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DenguePhase 1NCT02372175

Assessment of a Dengue-1-Virus-Live Virus Human Challenge - (DENV-1-LVHC) Virus Strain

A Phase 1 study testing Dengue-1 Virus-Live Virus Human Challenge (DENV-1-LVHC) in people with Dengue, run by U.S. Army Medical Research and Development Command 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
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Trial 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… 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
27 participants
Where
1 siteUnited States
Study dates
Oct 2015to 28 Jun 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

  • 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

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, 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)
Show all 26Show fewer
  • 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
  • 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 6 months)
  • 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
  • Participation 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
  • 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 migrainous, 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, Assessment 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. 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.

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

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 administered as a single injection.

Study groups in NCT02372175
Study groupRoleWhat they receive
Low dose DENV-1-LVHCExperimentalDengue-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
Receives: Biological: Dengue-1 Virus-Live Virus Human Challenge (DENV-1-LVHC)
Medium dose DENV-1-LVHCExperimentalDengue-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
Receives: Biological: Dengue-1 Virus-Live Virus Human Challenge (DENV-1-LVHC)
High dose DENV-1-LVHCExperimentalDengue-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
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 Measurements

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

  2. Intensity of Abnormal Laboratory Measurements

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

  3. Duration of Abnormal Laboratory Measurements

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

  4. Occurrence of Solicited Injection Site Symptoms

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

  5. Intensity of Solicited Injection Site Symptoms

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

  6. Duration of Solicited Injection Site Symptoms

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

  7. Occurrence of unsolicited Injection Site Symptoms

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

  8. Intensity of Unsolicited Injection Site Symptoms

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

  9. Duration of Unsolicited Injection Site Symptoms

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

  10. Occurrence of Solicited Systemic Symptoms

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

  11. Intensity of Solicited Systemic Symptoms

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

  12. Duration of Solicited Systemic Symptoms

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

  13. Occurrence of Unsolicited Systemic Symptoms

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

  14. Intensity of Unsolicited Systemic Symptoms

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

  15. Duration of Unsolicited Systemic Symptoms

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

  16. Number of Serious Adverse Events

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

  17. Number of Serious Adverse Events

    Measured: 6 months post virus inoculation

Secondary outcomes (15)

  1. Incubation period before onset of fever

    Measured: Up to 28 days post virus inoculation

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

    Measured: Up to 28 days post virus inoculation

  3. Occurrence of fever without other identifiable cause, such as strep throat 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 96 hours up to 28 days post virus inoculation without other identifiable cause, such as strep infection or influenza.

    Measured: Up to 28 days post virus inoculation

  4. Occurrence of Headache

    Measured: Up to 28 days post virus inoculation

  5. Grade of Headache

    Measured: Up to 28 days post virus inoculation

  6. Occurrence of Myalgia

    Measured: Up to 28 days post virus inoculation

  7. Grade of Myalgia

    Measured: Up to 28 days post virus inoculation

  8. Occurrence of Rash

    Measured: Up to 28 days post virus inoculation

  9. Grade of Rash

    Measured: Up to 28 days post virus inoculation

  10. Occurrence of Liver Function Tests Abnormalities [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)]

    Measured: Up to 28 days post virus inoculation

  11. Grade of Liver Function Tests Abnormalities [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)]

    Measured: Up to 28 days post virus inoculation

  12. Occurrence of Leukopenia

    Measured: Up to 28 days post virus inoculation

  13. Grade of Leukopenia

    Measured: Up to 28 days post virus inoculation

  14. Occurrence of Thrombocytopenia

    Measured: Up to 28 days post virus inoculation

  15. Grade of Thrombocytopenia

    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 posted26 Feb 2015 (estimated)
  2. Study startOct 2015
  3. Primary completion28 Jun 2019
  4. Study completion28 Jun 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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02372175
Sponsor's protocol ID
S-14-09
Status last verified
Jul 2019
First submitted
10 Feb 2015
Last updated
15 Jul 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 32572470

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 U.S. Army Medical Research and Development Command 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 7 inclusion and 26 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 15 Jul 2019. 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 Measurements (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 NCT02372175, which also lists 1 linked publication.

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 15 Jul 2019.

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