NCT00473135

Brief Summary

Dengue fever, caused by dengue viruses, is a major health problem in tropical and subtropical regions of the world. The purpose of this study is to evaluate the safety of and immune response to a 2-dose regimen of a new monovalent dengue virus vaccine. This study will test the dengue virus vaccine DEN1delta30 in healthy adults.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P75+ for phase_1

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

May 1, 2007

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 14, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Last Updated

January 13, 2010

Status Verified

January 1, 2008

Enrollment Period

2.7 years

First QC Date

May 11, 2007

Last Update Submit

January 11, 2010

Conditions

Dengue

Keywords

Dengue FeverDengue VaccineDengue VirusDengue Hemorrhagic FeverDengue Shock Syndrome

Outcome Measures

Primary Outcomes (2)

  • To determine the safety and immunogenicity of a two-dose regimen of the rDEN1delta30 vaccine given as two doses separated by four or six months

    Throughout study

  • To determine the optimum interval between first and second dose of rDEN1delta30 vaccine, as assessed by neutralizing antibody response to DEN1 induced by the vaccine

    At 4 and 6 weeks after first and second vaccination

Secondary Outcomes (5)

  • To assess the frequency, quantity, and duration of viremia following each vaccine dose, based on the mean peak viremia, mean day of onset, and mean duration of viremia

    Throughout study

  • To determine the number of vaccinees infected with rDEN1delta30 virus

    Throughout study

  • To compare the infectivity rates, safety, and immunogenicity between dose 1 and 2 within a cohort and between cohorts

    Throughout study

  • To evaluate the immunopathological mechanism of vaccine-associated rash in participants willing to undergo skin biopsy

    Throughout study

  • To evaluate the phenotype and activation of peripheral blood mononuclear cells (PBMCs) at primary infection and challenge with DEN1

    Throughout study

Study Arms (3)

1

EXPERIMENTAL

Two subcutaneous vaccinations with rDEN1delta30 into the deltoid region or either arm. One vaccination is given on Day 0 and one vaccination is given on Day 120.

Biological: rDEN1delta30

2

EXPERIMENTAL

Two subcutaneous vaccinations with rDEN1delta30 into the deltoid region or either arm. One vaccination is given on Day 0 and one vaccination is given on Day 180.

Biological: rDEN1delta30

3

PLACEBO COMPARATOR

Two subcutaneous vaccinations with placebo into the deltoid region or either arm. One vaccination is given on Day 0 and one vaccination is given on either Day 120 or 180, depending on arm assignment.

Biological: Placebo

Interventions

rDEN1delta30BIOLOGICAL

Live attenuated rDEN1delta30 vaccine at a dose of 10\^3 PFU

12
PlaceboBIOLOGICAL

Placebo for rDEN1delta30

3

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 (23 weeks for Cohort 1 and 32 weeks for Cohort 2)
  • Willing to use acceptable forms of contraception for the duration of the study

You may not qualify if:

  • Clinically 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
  • Severe asthma
  • HIV-1 infected
  • Hepatitis C virus (HCV) infected
  • Hepatitis B surface antigen positive
  • Known immunodeficiency syndrome
  • Use of corticosteroids or immunosuppressive medications within 30 days prior to study entry. Individuals using topical or nasal corticosteroids are not excluded.
  • Previous receipt of a live vaccine within 4 weeks prior to study entry
  • Previous receipt of a killed vaccine within 2 weeks prior to study entry
  • Absence of spleen
  • Previous receipt of 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, Johns Hopkins School of Public Health

Baltimore, Maryland, 21205, United States

Location

Related Publications (8)

  • Blaney JE Jr, Sathe NS, Hanson CT, Firestone CY, Murphy BR, Whitehead SS. Vaccine candidates for dengue virus type 1 (DEN1) generated by replacement of the structural genes of rDEN4 and rDEN4Delta30 with those of DEN1. Virol J. 2007 Feb 28;4:23. doi: 10.1186/1743-422X-4-23.

    PMID: 17328799BACKGROUND

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

    PMID: 15937367BACKGROUND

  • Durbin AP, McArthur J, Marron JA, Blaney JE Jr, Thumar B, Wanionek K, Murphy BR, Whitehead SS. The live attenuated dengue serotype 1 vaccine rDEN1Delta30 is safe and highly immunogenic in healthy adult volunteers. Hum Vaccin. 2006 Jul-Aug;2(4):167-73. doi: 10.4161/hv.2.4.2944. Epub 2006 Jul 24.

    PMID: 17012875BACKGROUND

  • Jacobs M, Young P. Dengue vaccines: preparing to roll back dengue. Curr Opin Investig Drugs. 2003 Feb;4(2):168-71.

    PMID: 12669377BACKGROUND

  • Pang T. Vaccines for the prevention of neglected diseases--dengue fever. Curr Opin Biotechnol. 2003 Jun;14(3):332-6. doi: 10.1016/s0958-1669(03)00061-2.

    PMID: 12849789BACKGROUND

  • Rothman AL. Dengue: defining protective versus pathologic immunity. J Clin Invest. 2004 Apr;113(7):946-51. doi: 10.1172/JCI21512.

    PMID: 15057297BACKGROUND

  • Senanayake S. Dengue fever and dengue haemorrhagic fever--a diagnostic challenge. Aust Fam Physician. 2006 Aug;35(8):609-12.

    PMID: 16894436BACKGROUND

  • Katzelnick LC, Fonville JM, Gromowski GD, Bustos Arriaga J, Green A, James SL, Lau L, Montoya M, Wang C, VanBlargan LA, Russell CA, Thu HM, Pierson TC, Buchy P, Aaskov JG, Munoz-Jordan JL, Vasilakis N, Gibbons RV, Tesh RB, Osterhaus AD, Fouchier RA, Durbin A, Simmons CP, Holmes EC, Harris E, Whitehead SS, Smith DJ. Dengue viruses cluster antigenically but not as discrete serotypes. Science. 2015 Sep 18;349(6254):1338-43. doi: 10.1126/science.aac5017.

    PMID: 26383952DERIVED

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 (CIR), 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

May 11, 2007

First Posted

May 14, 2007

Study Start

May 1, 2007

Primary Completion

January 1, 2010

Last Updated

January 13, 2010

Record last verified: 2008-01

Locations

US(1)