Experimental Ebola Vaccine Trial
|First Received Date ICMJE||November 4, 2003|
|Last Updated Date||August 23, 2007|
|Start Date ICMJE||October 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00072605 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Experimental Ebola Vaccine Trial|
|Official Title ICMJE||A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of a Multiple Strain Ebola DNA Plasmid Vaccine, VRC-EBODNA012-00-VP, in Adult Volunteers|
This study will test the safety of an experimental vaccine developed to protect against Ebola virus infection and to determine if the vaccine induces an immune response to the virus. The Ebola virus causes a disease called Ebola hemorrhagic fever. Symptoms begin with fever and muscle aches and progress to breathing problems, severe bleeding, kidney problems, and shock. The infection may be mild, but it can also lead to death. The vaccine used in this study is made from small parts of Ebola genetic material. It cannot cause Ebola hemorrhagic fever to develop in those who receive it.
Healthy volunteers 18 to 44 years of age may be eligible for this study. Candidates will be screened with a medical history, physical examination, and laboratory tests, and complete an "assessment of understanding" questionnaire to show that they understand the study.
Depending on their order of entry into the study, participants are assigned to receive one of three vaccine doses or placebo. The first group receives the lowest dose (2 milligram) of vaccine or placebo. If this dose is safe, then the second group receives 4 mg, and if this dose is safe, the third group receives 8 mg. Injections are given in a muscle in the upper arm. Participants receive three injections, each 4 weeks apart (on study days 0, 28, and 56).
Participants record their temperature and symptoms in a diary card for 7 days following each injection. They return to the clinic 2 to 3 days after each injection and then 2 weeks after each injection until study week 10. Additional follow-up visits are then scheduled at weeks 12, 24, 38, and 52. At each visit, participants provide a blood and urine sample for testing and have their vital signs, and lymph nodes checked, their weight measured, and their symptoms reviewed. Additional laboratory tests may be requested between visits.
This is a Phase I, randomized, placebo-controlled, dose-escalation study of an Ebola DNA plasmid vaccine. The hypothesis is that the vaccine will be safe for human administration and elicit immune responses to Ebola. Primary objectives are to evaluate the safety and tolerability of the investigational vaccine and the secondary objective is to evaluate immune responses. Randomization assignment will be blinded to subjects, clinical investigators and laboratory investigators.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1|
|Study Design ICMJE||Primary Purpose: Treatment|
|Intervention ICMJE||Drug: VRC-EBODNA012-00-VP|
|Study Arm (s)||Not Provided|
|Publications *||Birmingham K, Cooney S. Ebola: small, but real progress. Nat Med. 2002 Apr;8(4):313. No abstract available.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||August 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
A volunteer must meet all of the following inclusion criteria:
No reproductive potential because of menopause (one year without menses) or because of a hysterectomy, bilateral oophorectomy, or tubal ligation,
Participant agrees to be heterosexually inactive at least 21 days prior to enrollment and throughout the duration of the study,
Participant agrees to consistently practice contraception at least 21 days prior to enrollment and throughout the duration of the study by one of the following methods:
A volunteer will be excluded if one or more of the following conditions apply.
|Ages||18 Years to 44 Years|
|Accepts Healthy Volunteers||Yes|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00072605|
|Other Study ID Numbers ICMJE||040028, 04-I-0028|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Allergy and Infectious Diseases (NIAID)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||August 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP