Phase 1 safety and immunogenicity study of a quadrivalent seasonal flu vaccine comprising recombinant hemagglutinin-flagellin fusion proteins

Open Forum Infectious Diseases

Volumn 3, Issue 1, 2016, Pages

  Tussey, Lynda ^a   Strout, Cynthia ^b   Davis, Matthew ^c   Johnson, Casey ^d   Lucksinger, Gregg ^e   Umlauf, Scott ^a   Song, Langzhou ^a   Liu, Ge ^a   Abraham, Katalin ^f   White, C Jo ^g  

^a VaxInnate Corporation   (United States)

^b Coastal Carolina Research ^*  (United States)

^c Rochester Clinical Research   (United States)

^d Johnson County Clin Trials   (United States)

^e Tekton Research   (United States)

^f MERCK RESEARCH LABORATORIES   (United States)

^g Independent Consultant Medical Monitor   (United States)

Author keywords

Flagellin adjuvant; Influenza vaccine; Recombinant vaccine; Seasonal influenza; Vaccine

Indexed keywords

C REACTIVE PROTEIN; INFLUENZA VACCINE; INTERLEUKIN 10; INTERLEUKIN 12P70; INTERLEUKIN 1BETA; INTERLEUKIN 6; INTERLEUKIN 8; QUADRIVALENT SEASONAL FLU VACCINE; TUMOR NECROSIS FACTOR; UNCLASSIFIED DRUG;

ADULT; ARTHRALGIA; ARTICLE; CHILL; DRUG SAFETY; DRUG TOLERABILITY; ENZYME LINKED IMMUNOSORBENT ASSAY; ERYTHEMA; FATIGUE; FEMALE; FEVER; HEADACHE; HEMAGGLUTINATION INHIBITION TEST; HEMATOMA; HUMAN; HYPERSENSITIVITY; IMMUNE RESPONSE; IMMUNOGENICITY; IMMUNOSUPPRESSIVE TREATMENT; INFLUENZA; INJECTION SITE CONTUSION; INJECTION SITE PAIN; MAJOR CLINICAL STUDY; MALE; MYALGIA; NORMAL HUMAN; OPEN STUDY; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; REVERSED PHASE LIQUID CHROMATOGRAPHY; SEROCONVERSION; SWELLING;

EID: 85000766314     PISSN: None     EISSN: 23288957     Source Type: Journal    
DOI: 10.1093/ofid/ofw015     Document Type: Article

References (20)

1. Rolfes M, Blanton L, Brammer L, et al. Update: influenza activity - United States, September 28-December 6, 2014. MMWR Morb Mortal Wkly Rep 2014; 63:1189-94.
2. Skowronski DM, Janjua NZ, De Serres G, et al. Low 2012-13 influenza vaccine effectiveness associated with mutation in the egg-adapted H3N2 vaccine strain not antigenic drift in circulating viruses. PLoS One 2014; 9:e92153.
3. Treanor JJ, Schiff GM, Hayden FG, et al. Safety and immunogenicity of a baculovirus- expressed hemagglutinin influenza vaccine: a randomized controlled trial. JAMA 2007; 297:1577-82.
4. Mahmood K, Bright RA, Mytle N, et al. H5N1 VLP vaccine induced protection in ferrets against lethal challenge with highly pathogenic H5N1 influenza viruses. Vaccine 2008; 26:5393-9.
5. Bright RA, Carter DM, Crevar CJ, et al. Cross-clade protective immune responses to influenza viruses with H5N1 HA and NA elicited by an influenza virus-like particle. PLoS One 2008; 3:e1501.
6. Hessel A, SchwendingerM, Fritz D, et al. A pandemic influenza H1N1 live vaccine based on modified vaccinia Ankara is highly immunogenic and protects mice in active and passive immunizations. PLoS One 2010; 5:e12217.
7. Khurana S, Verma S, Verma N, et al. Properly folded bacterially expressed H1N1 hemagglutinin globular head and ectodomain vaccines protect ferrets against H1N1 pandemic influenza virus. PLoS One 2010; 5:e11548.
8. Steel J, Lowen AC, Wang TT, et al. Influenza virus vaccine based on the conserved hemagglutinin stalk domain. MBio 2010; 1:e00018-10.
9. Lalor PA, Webby RJ, Morrow J, et al. Plasmid DNA-based vaccines protect mice and ferrets against lethal challenge with A/Vietnam/1203/04 (H5N1) influenza virus. J Infect Dis 2008; 197:1643-52.
10. Huleatt JW, Jacobs AR, Tang J, et al. Vaccination with recombinant fusion proteins incorporating Toll-like receptor ligands induces rapid cellular and humoral immunity. Vaccine 2007; 25:763-75.
11. Song L, Nakaar V, Kavita U, et al. Efficacious recombinant influenza vaccines produced by high yield bacterial expression: a solution to global pandemic and seasonal needs. PLoS One 2008; 3:e2257.
12. Song L, Zhang Y, Yun NE, et al. Superior efficacy of a recombinant flagellin:H5N1 HA globular head vaccine is determined by the placement of the globular head within flagellin. Vaccine 2009; 27:5875-84.
13. Treanor JJ, Taylor DN, Tussey L, et al. Safety and immunogenicity of a recombinant hemagglutinin influenza-flagellin fusion vaccine (VAX125) in healthy young adults. Vaccine 2010; 28:8268-74.
14. Liu G, Tarbet B, Song L, et al. Immunogenicity and efficacy of flagellin-fused vaccine candidates targeting 2009 pandemic H1N1 influenza in mice. PLoS One 2011; 6:e20928.
15. Song L, Liu G, Umlauf S, et al. A rationally designed form of the TLR5 agonist, flagellin, supports superior immunogenicity of Influenza B globular head vaccines. Vaccine 2014; 32:4317-23.
16. Taylor DN, Treanor JJ, Strout C, et al. Induction of a potent immune response in the elderly using the TLR-5 agonist, flagellin, with a recombinant hemagglutinin influenza- flagellin fusion vaccine (VAX125, STF2.HA1 SI). Vaccine 2011; 29:4897-02.
17. Taylor DN, Treanor JJ, Sheldon EA, et al. Development of VAX128, a recombinant hemagglutinin (HA) influenza-flagellin fusion vaccine with improved safety and immune response. Vaccine 2012; 30:5761-9.
18. Mathian A, Devilliers H, Krivine A, et al. Factors influencing the efficacy of two injections of a pandemic 2009 influenza A (H1N1) nonadjuvanted vaccine in systemic lupus erythematosus. Arthritis Rheum 2011; 63:3502-11.
19. Pépin S, Donazzolo Y, Jambrecina A, et al. Safety and immunogenicity of a quadrivalent inactivated influenza vaccine in adults. Vaccine 2013; 31:5572-8.
20. Tinoco JC, Pavia-Ruz N, Cruz-Valdez A, et al. Immunogenicity, reactogenicity, and safety of inactivated quadrivalent influenza vaccine candidate versus inactivated trivalent influenza vaccine in healthy adults aged ≥18 years: a phase III, randomized trial. Vaccine 2014; 32:1480-7.