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Influenza Challenge Study of VIS410 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02468115
Recruitment Status : Completed
First Posted : June 10, 2015
Last Update Posted : April 5, 2016
Sponsor:
Information provided by (Responsible Party):
Visterra, Inc.

Brief Summary:
A phase 2 a study to assess the safety profile and the effect of VIS410 in healthy subjects after inoculation with influenza A virus (H1N1).

Condition or disease Intervention/treatment Phase
Influenza Drug: VIS410 Drug: Placebo Phase 2

Detailed Description:

This is a phase 2a randomized, double-blind, placebo-controlled study to be conducted in healthy volunteers. The study is designed to compare an infusion of a single dose of VIS410 against placebo. Eligible volunteers will be admitted to the clinical center and will receive a single intranasal administration of influenza A (H1N1). One day (24h) after inoculation, subjects will receive a single administration of VIS410 or placebo. Subjects will be confined in the clinical center for 10 days after virus administration.

Assessment of safety will be determined from vital sign measurements, physical examinations, hematology, chemistry and urinalysis laboratory testing, 12-lead electrocardiograms (ECGs), pulmonary function, use of concomitant medications, and review of adverse events (AEs) should they occur. During confinement in the clinical center a symptom score card of influenza symptoms will be completed three times a day; nasopharyngeal swabs will be obtained three times a day and assayed for the presence of influenza virus and VIS410 concentration; serum samples will be assayed for VIS410 and the presence of cytokines. Upon release from the clinical center subjects will return for follow-up visits on days 14, 28 and either 56 or 84.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2a Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Antiviral Activity of a Single Intravenous Dose of VIS410 in Healthy Subjects After a Viral Inoculation With Influenza A (H1N1)
Study Start Date : May 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: VIS410
Single intravenous fixed dose of VIS410
Drug: VIS410
Single fixed IV dose of VIS410

Placebo Comparator: Placebo
Single intravenous infusion of placebo
Drug: Placebo
Single IV dose of placebo




Primary Outcome Measures :
  1. To assess the effect of VIS410 on the area under the curve of viral shedding over time. [ Time Frame: 56-84 days ]
    The viral AUC will be measured, qRT-PCR, and compared between treatment groups

  2. To assess the safety profile of VIS410 [ Time Frame: 56-84 days ]
    The proportion of subjects with post-infusion adverse events will be compared between treatment groups.


Secondary Outcome Measures :
  1. Assess the effects of VIS410 on viral shedding [ Time Frame: 10 days ]
    The peak viral load and time to cessation of shedding will be measured (qRT-PCR and TCID50)

  2. Assess the pharmacokinetics of VIS410 in serum [ Time Frame: 56-84 days ]
    The following PK parameters will be calculated: Cmax, tmax, AUC, t1/2, Vd, Cl

  3. Assess the immunogenicity of VIS410 [ Time Frame: 56-84 days ]
    The development of anti-drug antibodies will be measured

  4. Assess the effect of VIS410 on clinical symptoms [ Time Frame: 10 days ]
    The duration of symptoms will be compared between treatment groups

  5. Assess antibody to challenge strain [ Time Frame: 28 days ]
    The HAI antibody titer will be measured


Other Outcome Measures:
  1. Assess the pharmacokinetics of VIS410 in the nasal mucosa [ Time Frame: 10 days ]
    The following PK parameters will be calculated: Cmax, tmax, AUC, t1/2

  2. Assess viral target sequence in viral isolates to determine emergence of resistant viruses [ Time Frame: 28 days ]
    Sequencing will be used to determine the emergence of resistant virus in the treatment groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female subjects of age 18-45 years, inclusive, at the time of informed consent.
  2. Women should fulfill one of the following criteria:

    • Post-menopausal; either amenorrhea ≥ 12 months or follicle stimulating hormone > 40 mIU/mL.
    • Surgically sterile; bilateral oophorectomy, hysterectomy, or tubal ligation.
    • Women of childbearing potential participating in heterosexual sexual relations must be willing to use adequate contraception until the end of the study.
    • Must be sexually inactive by abstinence which is consistent with the preferred and usual lifestyle of the subject.
  3. Women of childbearing potential must have a negative pregnancy test at screening (serum) and on Day -2 (urine).
  4. Non-vasectomized (or vasectomized less than 6 months prior to dosing) male subjects must use an effective birth control method (see Inclusion Criterion 2).
  5. Seronegative for the challenge virus (HAI ≤ 10).

Exclusion Criteria:

  1. Known or suspected intolerance or hypersensitivity to the investigational study drug or virus.
  2. Has an acute or chronic medical condition that would render the investigational study drug unsafe or would interfere with the evaluation of the responses.
  3. Subjects receiving medications that affect the immune system.
  4. Significant adulthood history of seasonal hay fever or a seasonal allergic rhinitis or perennial allergic rhinitis or chronic or nasal or sinus condition.
  5. Subjects who have received any vaccination within the last 3 months or influenza vaccine within the last 6 months.
  6. Subjects with a confirmed diagnosis of influenza A within the last 6 months prior to screening.
  7. Subjects with abnormal nasal structure (including septal deviation and nasal polyps), chronic sinusitis, or reason (i.e., intolerance) that complicates nasopharyngeal swabbing.
  8. Presence of lung disease, asthma, or chronic obstructive pulmonary disease.
  9. Has a history of alcohol or drug abuse.
  10. A positive HIV antibody screen, HBsAg, HBcAb or hepatitis C antibody screen.
  11. Cancer or treatment for cancer, within 3 years, excluding basal cell carcinoma of the skin, which is allowed.
  12. Presence of immunosuppression or any medical condition that may be associated with impaired immune responsiveness.
  13. Anticipated presence of a household contact with potential immunosuppression.
  14. History of Guillain-Barré syndrome.
  15. Current professional activity as a healthcare worker who will return to work within 2 weeks following challenge.
  16. Anticipated presence of a pregnant household contact, within 2 weeks following challenge.
  17. Women who are pregnant or breast-feeding, or consider becoming pregnant.
  18. Acute disease within 2 weeks prior to challenge.
  19. Elevated white blood cell count above 10.90 x 109/L or an absolute neutrophil count above 7.5 x 109/L.
  20. Current enrollment in any other investigational drug study or disease study or participation in an investigational drug study.
  21. Any other reasons for which the investigator considers the subject unfit for the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468115


Locations
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Belgium
SGS Life Sciences
Antwerp, Belgium
Sponsors and Collaborators
Visterra, Inc.
Investigators
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Principal Investigator: M Petkova SGS Life Sciences, a division of SGS Belgium NV
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Visterra, Inc.
ClinicalTrials.gov Identifier: NCT02468115    
Other Study ID Numbers: VIS410-201
First Posted: June 10, 2015    Key Record Dates
Last Update Posted: April 5, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases