scholarly journals Human Papillomavirus Vaccine Efficacy and Effectiveness against Cancer

Vaccines ◽  
2021 ◽  
Vol 9 (12) ◽  
pp. 1413
Author(s):  
Supitcha Kamolratanakul ◽  
Punnee Pitisuttithum

Human papillomavirus (HPV) is the most common sexually transmitted infection, with 15 HPV types related to cervical, anal, oropharyngeal, penile, vulvar, and vaginal cancers. However, cervical cancer remains one of the most common cancers in women, especially in developing countries. Three HPV vaccines have been licensed: bivalent (Cervarix, GSK, Rixensart, Belgium), quadrivalent (Merck, Sharp & Dome (Merck & Co, Whitehouse Station, NJ, USA)), and nonavalent (Merck, Sharp & Dome (Merck & Co, Whitehouse Station, NJ, USA)). The current HPV vaccine recommendations apply to 9 years old and above through the age of 26 years and adults aged 27–45 years who might be at risk of new HPV infection and benefit from vaccination. The primary target population for HPV vaccination recommended by the WHO is girls aged 9–14 years, prior to their becoming sexually active, to undergo a two-dose schedule and girls ≥ 15 years of age, to undergo a three-dose schedule. Safety data for HPV vaccines have indicated that they are safe. The most common adverse side-effect was local symptoms. HPV vaccines are highly immunogenic. The efficacy and effectiveness of vaccines has been remarkably high among young women who were HPV seronegative before vaccination. Vaccine efficacy was lower among women regardless of HPV DNA when vaccinated and among adult women. Comparisons of the efficacy of bivalent, quadrivalent, and nonavalent vaccines against HPV 16/18 showed that they are similar. However, the nonavalent vaccine can provide additional protection against HPV 31/33/45/52/58. In a real-world setting, the notable decrease of HPV 6/11/16/18 among vaccinated women compared with unvaccinated women shows the vaccine to be highly effective. Moreover, the direct effect of the nonavalent vaccine with the cross-protection of bivalent and quadrivalent vaccines results in the reduction of HPV 6/11/16/18/31/33/45/52/58. HPV vaccination has been shown to provide herd protection as well. Two-dose HPV vaccine schedules showed no difference in seroconversion from three-dose schedules. However, the use of a single-dose HPV vaccination schedule remains controversial. For males, the quadrivalent HPV vaccine possibly reduces the incidence of external genital lesions and persistent infection with HPV 6/11/16/18. Evidence regarding the efficacy and risk of HPV vaccination and HIV infection remains limited. HPV vaccination has been shown to be highly effective against oral HPV type 16/18 infection, with a significant percentage of participants developing IgG antibodies in the oral fluid post vaccination. However, the vaccines’ effectiveness in reducing the incidence of and mortality rates from HPV-related head and neck cancers should be observed in the long term. In anal infections and anal intraepithelial neoplasia, the vaccines demonstrate high efficacy. While HPV vaccines are very effective, screening for related cancers, as per guidelines, is still recommended.

Sexual Health ◽  
2014 ◽  
Vol 11 (6) ◽  
pp. 511 ◽  
Author(s):  
Lars Toft ◽  
Martin Tolstrup ◽  
Merete Storgaard ◽  
Lars Østergaard ◽  
Ole S. Søgaard

Background Men and women with HIV infection are at increased risk of developing cancers associated with human papillomavirus (HPV). The two licensed prophylactic HPV vaccines protect against de novo infection with HPV-16 and HPV-18, which cause the majority of HPV-associated cancers. Currently, no vaccine efficacy data are available for persons with HIV infection. Nevertheless, some countries have implemented specific HPV vaccination recommendations for HIV-positive populations. To specifically recommend prophylactic HPV vaccination in people with HIV, the vaccines must be safe and immunogenic in immunosuppressed people at a high risk of HPV infection. This review aims to summarise the current knowledge from published HPV vaccine trials in HIV-infected populations, to compile scheduled and ongoing HPV vaccine trials with HIV-positive study populations and to extrapolate the relevant knowledge about HPV vaccine efficacy in HIV-negative populations to an HIV context. Methods: The databases PubMed, Scopus and ClinicalTrials.gov were searched for peer-reviewed articles and scheduled or ongoing clinical HPV vaccine trials enrolling HIV-positive persons. Results: Current data indicate that prophylactic HPV vaccines are safe and immunogenic in different HIV-positive populations (children, female adolescents, adults). Increased immunogenicity has been reported in persons on antiretroviral therapy compared with antiretroviral-naïve persons, whereas no clear association has been found between CD4+ cell count at immunisation and vaccine response. Several scheduled and ongoing HPV vaccine trials aim to determine vaccine efficacy against disease endpoints in HIV-infected study populations. Conclusion: Prophylactic HPV vaccination appears safe, immunogenic and, by extrapolation, likely to reduce HPV-associated cancer development among persons with HIV infection.


2019 ◽  
Vol 29 (8) ◽  
pp. 1317-1326 ◽  
Author(s):  
Raúl Murillo ◽  
Camila Ordóñez- Reyes

Cervical cancer incidence and mortality have decreased in high-income countries, but low- and middle-income countries continue to bear a significant burden from the disease. Human papillomavirus (HPV) vaccines are a promising alternative for disease control; however, their introduction is slow in settings with greater need. We conducted a review of HPV vaccine efficacy and effectiveness reported in clinical trials and population-based studies. Efficacy of HPV vaccines is close to 100% when using a three-dose schedule in HPV-negative young women (<25 years old) for protection against persistent infection and HPV vaccine-type associated pre-cancerous lesions. Furthermore, sustained protection for up to 12 years of follow-up has been demonstrated; cross-protection against non-vaccine types is particularly observed for the bivalent vaccine, and preliminary data regarding impact on invasive cancer have emerged. Given its lower efficacy, catch-up vaccination beyond 19 years of age and proposals for vaccinating adult women deserve careful evaluation in accurately designed studies and economic analyses. Despite positive results regarding immunogenicity and post-hoc analysis for cervical intra-epithelial neoplasia in clinical trials, population-based data for prime and booster two-dose schedules are not available. Evaluation of vaccine safety from surveillance systems in immunization programs that have already distributed more than 270 million doses found no association of HPV vaccination with serious side effects. The introduction of HPV vaccination in national immunization programs remains the main challenge in tackling the burden of cervical cancer (up to 2018, only 89 countries have introduced vaccination worldwide, and most of these are high-income countries). Access models and technical capacity require further development to help low- and middle-income countries to increase the pace of vaccine delivery. Alternative approaches such as one-dose schedules and vaccination at younger ages may help reduce the programmatic and economic challenges to adolescent vaccination.


2013 ◽  
Vol 02 (04) ◽  
pp. 187-192 ◽  
Author(s):  
Partha Basu ◽  
Dipanwita Banerjee ◽  
Priyanka Singh ◽  
Chandrani Bhattacharya ◽  
Jaydip Biswas

AbstractThe Human Papillomavirus (HPV) vaccines have been widely introduced in the national immunization programs in most of the medium and high income countries following endorsement from national and international advisory bodies. HPV vaccine is unique and its introduction is challenging in many ways – it is the first vaccine developed to prevent any cancer, the vaccine is gender specific, it targets adolescent females who are difficult to reach by any health intervention programs. It is not unusual for such a vaccine to face scepticism and reservations not only from lay public but also from professionals in spite of the clinical trial results convincingly and consistently proving their efficacy and safety. Over the last few years millions of doses of the HPV vaccine have been administered round the world and the efficacy and safety data have started coming from the real life programs. A comprehensive cervical cancer control program involving HPV vaccination of the adolescent girls and screening of the adult women has been proved to be the most cost‑effective approach to reduce the burden of cervical cancer. The present article discusses the justification of HPV vaccination in the backdrop of natural history of cervical cancer, the mechanism of action of the vaccines, efficacy and safety data from phase III randomized controlled trials as well as from the national immunization programs of various countries.


2021 ◽  
Vol 3 ◽  
Author(s):  
David B. Buller ◽  
Sherry Pagoto ◽  
Kimberly Henry ◽  
Julia Berteletti ◽  
Barbara J. Walkosz ◽  
...  

Introduction: Parents acquire information about human papillomavirus (HPV) vaccines online and encounter vaccine-critical content, especially on social media, which may depress vaccine uptake. Secondary analysis in a randomized trial of a Facebook-delivered adolescent health campaign targeting mothers with posts on HPV vaccination was undertaken with the aims of (a) determining whether the pre–post-change occurred in self-reports of the mothers on HPV vaccination of their adolescent daughters; (b) describing the comments and reactions to vaccine posts; (c) exploring the relationship of campaign engagement of the mothers assessed by their comments and reactions to posts to change in the self-reports of the mothers of HPV vaccination.Materials and Methods: Mothers of daughters aged 14–17 were recruited from 34 states of the US (n = 869). A social media campaign was delivered in two Facebook private groups that differed in that 16% of posts in one were focused on indoor tanning (IT) and 16% in the other, on prescription drug misuse, assigned by randomization. In both groups, posts promoted HPV vaccination (n = 38 posts; no randomization) and vaccination for other disease (e.g., influenza, n = 49). HPV and other vaccination posts covered the need for a vaccine, the number of adolescents vaccinated, how vaccines are decreasing the infection rates, and stories of positive benefits of being vaccinated or harms from not vaccinating. Guided by social cognitive theory and diffusion of innovations theory, posts were intended to increase knowledge, perceived risk, response efficacy (i.e., a relative advantage over not vaccinated daughters), and norms for vaccination. Some vaccination posts linked to stories to capitalize on identification effects in narratives, as explained in transportation theory. All mothers received the posts on vaccination (i.e., there was no randomization). Mothers completed surveys at baseline and 12- and 18-month follow-up to assess HPV vaccine uptake by self-report measures. Reactions (such as sad, angry) and comments to each HPV-related post were counted and coded.Results: Initiation of HPV vaccination (1 dose) was reported by 63.4% of mothers at baseline, 71.3% at 12-month posttest (pre/post p &lt; 0.001), and 73.3% at 18-month posttest (pre/post p &lt; 0.001). Completion of HPV vaccination (two or three doses) was conveyed by 50.2% of mothers at baseline, 62.5% at 12-month posttest (pre/post p &lt; 0.001), and 65.9% at 18-month posttest (pre/post p &lt; 0.001). For posts on HPV vaccines, 8.1% of mothers reacted (n = 162 total), and 68.4% of posts received a reaction (63.2% like; 13.2% love, 7.9% sad). In addition, 7.6% of mothers commented (n = 122; 51 unfavorable, 68 favorable, 1 neutral), and 50.0% of these posts received a comment. There were no differences in pre–post change in vaccine status by the count of reactions or comments to HPV vaccine posts (Ps &gt; 0.05). Baseline vaccination was associated with the valence of comments to HPV vaccine posts (7.2% of mothers whose daughters had completed the HPV series at baseline made a favorable comment but 7.6% of mothers whose daughters were unvaccinated made an unfavorable comment).Conclusion: Effective strategies are needed in social media to promote HPV vaccines and counter misinformation about and resistance to them. Mothers whose daughters complete the HPV vaccine course might be recruited as influencers on HPV vaccines, as they may be predisposed to talk favorably about the vaccine. Comments from mothers who have not been vaccinated should be monitored to ensure that they do not spread vaccine-critical misinformation. Study limitations included lack of randomization and control group, relatively small number of messages on HPV vaccines, long measurement intervals, inability to measure views of vaccination posts, reduced generalizability related to ethnicity and social media use, and use of self-reported vaccine status.Clinical Trial Registration:www.clinicaltrials.gov, identifier NCT02835807.


2019 ◽  
Vol 71 (4) ◽  
pp. 1022-1029 ◽  
Author(s):  
Robine Donken ◽  
Simon R M Dobson ◽  
Kim D Marty ◽  
Darrel Cook ◽  
Chantal Sauvageau ◽  
...  

Abstract Background Several countries have implemented a 2-dose (2D) human papillomavirus (HPV) vaccination schedule for adolescents based on immunobridging studies. We compared immunogenicity of 2D vs 3-dose (3D) schedules of the quadrivalent vaccine (4vHPV) up to 10 years after the first dose. Methods Girls aged 9–13 years were randomized to receive 2D or 3D and were compared with women aged 16–26 receiving 3D at day 1 and months 7, 24, and 120 after the first dose. Antibody levels for HPV6/11/16/18 were evaluated using the competitive Luminex immunoassay (cLIA) and total immunoglobulin G assay. Geometric mean titers (GMTs) and seropositivity rates were compared between the different groups at different time points. Noninferiority of GMT ratios was defined as the lower bound of the 2-sided 95% confidence interval (CI) being greater than 0.5. Kinetics of antibody titers over time among study groups were examined. Results At 120 months, data from 35 2D girls, 38 3D girls, and 30 3D women were used for analyses. cLIA seropositivity rates were above 95% for all HPV vaccine types and all schedules, except HPV18, with the lowest seropositivity observed among 3D women (60.0%; 95% CI, 40.6%–77.3%). GMT ratios (cLIA) for both 2D and 3D girls were noninferior to 3 doses in women for HPV6/11/16/18. Trends were comparable between assays. Conclusions GMTs for HPV6/11/16/18 after 2D or 3D of 4vHPV in girls were noninferior to 3D in adult women up to 120 months postvaccination. This study demonstrates long-term immunogenicity of the 2D HPV vaccine schedule.


2019 ◽  
Vol 189 (4) ◽  
pp. 265-276
Author(s):  
Michelle L Johnson Jones ◽  
Julia Warner Gargano ◽  
Melissa Powell ◽  
Ina U Park ◽  
Linda M Niccolai ◽  
...  

Abstract Before 2016, human papillomavirus (HPV) vaccination was recommended on a 3-dose schedule. However, many vaccine-eligible US females received fewer than 3 doses, which provided an opportunity to evaluate the real-world vaccine effectiveness (VE) of 1, 2, and 3 doses. We analyzed data on cervical intraepithelial neoplasia (CIN) grades 2–3 and adenocarcinoma in situ (designated CIN2+) from the HPV Vaccine Impact Monitoring Project (HPV-IMPACT; 2008–2014). Archived tissue from CIN2+ lesions was tested for 37 types of HPV. Women were classified by number of doses received ≥24 months before CIN2+ detection. Using a test-negative design, VE was estimated as 1 minus the adjusted odds ratio from a logistic regression model that compared vaccination history for women whose lesions tested positive for HPV-16/18 (vaccine-type cases) with that for women who had all other CIN2+ lesions (controls). Among 3,300 women with available data on CIN2+, typing results, and vaccine history, 1,561 (47%) were HPV-16/18–positive, 136 (4%) received 1 dose of HPV vaccine, 108 (3%) received 2 doses, and 325 (10%) received 3 doses. Adjusted odds ratios for vaccination with 1, 2, and 3 doses were 0.53 (95% confidence interval (CI): 0.37, 0.76; VE = 47%), 0.45 (95% CI: 0.30, 0.69; VE = 55%), and 0.26 (95% CI: 0.20, 0.35; VE = 74%), respectively. We found significant VE against vaccine-type CIN2+ after 3 doses of HPV vaccine and lower but significant VE with 1 or 2 doses.


2018 ◽  
Vol 2 (4) ◽  
Author(s):  
Silvia de Sanjosé ◽  
Beatriz Serrano ◽  
Sara Tous ◽  
Maria Alejo ◽  
Belén Lloveras ◽  
...  

Abstract Background Many countries, mainly high- and upper-middle income, have implemented human papillomavirus (HPV) vaccination programs, with 47 million women receiving the full course of vaccine (three doses) in 2014. To evaluate the potential impact of HPV vaccines in the reduction of HPV-related disease, we aimed to estimate the HPV type distribution and burden of anogenital and head and neck cancers attributable to HPV types (HPVs 16/18/31/33/45/52/58/6/11) included in currently licensed HPV vaccines. Methods In all, 18 247 formalin-fixed paraffin-embedded specimens were retrieved from 50 countries. HPV DNA detection and typing were performed with the SPF-10 PCR/DEIA/LiPA25 system. With the exception of cervical cancer, HPV DNA-positive samples were additionally subjected to HPV E6*I mRNA detection and/or p16INK4a immunohistochemistry. For cervical cancer, estimates were based on HPV DNA, whereas for other sites, estimates were based on HPV DNA, E6*I mRNA, and p16INK4a biomarkers. Results The addition of HPVs 31/33/45/52/58 to HPVs 16/18/6/11 in the nonavalent HPV vaccine could prevent almost 90% of cervical cancer cases worldwide. For other sites, the nonavalent HPV vaccine could prevent 22.8% of vulvar, 24.5% of penile, 60.7% of vaginal, 79.0% of anal cancers, 21.3% of oropharyngeal, 4.0% of oral cavity, and 2.7% of laryngeal cancer cases. Conclusions Our estimations suggest a potential impact of the nonavalent HPV vaccine in reducing around 90% of cervical cancer cases and a global reduction of 50% of all the cases at HPV-related cancer sites.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 6033-6033 ◽  
Author(s):  
Donna M. Graham ◽  
Wanrudee Isaranuwatchai ◽  
Steven Habbous ◽  
Claire de Oliveira ◽  
Geoffrey Liu ◽  
...  

6033 Background: Many western countries have established female human papillomavirus (HPV) vaccination programmes for prevention of cervix cancer. Efficacy against additional HPV-related disease is proven in both sexes, but cost-effectiveness of male vaccination remains controversial. Projected figures suggest incidence and prevalence of oropharyngeal cancer (OPC) in North America will exceed that of cervix cancer by 2020 due to HPV-related cases. Two cost-effectiveness analyses evaluating male HPV vaccination have included OPC, with contrasting results. The Canadian government recommends, but does not fund, male vaccination. In order to assess the value for money of male HPV vaccination in Canada with respect to OPC, we performed a preliminary cost-effectiveness analysis. Methods: Following extensive literature review regarding HPV-related OPC in Canadian males, healthcare cost and clinical effectiveness estimates were obtained from published studies. A Markov model was used to compare potential costs and effectiveness of HPV vaccination against no vaccination among males aged 12 years old. A 3-month cycle length was used with a ‘lifetime’ time horizon. The outcome of the analysis was the incremental cost per quality-adjusted life-year (QALY). Sensitivity analyses were conducted on variables such as vaccine uptake rate and efficacy. Results: Assuming 99% vaccine efficacy and 70% uptake, the use of HPV vaccine produced 0.05 more QALYs and saved $204 Canadian dollars (CAD) per person compared with no vaccine (QALYs and costs discounted at 5% per year). Assuming 50% vaccine efficacy and 50% uptake, use of HPV vaccine produced 0.01 more QALYs and saved $43 CAD. Based on a population of 12 year old males of 192,940 in 2012, male HPV vaccination may potentially save $8.3-39.4 million CAD for this cohort over its lifetime. Conclusions: Knowledge gaps exist regarding male HPV vaccination for OPC prevention. Due to practical limitations, including lack of identifiable precursor lesions in OPC, clinical trials to evaluate this issue may not be feasible. Without considering the effects of herd immunity, this preliminary analysis highlights potential savings from male vaccination.


2020 ◽  
Author(s):  
Natalia Balera Ferreira Pinto ◽  
Ingrid Herta Rotstein Grein ◽  
Aline Lobo ◽  
Noortje Groot ◽  
Flavio Sztajnbok ◽  
...  

Abstract Background: Concerns about the safety and efficacy of vaccinations in patients with pediatric rheumatic diseases, such as juvenile dermatomyositis, have led to contradictions and low vaccination coverage in this group, who are at a higher risk of infections, including by human papillomavirus (HPV). Although HPV vaccine should be recommended for all juvenile dermatomyositis patients, there is a lack of data to support the safety of this vaccine. The aim of this study was to assess the safety and immunogenicity of the quadrivalent HPV vaccination in juvenile dermatomyositis patients.Methods: Juvenile dermatomyositis patients aged from 9-20 years and healthy controls were enrolled to receive a 3-dose schedule of quadrivalent HPV vaccination from March/2014 until March/2016. Study visits were performed before the first dose, one month after the second and third doses and one year after the first dose. Participants completed a diary of possible adverse events following each dose, and disease activity was measured. At each visit, serum samples was collected for testing antibody concentrations. Participants recruitment was conducted in ten Brazilian centers. From 48 eligible patients, 42 completed the 3 doses schedule of the vaccine (5 patients had received doses previously). The McNemar test and the Kappa concordance coefficient were applied to compare the disease activity scores used for juvenile dermatomyositis patients between quadrivalent HPV vaccine doses and before the vaccination. The software used was SAS 9.4.Results: No severe adverse events were related to the vaccination. The disease activity scores were usually low, and remained stable, or even improved during the follow-up. After three vaccine doses the juvenile dermatomyositis group presented seropositivity of 100% for HPV16 and 97% for HPV18, similarly to the control group who presented 100% for both. One year after the first dose the seropositivity for the patients group was 94% for both HPV types.Conclusions: The HPV vaccination in juvenile dermatomyositis patients is safe and immunogenic. Since the seropositivity against HPV16 and HPV18 was very high after the 3-dose schedule, this regimen should be recommended for juvenile dermatomyositis patients.


2021 ◽  
Vol 15 (S7) ◽  
Author(s):  
Dur-e-Nayab Waheed ◽  
John Schiller ◽  
Margaret Stanley ◽  
Eduardo L. Franco ◽  
Mario Poljak ◽  
...  

AbstractFor more than a decade human papillomavirus (HPV) vaccine have been implemented in most high-income countries, and more recently also in several low- and middle-income countries. The vaccines are safe and their impact and effectiveness in preventing HPV vaccine type infection and associated diseases has been thoroughly established. Currently, the primary recommended cohorts for immunisation are adolescents, 9–15 years of age but HPV is an ubiquitous infection that is mainly (but not exclusively) sexually transmitted. Sexually active adults remain susceptible to infection and continued transmission of the virus, representing a reservoir of infection in the population. A recent meeting, conducted by the HPV Prevention and Control Board (HPV-PCB), reviewed the current status of HPV vaccination of adults, discussed limitations, challenges and benefits of HPV vaccination of adults, evaluated the effectiveness of HPV vaccination after treatment of post cervical cancer and precancerous lesions, and discussed the potential impact of adult vaccination on cervical cancer elimination strategies in light of the current and future HPV vaccine shortage. HPV-PCB is an independent multidisciplinary board of international experts that disseminates relevant information on HPV to a broad array of stakeholders and provides guidance on strategic, technical and policy issues in the implementation of HPV prevention and control programs. The HPV-PCB concluded that, given the current data available on adult HPV vaccination and the ongoing vaccine supply constraints, it is too early to implement routine vaccination of adults. Many research gaps need to be filled before we have a better understanding of the efficacy and broader public health impact of HPV vaccination in adult women.


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