NCT00458120

Brief Summary

Dengue fever, which is caused by dengue viruses, is a major health problem in subtropical regions of the world. There are four different forms (serotypes) of dengue virus that can cause dengue fever. The purpose of this study is to determine the safety and immune response to a vaccine containing a particular dengue serotype when an individual has been previously vaccinated with a different dengue serotype.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2007

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

Study Start

First participant enrolled

March 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 6, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

December 14, 2010

Status Verified

December 1, 2010

Enrollment Period

1.4 years

First QC Date

April 6, 2007

Last Update Submit

December 13, 2010

Conditions

Dengue Hemorrhagic Fever

Keywords

Dengue FeverDengue Hemorrhagic FeverDengue Vaccination

Outcome Measures

Primary Outcomes (2)

  • Number, severity, and seriousness of vaccine-related adverse events observed through active and passive surveillance

    Throughout study

  • Neutralizing antibody to all four dengue serotypes

    At Days 0, 28, and 42

Secondary Outcomes (5)

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

    Throughout study

  • To determine if cellular targets of vaccine infection, including peripheral blood mononuclear cells and skin, are different after heterologous infection of a second dengue virus vaccine of a different serotype

    Throughout study

  • Compare the safety and immunogenicity between each heterologous dengue vaccine virus cohort

    At study completion

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

    Throughout study

  • Characterize the antibody response after heterolouous vaccine infection

    Throughout study

Study Arms (5)

1

EXPERIMENTAL

Participants previously vaccinated with rDEN4delta30 will receive one subcutaneous vaccination (10\^3 dose of vaccine) of rDEN1delta30 vaccine into the deltoid region of either arm.

Biological: rDEN1delta30

2

EXPERIMENTAL

Participants previously vaccinated with rDEN4delta30 will receive one subcutaneous vaccination (10\^3 dose of vaccine) of rDEN2/4delta30(ME) into the deltoid region of either arm.

Biological: rDEN2/4delta30(ME)

3

EXPERIMENTAL

Participants previously vaccinated with rDEN2/4delta30(ME) will receive one subcutaneous vaccination (10\^3 dose of vaccine) of rDEN1delta30 vaccine into the deltoid region of either arm.

Biological: rDEN1delta30

4

EXPERIMENTAL

Participants previously vaccinated with rDEN1delta30 will receive one subcutaneous vaccination (10\^3 dose of vaccine) of rDEN2/4delta30(ME) vaccine into the deltoid region of either arm.

Biological: rDEN2/4delta30(ME)

5

PLACEBO COMPARATOR

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

Biological: Placebo to rDEN1delta30 or rDEN2/4delta30(ME)

Interventions

rDEN1delta30BIOLOGICAL

Live attenuated 10\^3 dose of rDEN1delta30 vaccine. Participants must have been previously vaccinated with rDEN4delta30 or rDEN2/4delta30(ME) vaccines.

13
rDEN2/4delta30(ME)BIOLOGICAL

Live attenuated 10\^3 dose of rDEN2/4delta30(ME) vaccine. Participants must have been previously vaccinated with rDEN4delta30 or rDEN1delta30 vaccines.

24
Placebo to rDEN1delta30 or rDEN2/4delta30(ME)BIOLOGICAL

Placebo vaccines for rDEN1delta30 and rDEN2/4delta30(ME)

5

Eligibility Criteria

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

You may qualify if:

  • Previous vaccination with rDEN1delta30, rDEN2/4delta30(ME), OR rDEN4delta30 vaccine
  • General good health
  • Available for the duration of the study
  • Willing to use accepted forms of contraception

You may not qualify if:

  • Clinically significant neurologic, heart, lung, liver, rheumatologic, autoimmune, or kidney disease by history, physical examination, or laboratory studies including urinalysis
  • Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, may interfere with the study
  • Certain abnormal laboratory values
  • Medical, work, or family problems as a result of alcohol or illegal drug use within 12 months of study entry
  • History of severe allergy or anaphylaxis
  • Severe asthma requiring an emergency room visit or hospitalization within 6 months of study entry
  • HIV infected
  • Hepatitis C virus infected
  • Hepatitis B surface antibody positive
  • Known immunodeficiency syndrome
  • Use of corticosteroids or immunosuppressive drugs 30 days prior to study entry. Participants who have used topical or nasal corticosteroids are not excluded.
  • Receipt of live vaccine within 4 weeks of study entry
  • Receipt of killed vaccine within 2 weeks of study entry
  • Absence of spleen
  • Plan to travel to an area where dengue virus is common
  • +3 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)

  • 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

  • Chaturvedi UC, Shrivastava R, Nagar R. Dengue vaccines: problems and prospects. Indian J Med Res. 2005 May;121(5):639-52.

    PMID: 15937367BACKGROUND

  • Guzman MG, Mune M, Kouri G. Dengue vaccine: priorities and progress. Expert Rev Anti Infect Ther. 2004 Dec;2(6):895-911. doi: 10.1586/14789072.2.6.895.

    PMID: 15566333BACKGROUND

  • Durbin AP, Schmidt A, Elwood D, Wanionek KA, Lovchik J, Thumar B, Murphy BR, Whitehead SS. Heterotypic dengue infection with live attenuated monotypic dengue virus vaccines: implications for vaccination of populations in areas where dengue is endemic. J Infect Dis. 2011 Feb 1;203(3):327-34. doi: 10.1093/infdis/jiq059. Epub 2010 Dec 14.

    PMID: 21208923DERIVED

MeSH Terms

Conditions

Severe DengueDengue

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

April 6, 2007

First Posted

April 9, 2007

Study Start

March 1, 2007

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

December 14, 2010

Record last verified: 2010-12

Locations

US(1)