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COMPLETED
NCT05968989
PHASE1

Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Mosaic Hexavalent Influenza Vaccine VRC-FLUMOS0116-00-VP (FluMos-v2) in Healthy Adults

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

Summary

Background: Influenza (flu) virus causes 3 to 5 million cases of severe illness and up to 650,000 deaths per year worldwide. Current vaccines work well against single strains of flu virus. But no single vaccine works well against all flu viruses that can cause illness. Objective: To test an experimental flu vaccine (FluMos-v2) in healthy adults. Eligibility: Healthy adults aged 18 to 50 years. Design: Participants will have 11 clinic visits in 10 months. They must agree not to get a licensed flu vaccine while taking part in this study. FluMos-v2 will be given with a needle injected into a muscle in the upper arm. Participants will receive a follow-up phone call the following day. Participants will be given a diary card, a ruler, and a thermometer. They will take their temperature every day for 7 days after receiving the shot. They will measure any skin changes at the injection site. They will record their findings and how they feel. Participants will receive a second FluMos-v2 shot after 4 months. They will repeat the other follow-up steps. Participants will have 9 other clinic follow-up visits. Blood will be drawn at each visit. Participants should also come to the clinic if they develop flu-like symptoms during the study. Participants may opt for an apheresis 2 weeks after each shot: Blood will be removed through a needle in the vein of 1 arm. The blood will run through a machine that separates out the white blood cells. The remaining blood is returned through a needle in the other arm.

Official title: VRC 326 (001614): A Phase I Open-Label Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Mosaic Hexavalent Influenza Vaccine VRC-FLUMOS0116-00-VP (FluMos-v2) in Healthy Adults

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2023-08-09

Completion Date

2025-11-01

Last Updated

2026-07-13

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

VRC-FLUMOS0116-00-VP( FLUMos-v2)

The vaccine, FLUMos-v2, is composed of engineered pentamer yeast C. albican lumazine synthase assembled with 20 HA ectodomain trimers from the following 6 influenza strains: Influenza A: H1: A/Idaho/07/2018; H2: A/Singapore/1/1957; H3: A/Perth/1008/2019; H3: A/Darwin/106/2020 Influenza B: B/Victoria lineage: B/Colorado/06/2017; B/Yamagata lineage: B/Phuket/3073/2013

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States