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Pre-vaccination immunity and immune responses to a cell culture-derived whole-virus H1N1 vaccine are similar to a seasonal influenza vaccine.
Vaccine 2012; 30(30):4543-51V

Abstract

BACKGROUND

Immune responses to novel pandemic influenza vaccines may be influenced by previous exposure to antigenically similar seasonal strains.

METHODS

An open-label, randomized, phase I/II study was conducted to assess the immunogenicity and safety of a non-adjuvanted, inactivated whole-virus H1N1 A/California/07/2009 vaccine. 408 subjects were stratified by age (18-59 and >60 years) and randomized 1:1 to receive two vaccinations with either 3.75 or 7.5 μg hemagglutinin antigen 21 days apart. Safety, immunogenicity and the influence of seasonal influenza vaccination and antibody cross-reactivity with a seasonal H1N1 strain was assessed.

RESULTS

A single vaccination with either dose induced substantial increases in H1N1 A/California/07/2009 hemagglutination inhibition (HI) and neutralizing (MN) antibody titers in both adult and elderly subjects. A single 7.5 μg dose induced seroprotection rates of 86.9% in adults and 75.2% in elderly subjects. Two 7.5 μg vaccinations induced seroprotection rates in adult and elderly subjects of 90.9% and 89.1%, respectively. The robust immune response to vaccination was confirmed by analyses of neutralizing antibody titers. Both HI and MN antibodies persisted for ≥ 6 months post-vaccination. Between 34% and 49% of subjects had seroprotective levels of H1N1 A/California/07/2009 antibodies at baseline. Higher baseline HI titers were associated with receipt of the 2008-09 or 2009-10 seasonal influenza vaccine. High baseline A/California/07/2009 neutralizing antibody titers were also associated with high baseline titers against A/New Caledonia/20/99, a seasonal H1N1 strain which circulated and was included in the seasonal vaccine from 2000-01 to 2006-07. Pre-adsorption with A/H1N1/New Caledonia/20/99 antigen reduced A/H1N1/California/07/2009 baseline titers in 55% of tested sera. The vaccine was well tolerated with low rates of fever.

CONCLUSIONS

A whole-virus H1N1 A/California/07/2009 vaccine was safe and well tolerated and a single dose induced substantial immune responses similar to seasonal influenza vaccines, probably due to immunological priming by previous seasonal influenza vaccines or infections.

Authors+Show Affiliations

Global R&D, Baxter BioScience, Vienna, Austria. hartmut ehrlich@baxter.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22475864

Citation

Ehrlich, Hartmut J., et al. "Pre-vaccination Immunity and Immune Responses to a Cell Culture-derived Whole-virus H1N1 Vaccine Are Similar to a Seasonal Influenza Vaccine." Vaccine, vol. 30, no. 30, 2012, pp. 4543-51.
Ehrlich HJ, Müller M, Kollaritsch H, et al. Pre-vaccination immunity and immune responses to a cell culture-derived whole-virus H1N1 vaccine are similar to a seasonal influenza vaccine. Vaccine. 2012;30(30):4543-51.
Ehrlich, H. J., Müller, M., Kollaritsch, H., Pinl, F., Schmitt, B., Zeitlinger, M., ... Barrett, P. N. (2012). Pre-vaccination immunity and immune responses to a cell culture-derived whole-virus H1N1 vaccine are similar to a seasonal influenza vaccine. Vaccine, 30(30), pp. 4543-51. doi:10.1016/j.vaccine.2012.03.061.
Ehrlich HJ, et al. Pre-vaccination Immunity and Immune Responses to a Cell Culture-derived Whole-virus H1N1 Vaccine Are Similar to a Seasonal Influenza Vaccine. Vaccine. 2012 Jun 22;30(30):4543-51. PubMed PMID: 22475864.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Pre-vaccination immunity and immune responses to a cell culture-derived whole-virus H1N1 vaccine are similar to a seasonal influenza vaccine. AU - Ehrlich,Hartmut J, AU - Müller,Markus, AU - Kollaritsch,Herwig, AU - Pinl,Fritz, AU - Schmitt,Bernhard, AU - Zeitlinger,Markus, AU - Loew-Baselli,Alexandra, AU - Kreil,Thomas R, AU - Kistner,Otfried, AU - Portsmouth,Daniel, AU - Fritsch,Sandor, AU - Maritsch,Friedrich, AU - Aichinger,Gerald, AU - Pavlova,Borislava G, AU - Barrett,P Noel, Y1 - 2012/04/01/ PY - 2011/12/12/received PY - 2012/02/22/revised PY - 2012/03/20/accepted PY - 2012/4/6/entrez PY - 2012/4/6/pubmed PY - 2012/10/19/medline SP - 4543 EP - 51 JF - Vaccine JO - Vaccine VL - 30 IS - 30 N2 - BACKGROUND: Immune responses to novel pandemic influenza vaccines may be influenced by previous exposure to antigenically similar seasonal strains. METHODS: An open-label, randomized, phase I/II study was conducted to assess the immunogenicity and safety of a non-adjuvanted, inactivated whole-virus H1N1 A/California/07/2009 vaccine. 408 subjects were stratified by age (18-59 and >60 years) and randomized 1:1 to receive two vaccinations with either 3.75 or 7.5 μg hemagglutinin antigen 21 days apart. Safety, immunogenicity and the influence of seasonal influenza vaccination and antibody cross-reactivity with a seasonal H1N1 strain was assessed. RESULTS: A single vaccination with either dose induced substantial increases in H1N1 A/California/07/2009 hemagglutination inhibition (HI) and neutralizing (MN) antibody titers in both adult and elderly subjects. A single 7.5 μg dose induced seroprotection rates of 86.9% in adults and 75.2% in elderly subjects. Two 7.5 μg vaccinations induced seroprotection rates in adult and elderly subjects of 90.9% and 89.1%, respectively. The robust immune response to vaccination was confirmed by analyses of neutralizing antibody titers. Both HI and MN antibodies persisted for ≥ 6 months post-vaccination. Between 34% and 49% of subjects had seroprotective levels of H1N1 A/California/07/2009 antibodies at baseline. Higher baseline HI titers were associated with receipt of the 2008-09 or 2009-10 seasonal influenza vaccine. High baseline A/California/07/2009 neutralizing antibody titers were also associated with high baseline titers against A/New Caledonia/20/99, a seasonal H1N1 strain which circulated and was included in the seasonal vaccine from 2000-01 to 2006-07. Pre-adsorption with A/H1N1/New Caledonia/20/99 antigen reduced A/H1N1/California/07/2009 baseline titers in 55% of tested sera. The vaccine was well tolerated with low rates of fever. CONCLUSIONS: A whole-virus H1N1 A/California/07/2009 vaccine was safe and well tolerated and a single dose induced substantial immune responses similar to seasonal influenza vaccines, probably due to immunological priming by previous seasonal influenza vaccines or infections. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/22475864/Pre_vaccination_immunity_and_immune_responses_to_a_cell_culture_derived_whole_virus_H1N1_vaccine_are_similar_to_a_seasonal_influenza_vaccine_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(12)00453-7 DB - PRIME DP - Unbound Medicine ER -