Safety Study of a Dengue Virus DNA Vaccine

Dengue Clinical Trial

Official title:

Phase I Clinical Trial of a Dengue-1 DNA Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00290147
• Other study ID #: NMRC 2004.0002
• Secondary ID: WRAIR 1191HSRRB
• Status: Completed
• Phase: Phase 1
• First received: February 9, 2006
• Last updated: October 24, 2016
• Start date: January 2006
• Est. completion date: April 2009

Study information

• Verified date: June 2009
• Source: U.S. Army Medical Research and Materiel Command
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to exame the safety of a DNA vaccine against dengue-1.

Description:

Dengue is a desease that affects 100 million people throughout the world mainly in tropical countries in the South Pacific, Asia, the Caribbean, and Africa. The disease often presents with high fever, severe headache, and joint/muscle pain that usually goes away on its own, but it can also present as a sometimes deadly hemorrhagic (bleeding) disease. Humans catch this disease by being bitten by mosquitoes that have been infected with dengue virus. Scientists at the Naval Medical Research Center have been working on vaccines to prevent dengue disease. This vaccine, referred to as D1ME, is an experimental DNA vaccine that contains genes from the dengue-1 virus. The purpose of this study is to test the safety of a new experimental vaccine against dengue and to see if the vaccine can stimulate the immune system.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2009
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Available to participate for the duration of the study (approximately 12 months)

• Completion and review of knowledge assement quiz

Exclusion Criteria:

• Pregnant (by history or as ascertained by pregnancy test) or lactating female

• Female who intends to become pregnant during the study

• Plan to have elective surgery during the study period

• HIV infection

• Known immunodeficiency or currently receiving immunosuppressive therapy (inhaled and topical steroids are allowed)

• History of splenectomy

• Administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of vaccine and ending 30 days after vaccination

• Evidence of active (acute or chronic) hepatitis B or C infection

• Autoimmune diseaseor subjects who describe a first-degree relative with clearly documented autoimmune disease

• Acute or chronic, clinically significant cardiac, pulmonary, hepatic, or renal abnormality, as determined by physical examination or basic laboratory screening

• Clinical or laboratory evidence of significant anemia

• History of flavivirus infection or previous receipt of flavivirus vaccine

• Positive serology for flaviviruses (all four dengue virus serotypes, Japanese encephalitis, Yellow fever virus, and West Nile virus), HIV-1, Hepatitis B surface antigen, or anti-hepatitis C virus antibodies prior to enrollment

• Use of any investigational or non-registered drug or vaccine other than the study vaccine within 60 days preceding the first dose of study vaccine, or planned use during the study period.

• Previous history of allergic or anaphylactic reaction to any vaccine

• Planned travel to areas with endemic dengue during the study period

• Any other significant finding which, in the opinion of the investigator, would increase the risk of having an adverse outcome from participating in this protocol

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dengue

Intervention

Biological:
• D1ME (dengue-1 premembrane/envelope DNA vaccine)

Locations

Country	Name	City	State
United States	Walter Reed Army Institute of Research, Bldg 503	Silver Spring	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
U.S. Army Medical Research and Materiel Command	United States Army Medical Materiel Development Activity

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and reactogenicity as evaluated by clinical visits and safety labs.
Secondary	Measurement of anti-dengue antibody and T cell responses.