Efficacy of a prophylactic adjuvanted bivalent L1 virus-like-particle vaccine against infection with human papillomavirus types 16 and 18 in young women: an interim analysis of a phase III double-blind, randomised controlled trial

Paavonen, Jorma; Jenkins, David; Bosch, F. Xavier; Naud, Paulo; Salmerón, Jorge; Wheeler, Cosette M.; Chow, Song Nan; Apter, Dan; Kitchener, Henry C; Castellsagué, Xavier; Carvalho, Newton Sérgio de; Skinner, S. Rachel; Harper, Diane M.; Hedrick, James; Jaisamrarn, Unnop; Limson, Genara; Dionne, Marc; Quint, Wim; Spiessens, Bart; Peeters, Pascal; Struyf, Frank; Wieting, Susan L.; Lehtinen, Matti; Dubin, Gary

doi:10.1016/s0140-6736(07)60946-5

Cited by 1,164 publications

(964 citation statements)

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“…Antibody titers at Year 10 were still at least three times higher than those observed after natural infection across all age groups, and in the older age categories (≥25 years), titers were similar to or just below the plateau levels associated with long‐term efficacy 14, 22. These findings were in line with the results of the primary study and consistent with our expectations, since GMTs are known to decline with increasing age at vaccination 9.…”

Section: Discussionsupporting

confidence: 90%

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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: Discussionsupporting

confidence: 90%

“…The horizontal line indicates the mean antibody titer associated with natural infection in a previously published study 22. GMT , geometric mean titer.…”

Section: Resultsmentioning

confidence: 99%

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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“…In other clinical trials and surveillance studies conducted in different countries such as Japan, the Netherlands and United Kingdom7, 8, 9, 10, 11, 12, 13, 14, 15, 24, 25, 26, 27, 28, 29, transient injection‐site pain lasting for less than 5 days 30 was consistently the most commonly occurring AE. The results of the present study now provide further evidence that the safety profile of the HPV‐16/18 AS04‐adjuvanted vaccine is similar when administered to women in Korea.…”

Section: Discussionmentioning

confidence: 84%

“…The vaccine has been shown to be efficacious in preventing 93.2% of high grade cervical intraepithelial neoplasia (CIN3+) in naive population with an acceptable safety profile and sustained immunogenicity 7, 8, 9, 10, 11. Post‐licensure surveillance has confirmed the safety profiles of the vaccine in many populations 12, 13, 14, 15.…”

Section: Introductionmentioning

confidence: 99%

Six‐year multi‐centre, observational, post‐marketing surveillance of the safety of the HPV‐16/18 AS04‐adjuvanted vaccine in women aged 10–25 years in Korea

Kim

Song²,

Chen

et al. 2017

Pharmacoepidemiology and Drug

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PurposeTo evaluate the safety of HPV‐16/18 AS04‐adjuvanted vaccine when administered as per the PI in Korea.MethodsA total of 3084 women aged 10–25 years were enrolled in this post‐marketing surveillance from 2008 to 2014. Subjects were invited to receive three doses of the vaccine (0, 1 and 6 months), and participants who received at least one dose were included in the analysis. Adverse events (AEs), adverse drug reactions (ADRs) and serious AEs (SAEs) were recorded after each dose. All AEs, ADRs and SAEs were presented with exact 95% confidence intervals (CI) (NCT01101542).ResultsInjection‐site pain was the most frequent AE and ADR reported by 322 subjects (10.4% [95%CI: 9.4–11.6]); the local pain was transient and lasted 4–7 days in most cases. Dysmenorrhoea and vaginitis were the most common unexpected AEs reported by 30 (1.0% [95%CI: 0.7–1.4]) and 16 subjects (0.7% [95%CI: 0.3–0.8]), respectively. Pain (toe pain, leg pain and body pain [one case each]; foot pain [two cases]) was the most common unexpected ADR reported by five subjects (0.2% [95%CI: 0.1–0.4]). Four subjects reported a single SAE (one case each of exostosis, gastroenteritis, abortion and tonsillitis); none were fatal. All SAEs were assessed as unlikely to be related to vaccination; gastroenteritis, exostosis and tonsillitis resolved during the study period.ConclusionsThis is the first post‐marketing surveillance study in Korea that provides 6‐year safety data for HPV‐16/18 AS04‐adjuvanted vaccine. The vaccine showed an acceptable safety profile and favourable benefit/risk ratio when given to women aged 10–25 years in Korea. © 2017 The Authors. Pharmacoepidemiology & Drug Safety Published by John Wiley & Sons Ltd.

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“…HPV‐16 and HPV‐18 are related to >70% of cervical cancers, and HPV 16 is associated with anal, oropharyngeal, vaginal, vulval, and penile cancer 2. Prophylactic HPV vaccination can prevent against infection and disease caused by targeted HPV types 3, 4. Most Western countries have implemented national HPV vaccination programs for young girls, and countries withschool‐based vaccination programs tend to have the highest vaccine uptake 5, 6.…”

mentioning

confidence: 99%

To Consent or Decline HPV Vaccination: A Pilot Study at the Start of the National School‐Based Vaccination Program in Sweden

Grandahl

Tydén

Westerling

et al. 2016

Journal of School Health

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BACKGROUND Parents' beliefs about human papillomavirus (HPV) vaccination influence whether they allow their daughters to be vaccinated. We examined the association between parents' refusal and sociodemographic background, knowledge and beliefs about HPV, and the HPV vaccination in relation to the Health Belief Model. METHODS The sample consisted of 200 (55%) parents of children aged 11‐12 years in the Swedish national vaccination program. Data were collected using a self‐reported questionnaire. Most parents (N = 186) agreed to the vaccination. Pearson's chi‐square, Fisher's exact test, and the Mann‐Whitney U test were used to analyze data. RESULTS Declining parents saw more risks and fewer benefits of HPV vaccination but no differences in beliefs regarding the severity or young girls' susceptibility to HPV were found. There was an association between refusing the HPV vaccine and lower acceptance of previous childhood vaccinations, and their main source of information was the Internet. Parents who declined the vaccine believed it could adversely affect condom use, the age of their daughter's sexual debut, and the number of sexual partners. CONCLUSION Parents should have the possibility to discuss HPV and HPV vaccine with a school nurse or other health care professionals, and should have access to evidence‐based information on the Internet.

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Efficacy of a prophylactic adjuvanted bivalent L1 virus-like-particle vaccine against infection with human papillomavirus types 16 and 18 in young women: an interim analysis of a phase III double-blind, randomised controlled trial

Cited by 1,164 publications

References 20 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

Six‐year multi‐centre, observational, post‐marketing surveillance of the safety of the HPV‐16/18 AS04‐adjuvanted vaccine in women aged 10–25 years in Korea

To Consent or Decline HPV Vaccination: A Pilot Study at the Start of the National School‐Based Vaccination Program in Sweden

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