Antibody persistence and evidence of immune memory at 5 years following administration of the 9-valent HPV vaccine

Guevara, Ana María Agudelo; Cabello, Robinson; Woelber, Linn; Moreira, Edson Duarte; Joura, Elmar A.; Reich, Olaf; Shields, Christine; Ellison, Misoo C.; Joshi, Amita; Luxembourg, Alain

doi:10.1016/j.vaccine.2017.07.017

Cited by 32 publications

(26 citation statements)

References 21 publications

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“…Gardasil®9 has been reported to elicit comparable HPV-16 and HPV-18 antibody responses as Gardasil®. HPV-18 antibody levels induced by three doses of Gardasil®9 measured with the cLIA also declined over time and 78% seropositivity was observed 5 years after vaccination [49] . A similar decline in HPV-45 seropositivity was described, while antibody seropositivity for other types was maintained.…”

Section: Review Of Immunogenicity Of Licensed Hpv Vaccines and Duratimentioning

confidence: 95%

Immunogenicity of HPV prophylactic vaccines: Serology assays and their use in HPV vaccine evaluation and development

Pinto

Dillner

Beddows

et al. 2018

Vaccine

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When administered as standard three-dose schedules, the licensed HPV prophylactic vaccines have demonstrated extraordinary immunogenicity and efficacy. We summarize the immunogenicity of these licensed vaccines and the most commonly used serology assays, with a focus on key considerations for one-dose vaccine schedules. Although immune correlates of protection against infection are not entirely clear, both preclinical and clinical evidence point to neutralizing antibodies as the principal mechanism of protection. Thus, immunogenicity assessments in vaccine trials have focused on measurements of antibody responses to the vaccine. Non-inferiority of antibody responses after two doses of HPV vaccines separated by 6 months has been demonstrated and this evidence supported the recent WHO recommendations for two-dose vaccination schedules in both boys and girls 9–14 years of age. There is also some evidence suggesting that one dose of HPV vaccines may provide protection similar to the currently recommended two-dose regimens but robust data on efficacy and immunogenicity of one-dose vaccine schedules are lacking. In addition, immunogenicity has been assessed and reported using different methods, precluding direct comparison of results between different studies and vaccines. New head-to-head vaccine trials evaluating one-dose immunogenicity and efficacy have been initiated and an increase in the number of trials relying on immunobridging is anticipated. Therefore, standardized measurement and reporting of immunogenicity for the up to nine HPV types targeted by the current vaccines is now critical. Building on previous HPV serology assay standardization and harmonization efforts initiated by the WHO HPV LabNet in 2006, new secondary standards, critical reference reagents and testing guidelines will be generated as part of a new partnership to facilitate harmonization of the immunogenicity testing in new HPV vaccine trials.

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Section: Review Of Immunogenicity Of Licensed Hpv Vaccines and Duratimentioning

confidence: 95%

Immunogenicity of HPV prophylactic vaccines: Serology assays and their use in HPV vaccine evaluation and development

Pinto

Dillner

Beddows

et al. 2018

Vaccine

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“…In Study 001, serum samples were collected at Day 1, Months 3, 7, 12, 24, 36, and 42 for assessment of HPV antibody responses. A subset of participants (including 95 participants randomly selected at 3 sites in Latin America) who received 3 doses of the 9vHPV vaccine were assessed for HPV antibody responses at Month 60 in a study extension [31] ; participants in the extension then received a fourth dose of 9vHPV vaccine and were assessed for HPV antibodies at 1 week and 1 month following the fourth dose to determine whether re-exposure to the antigen via a challenge dose of the vaccine led to the development of an anamnestic response, a hallmark of immune memory. This evaluation is consistent with the guidelines set forth by the World Health Organization (WHO) requiring the assessment of induction of immune memory as part of the development of prophylactic HPV vaccines [32] .…”

Section: Methodsmentioning

confidence: 99%

Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women

Ruiz-Sternberg

Moreira

Restrepo³

et al. 2018

Papillomavirus Research

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BackgroundA 9-valent human papillomavirus (HPV6/11/16/18/31/33/45/52/58; 9vHPV) vaccine was developed to expand coverage of the previously developed quadrivalent (HPV6/11/16/18; qHPV) vaccine.MethodsEfficacy, immunogenicity, and safety outcomes were assessed in Latin American participants enrolled in 2 international studies of the 9vHPV vaccine, including a randomized, double-blinded, controlled with qHPV vaccine, efficacy, immunogenicity, and safety study in young women aged 16–26 years, and an immunogenicity and safety study in girls and boys aged 9–15 years. Participants (N=5312) received vaccination at Day 1, Month 2, and Month 6. Gynecological swabs were collected regularly in young women for cytological and HPV DNA testing. Serum was analyzed for HPV antibodies in all participants. Adverse events (AEs) were also monitored in all participants.ResultsThe 9vHPV vaccine prevented HPV 31-, 33-, 45-, 52-, and 58-related high-grade cervical, vulvar, and vaginal dysplasia with 92.3% efficacy (95% confidence interval 54.4, 99.6). Anti-HPV6, 11, 16, and 18 geometric mean titers at Month 7 were similar in the 9vHPV and qHPV vaccination groups. Anti-HPV antibody responses following vaccination were higher among girls and boys than in young women. Most (>99%) 9vHPV vaccine recipients seroconverted for all 9 HPV types at Month 7. Antibody responses to the 9 HPV types persisted over 5 years. The most common AEs were injection-site related, mostly of mild to moderate intensity.ConclusionsThe 9vHPV vaccine is efficacious, immunogenic, and well tolerated in Latin American young women, girls, and boys. These data support 9vHPV vaccination programs in Latin America, a region with substantial cervical cancer burden.

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“…All of the vaccines indeed elicit high titres of potent, type-specific nAbs that prevent infection by transudation or exudation through the epithelium at the site of infection [8,18,19] and induce protection against cervical cancer that is associated to the vaccine HPV with approximately 100% efficacy [20][21][22][23]. Indeed, follow up studies report long-term immune responses and protection up to 10-12 years for Cervarix and Gardasil [24][25][26] and up to five years for Gardasil 9 [13,27]. However, continued monitoring is important in identifying potential signals of waning, especially in women that are vaccinated after adolescence.…”

Section: Introductionmentioning

confidence: 99%

HPV-Specific Systemic Antibody Responses and Memory B Cells are Independently Maintained up to 6 Years and in a Vaccine-Specific Manner Following Immunization with Cervarix and Gardasil in Adolescent and Young Adult Women in Vaccination Programs in Italy

et al. 2020

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Human papillomavirus (HPV) persistent infections are associated with cervical cancer and other HPV-related diseases and tumors. Thus, the characterization of long lasting immunity to currently available HPV vaccines is important. A total of 149 female subjects vaccinated with Cervarix or Gardasil participated to the study and they were stratified according to age (10–12-year-old and 16–20-year-old). Humoral immune responses (IgG and neutralizing antibody titers, antibody avidity) and circulating memory B cells were analyzed after an average of 4–6 years from the third immunization. The humoral responses against HPV-16 and HPV-18 (and HPV-6 and HPV-11 for Gardasil) were high in both age groups and vaccines up to six years from the third dose. However, Cervarix induced significantly higher and more persistent antibody responses, while the two vaccines were rather equivalent in inducing memory B cells against HPV-16 and HPV-18. Moreover, the percentage of subjects with vaccine-specific memory B cells was even superior among Gardasil vaccinees and, conversely, Cervarix vaccinated individuals with circulating antibodies, but undetectable memory B cells were found. Finally, a higher proportion of Cervarix-vaccinated subjects displayed cross-neutralizing responses against non-vaccine types HPV-31 and HPV-45. Gardasil and Cervarix may, thus, differently affect long-lasting humoral immunity from both the quantitative and qualitative point of view.

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Antibody persistence and evidence of immune memory at 5 years following administration of the 9-valent HPV vaccine

Cited by 32 publications

References 21 publications

Immunogenicity of HPV prophylactic vaccines: Serology assays and their use in HPV vaccine evaluation and development

Immunogenicity of HPV prophylactic vaccines: Serology assays and their use in HPV vaccine evaluation and development

Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women

HPV-Specific Systemic Antibody Responses and Memory B Cells are Independently Maintained up to 6 Years and in a Vaccine-Specific Manner Following Immunization with Cervarix and Gardasil in Adolescent and Young Adult Women in Vaccination Programs in Italy

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