Cargando…
Comparison of long-term immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine in healthy women aged 18-45 years: End-of-study analysis of a Phase III randomized trial
The observer-blind, randomized, age-stratified, head-to-head study (NCT00423046) comparing immunogenicity and safety of HPV-16/18 and HPV-6/11/16/18 vaccines in healthy women aged 18-45 y was completed. Five y after vaccination, in subjects from the Month 60 according-to-protocol cohort (seronegativ...
Autores principales: | , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Taylor & Francis
2014
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4514070/ https://www.ncbi.nlm.nih.gov/pubmed/25483701 http://dx.doi.org/10.4161/hv.36121 |
_version_ | 1782382736195977216 |
---|---|
author | Einstein, Mark H Takacs, Peter Chatterjee, Archana Sperling, Rhoda S Chakhtoura, Nahida Blatter, Mark M Lalezari, Jacob David, Marie-Pierre Lin, Lan Struyf, Frank Dubin, Gary |
author_facet | Einstein, Mark H Takacs, Peter Chatterjee, Archana Sperling, Rhoda S Chakhtoura, Nahida Blatter, Mark M Lalezari, Jacob David, Marie-Pierre Lin, Lan Struyf, Frank Dubin, Gary |
author_sort | Einstein, Mark H |
collection | PubMed |
description | The observer-blind, randomized, age-stratified, head-to-head study (NCT00423046) comparing immunogenicity and safety of HPV-16/18 and HPV-6/11/16/18 vaccines in healthy women aged 18-45 y was completed. Five y after vaccination, in subjects from the Month 60 according-to-protocol cohort (seronegative and DNA negative for HPV type analyzed at baseline), serum neutralizing antibody (nAb) responses induced by HPV-16/18 vaccine remained 7.8-fold (18-26-y stratum), 5.6-fold (27-35-y stratum) and 2.3-fold (36-45-y stratum) higher than those induced by HPV-6/11/16/18 vaccine for HPV-16. For HPV-18, the fold differences were 12.1, 13.0 and 7.8, respectively. At Month 60, all (100%) subjects in HPV-16/18 vaccine group and the majority (95.7%-97.5%) in HPV-6/11/16/18 vaccine group were seropositive for HPV-16. For HPV-18, the majority (98.1%-100%) of subjects in HPV-16/18 vaccine group were seropositive; however, seropositivity rates in HPV-6/11/16/18 vaccine group decreased considerably (61.1%-76.9%) across the 3 age strata. In the total vaccinated cohort (received ≥ 1 dose regardless of baseline HPV serostatus and DNA status), geometric mean titers for anti-HPV-16 and anti-HPV-18 nAb were higher in HPV-16/18 vaccine group than in HPV-6/11/16/18 vaccine group. Based on the 5-y data, piece-wise and modified power-law models predicted a longer durability of nAb response for HPV-16/18 vaccine compared to HPV-6/11/16/18 vaccine. Beyond the differences apparent between the vaccines in terms of immunogenicity and modeled persistence of antibody responses, comparative studies including clinical endpoints would be needed to determine whether differences exist in duration of vaccine-induced protection. |
format | Online Article Text |
id | pubmed-4514070 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2014 |
publisher | Taylor & Francis |
record_format | MEDLINE/PubMed |
spelling | pubmed-45140702015-11-01 Comparison of long-term immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine in healthy women aged 18-45 years: End-of-study analysis of a Phase III randomized trial Einstein, Mark H Takacs, Peter Chatterjee, Archana Sperling, Rhoda S Chakhtoura, Nahida Blatter, Mark M Lalezari, Jacob David, Marie-Pierre Lin, Lan Struyf, Frank Dubin, Gary Hum Vaccin Immunother HPV/Research Papers The observer-blind, randomized, age-stratified, head-to-head study (NCT00423046) comparing immunogenicity and safety of HPV-16/18 and HPV-6/11/16/18 vaccines in healthy women aged 18-45 y was completed. Five y after vaccination, in subjects from the Month 60 according-to-protocol cohort (seronegative and DNA negative for HPV type analyzed at baseline), serum neutralizing antibody (nAb) responses induced by HPV-16/18 vaccine remained 7.8-fold (18-26-y stratum), 5.6-fold (27-35-y stratum) and 2.3-fold (36-45-y stratum) higher than those induced by HPV-6/11/16/18 vaccine for HPV-16. For HPV-18, the fold differences were 12.1, 13.0 and 7.8, respectively. At Month 60, all (100%) subjects in HPV-16/18 vaccine group and the majority (95.7%-97.5%) in HPV-6/11/16/18 vaccine group were seropositive for HPV-16. For HPV-18, the majority (98.1%-100%) of subjects in HPV-16/18 vaccine group were seropositive; however, seropositivity rates in HPV-6/11/16/18 vaccine group decreased considerably (61.1%-76.9%) across the 3 age strata. In the total vaccinated cohort (received ≥ 1 dose regardless of baseline HPV serostatus and DNA status), geometric mean titers for anti-HPV-16 and anti-HPV-18 nAb were higher in HPV-16/18 vaccine group than in HPV-6/11/16/18 vaccine group. Based on the 5-y data, piece-wise and modified power-law models predicted a longer durability of nAb response for HPV-16/18 vaccine compared to HPV-6/11/16/18 vaccine. Beyond the differences apparent between the vaccines in terms of immunogenicity and modeled persistence of antibody responses, comparative studies including clinical endpoints would be needed to determine whether differences exist in duration of vaccine-induced protection. Taylor & Francis 2014-11-01 /pmc/articles/PMC4514070/ /pubmed/25483701 http://dx.doi.org/10.4161/hv.36121 Text en © 2014 The Author(s). Published with license by Taylor & Francis Group, LLC http://creativecommons.org/licenses/by-nc/3.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution-Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. The moral rights of the named author(s) have been asserted. |
spellingShingle | HPV/Research Papers Einstein, Mark H Takacs, Peter Chatterjee, Archana Sperling, Rhoda S Chakhtoura, Nahida Blatter, Mark M Lalezari, Jacob David, Marie-Pierre Lin, Lan Struyf, Frank Dubin, Gary Comparison of long-term immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine in healthy women aged 18-45 years: End-of-study analysis of a Phase III randomized trial |
title | Comparison of long-term immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine in healthy women aged 18-45 years: End-of-study analysis of a Phase III randomized trial |
title_full | Comparison of long-term immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine in healthy women aged 18-45 years: End-of-study analysis of a Phase III randomized trial |
title_fullStr | Comparison of long-term immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine in healthy women aged 18-45 years: End-of-study analysis of a Phase III randomized trial |
title_full_unstemmed | Comparison of long-term immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine in healthy women aged 18-45 years: End-of-study analysis of a Phase III randomized trial |
title_short | Comparison of long-term immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine and HPV-6/11/16/18 vaccine in healthy women aged 18-45 years: End-of-study analysis of a Phase III randomized trial |
title_sort | comparison of long-term immunogenicity and safety of human papillomavirus (hpv)-16/18 as04-adjuvanted vaccine and hpv-6/11/16/18 vaccine in healthy women aged 18-45 years: end-of-study analysis of a phase iii randomized trial |
topic | HPV/Research Papers |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4514070/ https://www.ncbi.nlm.nih.gov/pubmed/25483701 http://dx.doi.org/10.4161/hv.36121 |
work_keys_str_mv | AT einsteinmarkh comparisonoflongtermimmunogenicityandsafetyofhumanpapillomavirushpv1618as04adjuvantedvaccineandhpv6111618vaccineinhealthywomenaged1845yearsendofstudyanalysisofaphaseiiirandomizedtrial AT takacspeter comparisonoflongtermimmunogenicityandsafetyofhumanpapillomavirushpv1618as04adjuvantedvaccineandhpv6111618vaccineinhealthywomenaged1845yearsendofstudyanalysisofaphaseiiirandomizedtrial AT chatterjeearchana comparisonoflongtermimmunogenicityandsafetyofhumanpapillomavirushpv1618as04adjuvantedvaccineandhpv6111618vaccineinhealthywomenaged1845yearsendofstudyanalysisofaphaseiiirandomizedtrial AT sperlingrhodas comparisonoflongtermimmunogenicityandsafetyofhumanpapillomavirushpv1618as04adjuvantedvaccineandhpv6111618vaccineinhealthywomenaged1845yearsendofstudyanalysisofaphaseiiirandomizedtrial AT chakhtouranahida comparisonoflongtermimmunogenicityandsafetyofhumanpapillomavirushpv1618as04adjuvantedvaccineandhpv6111618vaccineinhealthywomenaged1845yearsendofstudyanalysisofaphaseiiirandomizedtrial AT blattermarkm comparisonoflongtermimmunogenicityandsafetyofhumanpapillomavirushpv1618as04adjuvantedvaccineandhpv6111618vaccineinhealthywomenaged1845yearsendofstudyanalysisofaphaseiiirandomizedtrial AT lalezarijacob comparisonoflongtermimmunogenicityandsafetyofhumanpapillomavirushpv1618as04adjuvantedvaccineandhpv6111618vaccineinhealthywomenaged1845yearsendofstudyanalysisofaphaseiiirandomizedtrial AT davidmariepierre comparisonoflongtermimmunogenicityandsafetyofhumanpapillomavirushpv1618as04adjuvantedvaccineandhpv6111618vaccineinhealthywomenaged1845yearsendofstudyanalysisofaphaseiiirandomizedtrial AT linlan comparisonoflongtermimmunogenicityandsafetyofhumanpapillomavirushpv1618as04adjuvantedvaccineandhpv6111618vaccineinhealthywomenaged1845yearsendofstudyanalysisofaphaseiiirandomizedtrial AT struyffrank comparisonoflongtermimmunogenicityandsafetyofhumanpapillomavirushpv1618as04adjuvantedvaccineandhpv6111618vaccineinhealthywomenaged1845yearsendofstudyanalysisofaphaseiiirandomizedtrial AT dubingary comparisonoflongtermimmunogenicityandsafetyofhumanpapillomavirushpv1618as04adjuvantedvaccineandhpv6111618vaccineinhealthywomenaged1845yearsendofstudyanalysisofaphaseiiirandomizedtrial |