Noncontrolled Trial of Monovalent AS03A-Adjuvanted Vaccine for 2009 Pandemic Influenza A(H1N1) in Long-term Dialysis Patients and Transplant Recipients

ABSTRACTSince the first reports of the A/H1N1 virus in April 2009, the pandemic influenza virus spread globally and circulated for a long time. The primary method for the control of influenza is vaccination, but levels of influenza vaccine-induced antibody are known to decline rapidly during a 6-month period. In adults aged 18 to 64 years, we compared the long-term immunogenicity of two of the influenza A/H1N1 2009 monovalent vaccines, 3.75-μg MF59-adjuvanted vaccine and 15-μg unadjuvanted vaccine. The serum hemagglutinin inhibition (HI) titers were determined prevaccination and at 1, 6, and 10 months after vaccination. One hundred six (88.3%) of the 120 subjects were monitored for the entire 10-month period after receiving the influenza A/H1N1 2009 monovalent vaccine. There were 60 patients who received the unadjuvanted vaccine and 46 patients who received the MF59-adjuvanted vaccine. The seroprotection rates, seroconversion rates, and the geometric mean titer (GMT) folds fulfilled the criteria of the European Medicines Agency (EMA) for influenza A/California/7/2009 (H1N1) at 1 month after vaccination irrespective of the vaccine composition. Although the GMTs at 1 month postvaccination were somewhat higher in the unadjuvanted vaccine recipients than in the MF59-adjuvanted vaccine recipients, the difference was not significant (P= 0.29). The seroprotection rates at 6 and 10 months postvaccination were preserved above 70% but only in the MF59-adjuvanted vaccine recipients. In conclusion, low-dose MF59-adjuvanted influenza vaccine, even with 3.75 μg hemagglutinin antigen, might induce excellent long-term immunity that is comparable to the conventional dose of unadjuvanted vaccine among healthy adults aged 18 to 64 years.

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The Impact of Pandemic Influenza A H1N1 2009 on Australian Lung Transplant Recipients

American Journal of Transplantation ◽

10.1111/j.1600-6143.2010.03422.x ◽

2011 ◽

Vol 11 (3) ◽

pp. 568-574 ◽

Cited By ~ 35

Author(s):

B. J. H. Ng ◽

A. R. Glanville ◽

G. Snell ◽

M. Musk ◽

M. Holmes ◽

...

Keyword(s):

Pandemic Influenza ◽

Influenza A ◽

Lung Transplant ◽

Transplant Recipients ◽

Influenza A H1n1 ◽

Lung Transplant Recipients ◽

The Impact

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Immunogenicity and Efficacy in Hemodialysis Patients of an AS03A-Adjuvanted Vaccine for 2009 Pandemic Influenza A(H1N1): A Nonrandomized Trial

American Journal of Kidney Diseases ◽

10.1053/j.ajkd.2010.11.031 ◽

2011 ◽

Vol 57 (5) ◽

pp. 716-723 ◽

Cited By ~ 26

Author(s):

Ralf Dikow ◽

Isabella Eckerle ◽

Dorothea Ksoll-Rudek ◽

Heidrun Hampel ◽

Vedat Schwenger ◽

...

Keyword(s):

Pandemic Influenza ◽

Influenza A ◽

Hemodialysis Patients ◽

Adjuvanted Vaccine ◽

Influenza A H1n1 ◽

Nonrandomized Trial

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Long-Term Immunogenicity of an Inactivated Split-Virion 2009 Pandemic Influenza A H1N1 Virus Vaccine with or without Aluminum Adjuvant in Mice

Clinical and Vaccine Immunology ◽

10.1128/cvi.00662-14 ◽

2015 ◽

Vol 22 (3) ◽

pp. 327-335 ◽

Cited By ~ 5

Author(s):

Wenting Xu ◽

Mei Zheng ◽

Feng Zhou ◽

Ze Chen

Keyword(s):

Pandemic Influenza ◽

Influenza A ◽

H1n1 Virus ◽

Effective Means ◽

Lethal Dose ◽

Igg Antibody ◽

H1n1 Vaccine ◽

Influenza A H1n1 ◽

Homologous Virus

ABSTRACTIn 2009, a global epidemic of influenza A(H1N1) virus caused the death of tens of thousands of people. Vaccination is the most effective means of controlling an epidemic of influenza and reducing the mortality rate. In this study, the long-term immunogenicity of influenza A/California/7/2009 (H1N1) split vaccine was observed as long as 15 months (450 days) after immunization in a mouse model. Female BALB/c mice were immunized intraperitoneally with different doses of aluminum-adjuvanted vaccine. The mice were challenged with a lethal dose (10× 50% lethal dose [LD50]) of homologous virus 450 days after immunization. The results showed that the supplemented aluminum adjuvant not only effectively enhanced the protective effect of the vaccine but also reduced the immunizing dose of the vaccine. In addition, the aluminum adjuvant enhanced the IgG antibody level of mice immunized with the H1N1 split vaccine. The IgG level was correlated to the survival rate of the mice. Aluminum-adjuvanted inactivated split-virion 2009 pandemic influenza A H1N1 vaccine has good immunogenicity and provided long-term protection against lethal influenza virus challenge in mice.

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