AMA1-C1/Alhydrogel + CpG 7909 for Malaria

Completed · Phase 1

Conditions studied: Plasmodium Falciparum Malaria

In brief

The purpose of this study is to test an experimental malaria vaccine in about 75 healthy adults, 18-45 years of age. The study will also test an experimental adjuvant which is a material added to a vaccine to help the body make more defense cells. The body's immune response (response to foreign substances) and the safety of the vaccine will be tested. All subjects will receive 3 doses of vaccine on days 0, 28, and 56 and doses may increase during the study. Participation in the study is expected to be up to 323 days and includes 16 visits. Study procedures include medical history, physical exams, urine and blood testing.

Key facts

Study ID

NCT00344539

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

75

Starts

2005-05-01

Expected to finish

2007-01-01

Last updated by the study team

2013-06-03

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age between 18 and 45 years, inclusive.
• Good general health as a result of review of medical history and/or clinical tests.
• Available for the duration of the trial (34 weeks).
• Willingness to participate in the study as evidenced by signing the informed consent document.

You may not qualify if…

• Pregnancy as determined by a positive urine Beta-hCG (if female) at any point during the study.
• Participant unwilling to use highly effective contraception methods (such as: abstinence, birth control pills or birth control patches or vaginal ring, diaphragm with spermicide, IUD (intrauterine device), condom with spermicide, progestin implant or injection, surgical sterilization (hysterectomy, bilateral oophorectomy, tubal ligation), or a partner who has had a vasectomy) for the duration of the trial (if female).
• Currently lactating and breast-feeding (if female).
• Evidence of clinically significant immunosuppressive, neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies including urinalysis.
• Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the volunteer to understand and cooperate with the study protocol.
• Laboratory evidence of liver disease (aspartate aminotransferase greater than 1.25 times the upper limit of normal of the testing laboratory).
• Laboratory evidence of renal disease (serum creatinine greater than the upper limit of normal of the testing laboratory).
• Laboratory evidence of hematologic disease (absolute neutrophil count <1,500/cubic mm; hemoglobin < 0.9 times the lower limit of normal of the testing laboratory, by sex; or platelet count <140,000/cubic mm).
• Other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol.
• Participation in another investigational vaccine or drug trial within 30 days of starting this study, or while this study is ongoing.
• Volunteer 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.
• Severe asthma (emergency room visit or hospitalization within the last 6 months).
• Serologic evidence of infection with HIV-1, HBV, or HCV.
• Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days of starting this study or while the study is ongoing.
• 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 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.
• Prior malaria infection.
• Travel to a malaria-endemic country during the past 12 months or planned travel to a malaria-endemic country during the course of the study.
• History of a known allergy to nickel.
• Pre-existing autoimmune or antibody mediated diseases including but not limited to: systemic lupus erythematosis, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, autoimmune thrombocytopenia; or laboratory evidence of possible autoimmune disease determined by a positive anti-dsDNA titer, positive rheumatoid factor, proteinuria and/or a positive ANA.
• Chloroquine and related compounds within 12 weeks of study entry.

Where it is running

• University of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

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