Expansion of a Dengue-1 Live Virus Human Challenge

NCT03869060 | Completed Phase 1 FDA Drug

• 1 other identifier: 2018-01-UMU
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effectiveness of candidate dengue vaccine formulations, it is prudent to develop an appropriate challenge model. This study supports the expansion of the data set of the current Dengue 1 Live Virus Human Challenge (DENV-1-LVHC) model to produce uncomplicated dengue-like illness.

Conditions

Dengue

Keywords

Dengue; Flavivirus Infections; Virus Diseases

Outcome Measures

Primary Outcomes (17)

• Number of Abnormal Laboratory Parameters

  Total number of all abnormal labs

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

• Intensity of Abnormal Laboratory Parameters

  Graded according clinical laboratory normals and FDA toxicity scale

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

• Duration of Abnormal Laboratory Parameters

  Number of days of abnormal lab

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

• Occurrence of Solicited Injection site symptoms

  Number of solicited symptoms

  7 days post virus inoculation

• Intensity of Solicited Injection site symptoms

  Symptoms graded according to FDA toxicity scale

  7 days post virus inoculation

• Duration of Solicited Injection site symptoms

  Number of days per symptom

  7 days post virus inoculation

• Occurrence of Unsolicited Injection site symptoms

  Number of unsolicited site symptoms

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

• Intensity of Unsolicited Injection site symptoms

  Symptoms graded according to FDA toxicity scale

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

• Duration of Unsolicited Injection site symptoms

  Number of days per symptom

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

• Occurrence of Solicited systemic symptoms

  Number of systemic symptoms

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

• Intensity of Solicited systemic symptoms

  Symptoms graded according to FDA toxicity scale

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

• Duration of Solicited systemic symptoms

  Number of days per symptom

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

• Occurrence of Unsolicited systemic symptoms

  Number of symptoms

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

• Intensity of Unsolicited systemic symptoms

  Symptoms graded according to FDA toxicity scale

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

• Duration of Unsolicited systemic symptoms

  Number of days per symptom

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

• Number of Serious Adverse Events

  Total number

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

• Number of Serious Adverse Events

  Total number

  6 months post virus inoculation

Secondary Outcomes (16)

• 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

• Viremia by plaque assay

  Up to 28 days post virus inoculation

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

  Up to 28 days post virus inoculation

• Occurrence of Headache

  Up to 28 days post virus inoculation

Study Arms (1)

Inoculated Group

EXPERIMENTAL

Dengue-1 Virus-Live Virus Human Challenge (DENV-1-LVHC) given as a single 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)

Interventions

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

Dengue subtype 1 Challenge Virus (DENV-1) strain 45AZ5

Inoculated Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-45 at the time of consent
• Ability and willingness to sign informed consent
• Passing score on comprehension test of at least 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, adenomyosis, and uterine scarring (e.g., after D\&C)
• Blood tests confirming infection with human immunodeficiency virus- 1 (HIV-1), hepatitis C, hepatitis B (assessed by HbsAg) virus, or positive antibodies to the flaviviruses (FV) dengue, West Nile, Yellow Fever, Japanese encephalitis, or Zika.
• Active Diabetes or active peptic ulcer disease (PUD)
• Chronic obstructive pulmonary disease (COPD) or coronary artery disease (CAD)
• Known or suspected congenital or acquired immunodeficiency; or receipt of immunomodulation therapy such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
• 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
• Diagnosis with Bipolar Disorder or 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
• Subjects with the following grade 1 or greater lab abnormalities: Creatinine; Liver Function Tests - ALT, AST; Hemoglobin (females and males); White Blood Cell (WBC) decrease; Platelets decreased; Prothrombin Time (PT); Partial Thromboplastin Time (PTT); Fibrinogen decrease

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead
• Janssen Pharmaceutica N.V., Belgium: collaborator
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (1)

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

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Dengue; Flavivirus Infections; Virus Diseases

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Study Officials

• Stephen J Thomas, MD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: March 11, 2019
• Study Start: March 11, 2019
• Primary Completion: September 20, 2019
• Study Completion: September 20, 2019
• Last Updated: April 11, 2024

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)