First-in-Human Clinical Trial of a Mosaic Quadrivalent Influenza Vaccine Compared With a Licensed Inactivated Seasonal QIV, in Healthy Adults

Summary

Participation Requirements

Description

This is a Phase I, open-label, dose escalation study to evaluate the dose, safety, tolerability, and immunogenicity of the mosaic quadrivalent influenza vaccine VRC-FLUMOS0111-00-VP (FluMos-v1). The hypotheses are that the FluMos-v1 vaccine is safe and tolerable and will elicit an immune response. T...

This is a Phase I, open-label, dose escalation study to evaluate the dose, safety, tolerability, and immunogenicity of the mosaic quadrivalent influenza vaccine VRC-FLUMOS0111-00-VP (FluMos-v1). The hypotheses are that the FluMos-v1 vaccine is safe and tolerable and will elicit an immune response. The primary objective is to evaluate the safety and tolerability of the investigational vaccine in healthy adults. Secondary objectives are related to immunogenicity of the investigational vaccine and dosing regimen compared with the licensed inactivated seasonal Flucelvax (Registered Trademark) quadrivalent influenza vaccine (QIV) in Healthy Adults. The investigational vaccine FluMos-v1 was developed by the Vaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases (NIAID) and is composed of the following 4 influenza strains: Influenza A: H1: A/Idaho/07/2018 H3: A/Perth/1008/2019 Influenza B: B/Victoria lineage: B/Colorado/06/2017 B/Yamagata lineage: B/Phuket/3073/2013 FluMos-v1 is supplied in a single-use vial at a concentration of 180 mcg/mL. The FDA licensed inactivated 2020-2021 QIV Flucelvax(Registered Trademark) was developed by Seqirus, Inc. and is composed of the following 4 influenza strains: Influenza A: H1: A/Hawaii/70/2019 (H1N1) pdm09-like virus H3: A/Hong Kong/45/2019 (H3N2)-like virus Influenza B: B/Victoria lineage: B/Washington/02/2019-like virus B/Yamagata lineage: B/Phuket/3073/2013-like virus Flucelvax(Registered Trademark) is supplied in a single-use syringe at 15 mcg HA of each of the four influenza strains, for a total of 60 mcg HA per 0.5 mL dose. FluMos-v1 and Flucelvax(Registered Trademark) will be administered intramuscularly (IM) in the deltoid muscle via needle and syringe. Healthy adults between the ages of 18-50 years inclusive will be enrolled. The study will evaluate the safety, tolerability and immunogenicity of a single dose of FluMos-v1 vaccine in a dose-escalation design. In Group 1A-1B, five subjects will receive a dose of 20 mcg of FluMos-v1. If the 20 mcg dose is assessed as safe and tolerable, enrollment will begin for Group 2A-2B. In Group 2A-2B, subjects will receive a dose of 60 mcg of FluMos-v1. In Group 3A-3B, subjects will receive the licensed QIV Flucelvax(Registered Trademark) and may enroll at any time after the study is open to accrual. The protocol requires 1 vaccination visit, about 8 follow-up visits, and a telephone contact on the day after vaccination. For all groups, solicited reactogenicity will be evaluated using a 7-day diary card. Assessment of vaccine safety will include clinical observation and monitoring of hematological and chemical parameters at clinical visits throughout the study. Subjects will be evaluated for 40 weeks following vaccine administration and through an influenza season.

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