NCT02433652

Brief Summary

Infection with dengue viruses is the leading cause of hospitalization and death in children in many tropical Asian countries, and the development of a dengue vaccine is a top health priority. This study will evaluate the ability of a single dose of a trivalent dengue vaccine to protect against infection with an attenuated candidate DENV-2 vaccine, administered 6 months after the trivalent dengue vaccine.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

2 active sites

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

April 27, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 5, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Last Updated

February 28, 2018

Status Verified

February 1, 2018

Enrollment Period

1.2 years

First QC Date

April 27, 2015

Last Update Submit

February 27, 2018

Conditions

Dengue

Keywords

Dengue Vaccine

Outcome Measures

Primary Outcomes (2)

  • Frequency of trivalent dengue vaccine admixture and rDEN2Δ30-7169-related adverse events (AEs)

    Classified by both severity and seriousness, through active and passive surveillance.

    Measured through Day 360

  • Dengue virus neutralizing antibody titers (measured through blood collection)

    Measured through Day 360

Study Arms (2)

Trivalent dengue vaccine admixture + rDEN2Δ30-7169

EXPERIMENTAL

Participants will receive the trivalent dengue vaccine admixture at Day 0 and the rDEN2Δ30-7169 vaccine at Day 180.

Biological: Recombinant live attenuated trivalent dengue vaccineBiological: rDEN2Δ30-7169 vaccine

Placebo + rDEN2Δ30-7169

EXPERIMENTAL

Participants will receive a placebo vaccine at Day 0 and the rDEN2Δ30-7169 vaccine at Day 180.

Biological: PlaceboBiological: rDEN2Δ30-7169 vaccine

Interventions

Recombinant live attenuated trivalent dengue vaccineBIOLOGICAL

Contains 10\^3.3 plaque forming units (PFU)/mL of rDEN1Δ30, 10\^3.3 PFU/mL of rDEN3Δ30/31-7164 and 10\^3.3 PFU/mL of rDEN4Δ30. It is administered in 0.5 mL containing 10\^3.0 PFU of each component.

Trivalent dengue vaccine admixture + rDEN2Δ30-7169
PlaceboBIOLOGICAL
Placebo + rDEN2Δ30-7169
rDEN2Δ30-7169 vaccineBIOLOGICAL

Live recombinant attenuated DENV-2 candidate vaccine virus; will be administered at a dose of 10\^3 PFU

Placebo + rDEN2Δ30-7169Trivalent dengue vaccine admixture + rDEN2Δ30-7169

Eligibility Criteria

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

You may qualify if:

  • Adult male or female between 18 and 50 years of age, inclusive
  • Good general health as determined by physical examination, laboratory screening, and review of medical history
  • Available for the duration of the study, approximately 26 weeks post-second vaccination
  • Willingness to participate in the study as evidenced by signing the informed consent document
  • Females Only: Female participants of childbearing potential willing to use effective contraception. Reliable methods of contraception include: hormonal birth control, condoms with spermicide, diaphragm with spermicide, surgical sterilization, intrauterine device, abstinence (6 months or longer since last sexual encounter). All female participants will be considered having child-bearing potential except for those with hysterectomy, tubal ligation, tubal coil (at least 3 months prior to vaccination), or post-menopausal status documented as at least 1 year since last menstrual period.

You may not qualify if:

  • Females Only: Currently pregnant, as determined by positive beta-human choriogonadotropin (HCG) test, or breastfeeding
  • Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies
  • Behavioral, cognitive, psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the requirements of the study protocol
  • Screening laboratory values of Grade 1 or above for absolute neutrophil (ANC), alanine aminotransferase (ALT), and serum creatinine, as defined in this protocol
  • Any condition that in the opinion of the investigator would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
  • Any significant alcohol or drug abuse in the past 12 months that has caused medical, occupational, or family problems, as indicated by participant history
  • History of a severe allergic reaction or anaphylaxis
  • Severe asthma (emergency room visit or hospitalization within the last 6 months)
  • HIV infection, by screening and confirmatory assays
  • Hepatitis C virus (HCV) infection, by screening and confirmatory assays
  • Hepatitis B virus (HBV), by HBV surface antigen (HBsAg) screening
  • Any known immunodeficiency syndrome
  • Use of anticoagulant medications
  • Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 28 days prior to or following vaccination. Immunosuppressive dose of corticosteroids is defined as greater than or equal to 10 mg prednisone equivalent per day for greater than or equal to 14 days
  • Receipt of a live vaccine within 28 days or a killed vaccine within the 14 days prior to vaccination or anticipated receipt of any vaccine during the 28 days following vaccination
  • +35 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Center for Immunization Research (CIR), Johns Hopkins School of Public Health

Baltimore, Maryland, 21205, United States

Location

University of Vermont

Burlington, Vermont, 05405, United States

Location

MeSH Terms

Conditions

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

  • Kristen Pierce, MD

    University of Vermont

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2015

First Posted

May 5, 2015

Study Start

September 1, 2015

Primary Completion

November 1, 2016

Last Updated

February 28, 2018

Record last verified: 2018-02

Locations

US(2)