmacologic contraceptives including oral, parenteral, and transcutaneous delivery; condoms with spermicide; diaphragm with spermicide; surgical sterilization; vaginal ring; intrauterine device; abstinence; and post-menopause (if female).
3. Currently breast-feeding (if female).
4. Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the study protocol.
5. Neutropenia as defined by an absolute neutrophil count less than 1500/mm(3).
6. Alanine aminotransaminase (ALT) level above the laboratory-defined upper limit of normal.
7. Serum creatinine level above the laboratory-defined upper limit of normal.
8. Hemoglobin below the laboratory-defined lower limit of normal, by sex.
9. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies including urinalysis.
10. Other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant participating in the trial or would render the subject unable to comply with the protocol.
11. History of receiving any investigational product within the past 30 days.
12. Participant has had 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 or anaphylaxis.
14. Positive ELISA and confirmatory Western blot tests for HIV-1.
15. Positive ELISA and confirmatory immunoblot tests for hepatitis C virus (HCV).
16. Positive hepatitis B surface antigen (HBsAg) by ELISA.
17. 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.
18. Known immunodeficiency syndrome.
19. Positive serum anti-dsDNA titer.
20. Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days of starting this study.
21. Receipt of a live vaccine within past 4 weeks or a killed vaccine within past 2 weeks prior to entry into the study.
22. History of a surgical splenectomy.
23. Receipt of blood products within the past 6 months.
24. Previous receipt of an investigational malaria vaccine.
25. Receipt of antimalarial prophylaxis during the past 12 months, or receipt of chloroquine or related compounds (amodiaquine or primaquine) in the previous 8 weeks prior to study entry.
26. Prior malaria infection.
27. Any medical, psychiatric, social, or occupational condition or other responsibility that, in the judgment of the Principal Investigator (PI), would interfere with the evaluation of study objectives.
28. History of a known allergy to nickel.