scholarly journals Safety and Immunogenicity of the Quadrivalent Human Papillomavirus Vaccine in Patients with Juvenile Dermatomyositis: A Real-World Multicentre Study

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.

2020 ◽  
Vol 18 (1) ◽  
Author(s):  
Ingrid Herta Rotstein Grein ◽  
Natalia Balera Ferreira Pinto ◽  
Noortje Groot ◽  
Camila Bertini Martins ◽  
Aline Lobo ◽  
...  

Abstract Background Concerns about the safety and efficacy of vaccines in patients with autoimmune diseases (AID) have led to contradictions and low vaccination coverage in this population, who are at a higher risk of infections, including by human papillomavirus (HPV). Although HPV vaccines have been recommended for immunocompromised patients, there is still a lack of data to support its use for AID patients, such as juvenile dermatomyositis (JDM) patients. The aim of this study was to assess the safety and immunogenicity of the quadrivalent HPV (qHPV) vaccine in a cohort of JDM patients. Methods JDM patients aged from 9 to 20 years and healthy controls (HC) were enrolled to receive a 3-dose schedule of qHPV vaccine from March/2014 to March/2016. Study visits were performed before the first dose, 1 month after the second and third doses, and 6 months after the third dose. Participants completed a diary of possible adverse events for 14 days following each dose of vaccination (AEFV). Disease activity and current therapy were analyzed at each visit for JDM patients. In addition, serum samples from all participants were collected to test antibody concentrations against HPV16 and 18 at each visit. Participant recruitment was conducted in ten Brazilian centres. From 47 eligible JDM patients and 41 HC, 42 and 35, respectively, completed the 3-dose schedule of the vaccine, given that five JDM patients and two HC had received doses prior to their inclusion in the study. Results The AEFVs presented by the participants were mild and in general did not differ between JDM and HC groups. No severe AEFVs were related to the vaccination. Disease activity was stable, or even improved during the follow-up. One month after the third dose of the vaccine the JDM group presented seropositivity of 100% for HPV16 and 97% for HPV18, similarly to the HC group, who presented 100% for both serotypes (p = 1.000). Six months after the third dose the seropositivity for the patient group was 94% for both HPV types. Conclusions The HPV vaccination in this cohort of JDM patients was safe and immunogenic. Since the seropositivity against HPV16 and 18 was very high after the 3-dose schedule, this regimen should be recommended for JDM patients. Trial registration Brazilian Clinical Trials Registry, number: RBR-9ypbtf. Registered 20 March 2018 – Retrospectively registered.


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

Abstract Background: Concerns about the safety and efficacy of vaccines in patients with autoimmune diseases (AID) have led to contradictions and low vaccination coverage in this population, who are at a higher risk of infections, including by human papillomavirus (HPV). Although HPV vaccines have been recommended for immunocompromised patients, there is still a lack of data to support its use for AID patients, such as juvenile dermatomyositis (JDM) patients. The aim of this study was to assess the safety and immunogenicity of the quadrivalent HPV (qHPV) vaccine in a cohort of JDM patients.Methods: JDM patients aged from 9-20 years and healthy controls (HC) were enrolled to receive a 3-dose schedule of qHPV vaccine from March/2014 to March/2016. Study visits were performed before the first dose, one month after the second and third doses, and six months after the third dose. Participants completed a diary of possible adverse events for 14 days following each dose of vaccination (AEFV). Disease activity and current therapy were analyzed at each visit for JDM patients. In addition, serum samples from all participants were collected to test antibody concentrations against HPV16 and 18 at each visit. Participant recruitment was conducted in ten Brazilian centres. From 47 eligible JDM patients and 41 HC, 42 and 35, respectively, completed the 3-dose schedule of the vaccine, given that five JDM patients and two HC had received doses prior to their inclusion in the study.Results: The AEFVs presented by the participants were mild and in general did not differ between JDM and HC groups. No severe AEFVs were related to the vaccination. Disease activity was stable, or even improved during the follow-up. One month after the third dose of the vaccine the JDM group presented seropositivity of 100% for HPV16 and 97% for HPV18, similarly to the HC group, who presented 100% for both serotypes (p = 1.000). Six months after the third dose the seropositivity for the patient group was 94% for both HPV types.Conclusions: The HPV vaccination in this cohort of JDM patients was safe and immunogenic. Since the seropositivity against HPV16 and 18 was very high after the 3-dose schedule, this regimen should be recommended for JDM patients.Trial registration: Brazilian Clinical Trials Registry, number: RBR-9ypbtf, link: http://www.ensaiosclinicos.gov.br/rg/RBR-9ypbtf/. Registered 20 March 2018 – Retrospectively registered.


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.


Lupus ◽  
2020 ◽  
Vol 29 (8) ◽  
pp. 934-942 ◽  
Author(s):  
Ingrid Herta Rotstein Grein ◽  
Natalia Ferreira Pinto ◽  
Aline Lobo ◽  
Noortje Groot ◽  
Flavio Sztajnbok ◽  
...  

Objective This study aimed to assess the safety and immunogenicity of the quadrivalent human papillomavirus (qHPV) vaccination in childhood-onset systemic lupus erythematosus (cSLE) patients. Methods Volunteer cSLE patients aged 9–20 years and healthy controls (HC) were enrolled to receive a two- or three-dose qHPV vaccination schedule from March 2014 to 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. In each study visit, disease activity and adverse events following vaccination were analyzed, and a serum sample was collected for testing antibody concentrations. Participant recruitment was conducted in 15 Brazilian paediatric rheumatology units. Of the 256 cSLE patients included, 210 completed the two- or three-dose schedules; 15 had previously received one dose, and 18 had received two doses of the vaccine. The analysis was based on intention-to-treat so that participants who did not complete the entire study protocol were also included. Results No severe adverse events were related to the vaccination. Disease activity was generally low and remained stable or even improved. The HC presented 100% seropositivity to HPV16 and HPV18, whereas the two- and three-dose cSLE groups presented 93% and 83% versus 97% and 91%, respectively. One year after the first dose, seropositivity of the three-dose cSLE group was 91% to HPV16 and 84% to HPV18. Conclusions HPV vaccination in cSLE patients is safe and immunogenic. Since the seropositivity to HPV16 and HPV18 was higher for the three-dose schedule group, this regimen should be recommended for cSLE patients.


2017 ◽  
Vol 7 (6) ◽  
pp. 35 ◽  
Author(s):  
Kimberlee Dayal ◽  
Sarah Robinson ◽  
Jessica Schoening ◽  
Mary Catherine Smith ◽  
Son Chae Kim

Aim: The aim of this study was to examine predictors of human papillomavirus (HPV) vaccine uptake or intent among parents of pre-adolescents and adolescents.Methods: A cross-sectional descriptive study was conducted among parents of girls aged 9 to 18 years, visiting two primary care clinics in central Texas from September to November 2015. Pearson’s product-moment correlation procedures and path analyses based on Health Belief Model were performed.Results: Path analysis showed that provider recommendation for HPV vaccination (β = 0.37; p < .001) and perceived HPV vaccine harm (β = -0.48; p < .001) had statistically significant direct effects on HPV vaccine uptake or intent. The perceived HPV vaccine effectiveness was directly influenced by HPV knowledge (β = 0.39; p < .001), empowerment in parent-provider relationships (β = 0.30; p = .006) and parental college education (β = 0.23; p = .039).}Conclusions: Together with parental empowerment fostering an equal partnership with providers, targeted education to improve parental HPV knowledge may convince them of the HPV vaccine effectiveness. This, in turn, may help them put the perceived HPV vaccine harm in proper perspective and allow them to make informed decisions regarding the timely HPV vaccination of their children. Because provider recommendation is one of the most important contributing factors for HPV vaccine uptake or intent, parental education and recommendations from nurses will help reduce the knowledge gaps and empower parents to make the timely decisions to vaccinate their children.


Author(s):  
Pooja Shah ◽  
Veena Shetty ◽  
Maithri Ganesh ◽  
Avinash K. Shetty

Cervical cancer is the second leading cause of cancer and one of the leading causes of cancer-related death in women in India. Human papillomavirus (HPV) vaccine uptake in India is low due to cost, low awareness of HPV, social stigma, and other factors. We assessed the awareness, attitudes, and beliefs regarding HPV and HPV vaccination and explored the barriers and challenges to HPV vaccine intent among women in Mangalore, India. An exploratory study was conducted using two focus group discussions (FGDs) and six in-depth one-on-one interviews. FGD-1 comprised nine women aged 18 to 26 years, and FGD-2 comprised seven women aged 27 to 45 years. The FGDs were recorded, transcribed, and analyzed using thematic content analysis. Themes identified were limited knowledge of HPV and vaccine, stigma associated with receiving HPV vaccine, vaccine safety concerns, and cost as a barrier to receiving vaccine. Participants expressed desire for physician and government recommendation of the HPV vaccine to validate vaccine intent. Contrasting themes between the two FGDs include support for vaccination at a younger age and lower perception of stigma and judgment in the 18- to 26-year-old group; however, participants in the 27- to 45-year-old group support vaccination at an older age and endorse greater fear of stigma and judgment associated with obtaining vaccination. Education regarding HPV-associated diseases and the HPV vaccine for the general public, physicians, and government officials in conjunction with lowering vaccine cost, improving vaccine access, and encouraging strong physician recommendations are key strategies to scale up HPV vaccine implementation in India.


JMIR Nursing ◽  
10.2196/19503 ◽  
2020 ◽  
Vol 3 (1) ◽  
pp. e19503
Author(s):  
Anne M Teitelman ◽  
Emily F Gregory ◽  
Joshua Jayasinghe ◽  
Zara Wermers ◽  
Ja H Koo ◽  
...  

Background More than 90% of human papillomavirus (HPV)-related cancers could be prevented by widespread uptake of the HPV vaccine, yet vaccine use in the United States falls short of public health goals. Objective The purpose of this study was to describe the development, acceptability, and intention to use the mobile app Vaccipack, which was designed to promote uptake and completion of the adolescent HPV vaccine series. Methods Development of the mobile health (mHealth) content was based on the integrated behavioral model (IBM). The technology acceptance model (TAM) was used to guide the app usability evaluation. App design utilized an iterative process involving providers and potential users who were parents and adolescents. App features include a vaccine-tracking function, a discussion forum, and stories with embedded messages to promote intention to vaccinate. Parents and adolescents completed surveys before and after introducing the app in a pediatric primary care setting with low HPV vaccination rates. Results Surveys were completed by 54 participants (20 adolescents aged 11 to 14 years and 34 parents). Notably, 75% (15/20) of adolescents and 88% (30/34) of parents intended to use the app in the next 2 weeks. Acceptability of the app was high among both groups: 88% (30/34) of parents and 75% (15/20) of adolescents indicated that Vaccipack was easy to use, and 82% (28/34) of parents and 85% (17/20) of adolescents perceived the app to be beneficial. Higher levels of app acceptability were found among parents with strong intentions to use the app (P=.09; 95% CI –2.15 to 0.15). Conclusions mHealth technology, such as Vaccipack, may be an acceptable and nimble platform for providing information to parents and adolescents and advancing the uptake of important vaccines.


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.


2003 ◽  
Vol 14 (5) ◽  
pp. 300-306 ◽  
Author(s):  
Jessica A Kahn ◽  
Susan L Rosenthal ◽  
Tara Hamann ◽  
David I Bernstein

Human papillomavirus (HPV) vaccines are under investigation, but little is known about attitudes regarding vaccination. The aims of this study were to identify attitudes about and intention to receive an HPV vaccine in young women using a theory-based model. Young women ( n=52, mean age 25 years, range 18-30 years, 35% Black/Non-Hispanic) completed a survey assessing knowledge, attitudes about HPV vaccination, and risk behaviours. Associations between attitudes and intention to receive the vaccine were assessed using Mann-Whitney U or chi-square tests. Subjects reported positive attitudes about receiving an HPV vaccine and high intention to receive the vaccine both for themselves and their daughters. Variables associated significantly with intention included knowledge ( P=0.004), personal beliefs about vaccination ( P=0.004), belief that others would approve of vaccination ( P=0.005), and higher number of sexual partners ( P=0.028). Information on attitudes about HPV vaccination and predictors of intention to receive a vaccine may guide immunization initiatives for young adults.


2012 ◽  
Vol 7 (1) ◽  
pp. 27-36 ◽  
Author(s):  
Baudelio Gutierrez ◽  
Anthony Leung ◽  
Kevin Trimell Jones ◽  
Peter Smith ◽  
Randee Silverman ◽  
...  

The human papillomavirus (HPV) vaccine was recently approved for use in males. Certain groups, such as men who have sex with men (MSM), are at increased risk of HPV infection. The purpose of the study was to understand perceptions of HPV and the vaccine among adolescent and young adult males, both heterosexual and MSM. Seventy-six males (45 heterosexual, 31 MSM) completed a questionnaire and participated in a focus group. Overall, 42% had heard of HPV and 39% had heard of the HPV vaccine. Males had moderate to favorable attitudes toward vaccination, although intentions to vaccinate were more neutral. MSM were more knowledgeable, aware, and in control of the decision to vaccinate than heterosexual males. Increasing awareness and knowledge about HPV and the vaccine may be necessary to encourage vaccination; certain subgroups of males may be more receptive to HPV vaccination than others.


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