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

Primary Purpose

Dengue Fever

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
DENV-1 PIV, 2.5 µg
DENV-1 PIV, 5 µg
Sponsored by
U.S. Army Medical Research and Development Command
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dengue Fever focused on measuring dengue, dengue fever, monovalent dengue vaccine

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • WRAIR, Clinical Trials Center (CTC)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

DENV-1 PIV (high dose)

DENV-1 PIV (low dose)

Arm Description

Outcomes

Primary Outcome Measures

Number of subjects with solicited adverse events (AEs) from study day 0 to 90
Number of subjects with unsolicited AEs from study day 0 to 90
Number of subjects who experience serious adverse events (SAEs) during the study period

Secondary Outcome Measures

Number of subjects with a change in geometric mean titer of neutralizing antibody to DENV types 1,2,3, and 4
Number of subjects with a change in geometric mean titer of neutralizing antibody to DENV types 1,2,3, and 4

Full Information

First Posted
December 16, 2011
Last Updated
April 21, 2015
Sponsor
U.S. Army Medical Research and Development Command
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1. Study Identification

Unique Protocol Identification Number
NCT01502735
Brief Title
Safety Study of a Vaccine (DENV-1 PIV) to Prevent Dengue Disease
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
U.S. Army Medical Research and Development Command

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dengue Fever
Keywords
dengue, dengue fever, monovalent dengue vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DENV-1 PIV (high dose)
Arm Type
Experimental
Arm Title
DENV-1 PIV (low dose)
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
DENV-1 PIV, 2.5 µg
Intervention Description
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)
Intervention Type
Biological
Intervention Name(s)
DENV-1 PIV, 5 µg
Intervention Description
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)
Primary Outcome Measure Information:
Title
Number of subjects with solicited adverse events (AEs) from study day 0 to 90
Time Frame
Up to 90 days
Title
Number of subjects with unsolicited AEs from study day 0 to 90
Time Frame
Up to 90 days
Title
Number of subjects who experience serious adverse events (SAEs) during the study period
Time Frame
Up to 360 Days
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Thomas, MD
Organizational Affiliation
Walter Reed Army Institute of Research (WRAIR)
Official's Role
Principal Investigator
Facility Information:
Facility Name
WRAIR, Clinical Trials Center (CTC)
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20910
Country
United States

12. IPD Sharing Statement

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

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