Active Studies at the Clinical Core CIVICs
The purpose of this protocol is to establish and maintain a repository of biological specimens collected from subjects enrolled in CIVICs clinical studies including but not limited to Phase I, Phase I/II, Phase II, and Human Challenge trials, screening protocols, influenza, or other respiratory pathogen related clinical studies with human subjects supporting the development of novel influenza vaccines. The repository will be established for the purposes of storing specimens prior to conducting secondary, not yet designated research.
This registry protocol is necessary to understand the background population immunity to common influenza viruses, SARS-CoV-2, and other respiratory pathogens and to establish a volunteer registry of healthy adults who would be pre-screened and readily available to enroll into influenza virus challenge and vaccine studies, SARS-CoV-2 studies, and other respiratory pathogen studies. In addition, evaluating the frequency of antibody titers in the local community of the CIVICs sites will help inform screening and recruitment planning for future challenge and vaccine studies.
This study is designed to determine the optimal infectious dose of the H3N2 (A/Texas/71/2017 (H3N2), clade 3C3a) influenza virus challenge strain for use in future Phase I clinical trials evaluating vaccine candidates. The study will enroll and challenge healthy adult volunteers with the H3N2 (A/Texas/71/2017 (H3N2), clade 3C3a) influenza virus challenge strain. Eligible participants will be enrolled sequentially into dosing cohorts and will be randomly assigned to receive a single dose of either placebo (sham inoculum) or a virus dose between 104 to 106 TCID50. Dose titration will be conducted under an adaptive escalation schedule whereby dosing will start at the lowest dose (104 TCID50) and only escalate to the next dose if a pre-determined infection and symptomatic attack rate are not met and the dose is determined to be safe and no pre-defined halting rule is met.
In this study, we will perform a Phase 1b, double-blind, dose-escalating, age de-escalating study of the Sing2016 M2SR H3N2 vaccine in children ages 6 months to 17 years. The purpose of the study is to assess the safety, tolerability/reactogenicity, and immunogenicity of the vaccine.