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

NCT ID: NCT01502735

Last Updated: 2015-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-09-30

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.

Conditions

Dengue Fever

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

DENV-1 PIV (high dose)

Group Type: EXPERIMENTAL

DENV-1 PIV, 5 µg

Intervention Type: 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 (low dose)

Group Type: EXPERIMENTAL

DENV-1 PIV, 2.5 µg

Intervention Type: 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)

Interventions

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)

Intervention Type: 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)

Intervention Type: BIOLOGICAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

U.S. Army Medical Research and Development Command

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Thomas, MD

Role: PRINCIPAL_INVESTIGATOR

Walter Reed Army Institute of Research (WRAIR)

Locations

WRAIR, Clinical Trials Center (CTC)

Silver Spring, Maryland, United States

Countries

United States

Other Identifiers

WRAIR IRB Protocol # 1856

Identifier Type: OTHER

Identifier Source: secondary_id

HSRRB Protocol #: A-17104

Identifier Type: OTHER

Identifier Source: secondary_id

IND 14338

Identifier Type: OTHER

Identifier Source: secondary_id

S-10-0003

Identifier Type: -

Identifier Source: org_study_id