Safety and immunogenicity of a 9-valent HPV vaccine in females 12-26 years of age who previously received the quadrivalent HPV vaccine

Suzanne M Garland, Tak-Hong Cheung, Shelly McNeill, Lone Kjeld Petersen, Josefina Romaguera, Jorge Vazquez-Narvaez, Oliver Bautista, Christine Shields, Scott Vuocolo, Alain Luxembourg

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Resumé

OBJECTIVES: To assess the safety and immunogenicity of the investigational 9-valent (6/11/16/18/31/33/45/52/58) HPV (9vHPV) vaccine in prior recipients of a 3-dose regimen of quadrivalent (6/11/16/18) HPV (qHPV) vaccine.

METHODS: V503-006 was a randomized, double-blinded, safety/tolerability and immunogenicity study of the 9vHPV vaccine in females 12-26 years of age who were previously vaccinated with qHPV vaccine. Subjects were randomized in a 2:1 ratio to receive 3 doses of 9vHPV vaccine (n=618) or saline placebo (n=306) at day 1, month 2, and month 6. Systemic, injection-site and serious adverse experiences (AEs) were monitored. Serum samples were collected at day 1, month 2, and month 7. Anti-HPV 6/11/16/18/31/33/45/52/58 titers were measured using the 9-valent HPV competitive Luminex Immunoassay (cLIA).

RESULTS: The frequency of injection-site AEs (days 1-5 following any vaccination) was higher in the 9vHPV vaccine group than in the placebo group (91.1% and 43.9%, respectively). The frequencies of vaccine-related systemic AEs (days 1-15 following any vaccination) were generally comparable between the 2 groups (30.6% in the 9vHPV vaccine group, and 25.9% in the placebo group). One vaccine-related serious AE was reported in each of the 9vHPV vaccine and placebo groups. Few subjects (9vHPV=0.5%; placebo=0%) discontinued due to an AE. At 4 weeks post-dose 3, over 98% of subjects in the 9vHPV vaccine group were seropositive for HPV types 31/33/45/52/58, with marked elevations in cLIA geometric mean titers (GMTs) to these HPV types. Anti-HPV 31/33/45/52/58 GMTs were lower than in subjects administered 9vHPV vaccine who had not previously received qHPV vaccine (based on cross-study analyses); the clinical significance of this difference is unknown.

CONCLUSIONS: Administration of a 3-dose regimen of 9vHPV vaccine to adolescent girls and young women 12-26 years of age who are prior qHPV vaccine recipients is highly immunogenic with respect to HPV types 31/33/45/52/58 and generally well tolerated.

OriginalsprogEngelsk
TidsskriftVaccine
Vol/bind33
Udgave nummer48
Sider (fra-til)6855-64
Antal sider10
ISSN0264-410X
DOI
StatusUdgivet - 27. nov. 2015

Fingeraftryk

Safety
Placebos
Immunoassay
Human papillomavirus 11
Human papillomavirus 6
Serum

Citer dette

Garland, Suzanne M ; Cheung, Tak-Hong ; McNeill, Shelly ; Petersen, Lone Kjeld ; Romaguera, Josefina ; Vazquez-Narvaez, Jorge ; Bautista, Oliver ; Shields, Christine ; Vuocolo, Scott ; Luxembourg, Alain. / Safety and immunogenicity of a 9-valent HPV vaccine in females 12-26 years of age who previously received the quadrivalent HPV vaccine. I: Vaccine. 2015 ; Bind 33, Nr. 48. s. 6855-64.
@article{e1b45d6d3d1e43a2ae67fda12872f22e,
title = "Safety and immunogenicity of a 9-valent HPV vaccine in females 12-26 years of age who previously received the quadrivalent HPV vaccine",
abstract = "OBJECTIVES: To assess the safety and immunogenicity of the investigational 9-valent (6/11/16/18/31/33/45/52/58) HPV (9vHPV) vaccine in prior recipients of a 3-dose regimen of quadrivalent (6/11/16/18) HPV (qHPV) vaccine.METHODS: V503-006 was a randomized, double-blinded, safety/tolerability and immunogenicity study of the 9vHPV vaccine in females 12-26 years of age who were previously vaccinated with qHPV vaccine. Subjects were randomized in a 2:1 ratio to receive 3 doses of 9vHPV vaccine (n=618) or saline placebo (n=306) at day 1, month 2, and month 6. Systemic, injection-site and serious adverse experiences (AEs) were monitored. Serum samples were collected at day 1, month 2, and month 7. Anti-HPV 6/11/16/18/31/33/45/52/58 titers were measured using the 9-valent HPV competitive Luminex Immunoassay (cLIA).RESULTS: The frequency of injection-site AEs (days 1-5 following any vaccination) was higher in the 9vHPV vaccine group than in the placebo group (91.1{\%} and 43.9{\%}, respectively). The frequencies of vaccine-related systemic AEs (days 1-15 following any vaccination) were generally comparable between the 2 groups (30.6{\%} in the 9vHPV vaccine group, and 25.9{\%} in the placebo group). One vaccine-related serious AE was reported in each of the 9vHPV vaccine and placebo groups. Few subjects (9vHPV=0.5{\%}; placebo=0{\%}) discontinued due to an AE. At 4 weeks post-dose 3, over 98{\%} of subjects in the 9vHPV vaccine group were seropositive for HPV types 31/33/45/52/58, with marked elevations in cLIA geometric mean titers (GMTs) to these HPV types. Anti-HPV 31/33/45/52/58 GMTs were lower than in subjects administered 9vHPV vaccine who had not previously received qHPV vaccine (based on cross-study analyses); the clinical significance of this difference is unknown.CONCLUSIONS: Administration of a 3-dose regimen of 9vHPV vaccine to adolescent girls and young women 12-26 years of age who are prior qHPV vaccine recipients is highly immunogenic with respect to HPV types 31/33/45/52/58 and generally well tolerated.",
keywords = "Adolescent, Adult, Antibodies, Viral/blood, Child, Double-Blind Method, Drug-Related Side Effects and Adverse Reactions/epidemiology, Female, Humans, Immunoassay, Papillomavirus Infections/prevention & control, Papillomavirus Vaccines/administration & dosage, Placebos/administration & dosage, Treatment Outcome, Young Adult",
author = "Garland, {Suzanne M} and Tak-Hong Cheung and Shelly McNeill and Petersen, {Lone Kjeld} and Josefina Romaguera and Jorge Vazquez-Narvaez and Oliver Bautista and Christine Shields and Scott Vuocolo and Alain Luxembourg",
note = "Copyright {\circledC} 2015 Elsevier Ltd. All rights reserved.",
year = "2015",
month = "11",
day = "27",
doi = "10.1016/j.vaccine.2015.08.059",
language = "English",
volume = "33",
pages = "6855--64",
journal = "Vaccine",
issn = "0264-410X",
number = "48",

}

Garland, SM, Cheung, T-H, McNeill, S, Petersen, LK, Romaguera, J, Vazquez-Narvaez, J, Bautista, O, Shields, C, Vuocolo, S & Luxembourg, A 2015, 'Safety and immunogenicity of a 9-valent HPV vaccine in females 12-26 years of age who previously received the quadrivalent HPV vaccine', Vaccine, bind 33, nr. 48, s. 6855-64. https://doi.org/10.1016/j.vaccine.2015.08.059

Safety and immunogenicity of a 9-valent HPV vaccine in females 12-26 years of age who previously received the quadrivalent HPV vaccine. / Garland, Suzanne M; Cheung, Tak-Hong; McNeill, Shelly; Petersen, Lone Kjeld; Romaguera, Josefina; Vazquez-Narvaez, Jorge; Bautista, Oliver; Shields, Christine; Vuocolo, Scott; Luxembourg, Alain.

I: Vaccine, Bind 33, Nr. 48, 27.11.2015, s. 6855-64.

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

TY - JOUR

T1 - Safety and immunogenicity of a 9-valent HPV vaccine in females 12-26 years of age who previously received the quadrivalent HPV vaccine

AU - Garland, Suzanne M

AU - Cheung, Tak-Hong

AU - McNeill, Shelly

AU - Petersen, Lone Kjeld

AU - Romaguera, Josefina

AU - Vazquez-Narvaez, Jorge

AU - Bautista, Oliver

AU - Shields, Christine

AU - Vuocolo, Scott

AU - Luxembourg, Alain

N1 - Copyright © 2015 Elsevier Ltd. All rights reserved.

PY - 2015/11/27

Y1 - 2015/11/27

N2 - OBJECTIVES: To assess the safety and immunogenicity of the investigational 9-valent (6/11/16/18/31/33/45/52/58) HPV (9vHPV) vaccine in prior recipients of a 3-dose regimen of quadrivalent (6/11/16/18) HPV (qHPV) vaccine.METHODS: V503-006 was a randomized, double-blinded, safety/tolerability and immunogenicity study of the 9vHPV vaccine in females 12-26 years of age who were previously vaccinated with qHPV vaccine. Subjects were randomized in a 2:1 ratio to receive 3 doses of 9vHPV vaccine (n=618) or saline placebo (n=306) at day 1, month 2, and month 6. Systemic, injection-site and serious adverse experiences (AEs) were monitored. Serum samples were collected at day 1, month 2, and month 7. Anti-HPV 6/11/16/18/31/33/45/52/58 titers were measured using the 9-valent HPV competitive Luminex Immunoassay (cLIA).RESULTS: The frequency of injection-site AEs (days 1-5 following any vaccination) was higher in the 9vHPV vaccine group than in the placebo group (91.1% and 43.9%, respectively). The frequencies of vaccine-related systemic AEs (days 1-15 following any vaccination) were generally comparable between the 2 groups (30.6% in the 9vHPV vaccine group, and 25.9% in the placebo group). One vaccine-related serious AE was reported in each of the 9vHPV vaccine and placebo groups. Few subjects (9vHPV=0.5%; placebo=0%) discontinued due to an AE. At 4 weeks post-dose 3, over 98% of subjects in the 9vHPV vaccine group were seropositive for HPV types 31/33/45/52/58, with marked elevations in cLIA geometric mean titers (GMTs) to these HPV types. Anti-HPV 31/33/45/52/58 GMTs were lower than in subjects administered 9vHPV vaccine who had not previously received qHPV vaccine (based on cross-study analyses); the clinical significance of this difference is unknown.CONCLUSIONS: Administration of a 3-dose regimen of 9vHPV vaccine to adolescent girls and young women 12-26 years of age who are prior qHPV vaccine recipients is highly immunogenic with respect to HPV types 31/33/45/52/58 and generally well tolerated.

AB - OBJECTIVES: To assess the safety and immunogenicity of the investigational 9-valent (6/11/16/18/31/33/45/52/58) HPV (9vHPV) vaccine in prior recipients of a 3-dose regimen of quadrivalent (6/11/16/18) HPV (qHPV) vaccine.METHODS: V503-006 was a randomized, double-blinded, safety/tolerability and immunogenicity study of the 9vHPV vaccine in females 12-26 years of age who were previously vaccinated with qHPV vaccine. Subjects were randomized in a 2:1 ratio to receive 3 doses of 9vHPV vaccine (n=618) or saline placebo (n=306) at day 1, month 2, and month 6. Systemic, injection-site and serious adverse experiences (AEs) were monitored. Serum samples were collected at day 1, month 2, and month 7. Anti-HPV 6/11/16/18/31/33/45/52/58 titers were measured using the 9-valent HPV competitive Luminex Immunoassay (cLIA).RESULTS: The frequency of injection-site AEs (days 1-5 following any vaccination) was higher in the 9vHPV vaccine group than in the placebo group (91.1% and 43.9%, respectively). The frequencies of vaccine-related systemic AEs (days 1-15 following any vaccination) were generally comparable between the 2 groups (30.6% in the 9vHPV vaccine group, and 25.9% in the placebo group). One vaccine-related serious AE was reported in each of the 9vHPV vaccine and placebo groups. Few subjects (9vHPV=0.5%; placebo=0%) discontinued due to an AE. At 4 weeks post-dose 3, over 98% of subjects in the 9vHPV vaccine group were seropositive for HPV types 31/33/45/52/58, with marked elevations in cLIA geometric mean titers (GMTs) to these HPV types. Anti-HPV 31/33/45/52/58 GMTs were lower than in subjects administered 9vHPV vaccine who had not previously received qHPV vaccine (based on cross-study analyses); the clinical significance of this difference is unknown.CONCLUSIONS: Administration of a 3-dose regimen of 9vHPV vaccine to adolescent girls and young women 12-26 years of age who are prior qHPV vaccine recipients is highly immunogenic with respect to HPV types 31/33/45/52/58 and generally well tolerated.

KW - Adolescent

KW - Adult

KW - Antibodies, Viral/blood

KW - Child

KW - Double-Blind Method

KW - Drug-Related Side Effects and Adverse Reactions/epidemiology

KW - Female

KW - Humans

KW - Immunoassay

KW - Papillomavirus Infections/prevention & control

KW - Papillomavirus Vaccines/administration & dosage

KW - Placebos/administration & dosage

KW - Treatment Outcome

KW - Young Adult

U2 - 10.1016/j.vaccine.2015.08.059

DO - 10.1016/j.vaccine.2015.08.059

M3 - Journal article

VL - 33

SP - 6855

EP - 6864

JO - Vaccine

JF - Vaccine

SN - 0264-410X

IS - 48

ER -