Influenza Challenge Study of VIS410 in Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT02468115|
Recruitment Status : Completed
First Posted : June 10, 2015
Last Update Posted : April 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Drug: VIS410 Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Single intravenous fixed dose of VIS410
Single fixed IV dose of VIS410
Placebo Comparator: Placebo
Single intravenous infusion of placebo
Single IV dose of placebo
- 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
- 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.
- 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)
- 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
- Assess the immunogenicity of VIS410 [ Time Frame: 56-84 days ]The development of anti-drug antibodies will be measured
- Assess the effect of VIS410 on clinical symptoms [ Time Frame: 10 days ]The duration of symptoms will be compared between treatment groups
- Assess antibody to challenge strain [ Time Frame: 28 days ]The HAI antibody titer will be measured
- 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
- 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.
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
|SGS Life Sciences|
|Principal Investigator:||M Petkova||SGS Life Sciences, a division of SGS Belgium NV|