Expansion of a Dengue-1 Live Virus Human Challenge

April 9, 2024 updated by: State University of New York - Upstate Medical University

Phase One, Open Label Expansion of a Dengue-1-Virus-Live Virus Human Challenge - (DENV-1-LVHC) Virus Strain.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is an expansion of a previous study conducted under NCT02372175. In this study up to nine healthy subjects between 18 and 45 years old will be inoculated with Dengue 1 Live Virus Human Challenge (DENV-1-LVHC) at a dose used in the previous study. Subjects will be closely monitored for the first 28 days with continued follow up through 6 months. Clinical and laboratory parameters, viremia and antibody levels will be assess. The goal is to expand the data set of symptoms produced by uncomplicated dengue-like illness.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Syracuse, New York, United States, 13210
        • State University of New York, Upstate Medical University (SUNY-UMU)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age 18-45 at the time of consent
  2. Ability and willingness to sign informed consent
  3. Passing score on comprehension test of at least 75%, with up to 3 attempts
  4. Available for the study period
  5. Willing to use contraception for the duration of the study
  6. Provide consent for release of medical history records from primary care physician, college or university, urgent care or emergency room visit

Exclusion Criteria:

  1. Female: pregnant or lactating
  2. 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.
  3. Female subjects using an intrauterine device (IUD) or Mirena®
  4. Female subjects with fibroids or uterine polyps, endometriosis, adenomyosis, and uterine scarring (e.g., after D&C)
  5. 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.
  6. Active Diabetes or active peptic ulcer disease (PUD)
  7. Chronic obstructive pulmonary disease (COPD) or coronary artery disease (CAD)
  8. 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)
  9. Current, or a history of, auto-immune disease
  10. History of Guillain-Barré syndrome (GBS)
  11. Any history of FV infection or FV vaccination; or planned FV vaccination, outside the study protocol, during the study period
  12. 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.
  13. Planned travel during the study period (180 days) which would interfere with the ability to complete all study visits
  14. 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
  15. Any grade 2 laboratory abnormalities prior to inoculation for the tests specified in Table 18 and Table 19 of the protocol, except those listed in exclusion criteria 16
  16. 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
  17. Significant screening physical examination abnormalities at the discretion of the investigator
  18. Women who intend to become pregnant or men who intend to father a child during the study period (approximately 180 days)
  19. Hives, shortness of breath, swelling of the lips or throat, or hospitalization related to a previous vaccination or an allergy to specific medications/animals for which antigens may be in the virus preparations to include: shellfish allergy, fetal bovine serum, L-glutamine, neomycin and streptomycin
  20. Planning to donate blood in the 1 year following inoculation with dengue
  21. Recent blood donation within prior 56 days of inoculation
  22. Receipt of blood products or antibodies within 56 days of inoculation or during the study period
  23. Participation (active or follow-up phase) or planned participation in another vaccine, drug, medical device, or medical procedure clinical trial in the 4 weeks prior to this trial, during the trial, or 6 months following inoculation in this clinical trial
  24. Recent or scheduled receipt of any vaccine 4 weeks prior to or after virus inoculation
  25. Beliefs that bar the administration of blood products or transfusions
  26. Positive urine screen for cocaine, amphetamines, or opiates
  27. Currently taking Methadone or Suboxone
  28. Currently taking anti-coagulant medication, aspirin or non-steroidal anti-inflammatory drugs (NSAIDs)
  29. Chronic migraine headaches, defined as more than 15 headache days per month over a 3 month period of which more than 8 are migraines, in the absence of medication over use
  30. Chronic medical condition that, in the opinion of the investigator, impacts subject safety.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Inoculated Group
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)
Dengue subtype 1 Challenge Virus (DENV-1) strain 45AZ5

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Abnormal Laboratory Parameters
Time Frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Total number of all abnormal labs
28 days post virus inoculation or 7 days post hospitalization, whichever is later
Intensity of Abnormal Laboratory Parameters
Time Frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
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
Time Frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
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
Time Frame: 7 days post virus inoculation
Number of solicited symptoms
7 days post virus inoculation
Intensity of Solicited Injection site symptoms
Time Frame: 7 days post virus inoculation
Symptoms graded according to FDA toxicity scale
7 days post virus inoculation
Duration of Solicited Injection site symptoms
Time Frame: 7 days post virus inoculation
Number of days per symptom
7 days post virus inoculation
Occurrence of Unsolicited Injection site symptoms
Time Frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Number of unsolicited site symptoms
28 days post virus inoculation or 7 days post hospitalization, whichever is later
Intensity of Unsolicited Injection site symptoms
Time Frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
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
Time Frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Number of days per symptom
28 days post virus inoculation or 7 days post hospitalization, whichever is later
Occurrence of Solicited systemic symptoms
Time Frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Number of systemic symptoms
28 days post virus inoculation or 7 days post hospitalization, whichever is later
Intensity of Solicited systemic symptoms
Time Frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
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
Time Frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Number of days per symptom
28 days post virus inoculation or 7 days post hospitalization, whichever is later
Occurrence of Unsolicited systemic symptoms
Time Frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Number of symptoms
28 days post virus inoculation or 7 days post hospitalization, whichever is later
Intensity of Unsolicited systemic symptoms
Time Frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
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
Time Frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Number of days per symptom
28 days post virus inoculation or 7 days post hospitalization, whichever is later
Number of Serious Adverse Events
Time Frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later
Total number
28 days post virus inoculation or 7 days post hospitalization, whichever is later
Number of Serious Adverse Events
Time Frame: 6 months post virus inoculation
Total number
6 months post virus inoculation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incubation period before onset of fever
Time Frame: Up to 28 days post virus inoculation
Number of days prior to fever
Up to 28 days post virus inoculation
Viremia by Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR)
Time Frame: Up to 28 days post virus inoculation
Levels of viremia
Up to 28 days post virus inoculation
Viremia by plaque assay
Time Frame: Up to 28 days post virus inoculation
Quantitation of infectious virus
Up to 28 days post virus inoculation
Occurrence of fever without other identifiable cause, such as strep infection or influenza
Time Frame: Up to 28 days post virus inoculation
The occurrence of fever defined as greater than or equal to 38°C (100.4°F) measured at least 2 times in 24 hours but not lasting more than 72 hours
Up to 28 days post virus inoculation
Occurrence of Headache
Time Frame: Up to 28 days post virus inoculation
Number of headaches
Up to 28 days post virus inoculation
Grade of Headache
Time Frame: Up to 28 days post virus inoculation
Graded according to FDA toxicity scale
Up to 28 days post virus inoculation
Occurrence of Myalgia
Time Frame: Up to 28 days post virus inoculation
Number of reported myalgias
Up to 28 days post virus inoculation
Grade of Myalgia
Time Frame: Up to 28 days post virus inoculation
Graded according to FDA toxicity scale
Up to 28 days post virus inoculation
Occurrence of Rash
Time Frame: Up to 28 days post virus inoculation
Number of rashes
Up to 28 days post virus inoculation
Grade of Rash
Time Frame: Up to 28 days post virus inoculation
Graded according to FDA toxicity scale
Up to 28 days post virus inoculation
Occurrence of Abnormal Liver Function Test [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)]
Time Frame: Up to 28 days post virus inoculation
Number of abnormal liver function tests
Up to 28 days post virus inoculation
Grade of Abnormal Liver Function Test [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)]
Time Frame: Up to 28 days post virus inoculation
Graded according clinical laboratory normals and FDA toxicity scale
Up to 28 days post virus inoculation
Occurrence of Leukopenia
Time Frame: Up to 28 days post virus inoculation
Number of occurrences
Up to 28 days post virus inoculation
Grade of Leukopenia
Time Frame: Up to 28 days post virus inoculation
Graded according clinical laboratory normals and FDA toxicity scale
Up to 28 days post virus inoculation
Occurrence of Thrombocytopenia
Time Frame: Up to 28 days post virus inoculation
Number of occurrences
Up to 28 days post virus inoculation
Grade of Thrombocytopenia
Time Frame: Up to 28 days post virus inoculation
Graded according clinical laboratory normals and FDA toxicity scale
Up to 28 days post virus inoculation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
State University of New York - Upstate Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
U.S. Army Medical Research and Development Command
Janssen Pharmaceutica N.V., Belgium

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stephen J Thomas, MD, State University of New York - Upstate Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 11, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 20, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 20, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 7, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018-01-UMU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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