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

NCT01502735 | Completed Phase 1 DMC

• 4 other identifiers: S-10-0003WRAIR IRB Protocol # 1856HSRRB Protocol #: A-17104IND 14338
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dengue Fever

Keywords

dengue; dengue fever; monovalent dengue vaccine

Outcome Measures

Primary Outcomes (3)

• Number of subjects with solicited adverse events (AEs) from study day 0 to 90

  Up to 90 days

• Number of subjects with unsolicited AEs from study day 0 to 90

  Up to 90 days

• Number of subjects who experience serious adverse events (SAEs) during the study period

  Up to 360 Days

Secondary Outcomes (2)

• 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

• 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

Study Arms (2)

DENV-1 PIV (high dose)

EXPERIMENTAL

Biological: DENV-1 PIV, 5 µg

DENV-1 PIV (low dose)

EXPERIMENTAL

Biological: DENV-1 PIV, 2.5 µg

Interventions

DENV-1 PIV, 2.5 µg BIOLOGICAL

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 (low dose)

DENV-1 PIV, 5 µg BIOLOGICAL

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 (high dose)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead

Study Sites (1)

WRAIR, Clinical Trials Center (CTC)

Silver Spring, Maryland, 20910, United States

Location

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Study Officials

• Stephen Thomas, MD

  Walter Reed Army Institute of Research (WRAIR)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2011
• First Posted: January 2, 2012
• Study Start: December 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: April 22, 2015

Record last verified: 2015-04

Locations

US (1)