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

Design:This is a Phase I, open-label, dose escalation study to evaluate the dose, safety, tolerability, and immunogenicity of the mosaic hexavalent influenza vaccine VRC-FLUMOS0116-00-VP (FluMos-v2). For Part A, the hypotheses are that the FluMos-v2 vaccine is safe and tolerable and will elicit an immune response. For Part B, the hypothesis is that the vaccine will generate a germinal center (GC) response in a draining lymph node as determined by fine needle aspiration of a reactive ipsilateral axillary lymph node. The primary objective is to evaluate the safety and tolerability of the investigational vaccine in healthy adults. Secondary objectives are related to the immunogenicity of the investigational vaccine.Study Products:The investigational vaccine, FluMos-v2, was developed by the Vaccine Research Center (VRC), National Institute of Allergy and Infectious Diseases (NIAID) and is composed of the following 6 influenza strains:Influenza A:H1: A/Idaho/07/2018H2: A/Singapore/1/1957H3: A/Perth/1008/2019H3: A/Darwin/106/2020Influenza B:B/Victoria lineage: B/Colorado/06/2017B/Yamagata lineage: B/Phuket/3073/2013FluMos-v2 is supplied in a single-use vial at a target concentration of 180 mcg/mL and will be administered intramuscularly (IM) in the deltoid muscle via needle and syringe.Subjects: Healthy adults between the ages of 18-50 years, inclusive, will be enrolled.Study Plan:In Part A, this study evaluates the safety, tolerability, and immunogenicity of FluMos-v2 in a dose escalation design.In Part B, this study assesses GC and peripheral blood immune responses at different time points after vaccination with FluMos-v2.For Part B: The protocol requires 2 vaccination visits, approximately 9-10 follow-up visits, 4 mandatory FNA visits and 1 optional FNA visit, and 10-12 telephone contacts. Safety phone calls occur one day after each vaccination, and 3 days after each FNA. Additional phone calls are related to scheduling the FNA procedures. Solicited reactogenicity is evaluated using a 7-day diary card. Assessment of vaccine safety includes clinical observation and monitoring of hematological and chemical parameters at clinical visits throughout the study.The study schema is as follows:VRC 326 Vaccination Schema:Part A:Group 1: Subjects:12, Day 0: 60 mcg, Week 16: 60 mcg, Product: FluMos-v2Group 2: Subjects: 12, Day 0: 180 mcg, Week 16: 180 mcg, Product: FluMos-v2Part B:Group 3: Subjects: 6, Day 0: 180 mcg, Week 16: 180 mcg, Product: FluMos-v2Total = 30 subjects (Enrollment up to 40 subjects is permitted if additional subjects are needed for safety or immunogenicity evaluations).Study Duration:Part A:Subjects will be evaluated for 40 weeks following first vaccine administration, including through the 2023-2024 influenza season.Part B:Subjects are evaluated for 40 weeks following the first vaccine administration, including through the 2024-2025 influenza season..

Medienart:	Klinische Studie

Erscheinungsjahr:	2024
Erschienen:	2024

Enthalten in:	ClinicalTrials.gov - (2024) vom: 12. Apr. Zur Gesamtaufnahme - year:2024

Sprache:	Englisch

Links:	Volltext [kostenfrei]

Themen:	610 Influenza, Human Phase: Phase 1 Recruitment Status: Recruiting Study Type: Interventional

Anmerkungen:	Source: Link to the current ClinicalTrials.gov record., First posted: August 1, 2023, Last downloaded: ClinicalTrials.gov processed this data on April 17, 2024, Last updated: April 17, 2024

Study ID:

NCT05968989 10001614 001614-I

Veröffentlichungen zur Studie:

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. Corbett 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. Yassine 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.

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PPN (Katalog-ID):	CTG00937423X