AzTrials
AzTrials

DenguePhase 1NCT03869060

Expansion of a Dengue-1 Live Virus Human Challenge

A Phase 1 study testing Dengue-1 Virus-Live Virus Human Challenge (DENV-1-LVHC) in people with Dengue, run by State University of New York - Upstate Medical University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Dengue
What is being tested?
Dengue-1 Virus-Live Virus Human Challenge (DENV-1-LVHC)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteUnited States
Study dates
11 Mar 2019to 20 Sep 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 30Show fewer
  • 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
  • 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
  • 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
  • Significant screening physical examination abnormalities at the discretion of the investigator
  • Women who intend to become pregnant or men who intend to father a child during the study period (approximately 180 days)
  • 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
  • Planning to donate blood in the 1 year following inoculation with dengue
  • Recent blood donation within prior 56 days of inoculation
  • Receipt of blood products or antibodies within 56 days of inoculation or during the study period
  • 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
  • Recent or scheduled receipt of any vaccine 4 weeks prior to or after virus inoculation
  • Beliefs that bar the administration of blood products or transfusions
  • Positive urine screen for cocaine, amphetamines, or opiates
  • Currently taking Methadone or Suboxone
  • Currently taking anti-coagulant medication, aspirin or non-steroidal anti-inflammatory drugs (NSAIDs)
  • 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
  • Chronic medical condition that, in the opinion of the investigator, impacts subject safety.

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Syracuse, New York, 13210

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Dengue
Being tested
Dengue-1 Virus-Live Virus Human Challenge (DENV-1-LVHC)
Keywords
Dengue, Flavivirus Infections, Virus Diseases
Medical subject headings
Dengue, Flavivirus Infections, Virus Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

Study groups in NCT03869060
Study groupRoleWhat they receive
Inoculated GroupExperimentalDengue-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.
Receives: Biological: Dengue-1 Virus-Live Virus Human Challenge (DENV-1-LVHC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Abnormal Laboratory Parameters

    Total number of all abnormal labs

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

  2. Intensity of Abnormal Laboratory Parameters

    Graded according clinical laboratory normals and FDA toxicity scale

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

  3. Duration of Abnormal Laboratory Parameters

    Number of days of abnormal lab

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

  4. Occurrence of Solicited Injection site symptoms

    Number of solicited symptoms

    Measured: 7 days post virus inoculation

  5. Intensity of Solicited Injection site symptoms

    Symptoms graded according to FDA toxicity scale

    Measured: 7 days post virus inoculation

  6. Duration of Solicited Injection site symptoms

    Number of days per symptom

    Measured: 7 days post virus inoculation

  7. Occurrence of Unsolicited Injection site symptoms

    Number of unsolicited site symptoms

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

  8. Intensity of Unsolicited Injection site symptoms

    Symptoms graded according to FDA toxicity scale

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

  9. Duration of Unsolicited Injection site symptoms

    Number of days per symptom

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

  10. Occurrence of Solicited systemic symptoms

    Number of systemic symptoms

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

  11. Intensity of Solicited systemic symptoms

    Symptoms graded according to FDA toxicity scale

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

  12. Duration of Solicited systemic symptoms

    Number of days per symptom

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

  13. Occurrence of Unsolicited systemic symptoms

    Number of symptoms

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

  14. Intensity of Unsolicited systemic symptoms

    Symptoms graded according to FDA toxicity scale

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

  15. Duration of Unsolicited systemic symptoms

    Number of days per symptom

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

  16. Number of Serious Adverse Events

    Total number

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

  17. Number of Serious Adverse Events

    Total number

    Measured: 6 months post virus inoculation

Secondary outcomes (16)

  1. Incubation period before onset of fever

    Number of days prior to fever

    Measured: Up to 28 days post virus inoculation

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

    Levels of viremia

    Measured: Up to 28 days post virus inoculation

  3. Viremia by plaque assay

    Quantitation of infectious virus

    Measured: Up to 28 days post virus inoculation

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

    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

    Measured: Up to 28 days post virus inoculation

  5. Occurrence of Headache

    Number of headaches

    Measured: Up to 28 days post virus inoculation

  6. Grade of Headache

    Graded according to FDA toxicity scale

    Measured: Up to 28 days post virus inoculation

  7. Occurrence of Myalgia

    Number of reported myalgias

    Measured: Up to 28 days post virus inoculation

  8. Grade of Myalgia

    Graded according to FDA toxicity scale

    Measured: Up to 28 days post virus inoculation

  9. Occurrence of Rash

    Number of rashes

    Measured: Up to 28 days post virus inoculation

  10. Grade of Rash

    Graded according to FDA toxicity scale

    Measured: Up to 28 days post virus inoculation

  11. Occurrence of Abnormal Liver Function Test [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)]

    Number of abnormal liver function tests

    Measured: Up to 28 days post virus inoculation

  12. Grade of Abnormal Liver Function Test [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)]

    Graded according clinical laboratory normals and FDA toxicity scale

    Measured: Up to 28 days post virus inoculation

  13. Occurrence of Leukopenia

    Number of occurrences

    Measured: Up to 28 days post virus inoculation

  14. Grade of Leukopenia

    Graded according clinical laboratory normals and FDA toxicity scale

    Measured: Up to 28 days post virus inoculation

  15. Occurrence of Thrombocytopenia

    Number of occurrences

    Measured: Up to 28 days post virus inoculation

  16. Grade of Thrombocytopenia

    Graded according clinical laboratory normals and FDA toxicity scale

    Measured: Up to 28 days post virus inoculation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2019
  2. Study start11 Mar 2019
  3. Primary completion20 Sep 2019
  4. Study completion20 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03869060
Sponsor's protocol ID
2018-01-UMU
Status last verified
Jan 2020
First submitted
5 Mar 2019
Last updated
11 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dengue-1 Virus-Live Virus Human Challenge (DENV-1-LVHC) in people with Dengue, run by State University of New York - Upstate Medical University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Abnormal Laboratory Parameters (time frame: 28 days post virus inoculation or 7 days post hospitalization, whichever is later). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03869060.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in