NCT02372175

Brief Summary

To evaluate the effectiveness of candidate dengue vaccine formulations, it is prudent to develop an appropriate challenge model. To this end, this first-in-human study will examine the safety and effectiveness of the Dengue 1 Live Virus Human Challenge (DENV-1-LVHC) product and assess the ability of this virus strain to elicit an uncomplicated dengue-like illness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2015

Typical duration 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

February 10, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 26, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2019

Completed
Last Updated

July 15, 2019

Status Verified

July 1, 2019

Enrollment Period

3.7 years

First QC Date

February 10, 2015

Last Update Submit

July 12, 2019

Conditions

Dengue

Keywords

Dengue

Outcome Measures

Primary Outcomes (17)

  • Number of Abnormal Laboratory Measurements

    28 days post virus inoculation or 7 days post hospitalization, whichever is later

  • Intensity of Abnormal Laboratory Measurements

    28 days post virus inoculation or 7 days post hospitalization, whichever is later

  • Duration of Abnormal Laboratory Measurements

    28 days post virus inoculation or 7 days post hospitalization, whichever is later

  • Occurrence of Solicited Injection Site Symptoms

    28 days post virus inoculation or 7 days post hospitalization, whichever is later

  • Intensity of Solicited Injection Site Symptoms

    28 days post virus inoculation or 7 days post hospitalization, whichever is later

  • Duration of Solicited Injection Site Symptoms

    28 days post virus inoculation or 7 days post hospitalization, whichever is later

  • Occurrence of unsolicited Injection Site Symptoms

    28 days post virus inoculation or 7 days post hospitalization, whichever is later

  • Intensity of Unsolicited Injection Site Symptoms

    28 days post virus inoculation or 7 days post hospitalization, whichever is later

  • Duration of Unsolicited Injection Site Symptoms

    28 days post virus inoculation or 7 days post hospitalization, whichever is later

  • Occurrence of Solicited Systemic Symptoms

    28 days post virus inoculation or 7 days post hospitalization, whichever is later

  • Intensity of Solicited Systemic Symptoms

    28 days post virus inoculation or 7 days post hospitalization, whichever is later

  • Duration of Solicited Systemic Symptoms

    28 days post virus inoculation or 7 days post hospitalization, whichever is later

  • Occurrence of Unsolicited Systemic Symptoms

    28 days post virus inoculation or 7 days post hospitalization, whichever is later

  • Intensity of Unsolicited Systemic Symptoms

    28 days post virus inoculation or 7 days post hospitalization, whichever is later

  • Duration of Unsolicited Systemic Symptoms

    28 days post virus inoculation or 7 days post hospitalization, whichever is later

  • Number of Serious Adverse Events

    28 days post virus inoculation or 7 days post hospitalization, whichever is later

  • Number of Serious Adverse Events

    6 months post virus inoculation

Secondary Outcomes (15)

  • Incubation period before onset of fever

    Up to 28 days post virus inoculation

  • Viremia by Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)

    Up to 28 days post virus inoculation

  • Occurrence of fever without other identifiable cause, such as strep throat or influenza

    Up to 28 days post virus inoculation

  • Occurrence of Headache

    Up to 28 days post virus inoculation

  • Grade of Headache

    Up to 28 days post virus inoculation

  • +10 more secondary outcomes

Study Arms (3)

Low dose DENV-1-LVHC

EXPERIMENTAL

Dengue-1 Virus-Live Virus Human Challenge (DENV-1-LVHC) single low dose (0.5 mL of 6.5 x 10\^3 plaque forming units/milliliter (PFU/mL) inoculated subcutaneously

Biological: Dengue-1 Virus-Live Virus Human Challenge (DENV-1-LVHC)

Medium dose DENV-1-LVHC

EXPERIMENTAL

Dengue-1 Virus-Live Virus Human Challenge (DENV-1-LVHC) single medium dose (0.5 mL of 6.5 x 10\^4 PFU/mL) inoculated subcutaneously

Biological: Dengue-1 Virus-Live Virus Human Challenge (DENV-1-LVHC)

High dose DENV-1-LVHC

EXPERIMENTAL

Dengue-1 Virus-Live Virus Human Challenge (DENV-1-LVHC) single high dose (0.5 mL of 6.5 x 10\^5 PFU/mL) inoculated subcutaneously

Biological: Dengue-1 Virus-Live Virus Human Challenge (DENV-1-LVHC)

Interventions

Dengue-1 Virus-Live Virus Human Challenge (DENV-1-LVHC)BIOLOGICAL

Dengue subtype 1 Challenge Virus (DENV-1) strain 45AZ5 administered as a single injection.

High dose DENV-1-LVHCLow dose DENV-1-LVHCMedium dose DENV-1-LVHC

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy, male or non-pregnant, non-lactating female
  • Age 18-45
  • Ability and willingness to sign informed consent
  • Passing score on comprehension test would be 75%, with up to 3 attempts
  • Available for the study period
  • Willing to use contraception for the duration of the study.
  • Provide consent for release of medical history records from primary care physician, college or university, urgent care or emergency room visit

You may not qualify if:

  • Female: pregnant or lactating
  • Heavy menstrual bleeding within the last 6 months-menstrual periods lasting longer than 6 days, or requiring 5 or more pads or tampons per day.
  • Female subjects using an intrauterine device (IUD) or Mirena®
  • Female subjects with fibroids or uterine polyps, endometriosis, dysmenorrhea, adenomyosis, and uterine scarring (e.g. after D\&C)
  • Blood tests confirming infection with human immunodeficiency virus- 1 (HIV-1), hepatitis C, hepatitis B surface antigen, or flavi viruses (FV) to include dengue fever, West Nile, Yellow Fever, and Japanese encephalitis.
  • Diabetes, chronic obstructive pulmonary disease (COPD), peptic ulcer disease (PUD), or coronary artery disease (CAD)
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
  • Immediate family member (e.g. parent, sibling, child) with current, or a history of immunodeficiency or autoimmune disease
  • Current or a history of auto-immune disease
  • History of Guillain Barré syndrome (GBS)
  • Any history of FV infection or FV vaccination; or planned FV vaccination, outside the study protocol, during the study period
  • History of Bipolar Disorder, Schizophrenia, hospitalization in the past year for a mental health disorder, or any other psychiatric condition, which in the opinion of the investigator prevents the subject from participating in the study.
  • Planned travel during the study period (180 days) which would interfere with the ability to complete all study visits
  • Recent (in the past 4 weeks) travel to any dengue endemic area. These potential subjects may be eligible for enrollment a minimum of 4 weeks later
  • Any laboratory abnormalities in the tests specified in Table 19 and Table 20 of the protocol. Note: these laboratory tests can be repeated if the screening physician believes 1) it is thought to be a normal variant of a healthy state or 2) it is a suspected laboratory error
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State University of New York, Upstate Medical University (SUNY-UMU)

Syracuse, New York, 13210, United States

Location

Related Publications (1)

  • Endy TP, Wang D, Polhemus ME, Jarman RG, Jasper LE, Gromowski G, Lin L, De La Barra RA, Friberg H, Currier JR, Abbott M, Ware L, Klick M, Paolino KM, Blair DC, Eckels K, Rutvisuttinunt W, Thomas SJ. A Phase 1, Open-Label Assessment of a Dengue Virus-1 Live Virus Human Challenge Strain. J Infect Dis. 2021 Feb 3;223(2):258-267. doi: 10.1093/infdis/jiaa351.

    PMID: 32572470DERIVED

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

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

Study Officials

  • Timothy P Endy, MD, MPH

    State University of New York, Upstate Medical University (SUNY-UMU)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2015

First Posted

February 26, 2015

Study Start

October 1, 2015

Primary Completion

June 28, 2019

Study Completion

June 28, 2019

Last Updated

July 15, 2019

Record last verified: 2019-07

Locations

US(1)