Experimental Ebola Vaccine Trial

NCT00072605 | Completed Phase 1

• 2 other identifiers: 04002804-I-0028
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemorrhagic Fever, Ebola; Healthy

Keywords

Healthy; T Cells; Immunity; Hemorrhagic Fever; Healthy Volunteer; HV

Interventions

VRC-EBODNA012-00-VP DRUG

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• to 44 years old.
• Available for follow-up for the duration of the study (12 months).
• Able to provide proof of identity to the acceptance of the study clinician completing the enrollment process.
• Completion of an Assessment of Understanding prior to enrollment and verbalize understanding of all questions answered incorrectly.
• Able and willing to complete the informed consent process.
• Willing to receive HIV test results and willing to abide by NIH guidelines for partner notification of positive HIV results.
• Willing to donate blood for sample storage.
• In good general health without clinically significant medical history.
• Physical examination and laboratory results without clinically significant findings within the 28 days prior to enrollment.
• Laboratory Criteria within 28 days prior to enrollment:
• Hematocrit equal to 34% for women; 38% for men.
• Normal fibrinogen levels, D-dimer immunoassay less than 2.0 microg/mL, and RBC morphology without evidence of microangiopathic hemolysis.
• WBC count: Non-African Americans: equal to 3,300-12,000 cells/mm3, African-Americans: equal to 2,500 - 12,000 cells/mm3 (in the absence of clinical or pathological etiology).
• Differential either within institutional normal range or accompanied by site physician approval.
• Total lymphocyte count: Non-African Americans: equal to 800 cells/mm3, African Americans: equal to 650 cells/mm3 (in the absence of clinical or pathological etiology)

You may not qualify if:

• A volunteer will be excluded if one or more of the following conditions apply.
• Women:
• Breast-feeding.
• Volunteer has received any of the following substances:
• Immunosuppressive or cytotoxic medications within the past six months with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis
• Blood products within 120 days prior to HIV screening.
• Immunoglobulin within 60 days prior to HIV screening.
• Live attenuated vaccines within 30 days prior to initial study injection.
• Investigational research agents within 30 days prior to initial study injection.
• Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days prior to initial study injection.
• Current anti-TB prophylaxis or therapy.
• Volunteer has a history of any of the following clinically significant conditions:
• Serious adverse reactions to vaccines, such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain.
• Autoimmune disease or immunodeficiency.
• Asthma that is unstable or required emergent care, urgent care, hospitalization or intubation during the past two years or that requires the use of oral or intravenous corticosteroids.

Sponsors & Collaborators

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

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Birmingham K, Cooney S. Ebola: small, but real progress. Nat Med. 2002 Apr;8(4):313. doi: 10.1038/nm0402-313. No abstract available.

  PMID: 11927920 BACKGROUND

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola; Hemorrhagic Fevers, Viral

Condition Hierarchy (Ancestors)

RNA Virus Infections; Virus Diseases; Infections; Filoviridae Infections; Mononegavirales Infections

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 4, 2003
• First Posted: November 5, 2003
• Study Start: October 30, 2003
• Study Completion: August 22, 2007
• Last Updated: December 17, 2019

Record last verified: 2007-08-22

Locations

US (1)