CS DNA MVA Trial in Mampong, Ghana

NCT00377494 | Withdrawn Phase 1

• 2 other identifiers: 04-070NMIMR: CPN 042/03-04
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 2

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 "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.

Conditions

Plasmodium Falciparum Malaria

Keywords

malaria, Plasmodium falciparum, vaccine, Ghana

Interventions

MVA-CSO Vaccine BIOLOGICAL

PfCSP DNA (VCL-2510) Vaccine BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

Naval Medical Research Center

Silver Spring, Maryland, 20910-7500, United States

Location

Noguchi Memorial Institute of Medical Research

Legon, Ghana

Location

MeSH Terms

Conditions

Malaria, Falciparum; Malaria

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 14, 2006
• First Posted: September 18, 2006
• Study Completion: July 1, 2008
• Last Updated: January 23, 2019

Record last verified: 2007-02

Locations

US (1); GH (1)