Trial to Evaluate the Safety, Tolerability, and Immunogenicity of a Mosaic Hexavalent Influenza Vaccine VRC-FLUMOS0116-00-VP (FluMos-v2) in Healthy Adults
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
2 other identifiers
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2023
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2023
CompletedFirst Posted
Study publicly available on registry
August 1, 2023
CompletedStudy Start
First participant enrolled
August 9, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2025
CompletedJanuary 6, 2026
January 2, 2026
2.2 years
July 31, 2023
January 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To evaluate the safety and tolerability
A 60 mcg dose of FluMos-v2 vaccine administered IM via needle on Day 0 and Week 16 to healthy adults.
Through 40 weeks following the first vaccine administration
To evaluate the safety and tolerability
A 180 mcg dose of FluMos-v2 vaccine administered IM administered via needle on Day 0 and Week 16 to healthy adults.
Through 40 weeks following the first vaccine administration
Secondary Outcomes (2)
To evaluate the antibody responses to FluMos-v2 vaccine
At two weeks after each injection at Week 2 and Week 18
To evaluate the antibody responses to FluMos-v2 vaccine
At two weeks after each injection at Week 2 and Week 18
Study Arms (3)
Group 1
EXPERIMENTAL60 mcg of FluMos-v2 on Day 0 and Week 16
Group 2
EXPERIMENTAL180 mcg of FluMos-v2 on Day 0 and Week16
Group 3
EXPERIMENTAL180 mcg of FluMos-v2 on Day 0 and Week16
Interventions
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
Eligibility Criteria
You may qualify if:
- A subject must meet all of the following criteria:
- Healthy adults between the ages of 18-50 years, inclusive
You may not qualify if:
- For Part A: Received at least one licensed influenza vaccine from 2018 through the 2022-2023 influenza season
- Able and willing to complete the informed consent process
- For Part A: Available for clinic visits for 40 weeks after enrollment, including through the 2023-2024 influenza season
- For Part B: Available for clinic visits for 40 weeks after enrollment, including through the 2024-2025 influenza season
- For Part B: Agrees to undergo four lymph node FNAs.
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process
- Physical examination and laboratory results without clinically significant findings and a Body Mass Index (BMI) \<= 35 within the 56 days before enrollment
- For both Parts A and B: Agrees to not receive any licensed influenza vaccine during study participation due to potential confounding of study results
- Willing to have blood samples collected, stored indefinitely, and used for research purposes
- For Part B: Willing to have lymph node samples collected, stored indefinitely, and used for research purposes
- Laboratory Criteria within 56 days before enrollment
- White blood cells (WBC) and differential within institutional normal range or accompanied by the site Principal Investigator (PI) or designee approval
- Total lymphocyte count \>= 800 cells/microliter
- Platelets = 125,000 - 500,000 cells/microliter
- Hemoglobin within institutional normal range or accompanied by the PI or designee approval
- +40 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Publications (3)
Kanekiyo M, Wei CJ, Yassine HM, McTamney PM, Boyington JC, Whittle JR, Rao SS, Kong WP, Wang L, Nabel GJ. Self-assembling influenza nanoparticle vaccines elicit broadly neutralizing H1N1 antibodies. Nature. 2013 Jul 4;499(7456):102-6. doi: 10.1038/nature12202. Epub 2013 May 22.
PMID: 23698367BACKGROUNDCorbett KS, Moin SM, Yassine HM, Cagigi A, Kanekiyo M, Boyoglu-Barnum S, Myers SI, Tsybovsky Y, Wheatley AK, Schramm CA, Gillespie RA, Shi W, Wang L, Zhang Y, Andrews SF, Joyce MG, Crank MC, Douek DC, McDermott AB, Mascola JR, Graham BS, Boyington JC. Design of Nanoparticulate Group 2 Influenza Virus Hemagglutinin Stem Antigens That Activate Unmutated Ancestor B Cell Receptors of Broadly Neutralizing Antibody Lineages. mBio. 2019 Feb 26;10(1):e02810-18. doi: 10.1128/mBio.02810-18.
PMID: 30808695BACKGROUNDYassine HM, Boyington JC, McTamney PM, Wei CJ, Kanekiyo M, Kong WP, Gallagher JR, Wang L, Zhang Y, Joyce MG, Lingwood D, Moin SM, Andersen H, Okuno Y, Rao SS, Harris AK, Kwong PD, Mascola JR, Nabel GJ, Graham BS. Hemagglutinin-stem nanoparticles generate heterosubtypic influenza protection. Nat Med. 2015 Sep;21(9):1065-70. doi: 10.1038/nm.3927. Epub 2015 Aug 24.
PMID: 26301691BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lasonji A Holman, C.R.N.P.
National Institute of Allergy and Infectious Diseases (NIAID)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2023
First Posted
August 1, 2023
Study Start
August 9, 2023
Primary Completion
November 1, 2025
Study Completion
November 1, 2025
Last Updated
January 6, 2026
Record last verified: 2026-01-02
Data Sharing
- IPD Sharing
- Will not share