Persistence of immune response to HPV-16/18 AS04-adjuvanted cervical cancer vaccine in women aged 15-55 years

Schwarz, Tino F.; Spaczyński, Marek; Schneider, Achim; Wysocki, Jacek; Galaj, Andrzej; Schulze, Karin; Poncelet, Sylviane; Catteau, Grégory; Thomas, Florence; Descamps, Dominique

doi:10.4161/hv.7.9.15999

Cited by 36 publications

(40 citation statements)

References 51 publications

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“…The kinetics of antibodies observed during the first three years post-second dose is similar to those reported after three doses in older females in which vaccine efficacy was demonstrated. 8,26 Additionally, the pattern of Table 3. Anti-HPV GMTs at different study time points (LU*; 95% cI; ATP analysis) *LU-Luminex Units; **qHPV vaccine -Gardasil ® antibody kinetics in our study is consistent with that reported recently in another Canadian study which compared the immunogenicity of two-dose schedule (0-6 mo; given at the age of 9-13) with that observed after three-dose schedule (0-2-6 mo; given at the age of 9-13 or 16-26) 27 and with those observed in a study conducted in Vietnam with alternative three-dose schedules (0-2-6; 0-3-9; 0-6-12 and 0-12-24 mo; with the start of vaccination at the age of 11-13).…”

Section: Discussionmentioning

confidence: 99%

Immunogenicity of quadrivalent HPV and combined hepatitis A and B vaccine when co-administered or administered one month apart to 9–10 year-old girls according to 0–6 month schedule

Gîlca

Sauvageau

Boulianne

et al. 2014

Human Vaccines & Immunotherapeutics

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IntroductionThe approved schedules for human papilloma virus (HPV) vaccines (qHPV (Gardasil®) and bHPV (Cervarix®)) include three doses administered at 0, 1-2 and 6 m. The first two doses given within a relatively short period of time are expected to prime the immune system and the third is expected to confer long-lasting immunity.1 When given according to this schedule to 16-45 y old females, HPV vaccines have been shown to be highly immunogenic and protect against persistent infection, anogenital warts and precancerous abnormalities.2-10 Post-licensure trials with bHPV showed that > 98% of 15-25 y old females developed antibodies to HPV 16 and HPV 18 which remain detectable up to 76 mo after a single vaccine dose.3 In addition, a significant increase in antibody titers resulted from a second dose of vaccine and high clinical efficacy was demonstrated in individuals who received less than three vaccine doses. [4][5][6] Finally, in preadolescents and adolescents, both HPV and combined HAV/HBV vaccines Background. No immunogenicity data has been reported after a single dose of the quadrivalent HPV vaccine (qHPVGardasil®) and no data are available on co-administration of this vaccine with the HAV/HBV vaccine (Twinrix-Junior®). Two pre-licensure studies reported similar anti-HPV but lower anti-HBs titers when co-administering HPV and HBV vaccines.Objectives. To assess the immunogenicity of the qHPV and HAV/HBV vaccine when co-administered (Group-co-adm) or given one month apart (Group-sep) and to measure the persistence of HPV antibodies three years post-second dose of qHPV vaccine in both study groups.Methods. 416 9-10 year-old girls were enrolled. Vaccination schedule was 0-6 months. Anti-HAV and anti-HBs were measured in all subjects 6 months post-first dose and 1 month post-second dose. Anti-HPV were measured 6 months post-first dose in Group-co-adm and in all subjects 1 and 36 months post-second dose.Results. six months post-first dose: 100% of subjects had detectable anti-HAV and 56% and 73% had detectable antiHBs in Group-co-Adm and Group-sep, respectively. In Group-co-adm 94, 100, 99 and 96% had detectable antibodies to HPV 6, 11, 16 and 18, respectively. One month post-second dose of qHPV and HAV/HBV vaccine, in both study groups 99.5-100% of subjects had an anti-HAV titer ≥ 20IU/L, 97.5-97.6% an anti-HBs level ≥ 10IU/L, and 100% had an anti-HPV titer ≥ 3LU. Thirty-six months post-second dose of qHPV all but four subjects (99%) had antibodies to HPV18 and 100% had antibodies to HPV6, 11 and 16. The great majority (97-100%) had an anti-HPV titer ≥ 3 LU. Post-second dose administration of qHPV and HAV/HBV, no meaningful difference was observed in the immune response in the two study groups to any component of vaccines.conclusions. The results indicate that qHPV and HAV/HBV can be given during the same vaccination session. Two doses of of qHPV and HAV/HBV vaccines induce a strong immune response. Three years post-second dose of qHPV, the great majority of subjects had antibodies to HPV types included in the v...

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Section: Discussionmentioning

confidence: 99%

Immunogenicity of quadrivalent HPV and combined hepatitis A and B vaccine when co-administered or administered one month apart to 9–10 year-old girls according to 0–6 month schedule

Gîlca

Sauvageau

Boulianne

et al. 2014

Human Vaccines & Immunotherapeutics

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“…The prophylactic HPV‐16/18 AS04‐adjuvanted vaccine (Cervarix ® ; GlaxoSmithKline, Rixensart, Belgium), which is licensed in over 100 countries worldwide, has been shown to be immunogenic and efficacious against HPV‐16/18 infections in women aged 15–25 years . Recently, a high vaccine efficacy has also been demonstrated in women aged ≥26 years .…”

Section: Introductionmentioning

confidence: 99%

Persistence of immune responses to the HPV‐16/18 AS04‐adjuvanted vaccine in women aged 15–55 years and first‐time modelling of antibody responses in mature women: results from an open‐label 6–year follow‐up study

Schwarz

Spaczyński

Kaufmann

et al. 2014

BJOG

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ObjectiveEvaluation of the long-term HPV-16/18 AS04-adjuvanted vaccine immunogenicity persistence in women.DesignMulticentre, open-label, long-term follow-up (NCT00947115) of a primary phase–III study (NCT00196937).SettingSix centres in Germany and Poland.Population488 healthy women (aged 15–55 years, age-stratified into groups: 15–25, 26–45, and 46–55 years) who received three vaccine doses in the primary study.MethodsImmune responses were evaluated in serum and cervicovaginal secretion (CVS) samples 6 years after dose 1. Anti-HPV-16/18 geometric mean titres (GMTs) were measured by enzyme-linked immunosorbent assay (ELISA), and were used to fit the modified power-law and piecewise models, predicting long-term immunogenicity. Serious adverse events (SAEs) were recorded.Main outcome measuresAnti-HPV-16/18 seropositivity rates and GMTs 6 years after dose 1.ResultsAt 6 years after dose 1, all women were seropositive for anti-HPV–16 and ≥97% were seropositive for anti-HPV–18 antibodies. GMTs ranged from 277.7 to 1344.6 EU/ml, and from 97.6 to 438.2 EU/ml, for anti-HPV–16 and anti-HPV–18, respectively. In all age groups, GMTs were higher (anti-HPV–16, 9.3–45.1-fold; anti-HPV–18, 4.3–19.4-fold) than levels associated with natural infection (29.8 EU/ml). A strong correlation between serum and CVS anti-HPV-16/18 levels was observed, with correlation coefficients of 0.81–0.96 (anti-HPV–16) and 0.69–0.84 (anti-HPV–18). Exploratory modelling based on the 6–year data predicted vaccine-induced anti-HPV-16/18 levels above natural infection levels for at least 20 years, except for anti-HPV–18 in the older age group (piecewise model). One vaccine-related and two fatal SAEs were reported.ConclusionsAt 6 years after vaccination, immune responses induced by the HPV-16/18 AS04-adjuvanted vaccine were sustained in all age groups.

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“…Several immunogenicity and efficacy studies have been performed to evaluate immunization of female adults (24-45 years old), showing that these women also benefit from Gardasil vaccination [52]. Likewise, immunization with Cervarix leads to persistent antibody responses against HPV-16/18 in women aged 15-55 years [53].…”

Section: Hpv Vaccination Of Hiv-positive and Immunosuppressed Individualsmentioning

confidence: 99%

Current Perspectives on HPV Vaccination: A Focus on Targeting the L2 Protein

Seitz

Müller

2014

Future Virol.

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Thirty years ago, human papillomavirus types 16 and 18 were isolated from cervical carcinomas, and it has been almost 10 years since the introduction of the first prophylactic virus-like particle (VLP) vaccine. The VLP vaccines have already impacted the reduction of pre-malignant lesions and genital warts, and it is expected that vaccination efforts will successfully lower the incidence of cervical cancer before the end of the decade. Here we summarize the historical developments leading to the prophylactic HPV vaccines and discuss current advances of next-generation vaccines that aim to overcome certain limitations of the VLP vaccines, including their intrinsic narrow range of protection, stability and production/distribution costs. KEYWORDS• cervical cancer • emerging HPV-associated diseases • human papillomavirus • major capsid protein L1-based virus-like particle vaccines • markers for protection • minor capsid protein L2-based crossprotective vaccines • neutralizing antibodies • nonavalent VLP vaccine • second-generation HPV vaccine • vaccine accessibility and production/ distribution costs Introduction & historyOver the last 150 years the recognition of papillomaviruses as causative agents for a number of malignancies in both animals and humans has evolved. In the 1960s sufficient evidence began accumulating demonstrating a causative role of certain human papillomaviruses (HPVs) in the development of cervical cancer beyond reasonable doubt [1]. Numerous investigations, among them a large number of epidemiological studies, were required to reach this point. As of 2007 we stand with two successful commercial prophylactic vaccines that efficiently protect against the most prevalent oncogenic HPV types.Early observations reported by the Italian physician Rigoni-Stern already hinted at the involvement of infectious agents in the development of cervical cancer when he suggested behavioral risks for this type of tumor [2]. These investigations were eventually resumed in the second half of the 20th century. Not only was the risk for cervical cancer attributed to genital infection, those studies eventually acquitted some of the suspects; for example, an involvement of herpes simplex virus 2 could be ruled out [3].In the 1970s HPV-6 and HPV-11 were isolated and cloned from condylomas and laryngeal papillomas, respectively. At this time, Harald zur Hausen had noted that condylomas and cervical carcinomas share a similar epidemiological pattern and this initiated the systematic hunt for novel papillomaviruses. The strategy at the time utilized Southern blot hybridization techniques under low stringency conditions using the DNA of already isolated HPV types as molecular probes. Within a few years a large number of human and animal papillomavirus genomes had been isolated [4][5][6][7]. Of the more than 200 papillomaviruses known today, many are infecting the genital epithelium and approximately 13 of them are recognized as human oncogenic viruses [8].In the following years it became evident that most if not all cases of ...

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Persistence of immune response to HPV-16/18 AS04-adjuvanted cervical cancer vaccine in women aged 15-55 years

Cited by 36 publications

References 51 publications

Immunogenicity of quadrivalent HPV and combined hepatitis A and B vaccine when co-administered or administered one month apart to 9–10 year-old girls according to 0–6 month schedule

Immunogenicity of quadrivalent HPV and combined hepatitis A and B vaccine when co-administered or administered one month apart to 9–10 year-old girls according to 0–6 month schedule

Persistence of immune responses to the HPV‐16/18 AS04‐adjuvanted vaccine in women aged 15–55 years and first‐time modelling of antibody responses in mature women: results from an open‐label 6–year follow‐up study

Current Perspectives on HPV Vaccination: A Focus on Targeting the L2 Protein

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