CS DNA MVA Trial in Mampong, Ghana

Withdrawn before enrolling · Phase 1

Conditions studied: Plasmodium Falciparum Malaria

In brief

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 "booster." Forty-eight adults in Ghana, ages 18-50 years, will participate for 17 months. They will be randomly assigned to 1 of 4 treatment groups. Group 1 will receive the DNA malaria vaccine at months 0 and 1, and the booster at month 7. Group 2 will receive a rabies vaccine at months 0 and 1, and an injection containing no vaccine at month 7. Group 3 will receive the DNA malaria vaccine at months 5 and 6, and the booster at month 7. Group 4 will receive the rabies vaccine at months 5 and 6, and an injection containing no vaccine at month 7. Blood samples and information regarding health problems that may occur after vaccination will be collected.

Key facts

Study ID

NCT00377494

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

0

Expected to finish

2008-07-01

Last updated by the study team

2019-01-23

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Naval Medical Research Center — Silver Spring, Maryland, United States
• Noguchi Memorial Institute of Medical Research — Legon, Ghana

Full record on ClinicalTrials.gov

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