Influenza Challenge Study of VIS410 in Healthy Volunteers

• Register: ClinicalTrials.gov
• Last refreshed on: 18 April 2016
• Main ID: NCT02468115
• Date of registration: 01/06/2015
• Prospective Registration: No
• Primary sponsor: Visterra, Inc.
• Public title: Influenza Challenge Study of VIS410 in Healthy Volunteers
• Scientific 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)
• Date of first enrolment: May 2015
• Target sample size: 46
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02468115
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Belgium

Contacts

• Name: M Petkova
• Affiliation: SGS Life Science Services

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Influenza

Intervention(s)

Drug: Placebo

Drug: VIS410

Primary Outcome(s)

To assess the effect of VIS410 on the area under the curve of viral shedding over time. [Time Frame: 56-84 days]

To assess the safety profile of VIS410 [Time Frame: 56-84 days]

Secondary Outcome(s)

Assess the effects of VIS410 on viral shedding [Time Frame: 10 days]

Assess the pharmacokinetics of VIS410 in serum [Time Frame: 56-84 days]

Assess the immunogenicity of VIS410 [Time Frame: 56-84 days]

Assess antibody to challenge strain [Time Frame: 28 days]

Assess the effect of VIS410 on clinical symptoms [Time Frame: 10 days]

Secondary ID(s)

VIS410-201

Source(s) of Monetary Support

Please refer to primary and secondary sponsors