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

PHASE1CompletedINTERVENTIONAL
Enrollment

63

Participants

Timeline

Start Date

May 24, 2021

Primary Completion Date

January 25, 2024

Study Completion Date

January 25, 2024

Conditions
InfluenzaSeasonal Influenza
Interventions
DRUG

VRC-GENADJ0110-AP-NV (Adjuplex)

Adjuplex is a sterile, pyrogen-free adjuvant solution produced by the VRC Pilot Plant. Adjuplex comprises highly purified de-oiled soy lecithin and benzene-free carbomer homopolymer formulated in phosphate buffered saline. Adjuplex adjuvant was mixed with FluMos-v1 at 20% by volume in the pharmacy during product preparation for the vaccinations of Groups 5A-5B.

BIOLOGICAL

Flucelvax

Flucelvax is an inactivated influenza vaccine licensed for the 2020-2021 season.

DRUG

VRC-FLUMOS0111-00-VP (FluMos-v1)

FluMos-v1 investigational vaccine is composed of engineered pentameric promoters based on C. albicans lumazine synthase assembled with 20 trimeric promoters displaying HA ectodomains. It contains hemagglutinin (HA) proteins from the following 4 influenza strains: A/Idaho/07/2018, A/Perth/1008/2019, B/Colorado/06/2017 and B/Phuket/3073/2013.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH