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PubMed2006

A national survey of pediatrician knowledge and attitudes regarding human papillomavirus vaccination.

OBJECTIVE: A human papillomavirus vaccine was licensed in June 2006. The vaccine is quadrivalent, protecting against 2 human papillomavirus strains that cause cervical cancer and 2 that cause genital warts. The objective of this study was to determine physician characteristics, knowledge, and attitudes associated with an intention to recommend human papillomavirus vaccination. METHODS: Between August and October 2005, a cross-sectional survey was administered to a national network of 431 pediatricians. The network was developed from a random sample of American Academy of Pediatrics members and was designed to be representative of the organization's membership with respect to urban/rural location, practice type, and region. The survey was conducted before human papillomavirus vaccine licensure and therefore focused on a candidate quadrivalent human papillomavirus vaccine and a range of potential vaccination recommendations. The main outcome measure was intention to recommend a quadrivalent human papillomavirus vaccine to young adolescent (10- to 12-year-old) females. RESULTS: Survey response rate was 68%. If endorsed by national health organizations, 46% of respondents would recommend vaccination for 10- to 12-year-old females, 77% for 13- to 15-year-old females, and 89% for 16- to 18-year-old females. Corresponding rates for males were 37%, 67%, and 82%, respectively. Whereas 60% of respondents thought that parents would be concerned that human papillomavirus vaccination may encourage risky sexual behaviors, 11% reported that they themselves had this concern. Respondents who believed that other new adolescent immunization recommendations (eg, meningococcal, pertussis) would facilitate human papillomavirus vaccine implementation were more likely to intend to recommend vaccination. CONCLUSIONS: Although a national sample of pediatricians expressed a high level of acceptance of human papillomavirus vaccination in older adolescent females, fewer than one half anticipated giving human papillomavirus vaccine to younger female patients. Provider concerns about parental vaccine acceptance will need to be addressed to optimize human papillomavirus vaccination implementation.

Attitude of Health Personnel↗
PubMed2006

Harnessing the power of prevention: human papillomavirus vaccines.

Human papillomavirus (HPV) infection and HPV-associated diseases pose a considerable health care burden in the United States. The morbidity and mortality associated with HPV infection and HPV-associated diseases, ranging from genital warts to cervical cancer, have prompted both the use of screening measures to monitor HPV infection and the development of numerous treatment modalities to address its clinical sequelae. Although screening programs have dramatically reduced the incidence of cervical cancer through early detection and treatment, this devastating illness, which frequently affects women of reproductive age, remains a major public health concern. Prophylactic vaccines that prevent HPV infection have proved to be safe, well tolerated, highly efficacious, and induce long-lasting immunity to HPV. Multivalent vaccines that protect against the most common disease-causing HPV types should significantly reduce the morbidity and mortality associated with HPV.

Adolescent↗
PubMed2005

Emerging human papillomavirus vaccines.

Human papillomavirus (HPV) infections are a leading cause of virus-associated cancers of the anogenital, oropharyneal and cutaneous epithelium. The most prevalent of these is cervical cancer, which is responsible for approximately 500,000 deaths annually worldwide. A group of about 15 serologically unrelated 'high-risk' HPV types are responsible for almost all HPV-associated cancers. Prevention of papillomavirus infection can be achieved by induction of capsid-specific neutralising antibodies in preclinical animal papillomavirus models and in recent human clinical trials. High titres of conformationally-dependent, type-specific HPV-neutralising antibodies are triggered by HPV virus-like particle (VLP) vaccines. Overcoming the problems of type-specificity of the responses to these VLP vaccines is a potentially important area of current HPV vaccine research, with an emphasis on induction of more broadly cross-protective neutralising responses. Viral oncogenes E6 and E7 are continuously present in HPV-associated cancers and are prime targets for HPV therapeutic vaccines. A variety of approaches are being tested in therapeutic vaccine clinical trials and in various preclinical animal papillomavirus models for efficacy. Approaches include genetic vaccines, recombinant virus vaccines, dendritic cell-based strategies, immunomodulatory strategies and various combination strategies to maximise cell-mediated immunity to papillomavirus proteins present in HPV infections and cancers. The success of preventive HPV VLP vaccines in clinical trials is clear. However, current therapeutic vaccine trials are less effective with respect to disease clearance. Nevertheless, a series of combination approaches have shown significant therapeutic enhancement in preclinical papillomavirus models and await testing in patient populations to determine the most effective strategy. There is much encouragement that HPV vaccines will be the most effective approach to prevention and cure of infections caused by this group of viruses, which re-present a significant human pathogen.

Clinical Trials as Topic↗
PubMed2006

Prophylactic human papillomavirus vaccines.

Human papillomavirus (HPV) infection causes virtually all cases of cervical cancer, the second most common cause of death from cancer among women worldwide. This Review examines prophylactic HPV subunit vaccines based on the ability of the viral L1 capsid protein to form virus-like particles (VLPs) that induce high levels of neutralizing antibodies. Following preclinical research by laboratories in the nonprofit sector, Merck and GlaxoSmithKline are developing commercial versions of the vaccine. Both vaccines target HPV16 and HPV18, which account for approximately 70% of cervical cancer. The Merck vaccine also targets HPV6 and HPV11, which account for approximately 90% of external genital warts. The vaccines have an excellent safety profile, are highly immunogenic, and have conferred complete type-specific protection against persistent infection and associated lesions in fully vaccinated women. Unresolved issues include the most critical groups to vaccinate and when the vaccine's cost may be low enough for widespread implementation in the developing world, where 80% of cervical cancer occurs.

Adolescent↗
PubMed2004

Anti human papillomavirus vaccine: the checkmate to human papillomavirus?

Cervical cancer is the second most frequently found neoplasia in women worldwide. At least 95% of cervical cancers contain viral DNA which, in 80% of cases, belongs to one of the human papillomavirus (HPV) viral types at high oncogenic risk: 16, 18, 31 and 45. HPV is, at this point, considered the first "necessary cause" of cervical cancer, against which primary prevention with a reduction in the risk of infection can be carried out. Numerous molecular biological studies have been conducted to identify the biological markers of this infection and to refine an effective and well tolerated vaccine capable of preventing HPV infection as well as possibly treating those cases in which the infection has already caused an HPV-related disease of the genital tract. In the near future, the real primary prevention of this disease will be conducted, similar to what occurred for Hepatitis B, using immunoprophylaxis with an anti-cancer vaccine.

Female↗
PubMed2006

The human papillomavirus vaccines.

Genital human papillomavirus (HPV) infection is the most common sexually transmitted infection (STI) among sexually active couples. Its annual incidence is approximately 5.5 million. Overall, an estimated 75% of sexually active men and women have been exposed to HPV at some point in their lives. HPV-16 and -18 account for about 70% of cancers of the cervix, vagina and anus, and for about 30%-40% of cancers of the vulva, penis and orophaynx. Cancer of the cervix uteri is the second most cancer among women worldwide. Cancer of the penis is a rare cancer, accounting for less than 0.5% of cancers in men. Spontaneous clearance of HPV infection is accompanied by humoral and cellular immune response against virus-specific antigens. Two vaccines, prophylactic and therapeutic ones, are considered. Prophylactic vaccines use L1 and L2 capsid proteins to induce production of conformationally-specific antibodies. They block HPV infection. Lone L1 and L2 proteins self-assemble into a capsid that is identical to the complete virion. In this way, an antibody-mediated response is induced before the body actually comes into contact with the live virion. Therapeutic vaccines are being developed to protect HPV-positive persons against tumor development. For these vaccines, researchers are targeting the activity of the E6 and E7 oncoproteines.On June 8, 2006, the U.S. Food and Drug Administration (FDA) approved an HPV vaccine for clinical use. The HPV vaccine that has been approved is the quadrivalent vaccine that consists of recombinant viral-like particles (VLPs) of HPV 6, 11, 16, 18 mixed with an aluminum-containing adjuvant. It is manufactured by Merck & Co., Inc. and sold under the name of Gardasil?. The new vaccine is approved for use in females 9-26 years of age. The primary target population for vaccination should be females aged 11-12 years. However, vaccination can be given to girls as young as 9 years of age. Vaccination can receive women aged 13-26 years who have been sexually active. There are still no data on the vaccine efficacy in women older than 26, and currently no data to demonstrate the efficacy of vaccination in males; male subjects should not be vaccinated until such data become available. The vaccine is to be administered intramuscularly either into the deltoid muscle of the arm or the high anteriolateral area of the leg. Each patient receives three 0.5 mL doses given according to the following schedule: first dose is given at the elected date, second dose two months after the first dose, and third dose six months after the first dose. According to statements from Merck, the list price of the vaccine is 120 USD per dose. GlaxoSmithKline is now conducting a phase III trial of a bivalent (HPV 16, 18) vaccine, and it is going to be presented under the name of Cervarix. Similar results to those obtained with the quadrivalent HPV vaccine have been reported with the bivalent vaccine. It is expected to be released in June next year. Evaluation of the HPV vaccine efficiency in preventing dysplasia and cancer has been recommended as a globally accepted endpoint for population based studies.

Adolescent↗
PubMed2006

A study of women's knowledge regarding human papillomavirus infection, cervical cancer and human papillomavirus vaccines.

AIMS: Human papillomavirus (HPV) infection is a common sexually transmitted viral infection and is associated with the development of cervical cancer. HPV vaccines are now undergoing phase 3 clinical trials in Australia. It is likely that an HPV vaccine will become licensed for use in the near future. METHODS: Ninety women aged 18-30 years from three different groups (those attending a dysplasia clinic, a local university health service and participants currently involved in a phase 3 HPV vaccine trial) completed a questionnaire assessing their knowledge base regarding HPV infection, cervical cancer, Pap tests and HPV vaccines. RESULTS: Respondents demonstrated good understanding of the Pap test and interpretation of an abnormal result. Most respondents (89%) had heard of HPV and attributed a number of different clinical symptoms to infection. For women who had not heard of an HPV vaccine, 79% of respondents stated that the most common resource they would use to obtain further information is their general practitioner. DISCUSSION: Many women do not understand the risk factors for HPV infection, the clinical problems it may cause and the potential long-term complications of infection. Few women have heard of a HPV vaccine, but most women surveyed would approach their general practitioner for more information if one became available. CONCLUSION: This study highlights the need for further education regarding HPV infection and the potential long-term complications such as cervical cancer. It also demonstrates that education of general practitioners regarding an HPV vaccine is essential, as this is the most likely resource women will use to obtain further information in the future.

Adolescent↗
PubMed2006

Recent advances in human papillomavirus vaccines.

The human papillomavirus (HPV) is one of the most common sexually transmitted infections and the etiologic agent of cervical dysplasia and cancer. Recent research on the safety and efficacy of prophylactic vaccines against HPV has shown promising results with nearly 100% efficacy in preventing persistent infections and cervical dysplasia. Several approaches are being tested in therapeutic vaccine clinical trials whereby E6, E7, or both agents are administered in live viral vectors, as proteins, or in nucleic acid form. Cell-based therapeutic vaccines are also being tested. HPV vaccines have the potential to eradicate a major cancer and source of morbidity around the world.

Combined Modality Therapy↗
PubMed1999

Human papillomavirus vaccines.

Genital human papillomavirus (HPV) infections are the viral sexually transmitted diseases most frequently diagnosed that include anogenital condylomas and squamous intra-$bepithelial lesions, among which the precursors of invasive carcinomas of the uterine cervix. In animal PV models, vaccination against L1 and/or L2 viral capsid proteins provides an efficient protection against infection, involving virus type-specific neutralizing antibodies. Vaccination against non-structural E1, E2, E6 or E7 viral proteins does not prevent infection, unless administered altogether, but tends to stimulate regression, warranting the design of therapeutic vaccines. Prophylactic vaccines based on the use of virus-like particles (VLPs) obtained by auto-assembly of L1 or L1 and L2 proteins produced by recombinant DNA technology are under phase I/II clinical trials for HPV6/11 associated with condylomas and for HPV16, the most frequent oncogenic genotype. Second generation vaccines are chimeric proteins or VLPs incorporating one of the structural proteins (L1 or L2) fused to a non-structural protein (E6, E7 or E2), which should induce both humoral and cellular immunity. Vaccine valency (number of genotypes), route of administration (humoral versus local immunity), vaccinees (children, young adults, gender) and forms of vaccines (recombinant $LSalmonella typhimurium*I$L, edible plants expressing L1 and L2 proteins, DNA vaccines, synthetic antigenic peptides) are under study. End points to evaluate vaccine efficacy in phase III trials should include viral DNA detection and typing, and screening for low or high grade intraepithelial lesions. Therapeutic vaccines based on recombinant HPV E6 and/or E7 vaccinia virus, L2-E7 fusion proteins or E7 peptides corresponding to cytotoxic T cell epitopes are currently tested (phase I/II trials) in patients with cervical carcinomas of advanced clinical stages or high grade intraepithelial lesions. Animal studies, phase I/II clinical trials and implementation of the community support that HPV vaccines will constitute an efficient means to prevent carcinoma of the uterine cervix.

Animals↗
PubMed2001

A murine model for the effects of pelvic radiation and cisplatin chemotherapy on human papillomavirus vaccine efficacy.

Therapeutic human papillomavirus (HPV) vaccines for cervical cancer depend on a competent immune system to be effective. However, cancer patients are often found to be immunosuppressed, which could be attributable to prior radiation, chemotherapy, or the tumor burden itself. This study investigated whether pelvic radiation or cisplatin treatment affected the efficacy of an HPV vaccine and how long these effects lasted. Mice were given pelvic radiation, 2 Gy/day to a total dose of 45 Gy, or 5 mg/kg/week of cisplatin for 3 weeks. Mice were then immunized with an HPV-16 peptide vaccine between 0 and 16 weeks after their treatment. An ELISPOT analysis revealed that a reduced level of peptide-specific, IFNgamma-producing spleen cells was present in immunized mice treated previously with pelvic radiation or cisplatin compared with immunized mice that had not been treated. However, when mice were challenged with HPV-16-expressing tumor cells, immunized mice developed no tumors, regardless of prior treatment, whereas nonimmunized mice did develop tumors. Our results suggest that pretreatment with pelvic radiation or cisplatin alone does not prevent the induction of an effective immune response by a peptide vaccine. These data will have important implications for immunotherapeutic treatment of pretreated cancer patients, especially in the adjuvant setting when immunosuppression by tumor burden would be low.

Animals↗
PubMed2006

Fostering acceptance of human papillomavirus vaccines.

Multivalent prophylactic human papillomavirus (HPV) vaccines currently in the late stages of clinical testing are safe, immunogenic, and efficacious; and phase 3 tests of a quadrivalent vaccine show that it is 100% effective at preventing HPV types 16 and 18-associated cervical intraepithelial neoplasia grades 2 and 3, adenocarcinoma in situ, and cervical cancer through 2 years of postvaccination follow-up. These vaccines promise to reduce the burden of HPV-related disease. Realizing the full benefit of these vaccines will require a vaccination program that addresses the needs and concerns of healthcare providers, parents, and young adolescent patients who will be involved in the vaccine decisionmaking process. Osteopathic physicians, by virtue of their dedication to holistic care, are in an optimal position to play a key role in facilitating acceptance of these vaccines among potential vaccinees and their parents and guardians.

Adolescent↗
PubMed2004

Evaluating human papillomavirus vaccination programs.

Human papillomavirus (HPV) has been implicated as the primary etiologic agent of cervical cancer. Potential vaccines against high-risk HPV types are in clinical trials. We evaluated vaccination programs with a vaccine against HPV-16 and HPV-18. We developed disease transmission models that estimated HPV prevalence and infection rates for the population overall, by age group, by level of sexual activity within each age group, and by sex. Data were based on clinical trials and published and unpublished sources. An HPV-16/18 vaccine for 12-year-old girls would reduce cohort cervical cancer cases by 61.8%, with a cost-effectiveness ratio of 14,583 dollars per quality-adjusted life year (QALY). Including male participants in a vaccine rollout would further reduce cervical cancer cases by 2.2% at an incremental cost-effectiveness ratio of 442,039 dollars/QALY compared to female-only vaccination. Vaccination against HPV-16 and HPV-18 can be cost-effective, although including male participants in a vaccination program is generally not cost-effective, compared to female-only vaccination.

Adolescent↗
PubMed2003

Attitudes about human papillomavirus vaccine in young women.

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.

Adolescent↗
PubMed1998

Prospects for human papillomavirus vaccine development: emerging HPV vaccines.

This review concentrates on recent advances in human papillomavirus vaccine development. Strategies for prophylactic HPV subunit vaccines utilizing recombinantly synthesized, immunogenic virus-like particles are discussed. Therapeutic strategies focusing on the induction of cell-mediated immunity and gene manipulation for the treatment of established HPV-associated disease are also reviewed.

Drug Evaluation↗
PubMed2001

The role of human papillomavirus vaccines in cervical neoplasia.

Cervical cancer is the second most common cause of cancer-related death in women, in some developing countries accounting for the highest cancer mortality. The evidence for the association of high-risk human papillomavirus types with the aetiology of cervical neoplasia is firmly established, human papillomavirus being detected in virtually all cervical cancers. The risk of progression of precursor cervical intra-epithelial neoplasia lesions is associated with persistence of human papillomavirus infection. One strategy for the management of cervical neoplasia worldwide could be the development of prophylactic and/or therapeutic human papillomavirus vaccines. This chapter will discuss the natural history of human papillomavirus infection, viral immunity and the clinical course of resultant disease as the background to the effective design and use of human papillomavirus vaccines for protection or therapy. The progress of ongoing phase I and II clinical trials for several different vaccine preparations and the challenges for establishing their future use will be discussed.

Female↗
PubMed2006

Understanding and overcoming barriers to human papillomavirus vaccine acceptance.

New vaccines designed to prevent human papillomavirus (HPV) infection have the potential to reduce the incidence of serious illness and death worldwide among women, substantially reduce the emotional suffering associated with abnormal Papanicolaou (Pap) test results and the diagnosis of cervical cancer, and save significant health care dollars. However, these benefits may not be fully realized until the vaccine is accepted by patients, parents, and health care practitioners. Furthermore, there may be unique issues related to the acceptance of a vaccine designed to prevent a sexually transmitted infection that is poorly understood by many women. Among the acceptance issues are: individual comfort with a sexually transmitted infection (STI) vaccine; parental comfort with vaccination of their preadolescent/early adolescent daughters; physician comfort with recommending a human papillomavirus vaccine to women and parents of preadolescents; and physician communication skills related to talking with women and parents about the vaccine. Potentially difficult as it might be to implement a vaccination program, vaccination and prevention of HPV-associated disease are still infinitely preferable to observation and treatment. This article will review some of the potential barriers to HPV Vaccine acceptance, with a particular focus on factors relevant to female patients, parents, and health care providers.

Adolescent↗
PubMed2000

Comparison of papillomavirus and immunodeficiency virus evolutionary patterns in the context of a papillomavirus vaccine.

In contemplating a vaccine for human papillomaviruses (HPVs), it is important to consider the evolutionary context in which such a vaccine would be deployed. The human immunodeficiency virus, having been the subject of even more extensive study than HPV, shares certain salient features with regards to phylogenetic structure, and may serve as a model for contemplation of possible difficulties with HPV vaccination. However, there are also striking differences in the evolutionary potentials and histories of the viruses that permit an optimistic outlook for HPV. These similarities and differences, as well as their implications for vaccination studies, are reviewed.

Animals↗