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

NCT05968989 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-01-06

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Lasonji A Holman, C.R.N.P. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-09
Primary Completion
2025-11-01
Completion
2025-11-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05968989 on ClinicalTrials.gov