NCT00375726

Brief Summary

Dengue fever, caused by dengue viruses, is a major health problem in the tropical and subtropical regions of the world. The purpose of this study is to test the safety of and immune response to a new dengue virus vaccine in healthy adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 13, 2006

Completed
18 days until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

December 14, 2010

Status Verified

December 1, 2010

Enrollment Period

1.9 years

First QC Date

September 12, 2006

Last Update Submit

December 13, 2010

Conditions

Dengue

Keywords

Dengue FeverDengue VaccineDengue VirusDengue Hemorrhagic FeverDengue Shock Syndrome

Outcome Measures

Primary Outcomes (2)

  • Safety, as defined by frequency of vaccine-related adverse events, as classified by both intensity and severity through active and passive surveillance

    Throughout study

  • Immunogenicity, as determined by anti-DEN3 neutralizing antibody measured on Days 0, 21, 28, 42, and 180

    Throughout study

Secondary Outcomes (5)

  • Assess the frequency, quantity, and duration of viremia in each dose cohort studied

    Throughout study

  • Determine the number of vaccinees infected with rDEN3/4delta30(ME)

    Throughout study

  • Determine cellular targets of vaccine infection, including peripheral blood mononuclear cells (PBMCs) and skin from participants who are willing to undergo skin biopsy

    Throughout study

  • Compare the infectivity rates, safety, and immunogenicity between dose groups

    At study completion

  • Evaluate the immunopathological mechanism of vaccine-associated rash in those volunteers who are willing to undergo skin biopsy

    Throughout study

Study Arms (4)

1

EXPERIMENTAL

One subcutaneous vaccination with rDEN3/4delta30(ME) vaccine (10\^3 PFU dose) into the deltoid region of either arm.

Biological: rDEN3/4delta30(ME)

2

EXPERIMENTAL

One subcutaneous vaccination with rDEN3/4delta30(ME) vaccine (10\^5 PFU dose) into the deltoid region of either arm. This arm may enroll after Arm 1 depending on the immunological response of Arm 1.

Biological: rDEN3/4delta30(ME)

3

EXPERIMENTAL

One subcutaneous vaccination with rDEN3/4delta30(ME) vaccine (10\^1 PFU dose) into the deltoid region of either arm. This arm may enroll after Arm 1 depending on the immunological response of Arm 1.

Biological: rDEN3/4delta30(ME)

4

PLACEBO COMPARATOR

One subcutaneous vaccination with placebo into the deltoid region of either arm.

Biological: Placebo

Interventions

rDEN3/4delta30(ME)BIOLOGICAL

Live attenuated rDEN3/4delta30(ME) vaccine (one of three doses)

123
PlaceboBIOLOGICAL

Placebo for rDEN3/4delta30(ME)

4

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Good general health
  • Available for the duration of the study
  • Willing to use acceptable forms of contraception for the duration of the study

You may not qualify if:

  • Significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease
  • Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, may interfere with the study
  • Significant laboratory abnormalities
  • Medical, work, or family problems as a result of alcohol or illegal drug use within 12 months prior to study entry
  • History of severe allergic reaction or anaphylaxis
  • Emergency room visit or hospitalization for severe asthma within 6 months prior to study entry
  • HIV-1 infected
  • Hepatitis C virus (HCV) infected
  • Hepatitis B surface antigen positive
  • Immunodeficiency syndrome
  • Use of corticosteroids or immunosuppressive medications within 30 days prior to study entry. Participants using topical or nasal corticosteroids are not excluded.
  • Live vaccine within 4 weeks prior to study entry
  • Killed vaccine within 2 weeks prior to study entry
  • Absence of spleen
  • Blood products within 6 months prior to study entry
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Immunization Research

Baltimore, Maryland, 21205, United States

Location

Related Publications (4)

  • 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: 16553547BACKGROUND

  • Blaney JE Jr, Hanson CT, Firestone CY, Hanley KA, Murphy BR, Whitehead SS. Genetically modified, live attenuated dengue virus type 3 vaccine candidates. Am J Trop Med Hyg. 2004 Dec;71(6):811-21.

    PMID: 15642976BACKGROUND

  • Blaney JE Jr, Matro JM, Murphy BR, Whitehead SS. Recombinant, live-attenuated tetravalent dengue virus vaccine formulations induce a balanced, broad, and protective neutralizing antibody response against each of the four serotypes in rhesus monkeys. J Virol. 2005 May;79(9):5516-28. doi: 10.1128/JVI.79.9.5516-5528.2005.

    PMID: 15827166BACKGROUND

  • Durbin AP, Whitehead SS, McArthur J, Perreault JR, Blaney JE Jr, Thumar B, Murphy BR, Karron RA. rDEN4delta30, a live attenuated dengue virus type 4 vaccine candidate, is safe, immunogenic, and highly infectious in healthy adult volunteers. J Infect Dis. 2005 Mar 1;191(5):710-8. doi: 10.1086/427780. Epub 2005 Jan 27.

    PMID: 15688284BACKGROUND

MeSH Terms

Conditions

DengueSevere Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Study Officials

  • Anna Durbin, MD

    Center for Immunization Research, Johns Hopkins School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 12, 2006

First Posted

September 13, 2006

Study Start

October 1, 2006

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

December 14, 2010

Record last verified: 2010-12

Locations

US(1)