VRC 206: A Phase I Study to Evaluate the Safety and Immunogenicity of an Ebola DNA Plasmid Vaccine, VRC-EBODNA023-00-VP, and ... View Homepage


Ontology type: schema:MedicalStudy     


Clinical Trial Info

YEARS

2008-2010

ABSTRACT

This study will determine if experimental vaccines to prevent Ebola virus infection and Marburg virus infection are safe and what side effects, if any, they cause. Ebola virus infection may range from mild to severe, and may cause breathing problems, severe bleeding, kidney problems and shock that can lead to death. Marburg virus infection causes an illness similar to that caused by the Ebola virus. The vaccines used in this study contain genetic material produced in the laboratory that causes the body to make a small amount of either Ebola or Marburg virus proteins. No Ebola or Marburg virus is in the vaccines. Normal healthy volunteers between 18 and 60 years of age may be eligible for this study. Participants are assigned to receive injections of either the Marburg or the Ebola vaccine. The first group of participants will receive the Marburg vaccine and the second group will receive the Ebola vaccine. The injections are given at 4-week intervals (study weeks 0, 4 and 8). They are given into a muscle with a needleless system called the Biojector(Registered Trademark) 2000. Participants keep a diary at home (on paper or electronically) for 5 days, in which they record their temperature, symptoms and any reaction at the injection site. They call a study nurse the day after vaccination to report how they feel and return to the clinic for follow-up 2 weeks after each injection (weeks 2, 6 and 10). The visits include a check of vital signs, blood and urine tests, medical history and review of medications taken. Additional visits at weeks 12, 24 and 32 include a check of vital signs, medical history and blood tests. Detailed Description Study Design: This is an open label Phase I study to evaluate safety, tolerability, and immunogenicity of two recombinant DNA vaccines: one against Marburg virus infections and one against Ebola virus infections. The hypothesis is that each vaccine will be safe for human administration and elicit a humoral and T cell mediated immune response. The primary objectives are to evaluate the safety and tolerability of the investigational vaccines in healthy adults. Secondary and exploratory objectives are related to the immunogenicity of each study vaccine. Product Description: VRC-MARDNA025-00-VP (Marburg DNA) is composed of one closed-circular DNA plasmid encoding for the glycoprotein (GP) from the Angola strain of Marburg. VRC-EBODNA023-00-VP (Ebola DNA WT) is composed of two closed-circular DNA plasmids, one encodes for GP from the Zaire strain and one encodes for GP from the Sudan-Gulu strain of Ebola. DNA vaccine vials will be supplied at 4 mg/mL. Each DNA vaccination will be 1 mL of vaccine administered intramuscularly (IM) into the deltoid muscle using the Biojector[R] 2000 Needle-Free Injection Management System (Biojector). Subjects: A total of 20 healthy adults, ages 18-60 years, will be enrolled into two groups of 10 subjects each. No more than one subject per group may be in the age range of 51-60 years. Study Plan: Subjects will be sequentially enrolled into two groups. Group 1 subjects will receive the Marburg DNA vaccine and Group 2 subjects will receive the Ebola DNA WT vaccine. The first 3 enrollments in each group will occur no faster than one per day. Before completing enrollment into each group, there will be a study pause with review by the Protocol Safety Review Team (PSRT) when there is at least 2 weeks of safety follow-up on the third subject's first injection. Before the initiation of Group 2, the FDA must have assessed administration of the Ebola DNA WT vaccine as safe to proceed. In addition, there will be a study pause with review by the PSRT when there is at least two weeks of safety follow-up on the last subject enrolled into Group 1. VRC 206 Group 1 will receive Marburg DNA, accrue 10 subjects and deliver injections on Day 0 with a dose 4 mg, Day 28 plus or minus 7 with a dose 4 mg and Day 56 plus or minus 7 with a dose 4 mg. VRC 206 Group 2 will receive Ebola DNA WT, accrue 10 subjects and deliver injections on Day 0 with a dose of 4 mg, Day 28 plus or minus 7 with a dose 4 mg and Day 56 plus or minus 7 with a dose 4 mg. The total accrual will be 20 subjects. The injections will be administered at least 21 days between DNA injections. The original protocol design required 9 clinic visits and 3 telephone follow-up contacts for each subject. The Version 4.0 protocol amendment allows a 4th injection for those who consent. Consent and administration of the 4th injection could occur anytime in the interval starting with Study Week 32 through Study Week 52. The 4th injection follow-up schedule includes 1 telephone contact and 4 follow-up visits after the injection. Study Duration: The original study requires 32 weeks of clinical follow up for each participant. Subjects who consent to the amended schedule with a 4th injection will have an additional 12 weeks of follow up. More... »

URL

https://clinicaltrials.gov/show/NCT00605514

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