Influenza Challenge Study of VIS410 in Healthy Volunteers
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)
1 other identifier
interventional
46
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2015
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
June 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedApril 5, 2016
April 1, 2016
9 months
June 1, 2015
April 4, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
To assess the effect of VIS410 on the area under the curve of viral shedding over time.
The viral AUC will be measured, qRT-PCR, and compared between treatment groups
56-84 days
To assess the safety profile of VIS410
The proportion of subjects with post-infusion adverse events will be compared between treatment groups.
56-84 days
Secondary Outcomes (5)
Assess the effects of VIS410 on viral shedding
10 days
Assess the pharmacokinetics of VIS410 in serum
56-84 days
Assess the immunogenicity of VIS410
56-84 days
Assess the effect of VIS410 on clinical symptoms
10 days
Assess antibody to challenge strain
28 days
Other Outcomes (2)
Assess the pharmacokinetics of VIS410 in the nasal mucosa
10 days
Assess viral target sequence in viral isolates to determine emergence of resistant viruses
28 days
Study Arms (2)
VIS410
EXPERIMENTALSingle intravenous fixed dose of VIS410
Placebo
PLACEBO COMPARATORSingle intravenous infusion of placebo
Interventions
Eligibility Criteria
You may qualify if:
- Male or female subjects of age 18-45 years, inclusive, at the time of informed consent.
- 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.
- Women of childbearing potential must have a negative pregnancy test at screening (serum) and on Day -2 (urine).
- Seronegative for the challenge virus (HAI ≤ 10).
You may not qualify if:
- Known or suspected intolerance or hypersensitivity to the investigational study drug or virus.
- Has an acute or chronic medical condition that would render the investigational study drug unsafe or would interfere with the evaluation of the responses.
- Subjects receiving medications that affect the immune system.
- Significant adulthood history of seasonal hay fever or a seasonal allergic rhinitis or perennial allergic rhinitis or chronic or nasal or sinus condition.
- Subjects who have received any vaccination within the last 3 months or influenza vaccine within the last 6 months.
- Subjects with a confirmed diagnosis of influenza A within the last 6 months prior to screening.
- Subjects with abnormal nasal structure (including septal deviation and nasal polyps), chronic sinusitis, or reason (i.e., intolerance) that complicates nasopharyngeal swabbing.
- Presence of lung disease, asthma, or chronic obstructive pulmonary disease.
- Has a history of alcohol or drug abuse.
- A positive HIV antibody screen, HBsAg, HBcAb or hepatitis C antibody screen.
- Cancer or treatment for cancer, within 3 years, excluding basal cell carcinoma of the skin, which is allowed.
- Presence of immunosuppression or any medical condition that may be associated with impaired immune responsiveness.
- Anticipated presence of a household contact with potential immunosuppression.
- History of Guillain-Barré syndrome.
- Current professional activity as a healthcare worker who will return to work within 2 weeks following challenge.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Visterra, Inc.lead
Study Sites (1)
SGS Life Sciences
Antwerp, Belgium
Related Publications (1)
Sloan SE, Szretter KJ, Sundaresh B, Narayan KM, Smith PF, Skurnik D, Bedard S, Trevejo JM, Oldach D, Shriver Z. Clinical and virological responses to a broad-spectrum human monoclonal antibody in an influenza virus challenge study. Antiviral Res. 2020 Dec;184:104763. doi: 10.1016/j.antiviral.2020.104763. Epub 2020 Mar 7.
PMID: 32151645DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
M Petkova
SGS Life Sciences, a division of SGS Belgium NV
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2015
First Posted
June 10, 2015
Study Start
May 1, 2015
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
April 5, 2016
Record last verified: 2016-04