Evaluation of the Safety and Immune Response to an Investigational Dengue Type 1 Vaccine

NCT01084291 | Completed Phase 1 DMC

• 1 other identifier: CIR 253
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief Summary

Dengue viruses can cause dengue fever and other serious health conditions, primarily affecting people living in tropical regions of the world. There are four types of dengue virus, and infection with one does not offer protection against the others. This study will test whether a vaccine developed to prevent infection with dengue virus type 1 (DEN1) causes a response in people's immune system and is safe.

Conditions

Dengue Virus

Keywords

Vaccine; Dengue Hemorrhagic Fever

Outcome Measures

Primary Outcomes (2)

• Frequency of vaccine-related adverse events (AEs), as classified by both severity and seriousness, through active and passive surveillance

  Measured throughout study

• Immunogenicity to dengue virus subtype one (DEN1), as assessed by neutralizing antibody titers

  Measured 4 and 6 weeks after vaccination

Secondary Outcomes (3)

• Frequency, quantity, and duration of viremia following vaccination

  Measured every other day after vaccination for 16 days, and on Days 21, 28, and 42

• Number of vaccinees infected with DEN1, defined as recovery of vaccine virus from the blood or serum of a participant and/or by seroconversion to DEN1

  Measured at study completion

• Comparison of the infectivity rates, safety, and immunogenicity of a single dose of DEN1 vaccine to those rates of previous clinical trials

  Measured at study completion

Study Arms (2)

DEN1 Vaccine

EXPERIMENTAL

Participants will receive a single dose of investigational vaccine for dengue virus subtype 1.

Biological: Investigational Vaccine for DEN1

Placebo

PLACEBO COMPARATOR

Participants will receive a single dose of placebo vaccine.

Other: Placebo injection

Interventions

Investigational Vaccine for DEN1 BIOLOGICAL

Subcutaneous injection in upper arm of vaccine at dose of 10 plaque-forming units (PFU)

Also known as: rDEN1∆30 vaccine

DEN1 Vaccine

Placebo injection OTHER

Subcutaneous injection of placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• In good general health as determined by physical examination, laboratory screening, and review of medical history
• Available for the duration of the study, including approximately 6 weeks post-vaccination
• Female participants of childbearing potential must be willing to use effective contraception for the duration of the trial

You may not qualify if:

• Currently breast-feeding or pregnant
• Exhibits evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies
• Presence of a behavioral, cognitive, or psychiatric disease that affects the ability of the participant to understand and cooperate with the requirements of the study protocol
• Has screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC), ALT, and serum creatinine, as defined in this protocol
• Presence of any condition that would jeopardize the safety or rights of the participant or would render the participant unable to comply with the protocol
• Significant alcohol or drug abuse in the past 12 months which has caused medical, occupational, or family problems, as indicated by participant history
• History of a severe allergic reaction or anaphylaxis
• Severe asthma (emergency room visit or hospitalization within the last 6 months)
• Presence of HIV infection, determined by screening and confirmatory assays
• Presence of hepatitis C virus (HCV) infection, determined by screening and confirmatory assays
• Presence of hepatitis B virus (HBV) infection, determined by hepatitis B surface antigen (HBsAg) screening
• Presence of any known immunodeficiency syndrome
• Uses anticoagulant medications
• Has used corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 42 days prior to or following vaccination. An immunosuppressive dose of corticosteroids is defined as greater than or equal to 10 mg prednisone equivalent per day for greater than or equal to 14 days.
• Has received a live vaccine within 28 days or a killed vaccine within 14 days prior to vaccination or anticipated receipt of any vaccine during the 42 days following vaccination

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

Fletcher Allen Health Care (FAHC) General Clinical Research Center (GCRC)

Burlington, Vermont, 05401, United States

Location

University of Vermont Vaccine Testing Center

Burlington, Vermont, 05401, United States

Location

Related Publications (2)

• Blaney JE Jr, Durbin AP, Murphy BR, Whitehead SS. Development of a live attenuated dengue virus vaccine using reverse genetics. Viral Immunol. 2006 Spring;19(1):10-32. doi: 10.1089/vim.2006.19.10.

  PMID: 16553547 BACKGROUND

• Whitehead SS, Falgout B, Hanley KA, Blaney JE Jr, Markoff L, Murphy BR. A live, attenuated dengue virus type 1 vaccine candidate with a 30-nucleotide deletion in the 3' untranslated region is highly attenuated and immunogenic in monkeys. J Virol. 2003 Jan;77(2):1653-7. doi: 10.1128/jvi.77.2.1653-1657.2003.

  PMID: 12502885 BACKGROUND

MeSH Terms

Conditions

Severe Dengue

Condition Hierarchy (Ancestors)

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

Study Officials

• Anna Durbin, MD

  CIR, Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Beth Kirkpatrick, MD

  University of Vermont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2010
• First Posted: March 10, 2010
• Study Start: April 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: June 1, 2010
• Last Updated: January 3, 2013

Record last verified: 2012-12

Locations

US (2)