Sustained efficacy and immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine up to 7.3 years in young adult women

Carvalho, N. De; Teixeira, Júlio César; Roteli-Martins, Cecília Maria; Naud, Paulo; Borba, P. De; Zahaf, Toufik; Sánchez, Nervo; Schuind, Anne

doi:10.1016/j.vaccine.2010.07.007

Cited by 138 publications

(126 citation statements)

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“…Plateau levels (dashed lines) are 418.3 EU / mL and 242.6 EU / mL for HPV ‐16 and HPV ‐18, respectively (month 107–113 in reference study) 13, 14, 16. Natural infection levels (solid lines) are 29.8 EU / mL and 22.7 EU / mL for HPV ‐16 and HPV ‐18, respectively 15.…”

Section: Resultsmentioning

confidence: 98%

Ten‐year immune persistence and safety of the HPV‐16/18 AS04‐adjuvanted vaccine in females vaccinated at 15–55 years of age

et al. 2017

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Women remain at risk of human papillomavirus (HPV) infection for most of their lives. The duration of protection against HPV‐16/18 from prophylactic vaccination remains unknown. We investigated the 10‐year immune response and long‐term safety profile of the HPV‐16/18 AS04‐adjuvanted vaccine (AS04‐HPV‐16/18 vaccine) in females aged between 15 and 55 years at first vaccination. Females who received primary vaccination with three doses of AS04‐HPV‐16/18 vaccine in the primary phase‐III study (NCT00196937) were invited to attend annual evaluations for long‐term immunogenicity and safety. Anti‐HPV‐16/18 antibodies in serum and cervico‐vaginal secretions (CVS) were measured using enzyme‐linked immunosorbent assay (ELISA). Serious adverse events (SAEs) were recorded throughout the follow‐up period. Seropositivity rates for anti‐HPV‐16 remained high (≥96.3%) in all age groups 10 years after first vaccination. It was found that 99.2% of 15–25‐year olds remained seropositive for anti‐HPV‐18 compared to 93.7% and 83.8% of 26–45‐year olds and 45–55‐year olds, respectively. Geometric mean titers (GMT) remained above natural infection levels in all age groups. Anti‐HPV‐16 and anti‐HPV‐18 titers were at least 5.3‐fold and 3.1‐fold higher than titers observed after natural infection, respectively, and were predicted to persist above natural infection levels for ≥30 years in all age groups. At Year 10, anti‐HPV‐16/18 antibody titers in subjects aged 15–25 years remained above plateau levels observed in previous studies. Correlation coefficients for antibody titers in serum and CVS were 0.64 (anti‐HPV‐16) and 0.38 (anti‐HPV‐18). This study concluded that vaccinated females aged 15–55 years elicited sustained immunogenicity with an acceptable safety profile up to 10 years after primary vaccination, suggesting long‐term protection against HPV.

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Section: Resultsmentioning

confidence: 98%

Ten‐year immune persistence and safety of the HPV‐16/18 AS04‐adjuvanted vaccine in females vaccinated at 15–55 years of age

et al. 2017

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“…Immunogenicity data for approximately 2200 females 15 to 25 years of age from a number of phase II and III protocols (97,100,120) at seven months and at 7.3 year follow-up (n=304 women) (121) are available. Over 99% of women seroconverted to both vaccine genotypes, and seven-month anti-HPV type 16 geometric mean titer (GMT) were 9341.5 EU/mL (95% CI: 8760-9961) with anti-HPV type 18 GMT of 4769.6 EU/ mL (95% CI: 4491-5065).…”

Section: Immunogenicity Of Hpv2 In Femalesmentioning

confidence: 99%

Update on Human Papillomavirus (HPV) Vaccines

Dm¹,

Mt²,

Ds³

2012

Canada Communicable Disease Report

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“…GlaxoSmithKline Vaccines has developed a prophylactic vaccine against HPV types 16 and 18, formulated with the AS04 adjuvant system. This vaccine has been shown to be immunogenic and efficacious and to have a clinically acceptable safety profile (6)(7)(8)(9)(10)(11)(12)(13)(14).In the large, randomized, double-blind, controlled Papilloma Trial against Cancer in Young Adults (PATRICIA) (ClinicalTrials.gov registration no. NCT00122681), the HPV-16/18 AS04-adjuvanted vaccine prevented persistent infections and highgrade cervical lesions associated with HPV types 16 and/or 18 (11-13) and showed high efficacy against cervical intraepithelial…”

mentioning

confidence: 99%

mentioning

confidence: 99%

“…The protocol-specified testing algorithm for PATRICIA included the broad-spectrum L1-based SPF 10 PCR DNA immunoassay (DEIA) line probe assay (LiPA 25 ) system (here referred to as SPF 10 PCR-DEIA/LiPA 25 ) and type-specific PCRs for HPV-16 and HPV-18 (16, 17) but did not include type-specific PCRs for nonvaccine HPV types. It is well recognized that broad-spectrum PCRs are affected by competition between different HPV genotypes present in the same sample and may underestimate the prevalence of genotypes present at low relative concentrations in multiple infections due to the differential efficiency of amplification (16), a phenomenon that has been described as masking (18).…”

mentioning

confidence: 99%

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Post Hoc Analysis of the PATRICIA Randomized Trial of the Efficacy of Human Papillomavirus Type 16 (HPV-16)/HPV-18 AS04-Adjuvanted Vaccine against Incident and Persistent Infection with Nonvaccine Oncogenic HPV Types Using an Alternative Multiplex Type-Specific PCR Assay for HPV DNA

Struyf

Colau

Wheeler

et al. 2015

Clin Vaccine Immunol

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; GlaxoSmithKline Vaccines, King of Prussia, Pennsylvania, USA bb The efficacy of the human papillomavirus type 16 (HPV-16)/HPV-18 AS04-adjuvanted vaccine against cervical infections with HPV in the Papilloma Trial against Cancer in Young Adults (PATRICIA) was evaluated using a combination of the broad-spectrum L1-based SPF 10 PCR-DNA enzyme immunoassay (DEIA)/line probe assay (LiPA 25 ) system with type-specific PCRs for HPV-16 and -18. Broad-spectrum PCR assays may underestimate the presence of HPV genotypes present at relatively low concentrations in multiple infections, due to competition between genotypes. Therefore, samples were retrospectively reanalyzed using a testing algorithm incorporating the SPF 10 PCR-DEIA/LiPA 25 plus a novel E6-based multiplex type-specific PCR and reverse hybridization assay (MPTS12 RHA), which permits detection of a panel of nine oncogenic HPV genotypes (types 16, 18, 31, 33, 35, 45, 52, 58, and 59). For the vaccine against HPV types 16 and 18, there was no major impact on estimates of vaccine efficacy (VE) for incident or 6-month or 12-month persistent infections when the MPTS12 RHA was included in the testing algorithm versus estimates with the protocol-specified algorithm. However, the alternative testing algorithm showed greater sensitivity than the protocol-specified algorithm for detection of some nonvaccine oncogenic HPV types. More cases were gained in the control group than in the vaccine group, leading to higher point estimates of VE for 6-month and 12-month persistent infections for the nonvaccine oncogenic types included in the MPTS12 RHA assay (types 31, 33, 35, 45, 52, 58, and 59). This post hoc analysis indicates that the per-protocol testing algorithm used in PATRICIA underestimated the VE against some nonvaccine oncogenic HPV types and that the choice of the HPV DNA testing methodology is important for the evaluation of VE in clinical trials. (This study has been registered at ClinicalTrials.gov under registration no. NCT00122681.) P ersistent infection with oncogenic human papillomavirus (HPV) is a necessary prerequisite for the development of invasive cervical cancer (ICC) (1). HPV type 16 (HPV-16) and HPV-18 are found in approximately 70% of cases (2-5). Other common oncogenic HPV types causing ICC include types 31, 33, 35, 45, 52, and 58 (2-5). GlaxoSmithKline Vaccines has developed a prophylactic vaccine against HPV types 16 and 18, formulated with the AS04 adjuvant system. This vaccine has been shown to be immunogenic and efficacious and to have a clinically acceptable safety profile (6)(7)(8)(9)(10)(11)(12)(13)(14).In the large, randomized, double-blind, controlled Papilloma Trial against Cancer in Young Adults (PATRICIA) (ClinicalTrials.gov registration no. NCT00122681), the HPV-16/18 AS04-adjuvanted vaccine prevented persistent infections and highgrade cervical lesions associated with HPV types 16 and/or 18 (11-13) and showed high efficacy against cervical intraepithelial

show abstract

Sustained efficacy and immunogenicity of the HPV-16/18 AS04-adjuvanted vaccine up to 7.3 years in young adult women

Cited by 138 publications

References 28 publications

Ten‐year immune persistence and safety of the HPV‐16/18 AS04‐adjuvanted vaccine in females vaccinated at 15–55 years of age

Ten‐year immune persistence and safety of the HPV‐16/18 AS04‐adjuvanted vaccine in females vaccinated at 15–55 years of age

Update on Human Papillomavirus (HPV) Vaccines

Post Hoc Analysis of the PATRICIA Randomized Trial of the Efficacy of Human Papillomavirus Type 16 (HPV-16)/HPV-18 AS04-Adjuvanted Vaccine against Incident and Persistent Infection with Nonvaccine Oncogenic HPV Types Using an Alternative Multiplex Type-Specific PCR Assay for HPV DNA

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