Status:
COMPLETED
Phase I Study of AMA1-C1/Alhydrogel® (Registered Trademark) + CPG 7909 Malaria Vaccine
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Malaria
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This study will evaluate the safety and immune response of healthy volunteers to an experimental malaria vaccine called AMA1-C1/Alhydrogel® (Registered Trademark) + CPG 7909. Malaria is an infection o...
Detailed Description
AMA1-C1 + CPG 7909 is a blood stage malaria vaccine candidate. The objectives of this Phase 1 study are to confirm the previously demonstrated safety and immunogenicity of AMA1-C1 + CPG 7909 formulate...
Eligibility Criteria
Inclusion
- 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:
- Pregnancy as determined by a positive urine beta-hCG at any time during the study (if female).
- 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).
- Currently breast-feeding (if female).
- 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.
- Neutropenia as defined by an absolute neutrophil count less than 1500/mm(3).
- Alanine aminotransaminase (ALT) level above the laboratory-defined upper limit of normal.
- Serum creatinine level above the laboratory-defined upper limit of normal.
- Hemoglobin below the laboratory-defined lower limit of normal, by sex.
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies including urinalysis.
- 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.
- History of receiving any investigational product within the past 30 days.
- Participant has had medical, occupational or family problems as a result of alcohol or illicit drug use during the past 12 months.
- History of a severe allergic reaction or anaphylaxis.
- Positive ELISA and confirmatory Western blot tests for HIV-1.
- Positive ELISA and confirmatory immunoblot tests for hepatitis C virus (HCV).
- Positive hepatitis B surface antigen (HBsAg) by ELISA.
- 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.
- Known immunodeficiency syndrome.
- Positive serum anti-dsDNA titer.
- Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days of starting this study.
- Receipt of a live vaccine within past 4 weeks or a killed vaccine within past 2 weeks prior to entry into the study.
- History of a surgical splenectomy.
- Receipt of blood products within the past 6 months.
- Previous receipt of an investigational malaria vaccine.
- 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.
- Prior malaria infection.
- 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.
- History of a known allergy to nickel.
Exclusion
Key Trial Info
Start Date :
January 23 2007
Trial Type :
INTERVENTIONAL
End Date :
November 5 2008
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00427167
Start Date
January 23 2007
End Date
November 5 2008
Last Update
July 2 2017
Active Locations (2)
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1
Johns Hopkins University Bloomberg School of Public Health
Washington D.C., District of Columbia, United States, 20037
2
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892