Comparison of the immunogenicity of the human papillomavirus (HPV)-16/18 vaccine and the HPV-6/11/16/18 vaccine for oncogenic non-vaccine types HPV-31 and HPV-45 in healthy women aged 18-45 years

Mark H. Einstein; Mira Baron; Myron J. Levin; Archana Chatterjee; Bradley Fox; Sofia Scholar; Jeffrey Rosen; Nahida Chakhtoura; Marie Lebacq; Robbert Van Der Most; Philippe Moris; Sandra L. Giannini; Anne Schuind; Sanjoy K. Datta; Dominique Descamps

doi:10.4161/hv.7.12.18282

Comparison of the immunogenicity of the human papillomavirus (HPV)-16/18 vaccine and the HPV-6/11/16/18 vaccine for oncogenic non-vaccine types HPV-31 and HPV-45 in healthy women aged 18-45 years

Mark H. Einstein, Mira Baron, Myron J. Levin, Archana Chatterjee, Bradley Fox, Sofia Scholar, Jeffrey Rosen, Nahida Chakhtoura, Marie Lebacq, Robbert Van Der Most, Philippe Moris, Sandra L. Giannini, Anne Schuind, Sanjoy K. Datta, Dominique Descamps

Obstetrics & Gynecology and Women's Health

Research output: Contribution to journal › Article › peer-review

105 Scopus citations

Abstract

Protection against oncogenic non-vaccine types (cross-protection) offered by human papillomavirus (HPV) vaccines may provide a significant medical benefit. Available clinical efficacy data suggest the two licensed vaccines [HPV-16/18 vaccine, GlaxoSmithKline Biologicals (GSK), and HPV-6/11/16/18 vaccine, Merck and Co., Inc.,] differ in terms of protection against oncogenic non-vaccine HPV types -31/45. The immune responses induced by the two vaccines against these two non-vaccine HPV types (cross-reactivity) was compared in an observer-blind study up to Month 24 (18 mo postvaccination), in women HPV DNA-negative and seronegative prior to vaccination for the HPV type analyzed [HPV- 010 (NCT00423046)]. Geometric mean antibody titers (GMTs) measured by pseudovirion-based neutralization assay (PBNA) and enzyme-linked immunosorbent assay (ELISA ) were similar between vaccines for HPV-31/45. Seropositivity rates for HPV-31 were also similar between vaccines; however, there was a trend for higher seropositivity with the HPV-16/18 vaccine (13.0-16.7%) vs. the HPV-6/11/16/18 vaccine (0.0-5.0%) for HPV-45 with PBNA, but not ELISA . HPV-31/45 cross-reactive memory B-cell responses were comparable between vaccines. Circulating antigen-specific CD4+ T-cell frequencies were higher for the HPV-16/18 vaccine than the HPV-6/11/16/18 vaccine {HPV-31 [geometric mean ratio (GMR) = 2.0; p = 0.0002] and HPV-45 [GMR = 2.6; p = 0.0092]}, as were the proportion of T-cell responders (HPV-31, p = 0.0009; HPV-45, p = 0.0793). In conclusion, immune response to oncogenic non-vaccine HPV types -31/45 was generally similar for both vaccines with the exception of T-cell response which was higher with the HPV-16/18 vaccine. Considering the differences in cross-protective efficacy between the two vaccines, the results might provide insights into the underlying mechanism(s) of protection.

Original language	English (US)
Pages (from-to)	1359-1373
Number of pages	15
Journal	Human Vaccines
Volume	7
Issue number	12
DOIs	https://doi.org/10.4161/hv.7.12.18282
State	Published - Dec 2011

Keywords

Cervarix®
Cervical cancer
Cross-protection
Gardasil®
HPV-31
HPV-45
Human papillomavirus
Immunogenicity

ASJC Scopus subject areas

General Pharmacology, Toxicology and Pharmaceutics
Immunology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.4161/hv.7.12.18282

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Einstein, M. H., Baron, M., Levin, M. J., Chatterjee, A., Fox, B., Scholar, S., Rosen, J., Chakhtoura, N., Lebacq, M., Van Der Most, R., Moris, P., Giannini, S. L., Schuind, A., Datta, S. K., & Descamps, D. (2011). Comparison of the immunogenicity of the human papillomavirus (HPV)-16/18 vaccine and the HPV-6/11/16/18 vaccine for oncogenic non-vaccine types HPV-31 and HPV-45 in healthy women aged 18-45 years. Human Vaccines, 7(12), 1359-1373. https://doi.org/10.4161/hv.7.12.18282

Comparison of the immunogenicity of the human papillomavirus (HPV)-16/18 vaccine and the HPV-6/11/16/18 vaccine for oncogenic non-vaccine types HPV-31 and HPV-45 in healthy women aged 18-45 years. / Einstein, Mark H.; Baron, Mira; Levin, Myron J. et al.
In: Human Vaccines, Vol. 7, No. 12, 12.2011, p. 1359-1373.

Research output: Contribution to journal › Article › peer-review

Einstein, MH, Baron, M, Levin, MJ, Chatterjee, A, Fox, B, Scholar, S, Rosen, J, Chakhtoura, N, Lebacq, M, Van Der Most, R, Moris, P, Giannini, SL, Schuind, A, Datta, SK & Descamps, D 2011, 'Comparison of the immunogenicity of the human papillomavirus (HPV)-16/18 vaccine and the HPV-6/11/16/18 vaccine for oncogenic non-vaccine types HPV-31 and HPV-45 in healthy women aged 18-45 years', Human Vaccines, vol. 7, no. 12, pp. 1359-1373. https://doi.org/10.4161/hv.7.12.18282

@article{feafca30363540c29c7fe8e3b80e0492,

title = "Comparison of the immunogenicity of the human papillomavirus (HPV)-16/18 vaccine and the HPV-6/11/16/18 vaccine for oncogenic non-vaccine types HPV-31 and HPV-45 in healthy women aged 18-45 years",

abstract = "Protection against oncogenic non-vaccine types (cross-protection) offered by human papillomavirus (HPV) vaccines may provide a significant medical benefit. Available clinical efficacy data suggest the two licensed vaccines [HPV-16/18 vaccine, GlaxoSmithKline Biologicals (GSK), and HPV-6/11/16/18 vaccine, Merck and Co., Inc.,] differ in terms of protection against oncogenic non-vaccine HPV types -31/45. The immune responses induced by the two vaccines against these two non-vaccine HPV types (cross-reactivity) was compared in an observer-blind study up to Month 24 (18 mo postvaccination), in women HPV DNA-negative and seronegative prior to vaccination for the HPV type analyzed [HPV- 010 (NCT00423046)]. Geometric mean antibody titers (GMTs) measured by pseudovirion-based neutralization assay (PBNA) and enzyme-linked immunosorbent assay (ELISA ) were similar between vaccines for HPV-31/45. Seropositivity rates for HPV-31 were also similar between vaccines; however, there was a trend for higher seropositivity with the HPV-16/18 vaccine (13.0-16.7%) vs. the HPV-6/11/16/18 vaccine (0.0-5.0%) for HPV-45 with PBNA, but not ELISA . HPV-31/45 cross-reactive memory B-cell responses were comparable between vaccines. Circulating antigen-specific CD4+ T-cell frequencies were higher for the HPV-16/18 vaccine than the HPV-6/11/16/18 vaccine {HPV-31 [geometric mean ratio (GMR) = 2.0; p = 0.0002] and HPV-45 [GMR = 2.6; p = 0.0092]}, as were the proportion of T-cell responders (HPV-31, p = 0.0009; HPV-45, p = 0.0793). In conclusion, immune response to oncogenic non-vaccine HPV types -31/45 was generally similar for both vaccines with the exception of T-cell response which was higher with the HPV-16/18 vaccine. Considering the differences in cross-protective efficacy between the two vaccines, the results might provide insights into the underlying mechanism(s) of protection.",

keywords = "Cervarix{\textregistered}, Cervical cancer, Cross-protection, Gardasil{\textregistered}, HPV-31, HPV-45, Human papillomavirus, Immunogenicity",

author = "Einstein, {Mark H.} and Mira Baron and Levin, {Myron J.} and Archana Chatterjee and Bradley Fox and Sofia Scholar and Jeffrey Rosen and Nahida Chakhtoura and Marie Lebacq and {Van Der Most}, Robbert and Philippe Moris and Giannini, {Sandra L.} and Anne Schuind and Datta, {Sanjoy K.} and Dominique Descamps",

note = "Funding Information: All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf and declare: The submitted work got financial support from GlaxoSmithKline Biologicals. Funding Information: M.E. has advised or participated in educational speaking activities, but does not receive payments from any companies. In specific cases, Montefiore Medical Center has received payment for M.E. time spent for these activities from GSK and Merck. Also, Montefiore has received grant funding for research related costs of clinical trials that M.E. has been the Montefiore PI from GSK and Merck. A.C., N.C., J.R. received support for travel to meetings for the study. A.C., M.J.L., N.C., J.R. received grants for their institutions. A.C. received financial support for board membership. M.J.L. received financial support for consultancy. A.C., B.F., N.C., received payment for lectures including service on speaker bureaus. A.S., D.D., M.L., S.D., P.M., S.G., RvdM are GSK employees. A.S., D.D., S.D., P.M., RvdM have stock options from GSK. S.S., B.F., M.B. declare no conflict of interest.",

year = "2011",

month = dec,

doi = "10.4161/hv.7.12.18282",

language = "English (US)",

volume = "7",

pages = "1359--1373",

journal = "Human Vaccines",

issn = "1554-8600",

publisher = "Landes Bioscience",

number = "12",

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TY - JOUR

T1 - Comparison of the immunogenicity of the human papillomavirus (HPV)-16/18 vaccine and the HPV-6/11/16/18 vaccine for oncogenic non-vaccine types HPV-31 and HPV-45 in healthy women aged 18-45 years

AU - Einstein, Mark H.

AU - Baron, Mira

AU - Levin, Myron J.

AU - Chatterjee, Archana

AU - Fox, Bradley

AU - Scholar, Sofia

AU - Rosen, Jeffrey

AU - Chakhtoura, Nahida

AU - Lebacq, Marie

AU - Van Der Most, Robbert

AU - Moris, Philippe

AU - Giannini, Sandra L.

AU - Schuind, Anne

AU - Datta, Sanjoy K.

AU - Descamps, Dominique

N1 - Funding Information: All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf and declare: The submitted work got financial support from GlaxoSmithKline Biologicals. Funding Information: M.E. has advised or participated in educational speaking activities, but does not receive payments from any companies. In specific cases, Montefiore Medical Center has received payment for M.E. time spent for these activities from GSK and Merck. Also, Montefiore has received grant funding for research related costs of clinical trials that M.E. has been the Montefiore PI from GSK and Merck. A.C., N.C., J.R. received support for travel to meetings for the study. A.C., M.J.L., N.C., J.R. received grants for their institutions. A.C. received financial support for board membership. M.J.L. received financial support for consultancy. A.C., B.F., N.C., received payment for lectures including service on speaker bureaus. A.S., D.D., M.L., S.D., P.M., S.G., RvdM are GSK employees. A.S., D.D., S.D., P.M., RvdM have stock options from GSK. S.S., B.F., M.B. declare no conflict of interest.

PY - 2011/12

Y1 - 2011/12

N2 - Protection against oncogenic non-vaccine types (cross-protection) offered by human papillomavirus (HPV) vaccines may provide a significant medical benefit. Available clinical efficacy data suggest the two licensed vaccines [HPV-16/18 vaccine, GlaxoSmithKline Biologicals (GSK), and HPV-6/11/16/18 vaccine, Merck and Co., Inc.,] differ in terms of protection against oncogenic non-vaccine HPV types -31/45. The immune responses induced by the two vaccines against these two non-vaccine HPV types (cross-reactivity) was compared in an observer-blind study up to Month 24 (18 mo postvaccination), in women HPV DNA-negative and seronegative prior to vaccination for the HPV type analyzed [HPV- 010 (NCT00423046)]. Geometric mean antibody titers (GMTs) measured by pseudovirion-based neutralization assay (PBNA) and enzyme-linked immunosorbent assay (ELISA ) were similar between vaccines for HPV-31/45. Seropositivity rates for HPV-31 were also similar between vaccines; however, there was a trend for higher seropositivity with the HPV-16/18 vaccine (13.0-16.7%) vs. the HPV-6/11/16/18 vaccine (0.0-5.0%) for HPV-45 with PBNA, but not ELISA . HPV-31/45 cross-reactive memory B-cell responses were comparable between vaccines. Circulating antigen-specific CD4+ T-cell frequencies were higher for the HPV-16/18 vaccine than the HPV-6/11/16/18 vaccine {HPV-31 [geometric mean ratio (GMR) = 2.0; p = 0.0002] and HPV-45 [GMR = 2.6; p = 0.0092]}, as were the proportion of T-cell responders (HPV-31, p = 0.0009; HPV-45, p = 0.0793). In conclusion, immune response to oncogenic non-vaccine HPV types -31/45 was generally similar for both vaccines with the exception of T-cell response which was higher with the HPV-16/18 vaccine. Considering the differences in cross-protective efficacy between the two vaccines, the results might provide insights into the underlying mechanism(s) of protection.

AB - Protection against oncogenic non-vaccine types (cross-protection) offered by human papillomavirus (HPV) vaccines may provide a significant medical benefit. Available clinical efficacy data suggest the two licensed vaccines [HPV-16/18 vaccine, GlaxoSmithKline Biologicals (GSK), and HPV-6/11/16/18 vaccine, Merck and Co., Inc.,] differ in terms of protection against oncogenic non-vaccine HPV types -31/45. The immune responses induced by the two vaccines against these two non-vaccine HPV types (cross-reactivity) was compared in an observer-blind study up to Month 24 (18 mo postvaccination), in women HPV DNA-negative and seronegative prior to vaccination for the HPV type analyzed [HPV- 010 (NCT00423046)]. Geometric mean antibody titers (GMTs) measured by pseudovirion-based neutralization assay (PBNA) and enzyme-linked immunosorbent assay (ELISA ) were similar between vaccines for HPV-31/45. Seropositivity rates for HPV-31 were also similar between vaccines; however, there was a trend for higher seropositivity with the HPV-16/18 vaccine (13.0-16.7%) vs. the HPV-6/11/16/18 vaccine (0.0-5.0%) for HPV-45 with PBNA, but not ELISA . HPV-31/45 cross-reactive memory B-cell responses were comparable between vaccines. Circulating antigen-specific CD4+ T-cell frequencies were higher for the HPV-16/18 vaccine than the HPV-6/11/16/18 vaccine {HPV-31 [geometric mean ratio (GMR) = 2.0; p = 0.0002] and HPV-45 [GMR = 2.6; p = 0.0092]}, as were the proportion of T-cell responders (HPV-31, p = 0.0009; HPV-45, p = 0.0793). In conclusion, immune response to oncogenic non-vaccine HPV types -31/45 was generally similar for both vaccines with the exception of T-cell response which was higher with the HPV-16/18 vaccine. Considering the differences in cross-protective efficacy between the two vaccines, the results might provide insights into the underlying mechanism(s) of protection.

KW - Cervarix®

KW - Cervical cancer

KW - Cross-protection

KW - Gardasil®

KW - HPV-31

KW - HPV-45

KW - Human papillomavirus

KW - Immunogenicity

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ER -

Comparison of the immunogenicity of the human papillomavirus (HPV)-16/18 vaccine and the HPV-6/11/16/18 vaccine for oncogenic non-vaccine types HPV-31 and HPV-45 in healthy women aged 18-45 years

Abstract

Keywords

ASJC Scopus subject areas

UN SDGs

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