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Efficacy of fewer than three doses of an HPV-16/18 AS04-adjuvanted vaccine: combined analysis of data from the Costa Rica Vaccine and PATRICIA trials

Summary Background There is some evidence to suggest that one or two doses of the HPV vaccine provides similar protection to the three-dose regimen. The main aim of the study was to ascertain HPV-16/18 vaccine efficacy in both full and naive cohorts and to explore protection conferred against non-va... Full description

Journal Title: The lancet oncology 2015, Vol.16 (7), p.775-786
Main Author: Kreimer, Aimée R, Dr
Other Authors: Struyf, Frank, MD , Del Rosario-Raymundo, Maria Rowena, MD , Hildesheim, Allan, Prof , Skinner, S Rachel, PhD , Wacholder, Sholom, Prof , Garland, Suzanne M, Prof , Herrero, Rolando, PhD , David, Marie-Pierre, MSc , Wheeler, Cosette M, Dr Prof
Format: Electronic Article Electronic Article
Language: English
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Quelle: Alma/SFX Local Collection
Publisher: England: Elsevier Ltd
ID: ISSN: 1470-2045
Link: https://www.ncbi.nlm.nih.gov/pubmed/26071347
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title: Efficacy of fewer than three doses of an HPV-16/18 AS04-adjuvanted vaccine: combined analysis of data from the Costa Rica Vaccine and PATRICIA trials
format: Article
creator:
  • Kreimer, Aimée R, Dr
  • Struyf, Frank, MD
  • Del Rosario-Raymundo, Maria Rowena, MD
  • Hildesheim, Allan, Prof
  • Skinner, S Rachel, PhD
  • Wacholder, Sholom, Prof
  • Garland, Suzanne M, Prof
  • Herrero, Rolando, PhD
  • David, Marie-Pierre, MSc
  • Wheeler, Cosette M, Dr Prof
subjects:
  • Adjuvants, Immunologic - administration & dosage
  • Adolescent
  • Adult
  • Age Factors
  • Cervical cancer
  • Cervical Intraepithelial Neoplasia - prevention & control
  • Cervical Intraepithelial Neoplasia - virology
  • Costa Rica
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Follow-Up Studies
  • Hematology, Oncology and Palliative Medicine
  • Human papillomavirus
  • Human papillomavirus 16 - immunology
  • Human papillomavirus 16 - isolation & purification
  • Human papillomavirus 18 - immunology
  • Human papillomavirus 18 - isolation & purification
  • Humans
  • Papillomavirus Infections - prevention & control
  • Papillomavirus Vaccines - administration & dosage
  • Risk Assessment
  • Time Factors
  • Treatment Outcome
  • United States
  • Vaccination - methods
  • Vaccines
  • Womens health
  • Young Adult
ispartof: The lancet oncology, 2015, Vol.16 (7), p.775-786
description: Summary Background There is some evidence to suggest that one or two doses of the HPV vaccine provides similar protection to the three-dose regimen. The main aim of the study was to ascertain HPV-16/18 vaccine efficacy in both full and naive cohorts and to explore protection conferred against non-vaccine HPV types, by number of doses received. Methods Summary data from the Costa Rica Vaccine Trial (CVT; NCT00128661 ) and ~the PATRICIA trial ( NCT001226810 ), two phase 3, double-blind, randomised controlled clinical trials of the HPV-16/18 AS04-adjuvanted vaccine in young women, were combined in a post-hoc analysis (GlaxoSmithKline [GSK] e-track number 202142) to investigate the efficacy of fewer than three doses of the HPV-16/18 vaccine after 4 years of follow-up. Women were randomly assigned to receive three doses of the HPV-16/18 vaccine or to a control vaccine; yet, some received fewer doses. After exclusion of women with less than 12 months of follow-up or those who were HPV-16/18 DNA-positive at enrolment (for the HPV-16/18 endpoint), we calculated vaccine efficacy against one-time detection of incident HPV infections after three, two, and one dose(s). The primary study endpoint was one-time detection of first incident HPV-16/18 infections accumulated during the follow-up phase. Findings We assessed vaccine efficacy against incident HPV-16/18 infection in the modified total vaccinated cohort (22 327 received three doses, 1185 two doses, 543 one dose). Vaccine efficacy against incident HPV-16/18 infections for three doses was 77·0% (95% CI 74·7–79·1), two doses was 76·0% (62·0–85·3), and one dose was 85·7% (70·7–93·7). Vaccine efficacy against incident HPV-31/33/45 infections for three doses was 59·7% (56·0–63·0), two doses was 37·7% (12·4–55·9), and one dose was 36·6% (–5·4 to 62·2). Vaccine efficacy against incident HPV-16/18 infection for two-dose women who received their second dose at 1 month was 75·3% (54·2–87·5) and 82·6% (42·3–96·1) for those who received the second dose at 6 months (CVT data only). Vaccine efficacy against HPV-31/33/45 for two-dose women who received their second dose at 6 months (68·1%, 27·0–87·0; CVT data only), but not those receiving it at one month (10·1%, −42·0 to 43·3), was similar to the three-dose group. Interpretation 4 years after vaccination of women aged 15–25 years, one and two doses of the HPV-16/18 vaccine seem to protect against cervical HPV-16/18 infections, similar to the protection provided by the three-dos
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 1470-2045
fulltext: fulltext
issn:
  • 1470-2045
  • 1474-5488
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titleEfficacy of fewer than three doses of an HPV-16/18 AS04-adjuvanted vaccine: combined analysis of data from the Costa Rica Vaccine and PATRICIA trials
sourceAlma/SFX Local Collection
creatorKreimer, Aimée R, Dr ; Struyf, Frank, MD ; Del Rosario-Raymundo, Maria Rowena, MD ; Hildesheim, Allan, Prof ; Skinner, S Rachel, PhD ; Wacholder, Sholom, Prof ; Garland, Suzanne M, Prof ; Herrero, Rolando, PhD ; David, Marie-Pierre, MSc ; Wheeler, Cosette M, Dr Prof
creatorcontribKreimer, Aimée R, Dr ; Struyf, Frank, MD ; Del Rosario-Raymundo, Maria Rowena, MD ; Hildesheim, Allan, Prof ; Skinner, S Rachel, PhD ; Wacholder, Sholom, Prof ; Garland, Suzanne M, Prof ; Herrero, Rolando, PhD ; David, Marie-Pierre, MSc ; Wheeler, Cosette M, Dr Prof ; Costa Rica Vaccine Trial and the PATRICIA study groups ; GSK Vaccines Clinical Study Support Group ; Costa Rica Vaccine Trial Study Group Authors ; PATRICIA Study Group Authors ; HPV PATRICIA Principal Investigators/Co-Principal Investigator Collaborators
descriptionSummary Background There is some evidence to suggest that one or two doses of the HPV vaccine provides similar protection to the three-dose regimen. The main aim of the study was to ascertain HPV-16/18 vaccine efficacy in both full and naive cohorts and to explore protection conferred against non-vaccine HPV types, by number of doses received. Methods Summary data from the Costa Rica Vaccine Trial (CVT; NCT00128661 ) and ~the PATRICIA trial ( NCT001226810 ), two phase 3, double-blind, randomised controlled clinical trials of the HPV-16/18 AS04-adjuvanted vaccine in young women, were combined in a post-hoc analysis (GlaxoSmithKline [GSK] e-track number 202142) to investigate the efficacy of fewer than three doses of the HPV-16/18 vaccine after 4 years of follow-up. Women were randomly assigned to receive three doses of the HPV-16/18 vaccine or to a control vaccine; yet, some received fewer doses. After exclusion of women with less than 12 months of follow-up or those who were HPV-16/18 DNA-positive at enrolment (for the HPV-16/18 endpoint), we calculated vaccine efficacy against one-time detection of incident HPV infections after three, two, and one dose(s). The primary study endpoint was one-time detection of first incident HPV-16/18 infections accumulated during the follow-up phase. Findings We assessed vaccine efficacy against incident HPV-16/18 infection in the modified total vaccinated cohort (22 327 received three doses, 1185 two doses, 543 one dose). Vaccine efficacy against incident HPV-16/18 infections for three doses was 77·0% (95% CI 74·7–79·1), two doses was 76·0% (62·0–85·3), and one dose was 85·7% (70·7–93·7). Vaccine efficacy against incident HPV-31/33/45 infections for three doses was 59·7% (56·0–63·0), two doses was 37·7% (12·4–55·9), and one dose was 36·6% (–5·4 to 62·2). Vaccine efficacy against incident HPV-16/18 infection for two-dose women who received their second dose at 1 month was 75·3% (54·2–87·5) and 82·6% (42·3–96·1) for those who received the second dose at 6 months (CVT data only). Vaccine efficacy against HPV-31/33/45 for two-dose women who received their second dose at 6 months (68·1%, 27·0–87·0; CVT data only), but not those receiving it at one month (10·1%, −42·0 to 43·3), was similar to the three-dose group. Interpretation 4 years after vaccination of women aged 15–25 years, one and two doses of the HPV-16/18 vaccine seem to protect against cervical HPV-16/18 infections, similar to the protection provided by the three-dose schedule. Two doses separated by 6 months additionally provided some cross-protection. These data argue for a direct assessment of one-dose efficacy of the HPV-16/18 vaccine. Funding US National Cancer Institute, National Institutes of Health Office of Research on Women's Health, and Ministry of Health of Costa Rica (CVT); GlaxoSmithKline Biologicals SA (PATRICIA).
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1Struyf, Frank, MD
2Del Rosario-Raymundo, Maria Rowena, MD
3Hildesheim, Allan, Prof
4Skinner, S Rachel, PhD
5Wacholder, Sholom, Prof
6Garland, Suzanne M, Prof
7Herrero, Rolando, PhD
8David, Marie-Pierre, MSc
9Wheeler, Cosette M, Dr Prof
10Costa Rica Vaccine Trial and the PATRICIA study groups
11GSK Vaccines Clinical Study Support Group
12Costa Rica Vaccine Trial Study Group Authors
13PATRICIA Study Group Authors
14HPV PATRICIA Principal Investigators/Co-Principal Investigator Collaborators
title
0Efficacy of fewer than three doses of an HPV-16/18 AS04-adjuvanted vaccine: combined analysis of data from the Costa Rica Vaccine and PATRICIA trials
1The lancet oncology
addtitleLancet Oncol
descriptionSummary Background There is some evidence to suggest that one or two doses of the HPV vaccine provides similar protection to the three-dose regimen. The main aim of the study was to ascertain HPV-16/18 vaccine efficacy in both full and naive cohorts and to explore protection conferred against non-vaccine HPV types, by number of doses received. Methods Summary data from the Costa Rica Vaccine Trial (CVT; NCT00128661 ) and ~the PATRICIA trial ( NCT001226810 ), two phase 3, double-blind, randomised controlled clinical trials of the HPV-16/18 AS04-adjuvanted vaccine in young women, were combined in a post-hoc analysis (GlaxoSmithKline [GSK] e-track number 202142) to investigate the efficacy of fewer than three doses of the HPV-16/18 vaccine after 4 years of follow-up. Women were randomly assigned to receive three doses of the HPV-16/18 vaccine or to a control vaccine; yet, some received fewer doses. After exclusion of women with less than 12 months of follow-up or those who were HPV-16/18 DNA-positive at enrolment (for the HPV-16/18 endpoint), we calculated vaccine efficacy against one-time detection of incident HPV infections after three, two, and one dose(s). The primary study endpoint was one-time detection of first incident HPV-16/18 infections accumulated during the follow-up phase. Findings We assessed vaccine efficacy against incident HPV-16/18 infection in the modified total vaccinated cohort (22 327 received three doses, 1185 two doses, 543 one dose). Vaccine efficacy against incident HPV-16/18 infections for three doses was 77·0% (95% CI 74·7–79·1), two doses was 76·0% (62·0–85·3), and one dose was 85·7% (70·7–93·7). Vaccine efficacy against incident HPV-31/33/45 infections for three doses was 59·7% (56·0–63·0), two doses was 37·7% (12·4–55·9), and one dose was 36·6% (–5·4 to 62·2). Vaccine efficacy against incident HPV-16/18 infection for two-dose women who received their second dose at 1 month was 75·3% (54·2–87·5) and 82·6% (42·3–96·1) for those who received the second dose at 6 months (CVT data only). Vaccine efficacy against HPV-31/33/45 for two-dose women who received their second dose at 6 months (68·1%, 27·0–87·0; CVT data only), but not those receiving it at one month (10·1%, −42·0 to 43·3), was similar to the three-dose group. Interpretation 4 years after vaccination of women aged 15–25 years, one and two doses of the HPV-16/18 vaccine seem to protect against cervical HPV-16/18 infections, similar to the protection provided by the three-dose schedule. Two doses separated by 6 months additionally provided some cross-protection. These data argue for a direct assessment of one-dose efficacy of the HPV-16/18 vaccine. Funding US National Cancer Institute, National Institutes of Health Office of Research on Women's Health, and Ministry of Health of Costa Rica (CVT); GlaxoSmithKline Biologicals SA (PATRICIA).
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1Adolescent
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3Age Factors
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5Cervical Intraepithelial Neoplasia - prevention & control
6Cervical Intraepithelial Neoplasia - virology
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8Dose-Response Relationship, Drug
9Double-Blind Method
10Drug Administration Schedule
11Female
12Follow-Up Studies
13Hematology, Oncology and Palliative Medicine
14Human papillomavirus
15Human papillomavirus 16 - immunology
16Human papillomavirus 16 - isolation & purification
17Human papillomavirus 18 - immunology
18Human papillomavirus 18 - isolation & purification
19Humans
20Papillomavirus Infections - prevention & control
21Papillomavirus Vaccines - administration & dosage
22Risk Assessment
23Time Factors
24Treatment Outcome
25United States
26Vaccination - methods
27Vaccines
28Womens health
29Young Adult
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2Del Rosario-Raymundo, Maria Rowena, MD
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4Skinner, S Rachel, PhD
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6Garland, Suzanne M, Prof
7Herrero, Rolando, PhD
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titleEfficacy of fewer than three doses of an HPV-16/18 AS04-adjuvanted vaccine: combined analysis of data from the Costa Rica Vaccine and PATRICIA trials
authorKreimer, Aimée R, Dr ; Struyf, Frank, MD ; Del Rosario-Raymundo, Maria Rowena, MD ; Hildesheim, Allan, Prof ; Skinner, S Rachel, PhD ; Wacholder, Sholom, Prof ; Garland, Suzanne M, Prof ; Herrero, Rolando, PhD ; David, Marie-Pierre, MSc ; Wheeler, Cosette M, Dr Prof
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1Adolescent
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3Age Factors
4Cervical cancer
5Cervical Intraepithelial Neoplasia - prevention & control
6Cervical Intraepithelial Neoplasia - virology
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8Dose-Response Relationship, Drug
9Double-Blind Method
10Drug Administration Schedule
11Female
12Follow-Up Studies
13Hematology, Oncology and Palliative Medicine
14Human papillomavirus
15Human papillomavirus 16 - immunology
16Human papillomavirus 16 - isolation & purification
17Human papillomavirus 18 - immunology
18Human papillomavirus 18 - isolation & purification
19Humans
20Papillomavirus Infections - prevention & control
21Papillomavirus Vaccines - administration & dosage
22Risk Assessment
23Time Factors
24Treatment Outcome
25United States
26Vaccination - methods
27Vaccines
28Womens health
29Young Adult
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abstractSummary Background There is some evidence to suggest that one or two doses of the HPV vaccine provides similar protection to the three-dose regimen. The main aim of the study was to ascertain HPV-16/18 vaccine efficacy in both full and naive cohorts and to explore protection conferred against non-vaccine HPV types, by number of doses received. Methods Summary data from the Costa Rica Vaccine Trial (CVT; NCT00128661 ) and ~the PATRICIA trial ( NCT001226810 ), two phase 3, double-blind, randomised controlled clinical trials of the HPV-16/18 AS04-adjuvanted vaccine in young women, were combined in a post-hoc analysis (GlaxoSmithKline [GSK] e-track number 202142) to investigate the efficacy of fewer than three doses of the HPV-16/18 vaccine after 4 years of follow-up. Women were randomly assigned to receive three doses of the HPV-16/18 vaccine or to a control vaccine; yet, some received fewer doses. After exclusion of women with less than 12 months of follow-up or those who were HPV-16/18 DNA-positive at enrolment (for the HPV-16/18 endpoint), we calculated vaccine efficacy against one-time detection of incident HPV infections after three, two, and one dose(s). The primary study endpoint was one-time detection of first incident HPV-16/18 infections accumulated during the follow-up phase. Findings We assessed vaccine efficacy against incident HPV-16/18 infection in the modified total vaccinated cohort (22 327 received three doses, 1185 two doses, 543 one dose). Vaccine efficacy against incident HPV-16/18 infections for three doses was 77·0% (95% CI 74·7–79·1), two doses was 76·0% (62·0–85·3), and one dose was 85·7% (70·7–93·7). Vaccine efficacy against incident HPV-31/33/45 infections for three doses was 59·7% (56·0–63·0), two doses was 37·7% (12·4–55·9), and one dose was 36·6% (–5·4 to 62·2). Vaccine efficacy against incident HPV-16/18 infection for two-dose women who received their second dose at 1 month was 75·3% (54·2–87·5) and 82·6% (42·3–96·1) for those who received the second dose at 6 months (CVT data only). Vaccine efficacy against HPV-31/33/45 for two-dose women who received their second dose at 6 months (68·1%, 27·0–87·0; CVT data only), but not those receiving it at one month (10·1%, −42·0 to 43·3), was similar to the three-dose group. Interpretation 4 years after vaccination of women aged 15–25 years, one and two doses of the HPV-16/18 vaccine seem to protect against cervical HPV-16/18 infections, similar to the protection provided by the three-dose schedule. Two doses separated by 6 months additionally provided some cross-protection. These data argue for a direct assessment of one-dose efficacy of the HPV-16/18 vaccine. Funding US National Cancer Institute, National Institutes of Health Office of Research on Women's Health, and Ministry of Health of Costa Rica (CVT); GlaxoSmithKline Biologicals SA (PATRICIA).
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