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Vaccine
Available online 27 July 2012
In Press, Uncorrected Proof ? Note to users
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A non-adjuvanted whole-virus H1N1 pandemic vaccine is well tolerated and highly immunogenic in children and adolescents and induces substantial immunological memory
Alexandra Loew-Basellia,
Borislava G. Pavlovaa,
Sandor Fritscha,
Eva Maria Poellabauera,
Wolfgang Draxlera,
Otfried. Kistnerb,
Ulrich Behrec,
Rudolf Angermayrd,
Johannes Neugebauere,
Karola Kirstenf,
Elisabeth F?rster-Waldlg,
Ralph Koellgesh,
Hartmut J. Ehrlicha, Corresponding author contact information, E-mail the corresponding author,
P. Noel Barrettb
a Global R&D, Baxter BioScience, Vienna, Austria
b Vaccine Research & Development, Baxter BioScience, Orth/Donau, Austria
c Pediatric Practice, Hauptstrasse 240, 77694 Kehl, Germany
d Pediatric Practice, Grieskirchner Strasse 17, 4600 Wels, Austria
e Pediatric Practice, Unterer Graben 2, 4070 Eferding, Austria
f Pediatric Practice, Rheinstra?e 13, 77955 Ettenheim, Germany
g Department of Paediatrics & Adolescent Medicine, Medical University of Vienna, W?hringer G?rtel 18-20, 1090 Wien, Austria
h Pediatric Practice, Moses-Stern-Str. 28, 41236 M?nchengladbach, Germany
Received 23 April 2012. Revised 27 June 2012. Accepted 17 July 2012. Available online 27 July 2012.
http://dx.doi.org/10.1016/j.vaccine.2012.07.039, How to Cite or Link Using DOI
Abstract
This phase 1/2 open-label, randomized clinical study investigated the safety and immunogenicity of a non-adjuvanted, whole virus, Vero cell-derived H1N1 pandemic influenza vaccine (A/H1N1/California/07/2009) in children and adolescents (6 months to 17 years). Subjects were stratified by age (6?11 months, 12?35 months, 3?8 years, 9?17 years) to receive two vaccinations 21 days apart of either the 3.75 μg or 7.5 μg dose. A booster with a licensed trivalent seasonal (2010/2011) influenza vaccine was administered one year after the first vaccination to a subgroup that had previously received the 7.5 μg dose.
A single vaccination with the 7.5 μg dose induced high seroprotection rates in all subjects, namely: 88.0% (9?17 years); 68.0% (3?8 years); 42.9% (12?35 months); and 50.0% (6?11 months). Following a second vaccination, seroprotection rates ranged from 84.2% to 100%. GMTs after two vaccinations with the 7.5 μg dose (as determined by HI) were also substantial: reaching 210.0 (9?17 years), 196.2 (3?8 years), 118.9 (12?35 months) and 99.6 (6?11 months). Antibody persistence was demonstrated at 6 months (GMTs ranging from 65.6 to 212.8 with the 7.5 μg dose) and at 12 months (GMTs ranging from 33.6 to 124.1 with the 7.5 μg dose) after primary vaccination. The booster vaccination induced a strong response to the A/California/07/2009 strain, reaching 100% seroprotection in all age groups, with GMTs ranging from 640.0 to 886.3.
The vaccine was well tolerated, inducing low adverse reaction rates (overall fever rate: 6% after the first vaccination; 7% after the second vaccination), even in young children. These data confirm that the H1N1 whole-virus Vero cell-derived pandemic influenza vaccine is suitable for use in children and adolescents; a 2-dose primary vaccination induces a memory response in a na?ve population that can be effectively boosted with the A/H1N1/California/07/2009 component of a seasonal influenza vaccine. ClinicalTrials.gov Identifier: NCT00976469.
Highlights
► Vero cell-derived whole-virus H1N1 vaccine was well tolerated, inducing low adverse reaction rates (overall fever rate: 6% after the first vaccination; 7% after the second vaccination) in children and adolescents. ► Two vaccinations with the 7.5 μg dose induced high seroprotection rates in all subjects ranging from 84.2% to 100%. ► Persistence of antibodies against the vaccine strain was demonstrated at 6 months (GMTs ranging from 65.6 to 212.8) and at 12 months (GMTs ranging from 33.6 to 124.1) after primary vaccination. ► Vaccination with a seasonal influenza vaccine induced a strong booster response to the A/California/07/2009 strain reaching 100% seroprotection in all age groups, with GMTs ranging from 640.0 to 886.3.
Available online 27 July 2012
In Press, Uncorrected Proof ? Note to users
Cover image
A non-adjuvanted whole-virus H1N1 pandemic vaccine is well tolerated and highly immunogenic in children and adolescents and induces substantial immunological memory
Alexandra Loew-Basellia,
Borislava G. Pavlovaa,
Sandor Fritscha,
Eva Maria Poellabauera,
Wolfgang Draxlera,
Otfried. Kistnerb,
Ulrich Behrec,
Rudolf Angermayrd,
Johannes Neugebauere,
Karola Kirstenf,
Elisabeth F?rster-Waldlg,
Ralph Koellgesh,
Hartmut J. Ehrlicha, Corresponding author contact information, E-mail the corresponding author,
P. Noel Barrettb
a Global R&D, Baxter BioScience, Vienna, Austria
b Vaccine Research & Development, Baxter BioScience, Orth/Donau, Austria
c Pediatric Practice, Hauptstrasse 240, 77694 Kehl, Germany
d Pediatric Practice, Grieskirchner Strasse 17, 4600 Wels, Austria
e Pediatric Practice, Unterer Graben 2, 4070 Eferding, Austria
f Pediatric Practice, Rheinstra?e 13, 77955 Ettenheim, Germany
g Department of Paediatrics & Adolescent Medicine, Medical University of Vienna, W?hringer G?rtel 18-20, 1090 Wien, Austria
h Pediatric Practice, Moses-Stern-Str. 28, 41236 M?nchengladbach, Germany
Received 23 April 2012. Revised 27 June 2012. Accepted 17 July 2012. Available online 27 July 2012.
http://dx.doi.org/10.1016/j.vaccine.2012.07.039, How to Cite or Link Using DOI
Abstract
This phase 1/2 open-label, randomized clinical study investigated the safety and immunogenicity of a non-adjuvanted, whole virus, Vero cell-derived H1N1 pandemic influenza vaccine (A/H1N1/California/07/2009) in children and adolescents (6 months to 17 years). Subjects were stratified by age (6?11 months, 12?35 months, 3?8 years, 9?17 years) to receive two vaccinations 21 days apart of either the 3.75 μg or 7.5 μg dose. A booster with a licensed trivalent seasonal (2010/2011) influenza vaccine was administered one year after the first vaccination to a subgroup that had previously received the 7.5 μg dose.
A single vaccination with the 7.5 μg dose induced high seroprotection rates in all subjects, namely: 88.0% (9?17 years); 68.0% (3?8 years); 42.9% (12?35 months); and 50.0% (6?11 months). Following a second vaccination, seroprotection rates ranged from 84.2% to 100%. GMTs after two vaccinations with the 7.5 μg dose (as determined by HI) were also substantial: reaching 210.0 (9?17 years), 196.2 (3?8 years), 118.9 (12?35 months) and 99.6 (6?11 months). Antibody persistence was demonstrated at 6 months (GMTs ranging from 65.6 to 212.8 with the 7.5 μg dose) and at 12 months (GMTs ranging from 33.6 to 124.1 with the 7.5 μg dose) after primary vaccination. The booster vaccination induced a strong response to the A/California/07/2009 strain, reaching 100% seroprotection in all age groups, with GMTs ranging from 640.0 to 886.3.
The vaccine was well tolerated, inducing low adverse reaction rates (overall fever rate: 6% after the first vaccination; 7% after the second vaccination), even in young children. These data confirm that the H1N1 whole-virus Vero cell-derived pandemic influenza vaccine is suitable for use in children and adolescents; a 2-dose primary vaccination induces a memory response in a na?ve population that can be effectively boosted with the A/H1N1/California/07/2009 component of a seasonal influenza vaccine. ClinicalTrials.gov Identifier: NCT00976469.
Highlights
► Vero cell-derived whole-virus H1N1 vaccine was well tolerated, inducing low adverse reaction rates (overall fever rate: 6% after the first vaccination; 7% after the second vaccination) in children and adolescents. ► Two vaccinations with the 7.5 μg dose induced high seroprotection rates in all subjects ranging from 84.2% to 100%. ► Persistence of antibodies against the vaccine strain was demonstrated at 6 months (GMTs ranging from 65.6 to 212.8) and at 12 months (GMTs ranging from 33.6 to 124.1) after primary vaccination. ► Vaccination with a seasonal influenza vaccine induced a strong booster response to the A/California/07/2009 strain reaching 100% seroprotection in all age groups, with GMTs ranging from 640.0 to 886.3.
