Safety Study of a Vaccine (DENV-1 PIV) to Prevent Dengue Disease

Dengue Fever Clinical Trial

— DENV-1 PIV  

Official title:

A Phase 1 Trial of the Walter Reed Army Institute of Research (WRAIR) Dengue Virus Serotype-1 Purified Inactivated Vaccine (DENV-1 PIV) in Flavivirus Antibody Naïve Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01502735
• Other study ID #: S-10-0003
• Secondary ID: WRAIR IRB Protoc
• Status: Completed
• Phase: Phase 1
• First received: December 16, 2011
• Last updated: April 21, 2015
• Start date: December 2011
• Est. completion date: September 2013

Study information

• Verified date: April 2015
• 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

This is a phase 1 study to evaluate the safety of a vaccine (DENV-1 PIV) for the prevention of dengue fever.

Description:

DENV infections can cause self-limited but incapacitating acute illness lasting four to seven days. The illness is characterized by fever, headache, severe pain in muscles, joints, pain behind the eyes, and a rash. DENV infection can be complicated by the development of hemorrhagic fever (DHF) or shock syndrome (DSS), which is manifested by plasma leakage and a bleeding diathesis or frank hemorrhage. DHF is fatal in at least 0.5% of pediatric cases but rarely in adults. People, particularly children, living in hyper-endemic areas who have antibodies from an earlier dengue infection with one serotype are at increased risk for DHF if subsequently infected by another dengue virus serotype.

Currently, no specific anti-viral therapy exists. Therapy is largely supportive. Mosquito control has failed to prevent dengue transmission; therefore, prevention of dengue through vaccination is an important objective of the World Health Organization (WHO) and many national governments, including the United States.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Males and females 18 years of age or the legal age of consent (whichever is greater) to 50 (inclusive) years of age

• Negative screening laboratory test against dengue, Japanese Encephalitis, West Nile, and Yellow Fever viruses

• Healthy

• All subjects must agree to use contraception or to abstain from sex from enrollment through trial completion

• Able to provide informed consent and able to be followed throughout the trial period

Exclusion Criteria:

• History of Flavivirus infection or history of Flavivirus vaccine (experimental or licensed product) including Japanese encephalitis, West Nile virus, Yellow fever, and dengue

• Have a known or suspected hypersensitivity or adverse reaction to vaccines

• Have received a live-attenuated vaccine within 42 days prior to the initial injection on Day 0 or a subunit or killed vaccine within 30 days of the initial injection on Day 0

• Are pregnant or breastfeeding

• Known HIV, Hepatitis B and/or Hepatitis C infection

• Have any acute illness, including an oral body temperature greater than 100.4°F at the day of vaccination

• Have any occupational, social, or medical concerns that would impact subject safety, interfere with protocol adherence, or affect a subject's ability to give informed consent

• Have been using immunomodulatory therapy (use of systemic corticosteroids or chemotherapeutics that may influence antibody development) within the past 6 months; medications or nutritional supplements known to or which potentially could affect organ function within 30 days prior to the initial injection

• Have received an investigational drug or vaccine or participated in a drug product or vaccine study within a period of 30 days prior to Day 0

• Have received or donated blood or plasma within 90 days of Day 0 (or plan on receiving or donating blood or plasma during the study)

Study Design

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

Related Conditions & MeSH terms

• Dengue
• Dengue Fever

Intervention

Biological:
• DENV-1 PIV, 2.5 µg
2.5 µg Purified Inactivated Virus (PIV) in a volume of 0.5 mL administered via intramuscular injection on Study Days 0, and 28 (±4 days)
• DENV-1 PIV, 5 µg
5 µg Purified Inactivated Virus (PIV) in a volume of 0.5 mL administered via intramuscular injection on Study Days 0, and 28 (±4 days)

Locations

Country	Name	City	State
United States	WRAIR, Clinical Trials Center (CTC)	Silver Spring	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with solicited adverse events (AEs) from study day 0 to 90		Up to 90 days	Yes
Primary	Number of subjects with unsolicited AEs from study day 0 to 90		Up to 90 days	Yes
Primary	Number of subjects who experience serious adverse events (SAEs) during the study period		Up to 360 Days	Yes
Secondary	Number of subjects with a change in geometric mean titer of neutralizing antibody to DENV types 1,2,3, and 4		Up to Day 28	No
Secondary	Number of subjects with a change in geometric mean titer of neutralizing antibody to DENV types 1,2,3, and 4		Up to Day 90	No