NCT00094705

Brief Summary

Dengue fever, which is caused by dengue viruses, is a major health problem in 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
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2005

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

October 21, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2004

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2005

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

January 21, 2008

Status Verified

January 1, 2008

Enrollment Period

1.2 years

First QC Date

October 21, 2004

Last Update Submit

January 18, 2008

Conditions

Dengue Fever

Keywords

Dengue VaccineDengue VirusDengue Hemorrhagic FeverDengue Shock Syndrome

Outcome Measures

Primary Outcomes (2)

  • Frequency and severity of vaccine-related adverse effects for each dose graded by severity

    Throughout study

  • Amount of dengue 2 neutralizing antibody induced by the vaccine

    At Day 42

Secondary Outcomes (6)

  • To assess the durability of the antibody response out to Day 180

    Throughout study

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

    Throughout study

  • To determine the number of vaccinees infected with rDEN2/4delta30(ME)

    Throughout study

  • To compare the T cell mediated immune response against dengue viruses of those volunteers infected with the rDEN2/4delta30(ME) vaccine virus with that of uninfected volunteers and placebo recipients

    Throughout study

  • If both doses of vaccine are administered, to compare the infectivity rates, safety, and immunogenicity between dose groups

    At study completion

  • +1 more secondary outcomes

Study Arms (3)

1

EXPERIMENTAL

One subcutaneous vaccination with a 10\^3 PFU dose of rDEN2/4delta30(ME) vaccine given in the deltoid region of either arm.

Biological: rDEN2/4delta30(ME) Vaccine

2

EXPERIMENTAL

One subcutaneous vaccination with a 10\^5 PFU dose of rDEN2/4delta30(ME) vaccine given in the deltoid region of either arm.

Biological: rDEN2/4delta30(ME) Vaccine

3

PLACEBO COMPARATOR

One subcutaneous vaccination with a placebo vaccine given in the deltoid region of either arm.

Biological: Placebo

Interventions

rDEN2/4delta30(ME) VaccineBIOLOGICAL

Live attenuated rDEN2/4delta30(ME) vaccine (one of two doses)

12
PlaceboBIOLOGICAL

Placebo for rDEN2/4delta30(ME) vaccine

3

Eligibility Criteria

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

You may qualify if:

  • Willing to be followed for the duration of the study
  • Willing to use acceptable methods of contraception
  • Good general health

You may not qualify if:

  • Clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease
  • Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the ability of the volunteer to understand and cooperate with the study
  • Hematologic disease
  • Alcohol or drug abuse 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 infected
  • Hepatitis B surface antigen positive
  • Known immunodeficiency syndrome
  • Use of corticosteroids or immunosuppressive drugs within 30 days prior to study entry. Participants who have used 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
  • Blood products within 6 months prior to study entry
  • Participation in another investigational vaccine or drug trial within 60 days of starting this study, or while this trial is ongoing
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins School of Public Health

Baltimore, Maryland, 21205, United States

Location

Related Publications (5)

  • Edelman R. Dengue and dengue vaccines. J Infect Dis. 2005 Mar 1;191(5):650-3. doi: 10.1086/427784. Epub 2005 Jan 27. No abstract available.

    PMID: 15688277BACKGROUND

  • 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

  • Sabchareon A, Lang J, Chanthavanich P, Yoksan S, Forrat R, Attanath P, Sirivichayakul C, Pengsaa K, Pojjaroen-Anant C, Chokejindachai W, Jagsudee A, Saluzzo JF, Bhamarapravati N. Safety and immunogenicity of tetravalent live-attenuated dengue vaccines in Thai adult volunteers: role of serotype concentration, ratio, and multiple doses. Am J Trop Med Hyg. 2002 Mar;66(3):264-72. doi: 10.4269/ajtmh.2002.66.264.

    PMID: 12139219BACKGROUND

  • Sun W, Edelman R, Kanesa-Thasan N, Eckels KH, Putnak JR, King AD, Houng HS, Tang D, Scherer JM, Hoke CH Jr, Innis BL. Vaccination of human volunteers with monovalent and tetravalent live-attenuated dengue vaccine candidates. Am J Trop Med Hyg. 2003 Dec;69(6 Suppl):24-31. doi: 10.4269/ajtmh.2003.69.6_suppl.0690024.

    PMID: 14740952BACKGROUND

  • Whitehead SS, Hanley KA, Blaney JE Jr, Gilmore LE, Elkins WR, Murphy BR. Substitution of the structural genes of dengue virus type 4 with those of type 2 results in chimeric vaccine candidates which are attenuated for mosquitoes, mice, and rhesus monkeys. Vaccine. 2003 Oct 1;21(27-30):4307-16. doi: 10.1016/s0264-410x(03)00488-2.

    PMID: 14505913BACKGROUND

MeSH Terms

Conditions

DengueSevere Dengue

Interventions

Vaccines

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biological ProductsComplex Mixtures

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

October 21, 2004

First Posted

October 22, 2004

Study Start

January 1, 2005

Primary Completion

April 1, 2006

Study Completion

April 1, 2006

Last Updated

January 21, 2008

Record last verified: 2008-01

Locations

US(1)