A Cell Culture-derived Influenza Vaccine Provides Consistent Protection Against Infection and Reduces the Duration and Severity of Disease in Infected Individuals

Overview

Journal Clin Infect Dis

Publisher Oxford University Press

Specialty Infectious Diseases

Date 2012 Jan 24

PMID 22267715

Citations 16

Authors

Hartmut J Ehrlich

Julia Singer

Gregory Berezuk

Sandor Fritsch

Gerald Aichinger

Mary Kate Hart

Wael El-Amin

Daniel Portsmouth

Otfried Kistner

P Noel Barrett

Affiliations

Soon will be listed here.

Abstract

Background: Current knowledge of the consistency of protection induced by seasonal influenza vaccines over the duration of a full influenza season is limited, and little is known about the clinical course of disease in individuals who become infected despite vaccination.

Methods: Data from a randomized double-blind placebo-controlled clinical trial undertaken in healthy young adults in the 2008-2009 influenza season were used to investigate the weekly cumulative efficacy of a Vero cell culture-derived influenza vaccine. In addition, the duration and severity of disease in vaccine and placebo recipients with cell culture-confirmed influenza infection were compared.

Results: Vaccine efficacy against matching strains was consistently high (73%-82%) throughout the study, including the entire period of the influenza season during which influenza activity was above the epidemic threshold. Vaccine efficacy was also consistent (68%-83%) when calculated for all strains, irrespective of antigenic match. Vaccination also ameliorated disease symptoms when infection was not prevented. Bivariate analysis of duration and severity showed a significant amelioration of myalgia (P = .003), headache (P = .025), and fatigue (P = .013) in infected vaccinated subjects compared with placebo. Cough (P = .143) and oropharyngeal pain (P = .083) were also reduced in infected vaccinated subjects.

Conclusions: A Vero cell culture-derived influenza vaccine provides consistently high levels of protection against cell culture-confirmed infection by seasonal influenza virus and significantly reduces the duration and severity of disease in those individuals in which infection is not prevented.

Clinical Trials Registration: ClinicalTrials.gov NCT00566345.

Citing Articles

The respiratory syncytial virus prefusion F protein vaccine attenuates the severity of respiratory syncytial virus-associated disease in breakthrough infections in adults ≥60 years of age.

Curran D, Matthews S, Cabrera E, Perez S, Breva L, Ramet M Influenza Other Respir Viruses. 2024; 18(2):e13236.

PMID: 38314063 PMC: 10837780. DOI: 10.1111/irv.13236.

Patient-reported outcomes in vaccines research: relevance for decision-making.

Curran D, Cabrera E, Nelsen L Hum Vaccin Immunother. 2021; 18(1):1-8.

PMID: 33606595 PMC: 8920246. DOI: 10.1080/21645515.2021.1875762.

Burden-of-illness vaccine efficacy.

Callegaro A, Curran D, Matthews S Pharm Stat. 2020; 19(5):636-645.

PMID: 32220002 PMC: 9291914. DOI: 10.1002/pst.2020.

Quality of Life Impact of an Adjuvanted Recombinant Zoster Vaccine in Adults Aged 50 Years and Older.

Curran D, Oostvogels L, Heineman T, Matthews S, McElhaney J, McNeil S J Gerontol A Biol Sci Med Sci. 2018; 74(8):1231-1238.

PMID: 29955836 PMC: 6625590. DOI: 10.1093/gerona/gly150.

Recurrence of pericarditis after influenza vaccination: a case report and review of the literature.

Mei R, Raschi E, Poluzzi E, Diemberger I, De Ponti F BMC Pharmacol Toxicol. 2018; 19(1):20.

PMID: 29728118 PMC: 5935955. DOI: 10.1186/s40360-018-0211-8.

References

Beran J, Wertzova V, Honegr K, Kaliskova E, Havlickova M, Havlik J . Challenge of conducting a placebo-controlled randomized efficacy study for influenza vaccine in a season with low attack rate and a mismatched vaccine B strain: a concrete example. BMC Infect Dis. 2009; 9:2. PMC: 2639595. DOI: 10.1186/1471-2334-9-2. View

Ambrose C, Wu X, Belshe R . The efficacy of live attenuated and inactivated influenza vaccines in children as a function of time postvaccination. Pediatr Infect Dis J. 2010; 29(9):806-11. DOI: 10.1097/INF.0b013e3181e2872f. View

Kamada M, Nagai T, Kumagai T, Igarashi M, Ihara T, Okafuji T . Efficacy of inactivated trivalent influenza vaccine in alleviating the febrile illness of culture-confirmed influenza in children in the 2000-2001 influenza season. Vaccine. 2006; 24(17):3618-23. DOI: 10.1016/j.vaccine.2006.01.067. View

Monto A, Ohmit S, Petrie J, Johnson E, Truscon R, Teich E . Comparative efficacy of inactivated and live attenuated influenza vaccines. N Engl J Med. 2009; 361(13):1260-7. DOI: 10.1056/NEJMoa0808652. View

Jefferson T, Di Pietrantonj C, Rivetti A, Bawazeer G, Al-Ansary L, Ferroni E . Vaccines for preventing influenza in healthy adults. Cochrane Database Syst Rev. 2010; (7):CD001269. DOI: 10.1002/14651858.CD001269.pub4. View

Yang C, Belshe R, Kemble G, Song E, Ye D, Liang B . Genetic sequence analysis of influenza viruses and illness severity in ill children previously vaccinated with live attenuated or inactivated influenza vaccine. Vaccine. 2010; 28(31):5128-34. DOI: 10.1016/j.vaccine.2010.02.109. View

Fiore A, Uyeki T, Broder K, Finelli L, Euler G, Singleton J . Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP), 2010. MMWR Recomm Rep. 2010; 59(RR-8):1-62. View

Osterholm M, Kelley N, Sommer A, Belongia E . Efficacy and effectiveness of influenza vaccines: a systematic review and meta-analysis. Lancet Infect Dis. 2011; 12(1):36-44. DOI: 10.1016/S1473-3099(11)70295-X. View

Foy H, COONEY M, McMahan R, Bor E, GRAYSTON J . Single-dose monovalent A 2 -Hong Kong influenza vaccine. Efficacy 14 months after immunization. JAMA. 1971; 217(8):1067-71. View

10.

Jackson L, Gaglani M, Keyserling H, Balser J, Bouveret N, Fries L . Safety, efficacy, and immunogenicity of an inactivated influenza vaccine in healthy adults: a randomized, placebo-controlled trial over two influenza seasons. BMC Infect Dis. 2010; 10:71. PMC: 2845585. DOI: 10.1186/1471-2334-10-71. View

11.

Belshe R, Mendelman P, Treanor J, King J, Gruber W, Piedra P . The efficacy of live attenuated, cold-adapted, trivalent, intranasal influenzavirus vaccine in children. N Engl J Med. 1998; 338(20):1405-12. DOI: 10.1056/NEJM199805143382002. View

12.

Nichol K, Lind A, Margolis K, Murdoch M, McFadden R, Hauge M . The effectiveness of vaccination against influenza in healthy, working adults. N Engl J Med. 1995; 333(14):889-93. DOI: 10.1056/NEJM199510053331401. View

13.

Clark A, POTTER C, Jennings R, Nicholl J, Langrick A, Schild G . A comparison of live and inactivated influenza A (H1N1) virus vaccines. 2. Long-term immunity. J Hyg (Lond). 1983; 90(3):361-70. PMC: 2134281. DOI: 10.1017/s0022172400028990. View

14.

Foy H, COONEY M, McMahan R . A Hong Kong influenza immunity three years after immunization. JAMA. 1973; 226(7):758-61. View

15.

Barrett P, Mundt W, Kistner O, Howard M . Vero cell platform in vaccine production: moving towards cell culture-based viral vaccines. Expert Rev Vaccines. 2009; 8(5):607-18. DOI: 10.1586/erv.09.19. View

16.

Nichol K . Heterogeneity of influenza case definitions and implications for interpreting and comparing study results. Vaccine. 2006; 24(44-46):6726-8. DOI: 10.1016/j.vaccine.2006.05.064. View

17.

Ohmit S, Victor J, Teich E, Truscon R, Rotthoff J, Newton D . Prevention of symptomatic seasonal influenza in 2005-2006 by inactivated and live attenuated vaccines. J Infect Dis. 2008; 198(3):312-7. PMC: 2613648. DOI: 10.1086/589885. View

18.

Glezen W . Cell-culture-derived influenza vaccine production. Lancet. 2011; 377(9767):698-700. DOI: 10.1016/S0140-6736(11)60174-8. View

19.

Miettinen O, Nurminen M . Comparative analysis of two rates. Stat Med. 1985; 4(2):213-26. DOI: 10.1002/sim.4780040211. View

20.

Forrest B, Steele A, Hiemstra L, Rappaport R, Ambrose C, Gruber W . A prospective, randomized, open-label trial comparing the safety and efficacy of trivalent live attenuated and inactivated influenza vaccines in adults 60 years of age and older. Vaccine. 2011; 29(20):3633-9. DOI: 10.1016/j.vaccine.2011.03.029. View