AMA1-C1/Alhydrogel + CpG 7909 for Malaria
Phase I Study of the Safety and Immunogenicity of AMA1-C1/Alhydrogel® + CPG 7909, an Asexual Blood Stage Vaccine for Plasmodium Falciparum Malaria
1 other identifier
interventional
75
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started May 2005
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 22, 2006
CompletedFirst Posted
Study publicly available on registry
June 26, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedJune 3, 2013
March 1, 2013
1.7 years
June 22, 2006
May 30, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Cellular immune response to vaccination.
Anti-AMA1 antibody will be measured by ELISA on Days 0, 14, 28, 42, 56, 70, 84, 140, and 236.
Serum antibody response to vaccination.
Day 70.
Safety: frequency of vaccine-associated adverse events, as classified by severity through active and passive surveillance.
Duration of study.
Study Arms (3)
B
EXPERIMENTAL80 mcg AMA1-C1/Alhydrogel® with 368 mcg Aluminum and 500 mg CPG 7909.
C
EXPERIMENTAL80 mcg AMA1-C1/Alhydrogel® with 368 mcg Aluminum alone.
A
EXPERIMENTAL20 mcg AMA1-C1/Alhydrogel® with 377 mcg Aluminum and 500 mg CPG 7909.
Interventions
AMA1-C1/Alhydrogel malaria vaccine, cloudy suspension, 0.5 mL dose containing up to equivalent of 377 mcg of aluminum as Alhydrogel® (800 mcg of aluminum hydroxide gel per dose) onto which 20 mcg or 80 mcg of recombinant AMA1-C1 is bound. Dosages: 20 mcg and 80 mcg administered via the deltoid muscle by IM injection
CPG 7909 is an investigational agent and is supplied in sterile vials at 10mg/mL in phosphate buffered saline for intramuscular administration. Dosage 500 mcg.
Eligibility Criteria
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.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Rochester
Rochester, New York, 14642, United States
Related Publications (1)
Mullen GE, Ellis RD, Miura K, Malkin E, Nolan C, Hay M, Fay MP, Saul A, Zhu D, Rausch K, Moretz S, Zhou H, Long CA, Miller LH, Treanor J. Phase 1 trial of AMA1-C1/Alhydrogel plus CPG 7909: an asexual blood-stage vaccine for Plasmodium falciparum malaria. PLoS One. 2008 Aug 13;3(8):e2940. doi: 10.1371/journal.pone.0002940.
PMID: 18698359RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2006
First Posted
June 26, 2006
Study Start
May 1, 2005
Primary Completion
January 1, 2007
Study Completion
January 1, 2007
Last Updated
June 3, 2013
Record last verified: 2013-03