Clinical trial NCT00290147: Safety and Immunogenicity Study of a Dengue Virus DNA Vaccine
Official title: An Open-Label, Dose Escalation, Phase I Safety, and Immunogenicity Trial of a Dengue Serotype 1 (DEN-1) Premembrane (prM) and Envelope (E) DNA Vaccine (D1ME100) in Healthy Adults Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dengue
Keywords: Dengue
DNA vaccine
Lead sponsor: U.S. Army Medical Research and Development Command
Sponsor class: FED
Collaborators: name: United States Army Medical Materiel Development Activity
First posted: 2006-02-10
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Systemic and Local Reactogenicity Rates for Ungraded Symptoms
timeFrame: Months 0, 1 and 5
Secondary outcomes:
measure: Anti-dengue Antibody and T-cell and B-cell Responders
timeFrame: 12 months
Other outcomes:
Locations:
city: Silver Spring
country: United States
facility: Walter Reed Army Institute of Research, Bldg 503
state: Maryland
Study officials:
affiliation: Naval Medical Research Center
name: Charmagne Beckett, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Danko JR, Kochel T, Teneza-Mora N, Luke TC, Raviprakash K, Sun P, Simmons M, Moon JE, De La Barrera R, Martinez LJ, Thomas SJ, Kenney RT, Smith L, Porter KR. Safety and Immunogenicity of a Tetravalent Dengue DNA Vaccine Administered with a Cationic Lipid-Based Adjuvant in a Phase 1 Clinical Trial. Am J Trop Med Hyg. 2018 Mar;98(3):849-856. doi: 10.4269/ajtmh.17-0416. Epub 2018 Jan 18.
citation: Beckett CG, Tjaden J, Burgess T, Danko JR, Tamminga C, Simmons M, Wu SJ, Sun P, Kochel T, Raviprakash K, Hayes CG, Porter KR. Evaluation of a prototype dengue-1 DNA vaccine in a Phase 1 clinical trial. Vaccine. 2011 Jan 29;29(5):960-8. doi: 10.1016/j.vaccine.2010.11.050. Epub 2010 Nov 25.