Status:
COMPLETED
Safety of and Immune Response to a Malaria Vaccine (MSP1 42-C1) With or Without CPG 7909 Adjuvant
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsors:
Johns Hopkins Bloomberg School of Public Health
Conditions:
Malaria
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety of and immune response to a preventive malaria vaccine, MSP1 42-C1/Alhydrogel, in healthy adults. This study will also compare responses to two dif...
Detailed Description
In 2002, the World Health Organization reported a worldwide malaria incidence of approximately 300 million clinical cases annually, with approximately 1 million deaths attributed to malaria alone or i...
Eligibility Criteria
Inclusion
- Good general health
- Willing to be followed for the duration of the study
- Willing to use acceptable methods of contraception
Exclusion
- Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, may affect the ability of the volunteer to understand and cooperate with the study
- Liver disease (ALT greater than upper limit of normal \[ULN\])
- Kidney disease (serum creatinine greater than ULN)
- Hematologic disease (absolute neutrophil count of less than 1,500 cells/mm3; hemoglobin less than lower limit of normal, by sex; OR platelet count less than 140,000 mm3)
- Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease
- Participation in another investigational vaccine or drug trial within 30 days of study entry or while this study is ongoing
- Active drug or alcohol abuse causing medical, occupational, or family problems during the 12 months prior to study entry
- History of severe allergic reaction or anaphylaxis
- HIV-1 infected
- Hepatitis C virus infected
- Hepatitis B surface antigen positive
- Known immunodeficiency syndrome
- Use of corticosteroids or immunosuppressive drugs within 30 days prior to study entry. Participants who have used topical or nasal corticosteroids are not excluded.
- Live vaccine within 4 weeks prior to study entry
- Killed vaccine within 2 weeks prior to study entry
- Blood products within 6 months prior to study entry
- Absence of spleen
- Previously received an investigational malaria vaccine
- Received antimalarial prophylaxis during the 12 months prior to study entry
- Received chloroquine or other aminoquinolines within 12 weeks of study entry
- Prior malaria infection
- Known allergy to nickel
- Pre-existing autoimmune or antibody-mediated disease. More information about this criterion can be found in the protocol.
- Any medical, psychiatric, social, or occupational condition or other responsibility that, in the opinion of the investigator, would interfere with the study
- Other condition that, in the opinion of the investigator, would affect the volunteer's participation in the study
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00320658
Start Date
March 1 2006
End Date
July 1 2007
Last Update
January 21 2008
Active Locations (1)
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1
Center for Immunization Research, Johns Hopkins University, Bloomberg School of Public Health
Washington D.C., District of Columbia, United States, 20037