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Adenovirus Vaccine for Malaria
This study is not yet open for patient recruitment.
Verified by National Institute of Allergy and Infectious Diseases (NIAID) August 2006
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00371189 Purpose
The study’s purpose is to find out if a new malaria vaccine is effective, safe, and tolerated in healthy adults 18 to 45 years of age. The vaccine is expected to be tolerated in humans and boost immunity to malaria. At least 96 healthy male and female volunteers will participate in this study at Vanderbilt University Medical Center in Nashville, TN. Volunteers will receive 3 doses of either the new malaria vaccine being or a placebo (contains no vaccine) by injection into the shoulder muscle at 0, 1 and 6 months. Investigators will look at the safety and effectiveness of increasing dosage strengths of the vaccine. Increasing the dosage will proceed only after a review of the 2-week safety data of the 2 initial doses of the prior dosage level. Participants will have 13 study visits and complete a Memory Aid (study diary) at home. Blood will be drawn 7 times from each volunteer during participation in the study. Each participant will be followed for about 1 year.
Condition Intervention Phase
Malaria
Vaccine: Ad35, CS
Phase I
MedlinePlus related topics: Malaria
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Official Title: A Phase I Randomized, Controlled, Dosage-Escalation Trial to Evaluate the Immunogenicity, Safety, and Reactogenicity of an Adenovirus Type 35 Based Circumsporozoite Malaria Vaccine in Healthy Adults 18 to 45 Years of Age
Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):
Expected Total Enrollment: 96
The purpose of this phase I, randomized, controlled, dosage-escalation trial is to evaluate the immunogenicity, safety, and tolerability of an Adenovirus Type 35 Based Circumsporozoite Malaria vaccine in healthy adults 18 to 45 years of age. At least 96 healthy male and female subjects aged 18 to 64 years will be recruited in Nashville, Tennessee for this study conducted at Vanderbilt University Medical Center. Subjects will be randomized in a 5:1 ratio to receive 3 doses of the Adenovirus Type 35 Circumsporozoite (Ad35.CS) Malaria Vaccine or vaccine formulation buffer control by the intramuscular route at 0, 1 and 6 months. The safety and immunogenicity of ascending dosages of the vaccine will be assessed. Fifteen subjects will receive vaccine at each of the following dosage levels: 10 [to the 8th power] vp/ml and 10 [to the 9th power] vp/ml with three subjects receiving control at each of these dosage levels. Twenty-five subjects will receive vaccine at each of the next dosage levels of 10 [to the 10th power] vp/ml and 10 [to the 11th power] vp/ml with five subjects receiving control at each of these dosage levels. Dosage escalation will proceed only after review of the 2-week safety data of the 2 initial doses of the prior dosage level. The primary objective is to assess the safety and reactogenicity of ascending dosages of Adenovirus Type 35 based circumsporozoite malaria vaccine among healthy subjects given in 3 intramuscular doses at 0, 1 and 6 months. The secondary objective is to evaluate the immunogenicity of the Adenovirus Type 35 based circumsporozoite malaria vaccine through performance of Humoral Immune Assays (ELISA [enzyme-linked immunosorbent assay] for antibodies to circumsporozoite antigen and Adenovirus Neutralization Assay for neutralizing antibodies to Adenovirus type 35) and Cellular Immune Assays (Elispot and Flow Cytometry) for CS-specific CD4+ and CD8+ T cell responses. The primary outcome measure will be frequency and severity of local, systemic, and safety laboratory adverse events. The secondary outcome measures will be: 1) antibody titers against the malaria circumsporozoite antigen via ELISA, 2) neutralizing antibody titers against Adenovirus type 35 by Adenovirus Neutralization Assay, and 3) T cell responses against the malaria circumsporozoite antigen by Elispot and Flow Cytometry.
www.clinicaltrials.gov/ct/show/NCT003...***********************************
A malaria vaccine is also expected to enter a Phase I trial in the third quarter of 2006 at Vanderbilt University in the US. This randomized, double-blind, placebo-controlled study in 76 healthy volunteers will include dose-escalation studies and multiple vaccination regimens. Studies in large animal models have shown that Crucell's recombinant Ad35 vaccine provides a demonstrated higher level of protection than the existing RTS,S vaccines.