HPV antibody levels and clinical efficacy following administration of a prophylactic quadrivalent HPV vaccine

Elmar A Joura; Susanne K Kjaer; Cosette M Wheeler; Kristján Sigurdsson; Ole-Erik Iversen; Mauricio Hernandez-Avila; Gonzalo Perez; Darron R Brown; Laura A Koutsky; Eng Hseon Tay; Patricia García; Kevin A Ault; Suzanne M Garland; Sepp Leodolter; Sven-Eric Olsson; Grace W K Tang; Daron G Ferris; Jorma Paavonen; Matti Lehtinen; Marc Steben; Xavier Bosch; Joakim Dillner; Robert J Kurman; Slawomir Majewski; Nubia Muñoz; Evan R Myers; Luisa L Villa; Frank J Taddeo; Christine Roberts; Amha Tadesse; Janine Bryan; Lisa C Lupinacci; Katherine E D Giacoletti; Shuang Lu; Scott Vuocolo; Teresa M Hesley; Richard M Haupt; Eliav Barr

doi:10.1016/j.vaccine.2008.09.073

HPV antibody levels and clinical efficacy following administration of a prophylactic quadrivalent HPV vaccine

Elmar A Joura, Susanne K Kjaer, Cosette M Wheeler, Kristján Sigurdsson, Ole-Erik Iversen, Mauricio Hernandez-Avila, Gonzalo Perez, Darron R Brown, Laura A Koutsky, Eng Hseon Tay, Patricia García, Kevin A Ault, Suzanne M Garland, Sepp Leodolter, Sven-Eric Olsson, Grace W K Tang, Daron G Ferris, Jorma Paavonen, Matti Lehtinen, Marc StebenXavier Bosch, Joakim Dillner, Robert J Kurman, Slawomir Majewski, Nubia Muñoz, Evan R Myers, Luisa L Villa, Frank J Taddeo, Christine Roberts, Amha Tadesse, Janine Bryan, Lisa C Lupinacci, Katherine E D Giacoletti, Shuang Lu, Scott Vuocolo, Teresa M Hesley, Richard M Haupt, Eliav Barr

177 Citations (Scopus)

Abstract

The efficacy of the quadrivalent Human Papillomavirus (HPV) vaccine is thought to be mediated by humoral immunity. We evaluated the correlation between quadrivalent HPV vaccine-induced serum anti-HPV responses and efficacy. 17,622 women were vaccinated at day 1, and months 2 and 6. At day 1 and at 6-12 months intervals for up to 48 months, subjects underwent Papanicolaou and genital HPV testing. No immune correlate of protection could be found due to low number of cases. Although 40% of vaccine subjects were anti-HPV 18 seronegative at end-of-study, efficacy against HPV 18-related disease remained high (98.4%; 95% CI: 90.5-100.0) despite high attack rates in the placebo group. These results suggest vaccine-induced protection via immune memory, or lower than detectable HPV 18 antibody titers.

Original language	English
Journal	Vaccine
Volume	26
Issue number	52
Pages (from-to)	6844-51
Number of pages	8
ISSN	0264-410X
DOIs	https://doi.org/10.1016/j.vaccine.2008.09.073
Publication status	Published - 9 Dec 2008
Externally published	Yes

Keywords

Adolescent
Antibodies, Viral/analysis
Condylomata Acuminata/epidemiology
Female
Follow-Up Studies
Human papillomavirus 11/immunology
Human papillomavirus 16/immunology
Human papillomavirus 18/immunology
Human papillomavirus 6/immunology
Humans
Immunization Schedule
Papanicolaou Test
Papillomavirus Infections/immunology
Papillomavirus Vaccines/immunology
Reverse Transcriptase Polymerase Chain Reaction
Vagina/pathology
Vaginal Smears
Vulva/pathology
Young Adult

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10.1016/j.vaccine.2008.09.073

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Joura, E. A., Kjaer, S. K., Wheeler, C. M., Sigurdsson, K., Iversen, O.-E., Hernandez-Avila, M., Perez, G., Brown, D. R., Koutsky, L. A., Tay, E. H., García, P., Ault, K. A., Garland, S. M., Leodolter, S., Olsson, S.-E., Tang, G. W. K., Ferris, D. G., Paavonen, J., Lehtinen, M., ... Barr, E. (2008). HPV antibody levels and clinical efficacy following administration of a prophylactic quadrivalent HPV vaccine. Vaccine, 26(52), 6844-51. https://doi.org/10.1016/j.vaccine.2008.09.073

Joura, EA, Kjaer, SK, Wheeler, CM, Sigurdsson, K, Iversen, O-E, Hernandez-Avila, M, Perez, G, Brown, DR, Koutsky, LA, Tay, EH, García, P, Ault, KA, Garland, SM, Leodolter, S, Olsson, S-E, Tang, GWK, Ferris, DG, Paavonen, J, Lehtinen, M, Steben, M, Bosch, X, Dillner, J, Kurman, RJ, Majewski, S, Muñoz, N, Myers, ER, Villa, LL, Taddeo, FJ, Roberts, C, Tadesse, A, Bryan, J, Lupinacci, LC, Giacoletti, KED, Lu, S, Vuocolo, S, Hesley, TM, Haupt, RM & Barr, E 2008, 'HPV antibody levels and clinical efficacy following administration of a prophylactic quadrivalent HPV vaccine', Vaccine, vol. 26, no. 52, pp. 6844-51. https://doi.org/10.1016/j.vaccine.2008.09.073

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title = "HPV antibody levels and clinical efficacy following administration of a prophylactic quadrivalent HPV vaccine",

abstract = "The efficacy of the quadrivalent Human Papillomavirus (HPV) vaccine is thought to be mediated by humoral immunity. We evaluated the correlation between quadrivalent HPV vaccine-induced serum anti-HPV responses and efficacy. 17,622 women were vaccinated at day 1, and months 2 and 6. At day 1 and at 6-12 months intervals for up to 48 months, subjects underwent Papanicolaou and genital HPV testing. No immune correlate of protection could be found due to low number of cases. Although 40\% of vaccine subjects were anti-HPV 18 seronegative at end-of-study, efficacy against HPV 18-related disease remained high (98.4\%; 95\% CI: 90.5-100.0) despite high attack rates in the placebo group. These results suggest vaccine-induced protection via immune memory, or lower than detectable HPV 18 antibody titers.",

keywords = "Adolescent, Antibodies, Viral/analysis, Condylomata Acuminata/epidemiology, Female, Follow-Up Studies, Human papillomavirus 11/immunology, Human papillomavirus 16/immunology, Human papillomavirus 18/immunology, Human papillomavirus 6/immunology, Humans, Immunization Schedule, Papanicolaou Test, Papillomavirus Infections/immunology, Papillomavirus Vaccines/immunology, Reverse Transcriptase Polymerase Chain Reaction, Vagina/pathology, Vaginal Smears, Vulva/pathology, Young Adult",

author = "Joura, \{Elmar A\} and Kjaer, \{Susanne K\} and Wheeler, \{Cosette M\} and Kristj{\'a}n Sigurdsson and Ole-Erik Iversen and Mauricio Hernandez-Avila and Gonzalo Perez and Brown, \{Darron R\} and Koutsky, \{Laura A\} and Tay, \{Eng Hseon\} and Patricia Garc{\'i}a and Ault, \{Kevin A\} and Garland, \{Suzanne M\} and Sepp Leodolter and Sven-Eric Olsson and Tang, \{Grace W K\} and Ferris, \{Daron G\} and Jorma Paavonen and Matti Lehtinen and Marc Steben and Xavier Bosch and Joakim Dillner and Kurman, \{Robert J\} and Slawomir Majewski and Nubia Mu{\~n}oz and Myers, \{Evan R\} and Villa, \{Luisa L\} and Taddeo, \{Frank J\} and Christine Roberts and Amha Tadesse and Janine Bryan and Lupinacci, \{Lisa C\} and Giacoletti, \{Katherine E D\} and Shuang Lu and Scott Vuocolo and Hesley, \{Teresa M\} and Haupt, \{Richard M\} and Eliav Barr",

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doi = "10.1016/j.vaccine.2008.09.073",

language = "English",

volume = "26",

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T1 - HPV antibody levels and clinical efficacy following administration of a prophylactic quadrivalent HPV vaccine

AU - Joura, Elmar A

AU - Kjaer, Susanne K

AU - Wheeler, Cosette M

AU - Sigurdsson, Kristján

AU - Iversen, Ole-Erik

AU - Hernandez-Avila, Mauricio

AU - Perez, Gonzalo

AU - Brown, Darron R

AU - Koutsky, Laura A

AU - Tay, Eng Hseon

AU - García, Patricia

AU - Ault, Kevin A

AU - Garland, Suzanne M

AU - Leodolter, Sepp

AU - Olsson, Sven-Eric

AU - Tang, Grace W K

AU - Ferris, Daron G

AU - Paavonen, Jorma

AU - Lehtinen, Matti

AU - Steben, Marc

AU - Bosch, Xavier

AU - Dillner, Joakim

AU - Kurman, Robert J

AU - Majewski, Slawomir

AU - Muñoz, Nubia

AU - Myers, Evan R

AU - Villa, Luisa L

AU - Taddeo, Frank J

AU - Roberts, Christine

AU - Tadesse, Amha

AU - Bryan, Janine

AU - Lupinacci, Lisa C

AU - Giacoletti, Katherine E D

AU - Lu, Shuang

AU - Vuocolo, Scott

AU - Hesley, Teresa M

AU - Haupt, Richard M

AU - Barr, Eliav

PY - 2008/12/9

Y1 - 2008/12/9

N2 - The efficacy of the quadrivalent Human Papillomavirus (HPV) vaccine is thought to be mediated by humoral immunity. We evaluated the correlation between quadrivalent HPV vaccine-induced serum anti-HPV responses and efficacy. 17,622 women were vaccinated at day 1, and months 2 and 6. At day 1 and at 6-12 months intervals for up to 48 months, subjects underwent Papanicolaou and genital HPV testing. No immune correlate of protection could be found due to low number of cases. Although 40% of vaccine subjects were anti-HPV 18 seronegative at end-of-study, efficacy against HPV 18-related disease remained high (98.4%; 95% CI: 90.5-100.0) despite high attack rates in the placebo group. These results suggest vaccine-induced protection via immune memory, or lower than detectable HPV 18 antibody titers.

AB - The efficacy of the quadrivalent Human Papillomavirus (HPV) vaccine is thought to be mediated by humoral immunity. We evaluated the correlation between quadrivalent HPV vaccine-induced serum anti-HPV responses and efficacy. 17,622 women were vaccinated at day 1, and months 2 and 6. At day 1 and at 6-12 months intervals for up to 48 months, subjects underwent Papanicolaou and genital HPV testing. No immune correlate of protection could be found due to low number of cases. Although 40% of vaccine subjects were anti-HPV 18 seronegative at end-of-study, efficacy against HPV 18-related disease remained high (98.4%; 95% CI: 90.5-100.0) despite high attack rates in the placebo group. These results suggest vaccine-induced protection via immune memory, or lower than detectable HPV 18 antibody titers.

KW - Adolescent

KW - Antibodies, Viral/analysis

KW - Condylomata Acuminata/epidemiology

KW - Female

KW - Follow-Up Studies

KW - Human papillomavirus 11/immunology

KW - Human papillomavirus 16/immunology

KW - Human papillomavirus 18/immunology

KW - Human papillomavirus 6/immunology

KW - Humans

KW - Immunization Schedule

KW - Papanicolaou Test

KW - Papillomavirus Infections/immunology

KW - Papillomavirus Vaccines/immunology

KW - Reverse Transcriptase Polymerase Chain Reaction

KW - Vagina/pathology

KW - Vaginal Smears

KW - Vulva/pathology

KW - Young Adult

UR - https://www.scopus.com/pages/publications/56949087305

U2 - 10.1016/j.vaccine.2008.09.073

DO - 10.1016/j.vaccine.2008.09.073

M3 - Journal article

C2 - 18930097

SN - 0264-410X

VL - 26

SP - 6844

EP - 6851

JO - Vaccine

JF - Vaccine

IS - 52

ER -

HPV antibody levels and clinical efficacy following administration of a prophylactic quadrivalent HPV vaccine

Abstract

Keywords

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