Influenza Challenge Study of VIS410 in Healthy Volunteers

Status Completed

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02468115
Study type	Interventional
Source	Visterra, Inc.
Contact
Status	Completed
Phase	Phase 2
Start date	May 2015
Completion date	February 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05523089` - The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults	Phase 2
Completed	`NCT05009251` - Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake	N/A
Completed	`NCT03282240` - Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US	Phase 3
Completed	`NCT00968539` - Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults	Phase 3
Completed	`NCT00971425` - Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1)	Phase 3
Completed	`NCT00968526` - Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults	Phase 3
Completed	`NCT05525494` - Patient Portal Flu Vaccine Reminders (5)	N/A
Completed	`NCT04074928` - Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects	Phase 3
Completed	`NCT04695717` - This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Under 18 Years Old and the Elderly Over 60 Years Old in Vietnam	Phase 3
Completed	`NCT05012163` - Lottery Incentive Nudges to Increase Influenza Vaccinations	N/A
Completed	`NCT03888989` - Response to Influenza Vaccine During Pregnancy	Phase 1
Completed	`NCT04109222` - Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively	Phase 4
Completed	`NCT02587221` - Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age	Phase 3
Completed	`NCT03453801` - The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection	Phase 1
Completed	`NCT01440387` - A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older	Phase 3
Terminated	`NCT01195779` - Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children	Phase 2
Completed	`NCT03321968` - Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults	Phase 3
Completed	`NCT00972517` - Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children	Phase 3
Completed	`NCT04570904` - Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness
Recruiting	`NCT03331991` - Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel	N/A