Status:
WITHDRAWN
CS DNA MVA Trial in Mampong, Ghana
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Plasmodium Falciparum Malaria
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and effectiveness of 2 doses of a malaria vaccine (DNA) followed by a dose of another type of malaria vaccine (MVA) given as a "boost...
Detailed Description
The purpose of this study is to assess the safety, tolerability, and immunogenicity of immunization with 2 doses of the PfCSP DNA vaccine (given 1 month apart) followed by a single dose of MVA.CSO (gi...
Eligibility Criteria
Inclusion
- Healthy adults, 18-50 years of age.
- Available to participate for the duration of the study period.
- HIV seronegative, per written proof of assay collected within four weeks of screening
- Provision of personal (not proxy) agreement to consent to the study.
Exclusion
- Females who are pregnant or nursing, who plan on becoming pregnant or plan to nurse during the study period, or males who plan on fathering children during the study period.
- Have a history of diabetes or any cardiovascular disorder
- Have hypertension, or current treatment with anti-hypertensives.
- Have a total cholesterol \>197.5 mg/dL.
- Have an abnormal EKG (e.g., all kinds of atrioventricular or intraventricular conditions or blocks such as complete left or right bundle branch block, A-V node block, QTc or PR prolongation, premature atrial contractions or other atrial arrhythmia, sustained ventricular arrhythmia, or 2 premature ventricular contractions (PVC) in a row, or ST elevation consistent with ischemia).
- Have an abnormal Troponin I level.
- Are HIV positive or have any known immunodeficiency (including receiving immunosuppressive therapy or a history of splenectomy).
- Have a history of autoimmune disease (including inflammatory bowel disease, hemolytic anemia, autoimmune hepatitis, rheumatoid arthritis, lupus, etc.)
- Have or have had any other illness or condition which, in the investigator's judgment, will substantially increase the risk associated with their participation or will compromise the scientific objectives of the protocol.
- Have eczema/atopic dermatitis or other significant skin condition.
- Have anemia, defined by a hemoglobin level \< 12.7g/dl in males, and \< 10.5 g/dl in females.
- Have a creatinine level \>141.2 mmol/L (males) or \>120.5 mmol/L (females).
- Have an ALT value \>53.1 U/L in males, or \>39.2 U/L in females.
- Have an AST value \>65.0 U/L in males, or \>46.5 U/L in females.
- Have a total bilirubin value \> 1.4 mg/L
- Have an alkaline phosphatase level \> 297.8 U/L in males, or \> 255.4 U/L in females.
- Have a white cell count \<3.4 x 10(9th)/L or \> 8.8 x 10(9th)/L.
- Have a platelet count \<97.0 x 10(9th)/L in males, or \<118.0 x 10(9th)/L in females
- Have the presence of any glucose or greater than trace amounts of protein in the urine. Have the presence of greater than trace amounts of RBC in the urine of males and non-menstruating females.
- Plan to have surgery between enrollment and the last immunization.
- Have any known allergic reactions or hypersensitivity to any vaccinations in the past.
- Decision to participate in another investigational vaccine/drug research during the period of this study.
- Have any immunizations planned within three weeks of one of the study immunizations.
- Receipt of immunoglobulins or any blood products within three months preceding the initial study immunization or planned administration during the study period.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00377494
End Date
July 1 2008
Last Update
January 23 2019
Active Locations (2)
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1
Naval Medical Research Center
Silver Spring, Maryland, United States, 20910-7500
2
Noguchi Memorial Institute of Medical Research
Legon, Ghana