Author Interviews, CDC, HPV, OBGYNE, Vaccine Studies / 22.12.2014

MedicalResearch.com Interview with: Pedro Moro MD MPH Immunization Safety Office, Division of Healthcare Quality Promotion National Center for Emerging and Zoonotic Infectious Diseases Centers for Disease Control and Prevention Medical Research: What is the background for this study? What are the main findings? Dr. Moro: Gardasil® is a human papillomavirus (HPV) vaccine recommended for all girls and boys at age 11 or 12, and teens and young adults who did not get the vaccine when they were younger. Because there is limited safety data available on use of the vaccine during pregnancy, it is not currently recommended for pregnant women. However, some pregnant women will inadvertently receive Gardasil® because they do not yet know that they are pregnant at the time of vaccination. The study reviewed non-manufacturer reports to the Vaccine Adverse Event Reporting System (VAERS) about pregnant women who received Gardasil®. VAERS is a national vaccine safety surveillance program co-administered by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA). VAERS accepts reports of health problems that occur after any US-licensed vaccine (these are called adverse events). VAERS may also accept reports not describing any health problem but vaccination errors (for example, administration of a vaccine not recommended to a particular group of people like pregnant women). VAERS is an early-warning system and cannot generally assess if a vaccine caused an adverse event. After reviewing all non-manufacturer reports of Gardasil vaccination during pregnancy, this study found no unexpected patterns of safety issues for pregnant woman who received Gardasil®, or for their babies. This finding is reassuring and reconfirms the safety of this vaccine for pregnant women, as was previously reported by the pregnancy registry maintained by Gardasil®’s manufacturer.
Author Interviews, CMAJ, HPV, McGill, Vaccine Studies / 14.12.2014

Leah M. Smith PhD Department of Epidemiology, Biostatistics, and Occupational Health (Smith, Kaufman, Strumpf) McGill University, Montréal, QuebecMedicalResearch.com Interview with: Leah M. Smith PhD Department of Epidemiology, Biostatistics, and Occupational Health  (Smith, Kaufman, Strumpf) McGill University, Montréal, Quebec   Medical Research: What is the background for this study? What are the main findings? Dr. Smith: The human papillomavirus (HPV) vaccine protects against types of HPV that cause cervical cancer and anogenital warts. The vaccine first became available in 2006. Since then, it has faced a great deal of controversy surrounding, in part, some of the unanswered questions about the real-world effects of the vaccine, especially on the young girls targeted for immunization. One issue that has received a great deal of public attention has been the concern that HPV vaccination might give girls a false sense of protection against all sexually transmitted infections that might lead them to be more sexually active than they would otherwise. As a result, some parents have been reluctant to have their daughters vaccinated. It is also reason why some religious groups have spoken out against the vaccine. This question is further important from a public health perspective because increases in risky sexual behaviour would inevitably also lead to increases in teen pregnancy and sexually transmitted infections (excluding anogenital warts), which would of course undermine the potential health benefits of the vaccine.  In this study, we directly addressed the question of whether HPV vaccination has led to increases in pregnancy and non-HPV-related sexually transmitted infections (both of which are proxies for risky sexual behaviour) among adolescent girls. In our study of over 260,000 girls, we did not find any evidence that the HPV vaccine had a negative impact on these outcomes.
HPV, Vaccine Studies / 24.11.2014

Dr. Raquel Qualls-Hampton MD, MS Assistant Professor University of North Texas Health Science CenterMedicalResearch.com Interview with: Dr. Raquel Qualls-Hampton MD, MS Assistant Professor University of North Texas Health Science Center Medical Research: What is the background for this study? What are the main findings? Dr. Qualls-Hampton: There are currently two vaccines approved by the Food and Drug Administration (FDA)—Gardasil for males and Gardasil and Cervix for females – that protect against the human papilloma virus (HPV). These vaccines are recommended by the ACIP for females ages 9 to 26 years and males ages 9 to 21 years. Both vaccines protect males and females against some of the most common types of HPV.  HPV vaccines are administered in three doses over six months and are considered safe and effective. However, the promise of these vaccines is going unfulfilled as initiation and completion rates for the three doses are suboptimal among females and males. Nationally, although HPV vaccination initiation coverage is increasing, overall vaccine completion rates are at suboptimal levels and below the U.S. Department of Health and Human Services’ Healthy People 2020 initiative target of 80%. Thus, many states are turning to legislative interventions in efforts to increase initiation and completion rates. This study examines HPV vaccination legislative initiatives and their impact, specifically in estimating state legislation’s effects on HPV vaccine initiation, completion and patient care provider recommendations by gender.
Author Interviews, HPV, Sexual Health / 16.11.2014

Eduardo L. Franco DrPH, FRSC, FCAHS James McGill Professor Departments of Oncology and Epidemiology & Biostatistics, Director, Division of Cancer Epidemiology Minda de Gunzburg Chair, Department of Oncology, Division of Cancer Epidemiology Department of Oncology McGill University Montreal, Quebec, CanadaMedicalResearch.com Interview with; Eduardo L. Franco DrPH, FRSC, FCAHS James McGill Professor Departments of Oncology and Epidemiology & Biostatistics, Director, Division of Cancer Epidemiology, Minda de Gunzburg Chair, Department of Oncology, Division of Cancer Epidemiology Department of Oncology McGill University, Montreal, Quebec, Canada Medical Research: What should clinicians and patients take away from your report? Dr. Franco: Our findings of oral transmission of human papillomavirus (HPV) infection in men are part of a larger molecular epidemiologic study called ‘HPV Infection and Transmission among Couples through Heterosexual Activity’ (HITCH) cohort study. The focus of the HITCH study is to understand how HPV is transmitted within couples via sexual contact and other behaviors. We measure the presence of this virus using highly-sensitive molecular assays for HPV DNA in the genital surfaces (vagina and penis), oral cavity, and hands. We also take a blood sample to look for the presence of antibodies against HPV. We take multiple samples over a period of two years at pre-scheduled visits. We have previously published results focused exclusively on genital transmission. The present report is the first in the HITCH study to look at what happens in terms of characteristics that place male participants to be at risk of oral HPV infection. To our knowledge, this is the first study to show a high risk of oral HPV infection among men whose female partners had a genital or oral HPV infection, suggesting that transmission may occur through oral or genital routes. We looked at transmission for 36 individual HPV genotypes, which improved our ability to study risk determinants. Risk was also significantly higher among men who had ever smoked, had a high number of lifetime sex partners, or were in non-monogamous relationships. Our results are largely consistent with previous studies that have found male sex practices and smoking to be the most significant risk factors for oral HPV infection.
Alcohol, Author Interviews, BMJ, HPV, Sexual Health / 03.10.2014

Matthew B. Schabath, Ph.D Assistant Member, Department of Cancer Epidemiology Moffitt Cancer Center Tampa, Florida MedicalResearch.com: Interview with: Matthew B. Schabath, Ph.D Assistant Member, Department of Cancer Epidemiology Moffitt Cancer Center Tampa, Florida   Medical Research: What are the main findings of the study? Dr. Schabath: Overall, the results from these analyses demonstrated that men who consumed the highest amounts of alcohol were associated with an increased risk for genital human papillomavirus (HPV) infections.
Author Interviews, Cancer Research, HPV, Vaccine Studies / 01.10.2014

Elmar A. Joura, MD Department of Gynaecology and Obstetrics Medical University of Vienna, Comprehensive Cancer Center Vienna, AustriaMedicalResearch.com Interview with: Elmar A. Joura, MD Department of Gynaecology and Obstetrics Medical University of Vienna, Comprehensive Cancer Center Vienna, Austria Medical Research: What are the main findings of the study? Dr. Joura: The upcoming ninevalent vaccine has the potential to prevent 85% of the cervical precancers and surgeries such as LEEP (conization)
Author Interviews, BMJ, HPV / 17.09.2014

Dr Neha Pathak, MBBS MA(Cantab) Academic Clinical Fellow in Obstetrics and Gynaecology Queen Mary University London.MedicalResearch.com Interview with: Dr Neha Pathak, MBBS MA(Cantab) Academic Clinical Fellow in Obstetrics and Gynaecology Queen Mary University London. Medical Research: What are the main findings of the study? Dr. Pathak: Cervical testing for human papillomavirus (HPV) is being piloted as a more accurate method for cervical cancer screening than current cytology-based ("Pap smears"). However, cervical testing still requires gynaecological examination and a doctor or nurse to take the sample. This could be a deterrent to attending screening as it is invasive and time-consuming. Urine-based HPV testing would be a less invasive and more convenient alternative. Our study was completed at the Queen Mary University London Women's Health Research Unit. We pooled the results of 14 studies from around the world which tested 1443 women for HPV in urine and cervical samples. We found that detection of HPV in urine seems to have good accuracy for the detection of HPV present in the cervix. We also found that using first void samples (the first part of the stream of urine) was twenty-two times more accurate than random or midstream urine samples.
Author Interviews, Cancer Research, HPV / 08.06.2014

Dr. Christian S Hinrichs MD Assistant Clinical Investigator Center for Cancer Research National Cancer Institute Bethesda, MD 20814MedicalResearch.com Interview with: Dr. Christian S Hinrichs MD Assistant Clinical Investigator Center for Cancer Research National Cancer Institute Bethesda, MD 20814 MedicalResearch: What are the main findings of the study? Dr. Hinrichs: Objective tumor regression occurred in 3/9 patients with metastatic cervical cancer. Two responses were complete and are ongoing 22 and 15 months after treatment with a single infusion of T cells targeting the HPV oncoproteins.
HPV, MD Anderson / 26.03.2014

Dr. Judith A. Smith is an Associate Professor in the Department of Gynecologic Oncology & Reproductive Medicine in the Division of Surgery at The University of Texas MD Anderson Cancer Center in Houston (UTMDACC),MedicalResearch.com Interview with: Dr. Judith A. Smith Pharm.D. Associate Professor Department of Gynecologic Oncology & Reproductive Medicine Division of Surgery The University of Texas MD Anderson Cancer Center in Houston MedicalResearch.com: What are the main findings of the study? Dr. Smith: This study first demonstrated in vitro suppression of HPV expression. After a single dose at 24 hours and with repeated dosing every 24 hours for 7 days followed by 7 days of no treatment, HPV eradication was achieved. These findings were confirmed with in vivo animal studies. HPV expression was eradicated with once daily AHCC dosing for 90 days and sustained after 30 day observation off treatment.  Immune modulation (increase) of IFNα (p < 0.03), IFNβ (p <0.03), and IFN (p< 0.03) and IgG1 (P < 0.05) was observed in AHCC treated mice compared to untreated controls. AHCC mechanism of immune modulation of the IFN pathways to eradicate HPV was particularly relevant because E6/E7 oncogenic activity in HPV infection is believed to be related to suppression of IFN expression/signaling.  These data suggest AHCC may help clear HPV infections and have a potential role in the prevention of HPV-related cancers.
Author Interviews, BMJ, HPV, Vaccine Studies / 18.03.2014

MedicalResearch.com Interview with: Dr Rachel J Sacks Jefferiss Wing,  St Mary's Hospital Imperial College Healthcare NHS Trust, London UK MedicalResearch.com: What is the background of this study? Dr. Sacks: 2247 anonymous questionnaires were completed by young women, aged 13-19 years old, attending sexual health services across England, looking at their HPV vaccination outcomes and prevalence of risk factors associated with HPV acquisition and cervical cancer development, and comparing the survey results with national data where available. Known HPV acquisition and cervical cancer development risk factors include cigarette smoking, early age at first intercourse, increasing number of lifetime partners, co-infection with other sexually transmitted infections. MedicalResearch.com: What are the main findings of the study Dr. Sacks:
  •          Young women, aged 13  to 19 years old attending sexual health services across England had higher prevalence of known risk factors associated with HPV acquisition and cervical cancer development, compared with national data.
  •          Survey respondents had lower HPV vaccination offer and lower HPV vaccination completion rates than nationally.
  •          Subgroups within the survey respondents were identified as having a significantly lower offer and significantly lower completion rate of the HPV vaccination. These subgroups included respondents from London, those of non-white ethnicities, 17 to 19 year olds, smokers and those not in education, employment or training (NEETs).
  •          The highest risk individuals, in terms of HPV related risk factors, were the least likely to be offered and additional the least likely to complete the HPV vaccination course.
  •          Currently sexual health services in England are not involved in the delivery of the HPV vaccination programme and this is felt to be a huge missed opportunity for the primary prevention of HPV acquisition and its potential sequelae. Sexual health services should be included as a supplementary HPV vaccination delivery site in order to target these particularly vulnerable young women and to increase the success of the HPV vaccination programme in England.
Author Interviews, BMJ, Cancer Research, HPV, Vaccine Studies / 05.03.2014

MedicalResearch.com Interview with: Dr Julia Brotherton Victorian Cytology Service, Melbourne, Victoria, Australia Dr Elizabeth Crowe The University of Queensland, School of Population Health, Brisbane, Australia NHS Borders, Department of Public Health, Melrose, Scotland, UK Prof. David Whiteman Group Leader / Department Coordinator QIMR Berghofer Medical Research Institute Royal Brisbane Hospital, QLD 4029 MedicalResearch.com: What are the main findings of the study? 1.       We conducted a case-control study in which we retrieved the HPV vaccination histories of young Australian women who were notified to the Pap smear registry with high-grade cervical lesions or with other types of cervical lesions, and compared them with the vaccination histories of women whose Pap smears showed only normal cytology. 2.       We found that women with high grade cervical lesions were significantly less likely than women with normal cytology to have received 3 doses of the quadrivalent HPV vaccine, equivalent to a vaccine effectiveness of 46%. 3.       The vaccine effectiveness among 15-19 year old women was even higher at 57%. We believe this reflects the fact that HPV16 causes an even higher proportion of high grade disease in young women due to its higher oncogenicity and shorter latent period. 4.       The HPV vaccine had 34% effectiveness against other cervical lesions (i.e. those not proven to be high grade lesions on histology). 5.       We also observed that 2 doses of the vaccine were 21% effective in preventing both high grade lesions and other grade lesions.
Author Interviews, HPV, Outcomes & Safety / 13.02.2014

Craig Meyers, Ph.D. Distinguished Professor Department of Microbiology and Immunology H107 The Penn State College of Medicine Hershey, PA 17033MedicalResearch.com Interview with: Craig Meyers, Ph.D. Distinguished Professor Department of Microbiology and Immunology H107 The Penn State College of Medicine Hershey, PA 17033 MedicalResearch.com: What are the main findings of the study? Dr. Meyers: The human papillomavirus type 16 (HPV16) is the most common HPV type associated with human cancer. It has always been assumed that HPV16 was susceptible to commonly used disinfectants. However, this has never been tested. We developed the only reproducible method to grow authentic HPV in the laboratory. Our studies show that highly resistant virus; more so than other non-enveloped viruses previously tested. Simply stated that any materials in a healthcare facility that rely on disinfectants (those presently used by healthcare facilities) do absolutely nothing to HPV. This suggests the possibility of risk of infection from inanimate objects, particularly those use in healthcare and dental clinics that depend on disinfectant treatment. Additionally it has been reported that at any one time 20% of individuals with anogenital HPV infections have the virus on their fingertips and the common hand sanitizers do nothing to inactivate the virus.
Author Interviews, HPV, JAMA, Karolinski Institute, Vaccine Studies / 12.02.2014

Lisen Arnheim Dahlström Associate Professor (Docent) Institutionen för medicinsk epidemiologi och biostatistik Department of Medical Epidemiology and Biostatistics Karolinska Institutet SwedenMedicalResearch.com Interview with: Lisen Arnheim Dahlström Associate Professor (Docent) Institutionen för medicinsk epidemiologi och biostatistik Department of Medical Epidemiology and Biostatistics Karolinska Institutet Sweden MedicalResearch.com: What are the main findings of the study? Answer: The main finding, when studying HPV vaccine effectiveness against condyloma by dose level is that 3 doses offered the maximum protection, although 2 doses also offered a substantial protection.
Author Interviews, HPV, Vaccine Studies / 12.10.2013

Lisen Arnheim Dahlström, Associate Professor (Docent) Institutionen för medicinsk epidemiologi och biostatistik Department of Medical Epidemiology and Biostatistics Karolinska Institutet 171 77 Stockholm, SwedenMedicalResearch.com Interview with: Lisen Arnheim Dahlström, Associate Professor (Docent) Institutionen för medicinsk epidemiologi och biostatistik Department of Medical Epidemiology and Biostatistics Karolinska Institutet 171 77 Stockholm, Sweden   MedicalResearch.com: What are the main findings of the study? Answer: This is a Swedish/Danish population-based study comparing serious disease outcomes in girls immunized with the quadrivalent HPV vaccine against the unvaccinated population. The main finding of this study was that none of the 53 outcomes included in the study were more common in the vaccinated population compared to the non-vaccinated population.
Author Interviews, HPV, Infections, Race/Ethnic Diversity / 02.08.2013

MedicalResearch.com interview with: Matthew B. Schabath, Ph.D Assistant Member, Department of Cancer Epidemiology H. Lee Moffitt Cancer Center, 12902 Magnolia Drive MRC-CANCONT, Tampa, Florida MedicalResearch.com: What are the main findings of the study? Dr. Schabath: In this study we found that Asian/Pacific Islander men had the lowest incidence of human papillomavirus (HPV) infection and that they exhibited a lower probability of acquiring new HPV infections.   Furthermore, men of multiple and mixed race had the second lowest incidence of HPV infection and however, while they had a lower probability of acquiring HPV, they also had a lower probability of clearing an HPV infection once acquired.