Giuseppe
Emeritus
[Source: PLoS ONE, full text: (LINK). Abstract, edited.]
Immunogenicity and Tolerability after Two Doses of Non-Adjuvanted, Whole-Virion Pandemic Influenza A (H1N1) Vaccine in HIV-Infected Individuals
Heimo Lagler<SUP>1</SUP>, Katharina Grabmeier-Pfistershammer<SUP>2</SUP>, Veronique Touzeau-R?mer<SUP>2</SUP>, Selma Tobudic<SUP>1</SUP>, Michael Ramharter<SUP>1</SUP><SUP>,</SUP><SUP>3</SUP>, Judith Wenisch<SUP>1</SUP>, Guido Andr?s Gualdoni<SUP>1</SUP>, Monika Redlberger-Fritz<SUP>4</SUP>, Theresia Popow-Kraupp<SUP>4</SUP>, Armin Rieger<SUP>2</SUP>, Heinz Burgmann<SUP>1</SUP><SUP>*</SUP>
1 Department of Medicine I, Division of Infectious Diseases and Tropical Medicine, Medical University of Vienna, Vienna, Austria, 2 Department of Dermatology, Division of Immunology, Allergy and Infectious Diseases, Medical University of Vienna, Vienna, Austria, 3 Department of Tropical Medicine, University of T?bingen, T?bingen, Germany, 4 Department of Virology, Medical University of Vienna, Vienna, Austria
Abstract
Background
During the influenza pandemic of 2009/10, the whole-virion, Vero-cell-derived, inactivated, pandemic influenza A (H1N1) vaccine Celvapan? (Baxter) was used in Austria. Celvapan? is adjuvant-free and was the only such vaccine at that time in Europe. The objective of this observational, non-interventional, prospective single-center study was to evaluate the immunogenicity and tolerability of two intramuscular doses of this novel vaccine in HIV-positive individuals.
Methods and Findings
A standard hemagglutination inhibition (HAI) assay was used for evaluation of the seroconversion rate and seroprotection against the pandemic H1N1 strain. In addition, H1N1-specific IgG antibodies were measured using a recently developed ELISA and compared with the HAI results. Tolerability of vaccination was evaluated up to one month after the second dose. A total of 79 HIV-infected adults with an indication for H1N1 vaccination were evaluated. At baseline, 55 of the 79 participants had an HAI titer ≥1:40 and two patients showed a positive IgG ELISA. The seroconversion rate was 31% after the first vaccination, increasing to 41% after the second; the corresponding seroprotection rates were 92% and 83% respectively. ELISA IgG levels were positive in 25% after the first vaccination and in 37% after the second. Among the participants with baseline HAI titers <1:40, 63% seroconverted. Young age was clearly associated with lower HAI titers at baseline and with higher seroconversion rates, whereas none of the seven patients >60 years of age had a baseline HAI titer <1:40 or seroconverted after vaccination. The vaccine was well tolerated.
Conclusion
The non-adjuvanted pandemic influenza A (H1N1) vaccine was well tolerated and induced a measurable immune response in a sample of HIV-infected individuals.
Citation: Lagler H, Grabmeier-Pfistershammer K, Touzeau-R?mer V, Tobudic S, Ramharter M, et al. (2012) Immunogenicity and Tolerability after Two Doses of Non-Adjuvanted, Whole-Virion Pandemic Influenza A (H1N1) Vaccine in HIV-Infected Individuals. PLoS ONE 7(5): e36773. doi:10.1371/journal.pone.0036773
Editor: John E. Tavis, Saint Louis University, United States of America
Received: November 27, 2011; Accepted: April 5, 2012; Published: May 21, 2012
Copyright: ? 2012 Lagler et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Funding: The authors have no support or funding to report.
Competing interests: The authors have declared that no competing interests exist.
* E-mail: heinz.burgmann@meduniwien.ac.at
- ------Heimo Lagler<SUP>1</SUP>, Katharina Grabmeier-Pfistershammer<SUP>2</SUP>, Veronique Touzeau-R?mer<SUP>2</SUP>, Selma Tobudic<SUP>1</SUP>, Michael Ramharter<SUP>1</SUP><SUP>,</SUP><SUP>3</SUP>, Judith Wenisch<SUP>1</SUP>, Guido Andr?s Gualdoni<SUP>1</SUP>, Monika Redlberger-Fritz<SUP>4</SUP>, Theresia Popow-Kraupp<SUP>4</SUP>, Armin Rieger<SUP>2</SUP>, Heinz Burgmann<SUP>1</SUP><SUP>*</SUP>
1 Department of Medicine I, Division of Infectious Diseases and Tropical Medicine, Medical University of Vienna, Vienna, Austria, 2 Department of Dermatology, Division of Immunology, Allergy and Infectious Diseases, Medical University of Vienna, Vienna, Austria, 3 Department of Tropical Medicine, University of T?bingen, T?bingen, Germany, 4 Department of Virology, Medical University of Vienna, Vienna, Austria
Abstract
Background
During the influenza pandemic of 2009/10, the whole-virion, Vero-cell-derived, inactivated, pandemic influenza A (H1N1) vaccine Celvapan? (Baxter) was used in Austria. Celvapan? is adjuvant-free and was the only such vaccine at that time in Europe. The objective of this observational, non-interventional, prospective single-center study was to evaluate the immunogenicity and tolerability of two intramuscular doses of this novel vaccine in HIV-positive individuals.
Methods and Findings
A standard hemagglutination inhibition (HAI) assay was used for evaluation of the seroconversion rate and seroprotection against the pandemic H1N1 strain. In addition, H1N1-specific IgG antibodies were measured using a recently developed ELISA and compared with the HAI results. Tolerability of vaccination was evaluated up to one month after the second dose. A total of 79 HIV-infected adults with an indication for H1N1 vaccination were evaluated. At baseline, 55 of the 79 participants had an HAI titer ≥1:40 and two patients showed a positive IgG ELISA. The seroconversion rate was 31% after the first vaccination, increasing to 41% after the second; the corresponding seroprotection rates were 92% and 83% respectively. ELISA IgG levels were positive in 25% after the first vaccination and in 37% after the second. Among the participants with baseline HAI titers <1:40, 63% seroconverted. Young age was clearly associated with lower HAI titers at baseline and with higher seroconversion rates, whereas none of the seven patients >60 years of age had a baseline HAI titer <1:40 or seroconverted after vaccination. The vaccine was well tolerated.
Conclusion
The non-adjuvanted pandemic influenza A (H1N1) vaccine was well tolerated and induced a measurable immune response in a sample of HIV-infected individuals.
Citation: Lagler H, Grabmeier-Pfistershammer K, Touzeau-R?mer V, Tobudic S, Ramharter M, et al. (2012) Immunogenicity and Tolerability after Two Doses of Non-Adjuvanted, Whole-Virion Pandemic Influenza A (H1N1) Vaccine in HIV-Infected Individuals. PLoS ONE 7(5): e36773. doi:10.1371/journal.pone.0036773
Editor: John E. Tavis, Saint Louis University, United States of America
Received: November 27, 2011; Accepted: April 5, 2012; Published: May 21, 2012
Copyright: ? 2012 Lagler et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Funding: The authors have no support or funding to report.
Competing interests: The authors have declared that no competing interests exist.
* E-mail: heinz.burgmann@meduniwien.ac.at