Safety of and Immune Response to a Malaria Vaccine (MSP1 42-C1) With or Without CPG 7909 Adjuvant

Completed · Phase 1

Conditions studied: Malaria

In brief

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 different doses of the malaria vaccine given with or without the adjuvant CPG 7909.

Key facts

Study ID

NCT00320658

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

60

Starts

2006-03-01

Expected to finish

2007-07-01

Last updated by the study team

2008-01-21

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Good general health
• Willing to be followed for the duration of the study
• Willing to use acceptable methods of contraception

You may not qualify if…

• 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

Where it is running

• Center for Immunization Research, Johns Hopkins University, Bloomberg School of Public Health — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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