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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00605514 |
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.
Condition | Intervention | Phase |
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Ebola Vaccines Marburg Virus Disease Ebola Virus Disease Marburgvirus Ebolavirus |
Drug: VRC-EBODNA023-00-VP Drug: VRC-MARDNA025-00-VP |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study |
Official Title: | VRC 206: A Phase I Study to Evaluate the Safety and Immunogenicity of an Ebola DNA Plasmid Vaccine, VRC-EBODNA023-00-VP, and a Marburg DNA Plasmid Vaccine, VRC-MARDNA025-00-VP, in Healthy Adults |
Estimated Enrollment: | 20 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
The following eligibility criteria apply to initial enrollment into the study:
A participant must meet all of the following criteria:
Physical examination and laboratory results without clinically significant findings and a body mass index (BMI) less than 40 within the 28 days prior to enrollment
LABORATORY CRITERIA WITHIN 28 DAYS PRIOR TO ENROLLMENT:
Prothrombin time (PT) less than or equal to upper limit of normal
FEMALE-SPECIFIC CRITERIA:
A female participant must meet one of the following criteria:
OR
OR
Week 32 of the study by one of the following methods:
male partner has previously undergone a vasectomy
EXCLUSION CRITERIA:
A SUBJECT WILL BE EXCLUDED IF ONE OR MORE OF THE FOLLOWING CONDITIONS APPLY:
Women:
Breast-feeding or planning to become pregnant during the first 32 weeks after enrollment
SUBJECT HAS RECEIVED ANY OF THE FOLLOWING SUBSTANCES:
Current anti-tuberculosis prophylaxis or therapy
SUBJECT HAS A HISTORY OF ANY OF THE FOLLOWING CLINICALLY SIGNIFICANT CONDITIONS:
Eligibility for the Optional 4th Study Injection:
Eligibility to receive a 4th injection requires the original consent (Appendix I) to be reviewed again with a study clinician, as well as the consent for the optional 4th injection (Appendix V) to be reviewed and signed.
To be eligible the study subject must meet the following criteria:
Study ID Numbers: | 080065, 08-I-0065 |
Study First Received: | January 29, 2008 |
Last Updated: | September 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00605514 History of Changes |
Health Authority: | United States: Federal Government |
Hemorrhagic Fever Healthy Immunity T-Cells |
Filovirus Healthy Volunteer HV |
Virus Diseases Fever Ebola Virus Disease Hemorrhagic Fevers, Viral Hemorrhagic Fever, Ebola |
Marburg Hemorrhagic Fever Viral Hemorrhagic Fever Healthy Hemorrhagic Fever Marburg Virus Disease |
Virus Diseases RNA Virus Infections Hemorrhagic Fevers, Viral Filoviridae Infections |
Hemorrhagic Fever, Ebola Marburg Virus Disease Mononegavirales Infections |