Efficacy of recombinant influenza vaccine in adults 50 years of age or older

New England Journal of Medicine

Volumn 376, Issue 25, 2017, Pages 2427-2436

  Dunkle, Lisa M ^a   Izikson, Ruvim ^a   Patriarca, Peter ^b   Goldenthal, Karen L ^c   Muse, Derek ^d   Callahan, Janice ^e   Cox, Manon M J ^a  

^a Protein Sciences Corp   (United States)

^b Biologics Consulting Group Inc   (United States)

^c Jean Brown Research ^*  (United States)

^d Jean Brown Research   (United States)

^e Callahan Associates Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

INFLUENZA VACCINE; RECOMBINANT HEMAGGLUTININ; RECOMBINANT INFLUENZA VACCINE; RECOMBINANT VACCINE; UNCLASSIFIED DRUG; INACTIVATED VACCINE;

ADULT; AGED; ARTICLE; CLINICAL ARTICLE; CONTROLLED STUDY; COUGHING; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG SAFETY; FATIGUE; FEMALE; FEVER; FOLLOW UP; HEADACHE; HOSPITALIZATION; HUMAN; INFECTION RATE; INFLUENZA; INFLUENZA LIKE ILLNESS; INJECTION SITE FIRMNESS; INJECTION SITE REACTION; INJECTION SITE REDNESS; INJECTION SITE SWELLING; INTENTION TO TREAT ANALYSIS; MALE; MIDDLE AGED; MULTICENTER STUDY; MYALGIA; NASOPHARYNGEAL SWAB; OROPHARYNX PAIN; PHARYNX EXAMINATION; PHASE 3 CLINICAL TRIAL; PHASE 4 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; SYMPTOMATOLOGY; TREATMENT DURATION; UPPER RESPIRATORY TRACT INFECTION; VACCINATION; VERY ELDERLY; VIRUS STRAIN; CLINICAL TRIAL; COMPARATIVE STUDY; IMMUNOLOGY; INFLUENZA A VIRUS; INFLUENZA A VIRUS (H3N2); INFLUENZA B VIRUS; INFLUENZA, HUMAN; ISOLATION AND PURIFICATION; NASOPHARYNX; PROPORTIONAL HAZARDS MODEL; TREATMENT OUTCOME; VIROLOGY;

AGED; AGED, 80 AND OVER; DOUBLE-BLIND METHOD; FEMALE; HUMANS; INFLUENZA A VIRUS; INFLUENZA A VIRUS, H3N2 SUBTYPE; INFLUENZA B VIRUS; INFLUENZA VACCINES; INFLUENZA, HUMAN; MALE; MIDDLE AGED; NASOPHARYNX; PROPORTIONAL HAZARDS MODELS; TREATMENT OUTCOME; VACCINES, INACTIVATED; VACCINES, SYNTHETIC;

EID: 85021091838     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa1608862     Document Type: Article

References (31)

1. Cox MMJ, Hashimoto Y. A fast track influenza virus vaccine produced in insect cells. J Invertebr Pathol 2011; 107: Suppl: S31-S41.
2. Katz JM, Webster RG. Efficacy of inactivated influenza A virus (H3N2) vaccines grown in mammalian cells or embryonated eggs. J Infect Dis 1989; 160: 191-8.
3. Wang ML, Katz JM, Webster RG. Extensive heterogeneity in the hemagglutinin of egg-grown influenza viruses from different patients. Virology 1989; 171: 275-9.
4. Rajakumar A, Swierkosz EM, Schulze IT. Sequence of an influenza virus hemag-glutinin determined directly from a clinical sample. Proc Natl Acad Sci U S A 1990; 87:4154-8.
5. 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(3): e92153.
6. Johansson BE, Cox MMJ. Influenza viral neuraminidase: the forgotten antigen. Expert Rev Vaccines 2011; 10: 1683-95.
7. Johansson BE, Matthews JT, Kilbourne ED. Supplementation of conventional influenza A vaccine with purified viral neuraminidase results in a balanced and broadened immune response. Vaccine 1998; 16:1009-15.
8. Milián E, Kamen AA. Current and emerging cell culture manufacturing technologies for influenza vaccines. Biomed Res Int 2015; 2015:504831.
9. Appiah GD, Blanton L, D'Mello T, et al. Influenza activity - United States, 2014-15 season and composition of the 2015-16 influenza vaccine. MMWR Morb Mortal Wkly Rep 2015; 64:583-90.
10. Flannery B, Clippard J. End-of-season influenza vaccine effectiveness estimates for the 2014-15 season: US Influenza Vaccine Effectiveness (Flu VE) Network. Atlanta: Advisory Committee on Immunization Practices, June 24, 2015.
11. Guidance for industry: e6 good clinical practices; consolidated guidance. Silver Spring, MD: Food and Drug Administration, 1996 (https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm073122.pdf).
12. Davidoff F, DeAngelis CD, Drazen JM, et al. Sponsorship, authorship, and accountability. N Engl J Med 2001; 345: 825-7.
13. Gerdil C. The annual production cycle for influenza vaccine. Vaccine 2003; 21: 1776-9.
14. National and regional level outpatient and virus surveillance: FluView. Atlanta: Centers for Disease Control and Prevention, 2015 (http://gis.cdc.gov/grasp/fluview/fluportaldashboard.html); Season: 2014-15; Viral Surveillance: N/A.
15. PASS 13 statistical software. Salt Lake City: NCSS, 2014.
16. Keitel WA, Treanor JJ, El Sahly HM, et al. Comparative immunogenicity of recombinant influenza hemagglutinin (rHA) and trivalent inactivated vaccine (TIV) among persons > or = 65 years old. Vaccine 2009; 28:379-85.
17. Flannery B, Thaker SN, Clippard J, et al. Interim estimates of 2013-14 seasonal influenza vaccine effectiveness - United States, February 2014. MMWR Morb Mortal Wkly Rep 2014; 63: 137-42.
18. DiazGranados CA, Dunning AJ, Kimmel M, et al. Efficacy of high-dose versus standard-dose influenza vaccine in older adults. N Engl J Med 2014; 371: 635-45.
19. Farrington CP, Manning G. Test statistics and sample size formulae for comparative binomial trials with null hypothesis of non-zero risk difference or non-unity relative risk. Stat Med 1990; 9: 1447-54.
20. Wang R, Lagakos SW, Ware JH, Hunter DJ, Drazen JM. Statistics in medicine - reporting of subgroup analyses in clinical trials. N Engl J Med 2007; 357: 2189-94.
21. Dunn OJ. Multiple comparisons among means. J Am Stat Assoc 1961; 56: 52-64.
22. Estimates of deaths associated with seasonal influenza - United States, 1976-2007. MMWR Morb Mortal Wkly Rep 2010; 59:1057-62.
23. Simonsen L, Clarke MJ, Williamson GD, Stroup DF, Arden NH, Schonberger LB. The impact of influenza epidemics on mortality: introducing a severity index. Am J Public Health 1997; 87: 1944-50.
24. Treanor JJ, El Sahly HM, King, et al. Protective efficacy of a trivalent recombinant hemagglutinin protein vaccine (Flu-Blok) against culture-confirmed influenza in healthy adults: a randomized, placebo-controlled trial. Vaccine 2011; 29: 7733-9.
25. Cox MMJ, Karl Anderson D. Production of a novel influenza vaccine using insect cells: protection against drifted strains. Influenza Other Respir Viruses 2007; 1:35-40.
26. Baxter R, Patriarca PA, Ensor K, Izikson R, Goldenthal KL, Cox MM. Evaluation of the safety, reactogenicity and immuno-genicity of FluBlok trivalent recombinant baculovirus-expressed hemagglutinin influenza vaccine administered intramuscularly to healthy adults 50-64 years of age. Vaccine 2011; 29:2272-8.
27. Safdar A, Rodriguez MA, Fayad LE, et al. Dose-related safety and immunogenicity of baculovirus-expressed trivalent influenza vaccine: a double-blind, controlled trial in adult patients with non-Hodgkin B cell lymphoma. J Infect Dis 2006; 194: 1394-7.
28. Powers DC, Smith GE, Anderson EL, et al. Influenza A virus vaccines containing purified recombinant H3 hemagglutinin are well tolerated and induce protective immune responses in healthy adults. J Infect Dis 1995; 171: 1595-9.
29. 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.
30. Nachbagauer R, Choi A, Izikson R, Cox MM, Palese P, Krammer F. Age dependence and isotype specificity of influenza virus hemagglutinin stalk-reactive antibodies in humans. MBio 2016; 7(1): e01996-15.
31. Monto AS, Petrie JG, Cross RT, et al. Antibody to influenza virus neuraminidase: an independent correlate of protection. J Infect Dis 2015; 212: 1191-9.