Efficacy of the bivalent HPV vaccine against HPV 16/18-associated precancer: long-term follow-up results from the Costa Rica Vaccine Trial

Porras, Carolina; Tsang, Sabrina H.; Herrero, Rolando; Guillén, Diego Miguel Gracia; Darragh, Teresa M.; Stoler, Mark H.; Hildesheim, Allan; Wagner, Sarah; Boland, Joseph F.; Lowy, Douglas R.; Schiller, John T.; Schiffman, Mark; Schussler, John; Gail, Mitchell H.; Quint, Wim; Ocampo, Rebeca; Morales, Jorge; Hu, Shangying; Sampson, Joshua N.; Kreimer, Aimée R.; Cortés, Bernal; González, Paula; Jiménez, Silvia; Rodríguez, Ana Cecilia; Sherman, Mark E.; Pinto, Lígia A.; Kemp, Troy J.; Sidawy, Mary K.; Doorn, Leen Jan Van; Struijk, Linda; Palefsky, Joel M.

doi:10.1016/s1470-2045(20)30524-6

Cited by 68 publications

(61 citation statements)

References 27 publications

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“…In the Costa Rica Vaccine Trial, a randomized, double-blind, controlled trial that assessed the efficacy of the initial bivalent vaccination, women aged 18-25 years were enrolled. As a result, cumulative VE against HPV 16/18-associated CIN2+ (CIN2 or worse) and CIN3+ (CIN3 or worse) over the 11.1-year period was 97.4% (95% confidence interval [CI], 88.0-99.6) and 94.9% (73.7-99.4), respectively [36]. This report shows the longest efficacy period of a bivalent vaccine.…”

Section: Long-term Efficacy: Clinical Trialsmentioning

confidence: 72%

“…According to a previous review on the long-term effect on precancers [23], the observation period for the bivalent HPV vaccine was 3.6 years in the HPV 001 [25], 6.4 years in the HPV 007 [34], 8.4 years in the HPV 023 [56], and 9.4 years in the Extension HPV023 trial [34]. In the current situation, the longest follow-up period for bivalent vaccines to date is 11.1 years in the Costa Rica Vaccine Trial [36]. Extension NCT00196937 [37] and NCT 00947115 [35] were clinical trials of evaluations for long-term immunogenicity.…”

Section: Long-term Efficacy: Clinical Trialsmentioning

confidence: 99%

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Long-Term Effects of Human Papillomavirus Vaccination in Clinical Trials and Real-World Data: A Systematic Review

et al. 2022

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The preventive effect of HPV vaccines against anogenital and oropharyngeal cancers has been proven in both clinical trials and real-world data. We reviewed the published evidence about the long-term efficacy and effectiveness of the HPV vaccine in available papers of clinical trials and real-world data. As far as we searched, the longest period of preventive effect for the bivalent, 4-valent, and 9-valent vaccine were 11 years in the Costa Rica trial, 14 years in the FUTURE II, and 8 years in the LTFU extension study of V503-002 and the Scandinavian study, respectively. The sustained clinical effect during the observation period was longest for the 4-valent vaccine. In real-world data, the longest observation period of the vaccine effectiveness was 12 years in an Australian study for the 4-valent vaccine. On the other hand, the longest period of long-term persistence of HPV vaccine-induced seropositivity was 14 years in FUTURE II for the 4-valent vaccine. For the bivalent vaccine, additional long-term follow-up studies may not have been planned due to the launch of the 4-valent and 9-valent vaccines. In some studies of the 9-valent vaccine, the results have not yet been published because of the short observation period. The additional results are expected in the future. In a national immunization program, most girls and boys are inoculated with HPV vaccine by the time puberty begins; thus, it is important to monitor the vaccine effect at least until the sexually active period in their 20s and 30s.

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Section: Long-term Efficacy: Clinical Trialsmentioning

confidence: 72%

Section: Long-term Efficacy: Clinical Trialsmentioning

confidence: 99%

Long-Term Effects of Human Papillomavirus Vaccination in Clinical Trials and Real-World Data: A Systematic Review

et al. 2022

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“…Vaccine efficacy against incident HPV 16 or 18-associated CIN2+ was 100%, and the cumulative vaccine efficacy against HPV 16 or 18-associated CIN2+ was 97.4%. Similarly high levels of protection were seen against HPV 16 or 18-associated CIN3 [63].…”

Section: Costa Ricamentioning

confidence: 81%

“…The Costa Rica Vaccine Trial included data on more than 3700 women given the bivalent HPV vaccine and followed up for over 11 years [62,63]. Vaccine efficacy against incident HPV 16 or 18-associated CIN2+ was 100%, and the cumulative vaccine efficacy against HPV 16 or 18-associated CIN2+ was 97.4%.…”

Section: Costa Ricamentioning

confidence: 99%

Towards the elimination of cervical cancer: HPV epidemiology, real-world experiences and the potential impact of the 9-valent HPV vaccine

Prandi¹,

Cocchio²,

Fonzo³

et al. 2021

EJGO

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This review aims to describe the biology of human papillomavirus (HPV), the development of the related vaccine, real-life experiences from the perspective of the WHO's call on the elimination of cervical cancer, the vaccine's use as an adjuvant to treatments for HPV-related disease, and the international scientific societies' guidelines on HPV vaccination. A systematic review was conducted, also for the specific purpose of assessing the efficacy, immunogenicity and safety of the 9-valent HPV vaccine (the latest to become available). Data sources and study selection methods: PubMed was the primary source of data for this review, while additional information, such as scientific society guidelines, was found by directly searching the web. Publications were eligible if they had at least one result relating to the immunogenicity, safety and efficacy or effectiveness of HPV vaccines. Tabulation, integration and results: The search in the database for this systematic review yielded 266 records, none of which was a duplicate. A first screening procedure excluded 228 publications. Of the remaining 38 potentially eligible publications, 26 were ultimately included in the systematic review. Conclusion: While progress in vaccine development has added more tools to HPV vaccination programs, real-word studies have started to show the benefits of mass vaccination campaigns using bivalent and quadrivalent vaccines. National vaccination programs have also been a testing ground for gender-neutral vaccination-a strategy on which unanimous consensus may not still be lacking, but which undeniably responds to clinical and ethical needs. Much the same can be said of post-treatment vaccination-a relatively new, but promising practice that will certainly have a role in achieving the elimination of cervical cancer.

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“…Extended sensitivity cohort: The extended sensitivity cohort is de ned as the analysis cohort for participants who are HPV DNA negative from enrolment to (and including) the month 6 visit. Participants who are HPV DNA positive at month 6 are excluded to ensure exclusion of all participants who were infected at enrolment and for consistency with previous studies (24).…”

Section: Cohorts and Datasets For Primary And Supporting Analysesmentioning

confidence: 99%

Single-dose HPV Vaccination Efficacy Among Adolescent Girls and Young Women in Kenya (the KEN SHE Study): Study Protocol for a Randomized Controlled Trial

Barnabas

Brown

Onono

et al. 2021

Preprint

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Background: HPV infection is the primary cause of cervical cancer, a leading cause of cancer among women in Kenya and many sub-Saharan African countries. High coverage of HPV vaccination is a World Health Organization priority to eliminate cervical cancer globally, but vaccine supply and logistics limits widespread implementation of the current two or three dose HPV vaccine schedule. Methods: We are conducting an individual randomized controlled trial to evaluate whether a single dose of the bivalent (HPV 16/18) or nonavalent (HPV 16/18/31/33/45/52/58/6/11) HPV vaccine prevents persistent HPV infection, a surrogate marker for precancerous lesions and cervical cancer. The primary objective is to compare the efficacy of immediate, single-dose bivalent or nonavalent vaccination with delayed HPV vaccination. Kenyan women age 15-20 years old are randomized to immediate bivalent HPV and delayed meningococcal vaccine (group 1), immediate nonavalent HPV vaccine and delayed meningococcal vaccine (group 2), or immediate meningococcal vaccine and delayed HPV vaccine (group 3) with 36 months of follow-up. The primary outcome is persistent vaccine-type HPV infection by month 18 and by month 36 for the final durability outcome. The secondary objectives include to: 1) evaluate non-inferiority of antibody titers among girls and adolescents (age 9 to 14 years) from another Tanzanian study, the DoRIS Study (NCT02834637), compared to KEN SHE Study participants; 2) assess the memory B cell immune response at months 36 and 37; and 3) estimate cost-effectiveness using the trial results and health economic models. Discussion: This study will evaluate single-dose HPV vaccine efficacy in Africa and has the potential to guide public health policy and increase HPV vaccine coverage. The secondary aims will assess generalizability of the trial results by evaluating immunobridging from younger ages, durability of the immune response, and the long-term health benefits and cost of single-dose HPV vaccine delivery. Trial registration: NCT03675256

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Efficacy of the bivalent HPV vaccine against HPV 16/18-associated precancer: long-term follow-up results from the Costa Rica Vaccine Trial

Cited by 68 publications

References 27 publications

Long-Term Effects of Human Papillomavirus Vaccination in Clinical Trials and Real-World Data: A Systematic Review

Long-Term Effects of Human Papillomavirus Vaccination in Clinical Trials and Real-World Data: A Systematic Review

Towards the elimination of cervical cancer: HPV epidemiology, real-world experiences and the potential impact of the 9-valent HPV vaccine

Single-dose HPV Vaccination Efficacy Among Adolescent Girls and Young Women in Kenya (the KEN SHE Study): Study Protocol for a Randomized Controlled Trial

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