Experimental Vaccine for Prevention of Ebola Virus Infection

NCT00374309 | Completed Phase 1

• 2 other identifiers: 06023706-I-0237
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine if an experimental vaccine to prevent Ebola virus infection is safe and what side effects, if any, it causes. 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. The vaccine used in this study contains man-made genetic material similar to one part of the Ebola virus, which is designed to stimulate an immune response to the virus. The vaccine itself cannot cause Ebola virus infection because it does not contain any Ebola virus. Participants are assigned to one of three groups as they enter into the study. Of the first 16 people in the study, 12 receive the lowest study dose of vaccine and 4 receive placebo (an inactive substance). If this dose is safe, then of the next 16 people who enter the study, 12 receive a higher dose of the vaccine, and the remaining 4 receive placebo. If this dose is safe, the final 12 people in the last group of 16 receive the highest study dose, and 4 receive placebo. The vaccine is given as a single injection in the arm on the day of enrollment. Participants keep a diary for 5 days, recording 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 they return to the clinic approximately six times for follow-up evaluations. These visits may include a check of vital signs, physical examination, blood and urine tests, or other medical tests if needed. ...

Conditions

Ebola Hemorrhagic Fever; Ebola Virus Disease; Ebola Virus Vaccines; Envelope Glycoprotein, Ebola Virus; Filovirus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Safety (local and systemic reactogenicity, lab tests, AE's).

Secondary Outcomes (1)

• Immunogenicity (cellular and humoral immune function assays).

Interventions

VRC-EBOADV018-00-VP DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A subject must meet all of the following criteria:
• to 50 years old.
• Available for clinical follow-up through Week 48.
• Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
• Complete an AoU prior to enrollment and verbalize understanding of all questions answered incorrectly.
• Able and willing to complete the informed consent process.
• Willing to donate blood for sample storage to be used for future research.
• In good general health without clinically significant medical history.
• 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:
• Hemoglobin greater than or equal to 11.5 g/dL for women; greater than or equal to 13.5 g/dL for men
• White blood cells (WBC) equal to 3,300-12,000 cells/mm(3)
• Differential either within institutional normal range or accompanied by site physician approval
• Total lymphocyte count greater than or equal to 800 cells/mm(3)
• Platelets equal to 125,000 - 400,000/mm(3)

You may not qualify if:

• 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 24 weeks after enrollment.
• Subject has received any of the following substances:
• Ebola vaccines or any recombinant adenoviral vector vaccine in a prior clinical trial.
• Immunosuppressive medications, cytotoxic medications, inhaled corticosteroids, or long-acting beta-agonists within the past six months. \[Note: that use of corticosteroid nasal spray for allergic rhinitis, topical corticosteroids for an acute uncomplicated dermatitis, or short-acting beta-agonists in controlled asthmatics are not excluded.\]
• 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 vaccine administration
• Investigational research agents within 30 days prior to initial study vaccine administration
• Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days of study vaccine administration
• Current anti-tuberculosis prophylaxis or therapy
• Subject has a history of any of the following clinically significant conditions:
• Serious adverse reactions to vaccines such as anaphylaxis, urticaria (hives), respiratory difficulty, angioedema, or abdominal pain
• Idiopathic urticaria within the past 2 years

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 (3)

• Geisbert TW, Jahrling PB. Exotic emerging viral diseases: progress and challenges. Nat Med. 2004 Dec;10(12 Suppl):S110-21. doi: 10.1038/nm1142.

  PMID: 15577929 BACKGROUND

• Meslin FX. Global aspects of emerging and potential zoonoses: a WHO perspective. Emerg Infect Dis. 1997 Apr-Jun;3(2):223-8. doi: 10.3201/eid0302.970220.

  PMID: 9204308 BACKGROUND

• Okware SI, Omaswa FG, Zaramba S, Opio A, Lutwama JJ, Kamugisha J, Rwaguma EB, Kagwa P, Lamunu M. An outbreak of Ebola in Uganda. Trop Med Int Health. 2002 Dec;7(12):1068-75. doi: 10.1046/j.1365-3156.2002.00944.x.

  PMID: 12460399 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
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 8, 2006
• First Posted: September 11, 2006
• Study Start: September 5, 2006
• Study Completion: May 5, 2009
• Last Updated: July 2, 2017

Record last verified: 2009-05-05

Locations

US (1)