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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT01502735
First received: December 16, 2011
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention Phase
Dengue Fever
Biological: DENV-1 PIV, 2.5 µg
Biological: DENV-1 PIV, 5 µg
Phase 1

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

Resource links provided by NLM:


Further study details as provided by U.S. Army Medical Research and Materiel Command:

Primary Outcome Measures:
  • Number of subjects with solicited adverse events (AEs) from study day 0 to 90 [ Time Frame: Up to 90 days ] [ Designated as safety issue: Yes ]
  • Number of subjects with unsolicited AEs from study day 0 to 90 [ Time Frame: Up to 90 days ] [ Designated as safety issue: Yes ]
  • Number of subjects who experience serious adverse events (SAEs) during the study period [ Time Frame: Up to 360 Days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of subjects with a change in geometric mean titer of neutralizing antibody to DENV types 1,2,3, and 4 [ Time Frame: Up to Day 28 ] [ Designated as safety issue: No ]
  • Number of subjects with a change in geometric mean titer of neutralizing antibody to DENV types 1,2,3, and 4 [ Time Frame: Up to Day 90 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DENV-1 PIV (high dose) Biological: 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)
Experimental: DENV-1 PIV (low dose) 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)

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01502735

Locations
United States, Maryland
WRAIR, Clinical Trials Center (CTC)
Silver Spring, Maryland, United States, 20910
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Stephen Thomas, MD Walter Reed Army Institute of Research (WRAIR)
  More Information

No publications provided

Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT01502735     History of Changes
Other Study ID Numbers: S-10-0003, WRAIR IRB Protocol # 1856, HSRRB Protocol #: A-17104, IND 14338
Study First Received: December 16, 2011
Last Updated: June 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by U.S. Army Medical Research and Materiel Command:
dengue
dengue fever
monovalent dengue vaccine

Additional relevant MeSH terms:
Dengue
Fever
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral
Body Temperature Changes
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014