"You Don't Know If It's the Truth or a Lie": Exploring Human Papillomavirus (HPV) Vaccine Hesitancy among Communities with Low HPV Vaccine Uptake in Northern California.

BACKGROUND: Vaccine hesitancy, delaying or refusing to vaccinate despite the availability of vaccines, impedes the progress of achieving optimal HPV vaccine coverage. Little is known about the sources of human papillomavirus (HPV) vaccine hesitancy among racially/ethnically and geographically diverse communities. The purpose of this paper is to explore HPV vaccine hesitancy among rural, Slavic, and Latino communities that reside in counties with low HPV vaccine uptake rates. METHODS: Key informant interviews and focus groups were conducted with rural, Slavic, and Latino communities that reside within counties in California that have low HPV vaccine up to date rates (16-25%). Qualitative data were transcribed verbatim and analyzed using inductive and deductive thematic analysis. RESULTS: A total of seven focus groups and 14 key informant interviews were conducted with 39 individuals from seven California counties. Salient themes that contributed to HPV vaccine hesitancy included the following: social media and the anti-vaccination movement; a strong belief in acquiring immunity naturally; prior vaccine experiences; and vaccine timing concerns. Participants suggested the provision of culturally appropriate, in-language, in-person easy to understand HPV vaccine education to mitigate HPV vaccine hesitancy. CONCLUSIONS: Our findings can inform future interventions to increase HPV vaccine uptake among hesitant communities.

Human Papillomavirus Vaccination in Pediatric, Adolescent, and Young Adult Cancer Survivors-Opportunity to Address Gaps in Cancer Prevention and Survivorship.

The risks of secondary cancers associated with human papillomavirus (HPV) infection are as much as three times higher for survivors of pediatric, adolescent, and young adult cancer (PYAC) compared to the general population. Despite this, HPV vaccination rates among PYAC survivors remain low. Whereas pediatric oncology providers endorse HPV vaccination of PYAC survivors, many lack the resources or opportunities to intervene. The responsibility of HPV vaccination, therefore, falls to primary care providers and practices. This article provides an overview of the challenges with HPV vaccination that are distinct to PYAC survivors and discusses potential strategies to increase HPV vaccine coverage in this population.

Communication Interactions, Needs, and Preferences During Clinical Encounters of African American Parent-Child Dyads.

Human papillomavirus (HPV) vaccination rates remain suboptimal among African American adolescents. Although provider recommendations during clinical encounters are believed to be highly effective in increasing uptake and series completion, little has been reported about parent-child perspectives on the counseling received during these encounters. Among African American parent-child dyads, we sought to explore and compare interactions, needs, and preferences during clinical encounters by child's HPV vaccination status. We applied a qualitative, phenomenological study design to conduct semi-structured interviews with African American parent-child dyads representing children who were unvaccinated (n = 10), had initiated but not completed (n = 11), or had completed the HPV vaccine series (n = 9). Using iterative, inductive-deductive thematic analysis, five themes were generated: (1) parents' attitudes varied about the HPV vaccine but were mostly positive for vaccines in general; (2) patient-parent-provider clinical encounters from the parent perspective; (3) patient-parent-provider clinical encounters from the child perspective; (4) methods of distribution of supplemental HPV information; and (5) communication desired on HPV vaccination by parents and children. Parents stating they received a provider's recommendation increased by vaccination status (unvaccinated: 6 out of 10; initiated: 7 out of 11; completed: 9 out of 9). Most parents and children were not satisfied with provider communication on the HPV vaccine and used supplemental materials to inform decision-making. Ongoing communication on the HPV vaccine was requested even post-vaccination of the child. During clinical encounters, children and parental messaging needs are similar yet dissimilar. We offer communication strategies and messaging that can be used for African American parent-child dyads by child HPV vaccination status during a clinical encounter.

Factors Related to HPV Vaccination Intention among MSM in China: A Bayesian Network Model.

(1) Background: Men who have sex with men (MSM) are at high risk of human papillomavirus (HPV) infection, and HPV vaccination is the best strategy to prevent HPV infection. Accepting HPV vaccination is an essential factor affecting vaccine promotion among MSM. We aimed to explore the factors related to HPV vaccination intention among MSM and analyze the potential relationship between these factors. (2) Methods: We adopted a nonprobability sampling method to recruit MSM volunteers. Information collection included general demographics, personal behavioral characteristics, knowledge of HPV/vaccine attitudes, and risk threat perception. Bayesian networks (BNs) were used to analyze the data statistically. (3) Results: The BNs showed that perceived HPV risk and attitudes toward vaccine promotion were directly correlated factors, whereas knowledge of HPV/vaccines, a history of HIV testing, and the number of male sexual partners in the past 6 months were indirectly correlated factors. (4) Conclusions: The results of this study illustrate that MSM have a relatively high propensity to receive HPV vaccines. The proposal that strengthening the propagation of HPV and its relevant vaccines, encouraging MSM to undergo regular corresponding tests, and improving their risk perception of HPV infection can be raised to promote HPV vaccination among MSM.

Human papillomavirus vaccination uptake among childhood cancer survivors in Western New York.

INTRODUCTION: The risk of human papillomavirus (HPV)-associated cancers is significantly higher among survivors of a childhood cancer compared to the general population. Despite this, their HPV vaccine uptake rates are lower. We examined factors related to HPV vaccine uptake among childhood cancer survivors from Western New York over 13 years following the introduction of HPV vaccines. METHODS: Retrospective review of patients diagnosed with invasive or noninvasive cancerous conditions at age 9 or younger treated at Roswell Park Oishei Children's Cancer and Blood Disorder Program. We matched vaccine date information for patients aged 9-26 years between 2006 and 2020 from the New York State Immunization Information System. Demographic and cancer-related information was abstracted from electronic medical records. Cumulative vaccine uptake was assessed by Kaplan-Meier and Cox proportional hazards regression models. RESULTS: A total of 284 patients were included in the analyses. Most were non-Hispanic/White (80.3%) and resided in a metropolitan area (81.7%). Approximately half had leukemia or lymphoma (54.9%), and most received chemotherapy. Females were more likely to initiate the HPV vaccine and did so sooner (median = 5.5 years) than males (median = 5.7 years; log-rank p = .301). Patients who were older at vaccine eligibility and males who received blood product transfusions were significantly less likely to initiate the HPV vaccine. CONCLUSION: While rates of HPV vaccine initiation have been increasing with time among childhood cancer survivors, they remain low overall, with differences seen by treatment and diagnosis. Our findings support the need for further research to optimize HPV vaccine delivery in cancer care.

Multiple cohort HPV vaccination in Zimbabwe: 2018-2019 program feasibility, awareness, and acceptability among health, education, and community stakeholders.

INTRODUCTION: Zimbabwe introduced human papillomavirus (HPV) vaccine nationally in May 2018, targeting multiple cohorts (girls aged 10-14 years) through a school-based vaccination campaign. One year later, the second dose was administered to the multiple cohorts concurrently with the first dose given to a new single cohort of girls in grade 5. We conducted cross-sectional surveys among health workers, school personnel, and community members to assess feasibility of implementation, training, social mobilization, and community acceptability. METHODS: Thirty districts were selected proportional to the volume of the HPV vaccine doses delivered in 2018; two health facilities were randomly selected within each district. One health worker, school health coordinator, village health worker, and community leader were surveyed at each selected health facility and surrounding area during January-February 2020, using standard questionnaires. Descriptive analysis was completed across groups. RESULTS: There were 221 interviews completed. Over 60% of health workers reported having enough staff to carry out vaccination sessions in schools while maintaining routine vaccination services in health facilities. All school health coordinators felt the HPV vaccine should be delivered in schools in the future. Knowledge of the correct target cohort eligibility decreased from 91% in 2018 to 50% in 2020 among health workers. Understanding of HPV infection and use of HPV vaccine for cervical cancer prevention was above 90% for all respondents. Forty-two percent of respondents reported hearing rumors about the HPV vaccine, primarily regarding infertility and safety. CONCLUSIONS: Findings demonstrate the presence of highly knowledgeable staff at health facilities and schools, strong community acceptance, and a school-based HPV program considered feasible to implement in Zimbabwe. However, misunderstandings regarding target eligibility and rumors persist, which can impact vaccine uptake and coverage. Continued social mobilization efforts to maintain community demand and training on eligibility were recommended. Integration, partnerships, and resource mobilization are also needed to ensure program sustainability.

HPV Vaccine Intent among Adult Women Receiving Care at Community Health Centers.

Human papillomavirus (HPV) is a disease that exacts substantial costs in human life and public health expenditures. Fortunately, a vaccine exists that can mitigate these costs. This study reports the development and evaluation of the intervention designed to overcome these barriers by using culturally grounded narratives to promote HPV vaccination. Women's Stories (WS) targets women over the age of 18 and was originally successfully validated for use among college students resulting in NCI recognition. WS was adapted for touch pad delivery in Planned Parenthood clinics where a randomized clinical trial was conducted in 8 clinics in 3 cities. Two hundred seventeen women were randomly assigned to treatment and control, completing pretest and posttest surveys. This study examined data from the immediate posttest. An intent to treat analysis was conducted using a generalized linear mixed modeling approach using a multinomial link and accounting for repeated measures by site. Results demonstrate significant short-term effects on vaccine intentions and vaccine self-efficacy. When compared to control group participants, women in the treatment condition more likely to intend to get the shot today/the day of interview (p < 0.01), as well as in 1 (p < 0.01) and 6 (p < 0.01) months and had greater self-efficacy to receive the HPV vaccination (B = 0.54; p = 0.0002). These results are promising for the potential impact of the intervention in clinical settings as well as providing a model for overcoming lack of awareness and vaccine resistance in other segments of the population.

Impact of reduced human papillomavirus vaccination coverage rates due to COVID-19 in the United States: A model based analysis.

The coronavirus disease 2019 (COVID-19) pandemic has significantly affected utilization of preventative health care, including vaccines. We aimed to assess HPV vaccination rates during the pandemic, and conduct a simulation model-based analysis to estimate the impact of current coverage and future pandemic recovery scenarios on disease outcomes. The model population included females and males of all ages in the US. The model compares pre-COVID vaccine uptake to 3 reduced coverage scenarios with varying recovery speed. Vaccine coverage was obtained from Truven Marketscan™. Substantially reduced coverage between March-August 2020 was observed compared to 2018-2019. The model predicted that 130,853 to 213,926 additional cases of genital warts; 22,503 to 48,157 cases of CIN1; 48,682 to 110,192 cases of CIN2/3; and 2,882 to 6,487 cases of cervical cancer will occur over the next 100 years, compared to status quo. Providers should plan efforts to recover HPV vaccination and minimize potential long-term consequences.

National and State-Specific Estimates of Settings of Receiving Human Papillomavirus Vaccination Among Adolescents in the United States.

PURPOSE: Human papillomavirus (HPV) vaccination in the United States has been recommended for girls since 2006 and for boys since 2011. However, settings of receiving HPV vaccination have not been assessed. The purpose of this study is to assess settings of receiving HPV vaccination among adolescents in order to understand what strategies are needed to improve vaccination uptake. METHODS: Data from the 2018 National Immunization Survey-Teen (NIS-Teen) were analyzed to assess place of HPV vaccination overall, and by gender, quarter, and other selected variables among adolescents in the United States. The 2016-2018 NIS-Teen data were combined to assess state-specific place of HPV vaccination. RESULTS: Among vaccinated adolescents aged 13-17 years, a doctor's office was the most common place where HPV vaccination was received (79.2%), followed by clinics, health centers, or other medical facilities (13.5%), health department (4.1%), hospital or emergency room (2.3%), schools (.5%), and pharmacies or stores (.4%). Overall, 99.1% of adolescents aged 13-17 years received HPV vaccination at medical settings and only .9% at nonmedical settings. Reported vaccination in nonmedical settings by state ranged from less than .1% in Delaware, Florida, and New Hampshire to 4.1% in North Dakota, with a median of 1.0%. CONCLUSIONS: Doctor's offices were the most common medical setting for adolescents to receive HPV vaccination. Less than 1% of adolescents received vaccination at nonmedical settings. Continuing work with medical and nonmedical settings to identify and implement appropriate strategies are needed to improve HPV vaccination coverage among adolescents.

The Role of English Proficiency in HPV and HPV Vaccine Awareness: A Cross-Sectional Study Across Race/Ethnicity.

OBJECTIVE: Human papillomavirus (HPV) is the most common sexually transmitted infection in the United States and associated with over 90% of cervical cancer cases.  The present study aimed to examine levels of HPV and HPV vaccine awareness and associated factors, particularly English proficiency, across various racial/ethnic groups. METHODS: Two cross-sectional datasets, 2017 and 2018 Health Information National Trends Survey (HINTs), were analyzed for the current study. Binary logistic regression analyses were conducted. FINDINGS: Non-Hispanic Whites had the highest levels while non-Hispanic Asians had the lowest levels of awareness regarding HPV and the HPV vaccine. English proficiency was significantly associated with increased HPV awareness among all groups except non-Hispanic Asian, and was significantly associated with greater HPV vaccine awareness in all groups. DISCUSSION: In order to promote health equity across race/ethnicity, language barriers among minorities should be addressed when implementing health education on HPV and the HPV vaccine.

Public health impact and cost-effectiveness of catch-up 9-valent HPV vaccination of individuals through age 45 years in the United States.

The Advisory Committee on Immunization Practices (ACIP) recommended catch-up 9-valent Human Papillomavirus (HPV) vaccination through age 26 years, and shared clinical decision-making for adults aged 27-45 years, compared with catch-up through age 26 years and 21 years for females and males, respectively (status quo; pre-June-2019 recommendations). This study assessed the public health impact and cost-effectiveness of expanded catch-up vaccination through age 45 years (expanded catch-up) compared with status quo. We used an HPV dynamic transmission infection and disease model to assess disease outcomes and incremental cost-effectiveness ratio (ICER) of expanded catch-up compared with status quo. Costs (2018 USD), calculated from a healthcare sector perspective, and quality-adjusted life years (QALY) were discounted at 3% annually. Historical vaccination coverage was estimated using NIS-TEEN survey data (NHANES data for sensitivity analysis). Alternative scenario analyses included restricting upper age of expanded catch-up through 26 years (June-2019 ACIP recommendation), 29 years, and further 5-year increments. Our results show expanded catch-up vaccination would prevent additional 37,856 cancers, 314,468 cervical intraepithelial neoplasia-2/3s, 1,743,461 genital warts, and 10,698 deaths compared with status quo over 100 years at cost of $141,000/QALY. With NHANES coverage, the ICER was $96,000/QALY. The June-2019 ACIP recommendation also provided public health benefits with an ICER of $117,000/QALY, compared with status quo. The ICER for expanded vaccination through age 34 years was $107,000/QALY. Expanding catch-up vaccination program through age 45 years-old in the US is expected to provide public health benefits, and cost-effectiveness improves with expanding catch-up through age 34.

"I can be the Judge of What's Serious": A Qualitative Pilot Study of Parents' Responses to Messaging About Side Effects of the HPV Vaccine.

OBJECTIVE: Parents' concerns about vaccine safety and side effects likely contribute to low rates of human papillomavirus (HPV) vaccination among adolescents. To facilitate parent-provider discussions about the HPV vaccine, we developed and tested the content of a clinical decision support application for implementation in pediatric clinical settings. This study sought to elicit perspectives of parents and providers on the best way to communicate information on vaccine side effects. METHODS: To understand the acceptability of the application's content, we conducted focus groups with parents (n = 11) and providers (n = 9) at three primary care clinics. Focus groups transcriptions were analyzed using iterations of deductive and inductive coding, with independent coding by two trained reviewers to improve inter-rater reliability. RESULTS: Surprisingly, when parents reviewed screen shots of HPV vaccine safety and side effect messages, parents took exception to the expression "no evidence of serious side effects". Parents wanted side effects listed explicitly so they could decide for themselves which side effects were "serious". Parents also felt that the HPV vaccine did have serious side effects, and the wording undermined their trust in the vaccine messaging overall. Providers accepted the phrasing of side effects and did not express concerns that parents would object to the messaging. CONCLUSIONS: Further research is needed to confirm parents' concerns with the phrasing "no serious side effects" for the HPV vaccine and to assess the impact on HPV vaccination deferral or delay.

The controversy on HPV vaccination in Japan: Criticism of the ethical validity of the arguments for the suspension of the proactive recommendation.

The Human Papillomavirus (HPV) vaccine was integrated into Japan's national immunization program (NIP) in April 2013. However, numerous instances of serious adverse reactions were widely reported in the media, resulting in the Ministry of Health, Labor, and Welfare (MHLW) suspending the official recommendation of the HPV vaccine on June 14, 2013. Investigating the reported incidents, the Vaccine Adverse Reactions Review Committee (VARRC)-an MHLW advisory committee-found no high-quality evidence supporting a causal relationship between the reported events and the HPV vaccination. However, rather than lifting the suspension, they have opted to maintain a "pseudo informed consent" confirming the perceptions of Japanese citizens regarding the vaccine. Accordingly, there appears to be a fundamental difference in the approach to vaccine policymaking between Japan (MHLW/VARRC) and other countries and the World Health Organization, which base policy decisions on the effectiveness and safety of the vaccine. Consequently, the arguments for the suspension of the HPV vaccine recommendation are not ethically appropriate. Relevant bodies must make a clear decision regarding the HPV vaccine and its status in the NIP: the proactive recommendation must either be reinstated or the HPV vaccine legal framework altered to rely entirely on voluntary individual decisions.

Trends in human papillomavirus (HPV) vaccination initiation among adolescents aged 13-17 by metropolitan statistical area (MSA) status, National Immunization Survey - Teen, 2013 - 2017.

Disparities in HPV vaccination coverage by metropolitan statistical area (MSA) status were observed in the 2016 and 2017 National Immunization Survey - Teen (NIS-Teen). In 2017, HPV vaccination initiation (≥1dose) coverage was 11 percentage points lower for adolescents living in non-MSAs (mostly rural areas) and 7 percentage points lower among those living in MSA, non-principal cities (suburban areas) compared to those living in MSA, principal cities (mostly urban areas). In order to understand how this disparity has changed over time, we examined trends in HPV vaccine initiation by MSA status from 2013 to 2017. Weighted linear regression by survey year was used to estimate annual percentage point changes in HPV vaccination initiation. The five-year average annual percentage point increases in HPV vaccination initiation coverage were 5.2 in mostly urban areas, 4.9 for suburban areas, and 5.2 for mostly rural areas. Despite increases in each MSA area, coverage in mostly rural areas was consistently and significantly lower than coverage in mostly urban areas. Coverage was significantly lower among teens living in mostly rural areas regardless of poverty status, sex, and race/ethnicity except among black, non-Hispanic adolescents. There was no significant change in the magnitude of the disparity between mostly urban areas and mostly rural areas over time (p = .98). A better understanding of the facilitators and barriers to HPV vaccination in mostly rural areas is needed to identify and implement targeted strategies to improve HPV vaccination coverage and reduce these disparities.

Increasing human papillomavirus vaccination at the recommended age.

In the United States, human papillomavirus (HPV) vaccine has been recommended for females since 2006 and for males since 2011. However, national HPV vaccination coverage among adolescents is lower than national targets, and many adolescents initiate HPV vaccination later than the recommended age. We analyzed records for >2 million persons born during 1996-2000 who initiated HPV vaccination at age 9 through 16 years from six Immunization Information Systems Sentinel Sites, displayed the distribution of HPV vaccination initiation age, and calculated HPV vaccination coverage. More adolescents in recent cohorts initiated HPV vaccination at the recommended age of 11-12 years, the majority of whom received another recommended vaccine on the same day. However, >40% of all vaccinated adolescents did not initiate the HPV vaccination until age 13 years or later. Continued efforts are needed to increase HPV vaccination initiation at the recommended age.

Indicated or elective? The association of providers' words with HPV vaccine receipt.

BACKGROUND: Appropriate provider recommendation is crucial to raising HPV vaccination uptake, yet scant research has explored actual conversations between providers and parents, the effect of parental pre-visit vaccine intention on vaccination, or the effect of conversation style on parental satisfaction with that conversation. METHODS: We analyzed 146 audio-recorded clinical encounters between providers, parents/guardians, and HPV vaccine-eligible adolescents, from May 2015 to March 2017, at eight practices in Northeastern U.S. Parents completed pre-visit measures of intent to vaccinate and post-visit assessments of satisfaction with vaccine conversations. We qualitatively analyzed transcribed audio recordings and evaluated associations between providers' vaccine introductions and vaccine receipt. RESULTS: Provider recommendations were empirically defined as "indicated" (clear recommendation that the child receive HPV vaccination at that visit), "elective" (vaccination presented as optional), or "contraindicated" (delay recommended). The vaccination rates were 87%, 68%, and 0% following "indicated," "elective," and "contraindicated" presentations respectively. Providers' statements attesting to the vaccine's value to the child did not affect receipt. Parental pre-visit intent to vaccinate was associated with vaccine receipt: 100% for likely/very likely compared to 28% for very unlikely. The association between vaccine recommendation style and vaccine receipt was most pronounced with undecided parents, with 92% accepting vaccination after an "indicated" recommendation vs. 68% after an "elective" recommendation. Satisfaction with vaccine conversations was high regardless of recommendation style. CONCLUSIONS: The results suggest that the words used to introduce HPV vaccination have the potential to inform parents' HPV vaccination decisions. Providers should be encouraged to simply state, "Your child is due for the HPV vaccine today."

Knowledge, attitudes, and practices regarding cervical cancer and screening among women visiting primary health care Centres in Bahrain.

BACKGROUND: Cervical cancer is one of the most common cancers among women, with 80% of the cases occurring in developing countries. Cervical cancer is largely preventable by effective screening programs. This has not been possible with opportunistic screening and its low use in the Kingdom of Bahrain. The objective of this study was to explore the knowledge, attitudes, and practices of women attending primary care health centres for cervical cancer screening. METHODS: This was a cross-sectional study of 300 women attending primary health care centres in Bahrain. We used a validated tool comprised of 45 items to collect data through face-to-face interviews between December 2015 and February 2016. Descriptive data are presented for demographic data, and frequency distributions with percentages are presented for each item of the knowledge and attitude questionnaire. RESULTS: The mean age ± SD of the participants was 37.24 ± 11.89 years, they were mostly married (221; 73.7%), and had a high school or higher education (261; 87%). Over 64% (194 participants) had never heard of a Pap smear procedure and only 3.7% (11 participants) had heard about the human papillomavirus (HPV) vaccine. Nearly 64% (192 participants) believed that a Pap smear was helpful in detecting pre-cancer and cancer of the cervix, and 44.3% (133 participants) believed that they should have a Pap smear at least every 3 years. Regarding the practice, only 40.7% (122 participants) had a Pap smear in their lifetime. The majority of participants felt embarrassed when examined by a male doctor (250, 83.3%) and few underwent a Pap smear screening if they were never married (69, 23.0%). CONCLUSIONS: The participants demonstrated a wide range of knowledge and attitudes towards cervical cancer screening. However, the majority demonstrated positive attitudes towards the HPV vaccine.

Missed opportunities for catch-up human papillomavirus vaccination among university undergraduates: Identifying health decision-making behaviors and uptake barriers.

BACKGROUND: Suboptimal adolescent human papillomavirus (HPV) vaccine rates in the US highlight the need for catch-up vaccination. When teenagers enter college, there may be a shift in healthcare decision-making from parents and guardians to the students themselves. Little is known about factors influencing college students' healthcare decision-making processes. STUDY DESIGN: We evaluated HPV vaccine decision-making among 18-to-26-year-old college students through a self-administered, anonymous, cross-sectional survey. This survey was distributed to a sample of men and women in classroom settings at two universities. Categorical data comparisons were conducted using Chi-square and Fisher's exact tests. Multivariate Poisson regression was used to model initiation of HPV vaccine and compute prevalence ratios while controlling for key influential covariates at the 0.05 alpha level. RESULTS: A total of 527 students participated (response proportion=93.1%). Overall, 55.8% of participants received the HPV vaccine. Encouraging conversations with doctors and/or parents/guardians were identified as one of the most influential factors to increase vaccine uptake. Among students who received encouragement from both a doctor and parent, 95.8% received the vaccine. Campaigns about cancer prevention were viewed as more influential than those that focus on preventing genital warts. Approximately one-third of students indicated they didn't know where to get the HPV vaccine. Women were more likely to report that their parents would not let them get the HPV vaccine compared to men (26.7% vs. 2.3%). The majority of students (77.3%) indicated their parents were sometimes, equally, or mostly involved in making decisions about receiving vaccines (other than flu). CONCLUSION: Students' decision-making is greatly influenced by their parents; therefore, interventions for this population should work to increase students' control over decision-making while also addressing parental concerns.

Reports of Postural Orthostatic Tachycardia Syndrome After Human Papillomavirus Vaccination in the Vaccine Adverse Event Reporting System.

PURPOSE: Human papillomavirus (HPV) vaccination prevents infections with HPV strains that cause certain cancers. Reports of postural orthostatic tachycardia syndrome (POTS) following HPV vaccination have raised safety concerns. We reviewed POTS reports submitted to the Vaccine Adverse Event Reporting System (VAERS). METHODS: We searched the VAERS database for reports of POTS following any type of HPV vaccination (bivalent, quadrivalent, or nonavalent) from June 2006 to August 2015. We reviewed reports and applied established POTS diagnostic criteria. We calculated unadjusted POTS case reporting rates based on HPV vaccine doses distributed and conducted empirical Bayesian data mining to screen for disproportional reporting of POTS following HPV vaccination. RESULTS: Among 40,735 VAERS reports following HPV vaccination, we identified 29 POTS reports that fully met diagnostic criteria. Of these, 27 (93.1%) were in females and mean age was 14 years (range 12-32). Median time from vaccination to start of symptoms was 43 days (range 0-407); most (18, 75.0%) had onset between 0 and 90 days. Symptoms frequently reported concomitantly included headache (22, 75.9%) and dizziness (21, 72.4%). Twenty (68.9%) reports documented a history of pre-existing medical conditions, of which chronic fatigue (5, 17.2%), asthma (4, 13.8%), and chronic headache (3, 10.3%) were most common. Approximately one POTS case is reported for every 6.5 million HPV vaccine doses distributed in the United States. No empirical Bayesian data mining safety signals for POTS and HPV vaccination were detected. CONCLUSIONS: POTS is rarely reported following HPV vaccination. Our review did not detect any unusual or unexpected reporting patterns that would suggest a safety problem.

A novel HPV prophylactic peptide vaccine, designed by immunoinformatics and structural vaccinology approaches.

Human papillomavirus (HPV)-caused cervical cancer is the fourth common female cancer globally. Despite availability of three effective vaccines in market, development of HPV prophylactic vaccines is still pursued due to affordability issues and type-restricted protection of the marketed vaccines. Investigational second generation prophylactic HPV vaccines are mostly exploiting epitopes from the virus minor capsid protein (L2), which despite many advantages suffer from low immunogenicity, a common problem of epitope vaccines. Adjuvants such as TLR agonists may overcome this drawback. In this study, different immunoinformatics and computational tools were employed to design a novel peptide vaccine for protection against cervical cancer. Two immunodominant epitope domains (amino acids 10-36 and 65-89) from the L2 protein of HPV 16 with potential to promote Th1, Th2, CTL, B-cell, and INF-gamma responses were selected. Flagellin, as a TLR5 agonist, a short synthetic TLR4 agonist, and two universal T-helper agonists (PADRE and TpD) were added to ensure strong induction of immune responses. Different segments were joined by proper linkers, and the physicochemical, structural, and immunological characteristics of the resultant construct were evaluated. Modeling, refinement, and validation were done to achieve a high quality 3D structure of the vaccine protein. Docking and molecular dynamics (MD) studies demonstrated an appropriate and stable interaction between the vaccine and TLR5 during the simulation period. Totally, a potential vaccine candidate with proper immunological and physicochemical properties was designed for HPV prophylaxis. The designed vaccine is expected to be capable of generating humoral and cellular responses, which are vital for protection against HPV.