NCT00831012

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

80
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P50-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

First Submitted

Initial submission to the registry

January 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Last Updated

November 15, 2013

Status Verified

November 1, 2013

Enrollment Period

1.7 years

First QC Date

January 27, 2009

Last Update Submit

November 13, 2013

Conditions

Dengue Fever

Keywords

Dengue VaccineDengue VirusDengue Hemorrhagic FeverDengue Shock Syndrome

Outcome Measures

Primary Outcomes (2)

  • Determine the safety of a single dose of the rDEN3Δ30/31-7164 vaccine, as assessed by the frequency, severity, and seriousness of vaccine related adverse events (AEs).

    Throughout study

  • Determine the immunogenicity of a single dose of the rDEN3delta30/31-7164 vaccine, as assessed by neutralizing antibody titers to DEN3 at 4 weeks and 6 weeks after vaccination

    Throughout study

Secondary Outcomes (7)

  • Assess the frequency, quantity, and duration of viremia after a single dose of vaccine

    Throughout study

  • Determine the number of vaccinees infected with rDEN3delta30/31-7164. Infection is defined as recovery of vaccine virus from the blood or serum of a volunteer and/or by seroconversion to DEN3 (a ≥4-fold rise in DEN3 neutralizing antibody titers).

    Throughout study

  • Compare the infectivity rates, safety, and immunogenicity of a single dose of rDEN3delta30/31-7164 vaccine between the dose level groups.

    Throughout study

  • Determine the durability of antibody response 26 weeks after vaccination

    At 26 weeks

  • Obtain an estimate for the Human Infectious Dose-50% (HID50) if dose dependent infectivity is observed

    Throughout study

  • +2 more secondary outcomes

Study Arms (2)

Group 1

EXPERIMENTAL

Group 1 will consist of healthy participants receiving an immunization of 10\^3 PFU rDEN3delta30/31-7164

Biological: rDEN3delta30/31-7164

Group 2

EXPERIMENTAL

Group 2A will consist of healthy participants who will receive an immunization of 10\^5 PFU of rDEN3delta30/31-7164 vaccine or placebo. Group 2A participants will be enrolled if less that 90% of Group 1 participants seroconvert to DEN3 by Study Day 42. Group 2B will consist of healthy participants who will receive an immunization of 10\^1 PFU of rDEN3delta30/31-7164 vaccine or placebo. Group 2B participants will be enrolled if more that 90% of Group 1 participants seroconvert to DEN3 by Study Day 42.

Biological: rDEN3delta30/31-7164

Interventions

rDEN3delta30/31-7164BIOLOGICAL

A live attenuated, recombinant DEN3 candidate vaccine virus

Group 1Group 2

Eligibility Criteria

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

You may qualify if:

  • Adult male or non-pregnant female between 18 and 50 years of age, inclusive.
  • Good general health as determined by physical exam, laboratory screening, and review of medical history
  • Available for the duration of the study, approximately 26 weeks post-vaccination
  • Willing to use effective means of contraception for the duration of the trial

You may not qualify if:

  • Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies
  • Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the volunteer to understand and cooperate with the requirements of the study protocol
  • Grade 1 or above values for absolute neutrophil count (ANC), alanine aminotransferase (ALT), and serum creatinine, as protocol defined
  • Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating n the trial or would render the volunteer unable to comply with the protocol
  • Any significant alcohol or drug abuse in the past 12 months which has caused medical, occupational, or family problems, as indicated by volunteer history
  • History of a severe allergic reaction or anaphylaxis
  • Severe asthma (emergency room visit or hospitalization within the last 6 months)
  • Positive HIV-1 serology by screening and confirmatory assays
  • Positive for hepatitis C virus (HCV) by screening and confirmatory assays
  • Positive for hepatitis B virus (HBV) by hepatitis B surface antigen (HBsAg) screening
  • Any known immunodeficiency syndrome
  • Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 30 days prior to Study Day 0
  • Receipt of a live vaccine within 4 weeks or a killed vaccine within the 2 weeks prior to Study Day 0 or anticipated receipt of any vaccine during the 42 days following Study Day 0
  • History of a surgical splenectomy
  • Receipt of blood products within the past 6 months, including transfusions or immunoglobulin or anticipated receipt of any blood products or immunoglobulin during the 42 days following Study Day 0
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health

Baltimore, Maryland, United States

Location

Related Publications (2)

  • Popper SJ, Strouts FR, Lindow JC, Cheng HK, Montoya M, Balmaseda A, Durbin AP, Whitehead SS, Harris E, Kirkpatrick BD, Relman DA. Early Transcriptional Responses After Dengue Vaccination Mirror the Response to Natural Infection and Predict Neutralizing Antibody Titers. J Infect Dis. 2018 Nov 5;218(12):1911-1921. doi: 10.1093/infdis/jiy434.

    PMID: 30010906DERIVED

  • 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

    STUDY CHAIR

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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2009

First Posted

January 28, 2009

Study Start

September 1, 2009

Primary Completion

June 1, 2011

Last Updated

November 15, 2013

Record last verified: 2013-11

Locations

US(1)