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1.
Emerg Microbes Infect ; 10(1): 365-375, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1490458

ABSTRACT

Concerns about vaccine safety are an important reason for vaccine hesitancy, however, limited information is available on whether common adverse reactions following vaccination affect the immune response. Data from three clinical trials of recombinant vaccines were used in this post hoc analysis to assess the correlation between inflammation-related solicited adverse reactions (ISARs, including local pain, redness, swelling or induration and systematic fever) and immune responses after vaccination. In the phase III trial of the bivalent HPV-16/18 vaccine (Cecolin®), the geometric mean concentrations (GMCs) for IgG anti-HPV-16 and -18 (P<0.001) were significantly higher in participants with any ISAR following vaccination than in those without an ISAR. Local pain, induration, swelling and systemic fever were significantly correlated with higher GMCs for IgG anti-HPV-16 and/or anti-HPV-18, respectively. Furthermore, the analyses of the immunogenicity bridging study of Cecolin® and the phase III trial of a hepatitis E vaccine yielded similar results. Based on these results, we built a scoring model to quantify the inflammation reactions and found that the high score of ISAR indicates the strong vaccine-induced antibody level. In conclusion, this study suggests inflammation-related adverse reactions following vaccination potentially indicate a stronger immune response.


Subject(s)
Hepatitis E/immunology , Human papillomavirus 16/immunology , Human papillomavirus 18/immunology , Papillomavirus Infections/immunology , Papillomavirus Vaccines/immunology , Vaccines, Synthetic/immunology , Viral Hepatitis Vaccines/immunology , Adolescent , Adult , Aged , Antibodies, Viral/immunology , Female , Hepatitis E/prevention & control , Hepatitis E/virology , Human papillomavirus 16/genetics , Human papillomavirus 18/genetics , Humans , Immunity , Immunoglobulin G/immunology , Male , Middle Aged , Papillomavirus Infections/prevention & control , Papillomavirus Infections/virology , Papillomavirus Vaccines/administration & dosage , Papillomavirus Vaccines/adverse effects , Papillomavirus Vaccines/genetics , Vaccination/adverse effects , Vaccines, Synthetic/administration & dosage , Vaccines, Synthetic/adverse effects , Vaccines, Synthetic/genetics , Viral Hepatitis Vaccines/administration & dosage , Viral Hepatitis Vaccines/adverse effects , Viral Hepatitis Vaccines/genetics , Young Adult
2.
Viruses ; 13(3)2021 03 16.
Article in English | MEDLINE | ID: covidwho-1457709

ABSTRACT

BACKGROUND: Efficacy for cervical cancer prevention of opportunistic HPV vaccination in post-pubertal girls is lower than in 11-year-olds. METHODS: Women born between 1986 and 1992 vaccinated at 15-25 years of age (at least one dose of 4-valent HPV vaccine) and screened at 24-27 years of age were included. Frequency of opportunistic vaccination, overall and by birth cohort, was calculated; screening outcomes were compared between vaccinated and unvaccinated women. RESULTS: Overall, 4718 (4.9%) HPV-vaccinated, and 91,512 unvaccinated, women were studied. The frequency of vaccination increased by birth cohort, ranging between 1.8% and 9.8%; age at vaccination decreased progressively by birth cohort (p < 0.0001). Participation in screening was 60.8% among vaccinated, and 56.6% among unvaccinated, women (p < 0.0001). Detection rates (DR) for high-grade lesions were lower in vaccinated women (2.11‰ vs. 3.85‰ in unvaccinated, for CIN3+, p = 0.24; 0.0‰ vs. 0.22‰ for cancer). The DR of CIN3+ increased with age at vaccination, scoring respectively 0.0‰, 0.83‰, and 4.68‰ for women vaccinated when they were 15-16, 17-20, and 21-25 years old (p = 0.17). CONCLUSIONS: In comparison to unvaccinated women, higher compliance with cervical cancer screening invitation and lower CIN3+ DR among vaccinated women was observed. Age at vaccination was inversely correlated to vaccination efficacy.


Subject(s)
Papillomavirus Infections/prevention & control , Papillomavirus Vaccines/administration & dosage , Uterine Cervical Neoplasms/prevention & control , Adolescent , Adult , Early Detection of Cancer , Female , Humans , Italy/epidemiology , Mass Screening , Retrospective Studies , Young Adult
3.
Curr Oncol ; 28(5): 3705-3716, 2021 09 24.
Article in English | MEDLINE | ID: covidwho-1438539

ABSTRACT

Despite a global and nationwide decrease, Native Americans continue to experience high rates of cancer morbidity and mortality. Vaccination is one approach to decrease cancer incidence such as the case of cervical cancer. However, the availability of vaccines does not guarantee uptake, as evident in the Coronavirus 2019 pandemic. Therefore, as we consider current and future cancer vaccines, there are certain considerations to be mindful of to increase uptake among Native Americans such as the incidence of disease, social determinants of health, vaccine hesitancy, and historical exclusion in clinical trials. This paper primarily focuses on human papillomavirus (HPV) and potential vaccines for Native Americans. However, we also aim to inform researchers on factors that influence Native American choices surrounding vaccination and interventions including cancer therapies. We begin by providing an overview of the historical distrust and trauma Native Americans experience, both past and present. In addition, we offer guidance and considerations when engaging with sovereign Tribal Nations in vaccine development and clinical trials in order to increase trust and encourage vaccine uptake.


Subject(s)
Cancer Vaccines , Papillomavirus Infections , Papillomavirus Vaccines , Uterine Cervical Neoplasms , American Natives , Female , Humans , Papillomavirus Infections/prevention & control , Uterine Cervical Neoplasms/prevention & control
6.
BMJ Open ; 11(6): e051118, 2021 06 29.
Article in English | MEDLINE | ID: covidwho-1288397

ABSTRACT

INTRODUCTION: Squamous cell carcinoma of the anus is a common cancer among sexual minority men, especially HIV-positive sexual minority men; however, there is no evidenced-based national screening protocol for detection of anal precancers. Our objective is to determine compliance with annual anal canal self-sampling or clinician-sampling for human papillomavirus (HPV) DNA. METHODS AND ANALYSIS: This is a prospective, randomised, two-arm clinical study to evaluate compliance with annual home-based versus clinic-based HPV DNA screening of anal canal exfoliated cells. The setting is primary care community-based clinics. Recruitment is ongoing for 400 HIV-positive and HIV-negative sexual minority men and transgender persons, aged >25 years, English or Spanish speaking, no current use of anticoagulants other than nonsteroidal anti-inflammatory drugs and no prior diagnosis of anal cancer. Participants are randomised to either receive a swab in the mail for home-based collection of an anal canal specimen at 0 and 12 months (arm 1) or attend a clinic for clinician collection of an anal canal specimen at 0 and 12 months (arm 2). Persons will receive clinic-based Digital Anal Rectal Examinations and high-resolution anoscopy-directed biopsy to assess precancerous lesions, stratified by study arm. Anal exfoliated cells collected in the study are assessed for high-risk HPV persistence and host/viral methylation. The primary analysis will use the intention-to-treat principle to compare the proportion of those who comply with 0-month and 12-month sampling in the home-based and clinic-based arms. The a priori hypothesis is that a majority of persons will comply with annual screening with increased compliance among persons in the home-based arm versus clinic-based arm. ETHICS AND DISSEMINATION: The study has been approved by the Medical College of Wisconsin Human Protections Committee. Results will be disseminated to communities where recruitment occurred and through peer-reviewed literature and conferences. TRIAL REGISTRATION NUMBER: NCT03489707.


Subject(s)
Anus Neoplasms , Papillomavirus Infections , Pharmaceutical Preparations , Anal Canal , Anus Neoplasms/diagnosis , Anus Neoplasms/prevention & control , Early Detection of Cancer , Homosexuality, Male , Humans , Male , Papillomavirus Infections/diagnosis , Papillomavirus Infections/prevention & control , Prospective Studies , Randomized Controlled Trials as Topic , Wisconsin
8.
Prev Med ; 151: 106623, 2021 10.
Article in English | MEDLINE | ID: covidwho-1240652

ABSTRACT

COVID-19 has disrupted cervical screening in several countries, due to a range of policy-, health-service and participant-related factors. Using three well-established models of cervical cancer natural history adapted to simulate screening across four countries, we compared the impact of a range of standardised screening disruption scenarios in four countries that vary in their cervical cancer prevention programs. All scenarios assumed a 6- or 12-month disruption followed by a rapid catch-up of missed screens. Cervical screening disruptions could increase cervical cancer cases by up to 5-6%. In all settings, more than 60% of the excess cancer burden due to disruptions are likely to have occurred in women aged less than 50 years in 2020, including settings where women in their 30s have previously been offered HPV vaccination. Approximately 15-30% of cancers predicted to result from disruptions could be prevented by maintaining colposcopy and precancer treatment services during any disruption period. Disruptions to primary screening had greater adverse effects in situations where women due to attend for screening in 2020 had cytology (vs. HPV) as their previous primary test. Rapid catch-up would dramatically increase demand for HPV tests in 2021, which it may not be feasible to meet because of competing demands on the testing machines and reagents due to COVID tests. These findings can inform future prioritisation strategies for catch-up that balance potential constraints on resourcing with clinical need.


Subject(s)
COVID-19 , Papillomavirus Infections , Uterine Cervical Neoplasms , Early Detection of Cancer , Female , Humans , Mass Screening , Papillomavirus Infections/diagnosis , Papillomavirus Infections/prevention & control , SARS-CoV-2 , Uterine Cervical Neoplasms/diagnosis , Uterine Cervical Neoplasms/prevention & control
9.
Public Health Nurs ; 38(5): 715-719, 2021 09.
Article in English | MEDLINE | ID: covidwho-1211555

ABSTRACT

The COVID-19 pandemic has impacted routine health care services including immunization delivery. The most common sexually transmitted infection in the United States is the human papillomavirus (HPV), and its sequelae may be prevented by vaccination. Sequelae that can develop if one's immune system is not able to clear the infection include warts, precancerous lesions, and cancer. The American College of Obstetricians & Gynecologists (ACOG) reports almost everyone who is sexually active will encounter the virus at some time during their life. Most of the estimated 79 million infections occur among people who are in their late teens or early 20s. Since 2006, there has been a vaccine available to prevent HPV infections in both males and females; however, administration of this vaccine has only been about half the rate of other vaccines and vaccine hesitancy may play a role. Public health nurses are vital in providing accurate and nonjudgmental vaccine education to their clients, especially unaccompanied minors seeking care in public health department clinics. This paper will explore the recommendations for providing this vaccine as well as a snapshot of current practice in two health departments in the Southeast region of the United States during the COVID-19 pandemic.


Subject(s)
COVID-19 , Health Promotion , Papillomavirus Infections , Papillomavirus Vaccines , Adolescent , Female , Humans , Male , Nurses, Public Health , Papillomavirus Infections/epidemiology , Papillomavirus Infections/prevention & control , Papillomavirus Vaccines/administration & dosage , Public Health Administration , Southeastern United States/epidemiology , Young Adult
10.
Vaccine ; 39(20): 2731-2735, 2021 05 12.
Article in English | MEDLINE | ID: covidwho-1193499

ABSTRACT

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.


Subject(s)
Alphapapillomavirus , COVID-19 , Papillomavirus Infections , Papillomavirus Vaccines , Uterine Cervical Neoplasms , COVID-19 Vaccines , Female , Humans , Male , Papillomavirus Infections/epidemiology , Papillomavirus Infections/prevention & control , SARS-CoV-2 , United States/epidemiology , Uterine Cervical Neoplasms/epidemiology , Uterine Cervical Neoplasms/prevention & control , Vaccination , Vaccination Coverage
11.
Prev Med ; 144: 106399, 2021 03.
Article in English | MEDLINE | ID: covidwho-1139631

ABSTRACT

WHO/UNICEF estimates for HPV vaccination coverage from 2010 to 2019 are analyzed against the backdrop of the 90% coverage target for HPV vaccination by 2030 set in the recently approved global strategy for cervical cancer elimination as a public health problem. As of June 2020, 107 (55%) of the 194 WHO Member States have introduced HPV vaccination. The Americas and Europe are by far the WHO regions with the most introductions, 85% and 77% of their countries having already introduced respectively. A record number of introductions was observed in 2019, most of which in low- and middle- income countries (LMIC) where access has been limited. Programs had an average performance coverage of around 67% for the first dose and 53% for the final dose of HPV. LMICs performed on average better than high- income countries for the first dose, but worse for the last dose due to higher dropout. Only 5 (6%) countries achieved coverages with the final dose of more than 90%, 22 countries (21%) achieved coverages of 75% or higher while 35 (40%) had a final dose coverage of 50% or less. When expressed as world population coverage (i.e., weighted by population size), global coverage of the final HPV dose for 2019 is estimated at 15%. There is a long way to go to meet the 2030 elimination target of 90%. In the post-COVID era attention should be paid to maintain the pace of introductions, specially ensuring the most populous countries introduce, and further improving program performance globally.


Subject(s)
COVID-19 , Papillomavirus Infections , Papillomavirus Vaccines , Uterine Cervical Neoplasms , Europe , Female , Humans , Immunization Programs , Papillomavirus Infections/prevention & control , SARS-CoV-2 , United Nations , Uterine Cervical Neoplasms/prevention & control , Vaccination , Vaccination Coverage , World Health Organization
12.
J Pediatr ; 231: 24-30, 2021 04.
Article in English | MEDLINE | ID: covidwho-1120004

ABSTRACT

We address ethical, legal, and practical issues related to adolescent self-consent for human papillomavirus (HPV) vaccination. HPV vaccination coverage continues to lag well behind the national goal of 80% series completion. Structural and behavioral interventions have improved vaccination rates, but attitudinal, behavioral, and access barriers remain. A potential approach for increasing access and improving vaccination coverage would be to permit adolescents to consent to HPV vaccination for themselves. We argue that adolescent self-consent is ethical, but that there are legal hurdles to be overcome in many states. In jurisdictions where self-consent is legal, there can still be barriers due to lack of awareness of the policy among healthcare providers and adolescents. Other barriers to implementation of self-consent include resistance from antivaccine and parent rights activists, reluctance of providers to agree to vaccinate even when self-consent is legally supported, and threats to confidentiality. Confidentiality can be undermined when an adolescent's self-consented HPV vaccination appears in an explanation of benefits communication sent to a parent or if a parent accesses an adolescent's vaccination record via state immunization information systems. In the context of the COVID-19 pandemic, which has led to a substantial drop in HPV vaccination, there may be even more reason to consider self-consent. The atmosphere of uncertainty and distrust surrounding future COVID-19 vaccines underscores the need for any vaccine policy change to be pursued with clear communication and consistent with ethical principles.


Subject(s)
Informed Consent By Minors/ethics , Informed Consent By Minors/legislation & jurisprudence , Papillomavirus Infections/prevention & control , Papillomavirus Vaccines , Adolescent , Age Factors , COVID-19/prevention & control , COVID-19 Vaccines , Humans , Mental Competency/legislation & jurisprudence , Mental Competency/psychology , Patient Acceptance of Health Care/psychology , United States
13.
Sci Rep ; 11(1): 4954, 2021 03 02.
Article in English | MEDLINE | ID: covidwho-1114727

ABSTRACT

The prophylactic vaccines available to protect against infections by HPV are well tolerated and highly immunogenic. People with HIV have a higher risk of developing HPV infection and HPV-associated cancers due to a lower immune response, and due to viral interactions. We performed a systematic review of RCTs to assess HPV vaccines efficacy and safety on HIV-infected people compared to placebo or no intervention in terms of seroconversion, infections, neoplasms, adverse events, CD4+ T-cell count and HIV viral load. The vaccine-group showed a seroconversion rate close to 100% for each vaccine and a significantly higher level of antibodies against HPV vaccine types, as compared to the placebo group (MD = 4333.3, 95% CI 2701.4; 5965.1 GMT EL.U./ml for HPV type 16 and MD = 1408.8, 95% CI 414.8; 2394.7 GMT EL.U./ml for HPV type 18). There were also no differences in terms of severe adverse events (RR = 0.6, 95% CI 0.2; 1.6) and no severe adverse events (RR = 0.6, 95% CI 0.9; 1.2) between vaccine and placebo groups. Secondary outcomes, such as CD4 + T-cell count and HIV viral load, did not differ between groups (MD = 14.8, 95% CI - 35.1; 64.6 cells/µl and MD = 0.0, 95% CI - 0.3; 0.3 log10 RNA copies/ml, respectively). Information on the remaining outcomes was scarce and that did not allow us to combine the data. The results support the use of the HPV vaccine in HIV-infected patients and highlight the need of further RCTs assessing the effectiveness of the HPV vaccine on infections and neoplasms.


Subject(s)
CD4-Positive T-Lymphocytes/immunology , HIV Infections/immunology , Papillomavirus Infections/prevention & control , Papillomavirus Vaccines/immunology , Patient Safety , Adolescent , Adult , Antibodies, Viral , CD4 Lymphocyte Count , CD4-Positive T-Lymphocytes/virology , Female , Humans , Male , Papillomavirus Infections/virology , Papillomavirus Vaccines/adverse effects , Public Health , Randomized Controlled Trials as Topic , Risk , Treatment Outcome , Viral Load , Virus Shedding , Young Adult
15.
Crit Rev Eukaryot Gene Expr ; 31(1): 61-69, 2021.
Article in English | MEDLINE | ID: covidwho-1105917

ABSTRACT

The human papilloma virus (HPV) vaccine is the world's first proven and effective vaccine to prevent cancers in males and females when administered pre-exposure. Like most of the US, barely half of Vermont teens are up-to-date with the vaccination, with comparable deficits in New Hampshire and Maine. The rates for HPV vaccine initiation and completion are as low as 33% in rural New England. Consequently, there is a compelling responsibility to communicate its importance to unvaccinated teenagers before their risk for infection increases. Messaging in rural areas promoting HPV vaccination is compromised by community-based characteristics that include access to appropriate medical care, poor media coverage, parental and peer influence, and skepticism of science and medicine. Current strategies are predominantly passive access to literature and Internet-based information. Evidence indicates that performance-based messaging can clarify the importance of HPV vaccination to teenagers and their parents in rural areas. Increased HPV vaccination will significantly contribute to the prevention of a broadening spectrum of cancers. Reducing rurality-based inequities is a public health priority. Development of a performance-based peer-communication intervention can capture a window of opportunity to provide increasingly effective and sustained HPV protection. An effective approach can be partnering rural schools and regional health teams with a program that is nimble and scalable to respond to public health policies and practices compliant with COVID-19 pandemic-related modifications on physical distancing and interacting in the foreseeable future.


Subject(s)
Papillomavirus Infections/prevention & control , Papillomavirus Vaccines/administration & dosage , Physical Distancing , Rural Population/statistics & numerical data , Vaccination/methods , Adolescent , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19/virology , Female , Humans , Male , New England/epidemiology , Pandemics , Papillomavirus Infections/epidemiology , Papillomavirus Infections/virology , Patient Acceptance of Health Care/statistics & numerical data , Public Health/methods , SARS-CoV-2/physiology
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