Author Interviews, CDC, Flu - Influenza, Vaccine Studies / 29.05.2019

MedicalResearch.com Interview with: Megan C. Lindley, MPH Deputy Associate Director for Science Immunization Services Division CDC MedicalResearch.com: What is the background for this study? Response: Despite longstanding recommendations from the Advisory Committee on Immunization Practices, healthcare personnel influenza vaccination coverage remains below the Healthy People 2020 target of 90%. Healthcare employers use a variety of strategies to promote influenza vaccination among healthcare personnel, including facility-level mandates for vaccination. Several U.S. states have also enacted laws related to healthcare personnel influenza vaccination, but the effect of these laws on vaccination uptake is unclear. Our study used influenza vaccination coverage data reported by over 4,000 U.S. hospitals to examine three kinds of laws: (1) Assessment laws, which require hospitals to assess healthcare personnel influenza vaccination status; (2) Offer laws, which require hospitals to offer the influenza vaccine to healthcare personnel; and (3) Ensure laws, which require hospitals to require healthcare personnel to demonstrate proof of influenza vaccination. (more…)
Author Interviews, HIV, HPV, Race/Ethnic Diversity, STD, Vaccine Studies / 08.04.2019

MedicalResearch.com Interview with: Perry N Halkitis, PhD, MS, MPH Dean and Professor Department of Urban-Global Public Health Rutgers Public Health  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: The rate of human papillomavirus (HPV) infection is high among young minority gay, bisexual, and other men who have sex with men despite the availability of a vaccine that can prevent the infection, a Rutgers School of Public Health study found. (more…)
Author Interviews, BMJ, Cancer Research, HPV, OBGYNE, Sexual Health, Vaccine Studies / 05.04.2019

MedicalResearch.com Interview with: Dr. Tim Palmer Honorary Senior Lecturer Department of Pathology University of Edinburgh Edinburgh, UK  MedicalResearch.com: What is the background for this study? What are the main findings?  Response: High risk HPV infection is the obligate cause of between 70 and 90% of cervical cancers, depending upon the country. The development of vaccines against the commonest hr-HPV types has the potential to reduce the burden of cervical cancer, especially in low and middle income countries that cannot afford screening programmes. Cervical cancer affects predominantly women in their 30s and is a major public health issue even in countries with well-established screening programmes. Scotland has had a successful immunisation programme since 2008, and women immunised at age 12 to13 have been screened since 2015. We can therefore demonstrate the effect of hr-HPV immunisation on the pre-invasive stages of cervical cancer. (more…)
AACR, Author Interviews, Cancer Research, HPV, University of Michigan, Vaccine Studies / 05.04.2019

MedicalResearch.com Interview with: Diane Harper, M.D., M.P.H., M.S. Professor of Family Medicine and Obstetrics and Gynecology Senior Associate Director, Michigan Institute for Clinical and Health Research Physician Director for Community Outreach, Engagement and Health Disparities, Rogel Cancer Center Michigan Medicine  MedicalResearch.com: What is the background for this study? Response: There is no current cure for women with HPV infection that has progressed to CIN 2/3 disease. The only treatment is for the diseased cervix, and does not eliminate the risk of another CIN 2/3 from the HPV infection 15-20 years later. This vaccine is made from a live virus that has 3 genes inserted:  human cytokine IL-2, and modified forms of HPV 16 E6 and E7 proteins. When the vaccine is injected subcutaneously, the proteins for HPV 16/E6 and E7 and the cytokine LI-2 proteins are made. These proteins trigger the immune response.  This is very different form imiquimod which is topical and not specific for HPV. (more…)
Author Interviews, Cancer Research, Infections, STD, Vaccine Studies / 01.04.2019

MedicalResearch.com Interview with: Lisa T. Wigfall, PhD, MCHES(R) Assistant Professor, Health and Kinesiology Texas A&M MedicalResearch.com: What is the background for this study? Response: Human papilloma virus (or HPV) is a very common sexually transmitted infection that can cause some types of cancer. These include anal, cervical, oral, penile, vaginal, and vulvar cancers. Some people such as people who are HIV-positive and men who have sex with men have a greater risk for developing HPV-associated cancers. The risk of developing anal cancer is significantly higher for men who have sex with men who are also HIV-positive. Our study included adults who were at risk for becoming HIV-positive, which included having unprotected anal sex. (more…)
Author Interviews, Autism, Social Issues, University of Pittsburgh, Vaccine Studies / 26.03.2019

MedicalResearch.com Interview with: Beth Hoffman, B.Sc., graduate student University of Pittsburgh Graduate School of Public Health Research Assistant, University of Pittsburgh Center for Research on Media, Technology and Health MedicalResearch.com: What is the background for this study? What are the main findings? Response: Vaccine refusal is a public health crisis - low vaccination rates are leading to outbreaks of deadly vaccine-preventable diseases. In 2017, Kids Plus Pediatrics, a Pittsburgh-based pediatric practice, posted a video on its Facebook pagef eaturing its practitioners encouraging HPV vaccination to prevent cancer. Nearly a month after the video posted, it caught the attention of multiple anti-vaccination groups and, in an eight-day period, garnered thousands of anti-vaccination comments. Our team analyzed the profiles of a randomly selected sample of 197 commenters in the hopes that this crisis may be stemmed if we can better understand and communicate with vaccine-hesitant parents. We determined that, although Kids Plus Pediatrics is an independent practice caring for patients in the Pittsburgh region, the commenters in the sample were spread across 36 states and eight countries. By delving into the messages that each commenter had publicly posted in the previous two years, we also found that they clustered into four distinct subgroups:
  • “trust,” which emphasized suspicion of the scientific community and concerns about personal liberty;
  • “alternatives,” which focused on chemicals in vaccines and the use of homeopathic remedies instead of vaccination;
  • “safety,” which focused on perceived risks and concerns about vaccination being immoral; and
  • “conspiracy,” which suggested that the government and other entities hide information that this subgroup believes to be facts, including that the polio virus does not exist. 
(more…)
Author Interviews, Infections, Vaccine Studies / 23.01.2019

MedicalResearch.com Interview with: ValnevaThomas Lingelbach President & CEO of Valneva MedicalResearch.com: What is the background for this study? Would you briefly explain the significance of Chikungunya disease? Response: Chikungunya is a mosquito-borne viral disease caused by the Chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. The chikungunya virus causes clinical illness in 72-92% of infected humans around four to seven days after an infected mosquito bite. People infected with chikungunya may suffer from acute onset of fever, debilitating joint and muscle pain, headache, nausea and rash, potentially developing into long-term, serious health impairments such as visual, neurological, heart and gastrointestinal manifestations that in some extreme cases can lead to fatalities. Chikungunya outbreaks have been reported in Asia, Africa, the Americas and Europe. As of 2017, there have been more than one million reported cases in the Americas. The medical burden is expected to grow as the CHIKV primary mosquito vectors continue to further spread geographically. Currently there are no preventive vaccines against Chikungunya making it a major threat to public health. We set out to develop VLA1553, a live-attenuated vaccine candidate, as a potential solution to the growing unmet need chikungunya poses. Our hope is that having a preventative vaccine for chikungunya will allow people living in endemic areas to have peace of mind while enjoying the outdoors. (more…)
Author Interviews, Diabetes, Infections, JAMA, Pediatrics, Vaccine Studies / 22.01.2019

MedicalResearch.com Interview with: Dr Kirsten Perrett MBBS FRACP PhD Team Leader / Clinician-Scientist Fellow, Population Allergy, Murdoch Children's Research Institute Consultant Paediatrician, Department of Allergy and Immunology and General Medicine The Royal Children's Hospital Fellow, School of Population and Global Health The University of Melbourne Parkville, Victoria  Australia MedicalResearch.com: What is the background for this study? Response: Before rotavirus vaccines were available, rotavirus infection was the most common cause of severe gastroenteritis in infants and young children. Because it is so contagious, infection in childhood is thought to be universal in unvaccinated children. Previous studies indicated that rotavirus infection of infants might be an environmental promoter of type 1 diabetes. Therefore, we anticipated that the introduction of the rotavirus vaccine might alter the disease incidence in young children.  (more…)
Author Interviews, CDC, Infections, Pediatrics, Vaccine Studies / 18.01.2019

MedicalResearch.com Interview with: Sarah Anne Mbaeyi MD MPH Division of Bacterial Diseases CDC  MedicalResearch.com: What is the background for this study? Response: College freshman living in residence halls, though not college students overall, have previously been identified as being at increased risk for meningococcal disease. However, these evaluations were conducted in the 1990s when rates of disease were higher, serogroup C was the predominant cause of disease, and before the availability of quadrivalent meningococcal conjugate (MenACWY) or serogroup B meningococcal (MenB) vaccines. MenACWY vaccine is routinely recommended for all adolescents at age 11 years and 16 years, as well as unvaccinated or undervaccinated college freshmen living in residence halls. MenB vaccine is not routinely recommended for all adolescents or college students, but may be administered to persons aged 16-23 years, with the preferred age of 16-18 years, based on clinical decision-making. Meningococcal vaccines are also recommended during an outbreak, and in recent years MenB vaccines have been used during multiple outbreaks on college campuses. In this evaluation, we aimed to describe the current epidemiology of meningococcal disease among college-aged young adults in the United States. (more…)
Author Interviews, JAMA, Pediatrics, Transplantation, Vaccine Studies / 15.01.2019

MedicalResearch.com Interview with: Amy G. Feldman, MD, MSCS Assistant Professor, Pediatrics-Gastroenterology, Hepatology and Nutrition Program Director, Liver Transplant Fellowship Children's Hospital Colorado University of Colorado Medicine MedicalResearch.com: What is the background for this study? What are the main findings? Response: Pediatric solid organ transplant recipients are at increased risk for vaccine preventable infections due to life-long immunosuppressive medications.  The objectives of this study were to 1) evaluate in pediatric    solid organ transplant recipients the number of hospitalizations for vaccine-preventable infections in the first five years post-transplantation and 2) determine the associated morbidity, mortality and costs. In this multicenter cohort study of 6980 children who underwent solid organ transplantation from January 1, 2004, to December 31, 2011, at a center participating in Pediatric Health Information System (PHIS), 15% of individuals had at least 1 hospitalization for a vaccine-preventable infection in the first 5 years after transplant.  Children who received transplants when they were younger than 2 years and recipients of lung, intestine, heart, and multi-visceral organs were at increased risk for hospitalization with a vaccine-preventable infection.  Transplant hospitalizations complicated by a vaccine-preventable infection were $120,498 more expensive (median cost) and were on average 39 days longer than transplant hospitalizations not complicated by vaccine-preventable infections (more…)
Author Interviews, CDC, Global Health, Infections, Vaccine Studies / 11.01.2019

MedicalResearch.com Interview with: Kevin Chatham-Stephens, MD, MPH, FAAP CDR U.S. Public Health Service MedicalResearch.com: What is the background for this study? Response: Typhoid fever is a life-threatening disease caused by Salmonella Typhi bacteria. It spreads when someone consumes food or water that has been contaminated with feces (poop) from someone carrying the bacteria. About 12–27 million cases of typhoid fever occur worldwide every year. About 350 culture-confirmed cases of typhoid fever in the United States are reported to CDC each year. Most of these cases occur among international travelers. Symptoms of typhoid fever often include high fever, weakness, stomach pain, cough, and loss of appetite. Some people have diarrhea or constipation. Typhoid fever can be prevented through vaccination and safe food and water practices. Typhoid fever is treated with antibiotics, although most infections diagnosed in the United States cannot be successfully treated with the class of antibiotics called fluoroquinolones. (more…)
Author Interviews, Baylor College of Medicine Houston, Infections, Microbiome, OBGYNE, Vaccine Studies / 30.11.2018

MedicalResearch.com Interview with: Sasirekha Ramani, PhD Assistant Professor Molecular Virology and Microbiology Baylor College of Medicine Houston, TX MedicalResearch.com: What is the background for this study? Response: This work pertains to Rotavirus, a leading cause of diarrhea and vomiting in children under the age of 5 years. In this paper, we described our work with a rotavirus strain that almost exclusively causes neonatal infections. For many years, we have been trying to understand why this strain primarily infects newborns and why infection in some babies is associated with gastrointestinal symptoms while others are asymptomatic. A few years ago, we showed that this particular virus binds to developmentally-regulated glycans (sugars) in the gut as receptors. As the baby grows, these sugars get modified, and that potentially explains why infection with this virus is primarily restricted to neonates. However, we didn’t really have to answer to why there are differences in association with clinical presentations. (more…)
Author Interviews, CDC, Gastrointestinal Disease, Infections, Vaccine Studies / 15.11.2018

MedicalResearch.com Interview with: "Day 19: Norovirus (stomach flu) visits our home." by Loren Kerns is licensed under CC BY 2.0Rachel M. Burke, PhD, MPH Epidemiologist, Viral Gastroenteritis Branch Centers for Disease Control and Prevention Atlanta, GA 30329 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Noroviruses are the leading cause of vomiting and diarrhea from acute gastroenteritis (inflammation of the stomach or intestines) among people of all ages in the United States. Each year in the United States, norovirus illness is responsible for an estimated 19 to 21 million cases of acute gastroenteritis, and contributes to 56,000 to 71,000 hospitalizations and 570 to 800 deaths, mostly among children and the elderly. CDC linked information from two different surveillance systems to analyze 3,747 norovirus outbreaks reported by health departments from 2009 to 2016. Our study provides a comprehensive description of norovirus outbreaks from the epidemiology and laboratory perspectives, using the National Outbreak Reporting System (NORS) and CaliciNet, respectively.  Norovirus outbreaks caused by GII.4 strains occurred more often in healthcare settings, affected older adults, and caused more severe illness, leading to hospitalization or death. (more…)
Author Interviews, OBGYNE, Pediatrics, Vaccine Studies / 27.10.2018

MedicalResearch.com Interview with: Anna Beavis, MD, MPH Assistant Professor The Kelly Gynecologic Oncology Service Department of Gynecology and Obstetrics Johns Hopkins Medicine Baltimore, MD 21287-128 MedicalResearch.com: What is the background for this study? What are the main findings? Response: We wanted to look at reasons parents don’t vaccinate their children against HPV, including how those reasons have changed over time from 2010-2016 and how those reasons are different between boys and girls in the most recent data from 2016. We used a nationwide dataset which is publically available from the CDC (Centers for Disease Control) – the National Immunization Survey-Teen, or NIS-Teen - which surveys parents of teens ages 13-17 years old every year to determine rates of all recommended vaccinations. In parents who report that they don’t intend to vaccinate their child against HPV , the survey asks parents why. We found that from 2010 to 2016, the percentage of parents reporting concerns about their child not being sexually active yet went down significantly for both boys and girls. Also, in boys specifically, parents reported male gender as a less common reason for not vaccinating. For both boys and girls, we found that concerns about safety and side effects, necessity, and lack of knowledge about the vaccine were common reasons for not planning to vaccinate.  Also, 10% of parents of girls vs. 20% of parents of boys reporting never having a provider recommendation for the vaccine as their primary reason for not vaccinating. These results may reflect the growing public understanding of the HPV vaccine as a vaccine which is best given before exposure, so before initiation of sexual activity between the ages of 11 and 12, and that it is recommended for both boys and girls. Also, over 80% of people will have an HPV infection in their lifetime, so everyone should get vaccinated regardless of anticipated sexual activity. Additionally, providers should focus their counseling and recommendation on improving knowledge about the HPV vaccine, including its decade-long track record of safety and necessity.    (more…)
Author Interviews, CDC, Pediatrics, Vaccine Studies, Vanderbilt / 18.10.2018

MedicalResearch.com Interview with: "Vacuna influenza / Flu vaccine" by El Alvi is licensed under CC BY 2.0Kathryn M. Edwards, M.D. Sarah H. Sell and Cornelius Vanderbilt Chair in Pediatrics Professor of Pediatrics Vanderbilt University School of Medicine Dr. Edwards discusses the statement from the Infectious Diseases Society of America (IDSA) regarding the Centers for Disease Control and Prevention’s new data on child vaccine rates across the United States. MedicalResearch.com: What is the background for this study? What are the main findings? Response: To monitor the uptake of vaccines the CDC conducts a National Immunization Survey each year.  This survey is conducted by random-digit dialing (cell phones or landlines) of parents and guardians of children 19-35 months of age.  The interviewers ask the families who provides the vaccines for their children and if these providers can be contacted to inquire about the immunizations received.  The overall response rate to the telephone survey was 26% and immunization records were provided on 54% of the children where permission was granted.  Overall 15, 333 children had their immunization records reviewed. When comparing immunization rates for 2017 and 2016, the last two years of the study, several new findings were discovered. First the overall coverage rate for 3 doses of polio vaccine, one dose of MMR, 3 doses of Hepatitis b, and 1 dose of chickenpox vaccine was 90%, a high rate of coverage.  Children were less likely to be up to date on the hepatitis A vaccine (70%) and rotavirus vaccine (73%). Coverage was lower for children living in rural areas when compared with urban areas and children living in rural areas had higher percentages of no vaccine receipt at all (1.9%) compared with those living in urban areas (1%). There were more uninsured children in 2017 at 2.8% and these children had lower immunization rates.  In fact 7.1% of the children with no insurance were totally unimmunized when compared with 0.8% unimmunized in those with private insurance. Vaccine coverage varies by state and by vaccine. (more…)
Author Interviews, Cost of Health Care, Global Health, Infections, Vaccine Studies / 13.09.2018

MedicalResearch.com Interview with: Veronica Toffolutti PhD Research Fellow in Health Economics Bocconi University MedicalResearch.com: What is the background for this study? What are the main findings? Response: Austerity has been linked to several health damaging effects such as suicides, increase in unmet needs, disease outbreaks that affect vulnerable peoples such as malaria in Greece, HIV in Greece and Romania during the current economic crises or in the earlier economic crisis cuts in public health expenditure have been linked with diphtheria and TB. Europe is experiencing declining vaccination rates and resurgences in measles incidence rates. Italy appears to be particularly affected reporting the second largest number, second to Romania, of infection in Europe in 2017. Starting from the point that the primary reason for the outbreak in the decline in the measles vaccination we test the hypothesis that large budget reductions in public health spending were also a contributing factor. Using data on 20 Italian regions for the period 2000-2014 we found that each 1% reduction in the real per capita public health expenditure was associated with a decrease of 0.5 percentage points (95% CI: 0.36-0.65 percentage points) in MMR coverage, after adjusting for time and regional-specific time-trends.  (more…)
Author Interviews, Cancer Research, Dermatology, Heart Disease, JAMA, Vaccine Studies / 10.09.2018

MedicalResearch.com Interview with: Dr. Jeffrey Rapaport MD, PA Emeritus head of Dermatology Teaneck's Holy Name Hospital. Dr. Rapaport discusess a case recently reported in JAMA: In 2016: A 97-year-old female patient was suffering from multiple squamous cell carcinomas varying from small to incredibly large in size on both of her legs. She was injected with the HPV vaccine commonly known as Gardasil, which is also used to treat warts and oral papilloma. She was first injected in her arm, and then after a period of six weeks, the vaccine was directly injected into her tumors. It was observed that this treatment eventually killed off almost all the tumors on her legs. According to recent press coverage, she is now looking forward to celebrating her 100th birthday in fall 2018. MedicalResearch.com: What is the background for this study?Is HPV thought be a trigger for some cutaneous squamous cell carcinomas? Response: The link between skin cancers and HPV vaccinations has normally been investigated in patients who have received organ transplants. Due to the immune-suppressant drugs these patients must take, it is incredibly common to find cases of skin cancer in patients who have undergone transplants. The relaxed immune system, which would normally eliminate cancers caused by the HPV virus, would open the floodgates for multiple skin tumors to emerge. In this case of the 97 year old, I would assume her immune system was healthy. There is, however, growing evidence that receiving multiple vaccines for the HPV virus is necessary even in patients with healthy immune systems. So, regardless of immune health, I believe we need to expand the frequency of the HPV vaccine, even beyond the current three-tiered system for women below 26 and men below 21. (more…)
Author Interviews, Gastrointestinal Disease, Infections, JAMA, Pediatrics, Vaccine Studies / 07.09.2018

MedicalResearch.com Interview with: Chuanxi Fu, MD.PhD. Professor of Epidemiology, School of Public Health Zhejiang Chinese Medical University Associate editor, Human Vaccines & Immunotherapeutics  MedicalResearch.com: What is the background for this study? What are the main findings? Response: Since 2000, the Lanzhou lamb rotavirus vaccine has been exclusively licensed in China for voluntary rotavirus gastroenteritis prevention, however, the effects of the vaccination on population health, including any indirect impact to unvaccinated individuals have not been evaluated. In the study enrolled 33 407 patients with rotavirus gastroenteritis from 2007 to 2015 seasons in southern China shows vaccination effects in which the median age at onset increased by 4 months, and onset, peak, and cessation of incidence were delayed. The incidence rate ratio among children younger than 4 years and among children ineligible for vaccination decreased as citywide vaccination coverage increased, and the adjusted odds ratio for rotavirus gastroenteritis among unvaccinated infants decreased in areas with higher vaccination coverage.  (more…)
Author Interviews, Dermatology, Vaccine Studies / 30.08.2018

MedicalResearch.com Interview with: Eric Huang, PhD Professor, Department of Dermatology University of California, San Diego MedicalResearch.com: What is the background for this study? To whom would the vaccine be targeted?  Affected individuals?  Patients with strong family history? Resistant acne cases? Response: The background for this study is to develop vaccines to replace the antibiotics which may induce resistant bacteria. Preventive acne vaccines will be used for injection into elementary students to prevent the acne development when they become teenagers. Therapeutic acne vaccines using monoclonal antibodies will be used for those patients who already have acne vulgaris. Both patients with strong family history and resistant acne cases are highly recommended to use when the acne vaccines are available.   (more…)
Author Interviews, Endocrinology, Kaiser Permanente, Menopause, OBGYNE, Pediatrics, Pediatrics, Vaccine Studies / 30.08.2018

MedicalResearch.com Interview with: Allison L. Naleway, PhD Senior Investigator Associate Director, Science Programs Center for Health Research Kaiser Permanente MedicalResearch.com: What is the background for this study? Response: Reports of premature menopause after human papillomavirus (HPV) vaccination have received a lot of media attention, including on social media, but these reports were based on a small number of isolated cases. Large studies have demonstrated the safety of HPV vaccination, but parental safety concerns—including potential impact on future fertility—are often cited as one reason for lower HPV coverage. Rates of HPV vaccination have lagged behind coverage rates for other recommended adolescent vaccinations, such as tetanus-diphtheria-acellular pertussis and meningococcal conjugate. (Based on national coverage estimates from 2016, 65% of 13–17 year-old females received at least one HPV vaccination and only 49.5% were up to date with the series, compared to about 88% of adolescents who received Tdap.) We conducted a study of nearly 200,000 young women to determine whether there was any elevated risk of primary ovarian insufficiency (POI) after HPV or other recommended vaccinations.  (more…)
Author Interviews, Beth Israel Deaconess, HIV, Lancet, Vaccine Studies / 08.07.2018

MedicalResearch.com Interview with: Dan Barouch, M.D., Ph.D. Professor of Medicine Harvard Medical School Ragon Institute of MGH, MIT, and Harvard Director, Center for Virology and Vaccine Research Beth Israel Deaconess Medical Center Boston, MA 02215 MedicalResearch.com: What is the background for this study? What are the main findings? Response: This study demonstrates that the mosaic Ad26/Env HIV vaccine candidate induced robust and comparable immune responses in humans and monkeys. Moreover, the vaccine provided 67% protection against viral challenge in monkeys.    (more…)
Author Interviews, Brain Cancer - Brain Tumors, Cancer Research, Duke, Immunotherapy, NEJM, Vaccine Studies / 26.06.2018

MedicalResearch.com Interview with: Annick Desjardins, M.D., F.R.C.P.C. Associate Professor of Neurology Associate Professor of Neurosurgery Director of Clinical Research The Preston Robert Tisch Brain Tumor Center at Duke Duke University School of Medicine Durham, NC 27710 MedicalResearch.com: What is the background for this study? What are the main findings? Response: The poliovirus receptor (CD155) is an onco-fetal cell adhesion molecule with widespread expression in all solid tumors and particularly in primary CNS tumors (adult and pediatric). Recombinant nonpathogenic polio–rhinovirus chimera (PVSRIPO) was generated by replacing a critical piece of the genetic information from the Sabin type 1 polio vaccine, making PVSRIPO incapable of harming or killing normal brain cells, but toxic/lethal in cancer cells. In preclinical models, it has been demonstrated that the infection of tumor cells, leads to the release of danger signals, which triggers a recruitment of dendritic/CD4/CD8 T cells and a destruction of tumor cells by anti-tumor T cells. The manuscript reports the results of the phase 1 trial of PVSRSIPO in recurrent WHO grade IV malignant glioma patients. Adult patients with recurrence of a single glioblastoma lesion, 1-5.5cm in dimension, in a non-eloquent area of the brain, were enrolled on study. PVSRIPO is injected slowly over 6.5 hours directly into the tumor via a small catheter inserted via a small bur hole. Once intratumoral injection is completed, the catheter is removed and patients are observed for localized tumor inflammation, followed by tumor contraction. A total of 61 patients were treated on study, 9 patients in a dose escalation phase and 52 in a dose expansion phase. Side effects observed were in relation to the localized inflammation of the tumor and depending on the cerebral functions in close proximity to the tumor: headaches, visual field changes, hemiparesis, etc. One patient experienced a brain hemorrhage at the time of catheter removal, which triggered right sided weakness and aphasia. The patient remained alive 57.5 months after PVSRIPO infusion at data cutoff of March 20th, 2018. Two on-study death were observed, a patient died from cerebral edema and seizures, which was later found to be due to tumor progression, and one patient died from the complications of an intracranial hemorrhage while receiving anticoagulation and bevacizumab. The median overall survival among all 61 patients who received PVSRIPO was 12.5 months (95% CI, 9.9 to 15.2), comparatively to 11.3 months (95% CI, 9.8 to 12.5) in a historical control group of patients treated at Duke and who would have met eligibility on trial, would have the trial been available to them. At 24 months, the survival plateaued in patients treated with PVSRIPO with an overall survival rate of 21% (95% CI, 11 to 33) at 24 months and 36 months in PVSRIPO treated patients, while overall survival in the historical control group continued to decline, with an overall survival rates of 14% (95% CI, 8 to 21) at 24 months and 4% (95% CI, 1 to 9) at 36 months in the historical control group.  (more…)
Author Interviews, Infections, OBGYNE, Pediatrics, Vaccine Studies / 17.06.2018

MedicalResearch.com Interview with: Sylvia Becker-Dreps, MD MPH Associate Professor, Department of Family Medicine Associate Director, Office of International Activities (Latin America Focus) Director, UNC Program in Nicaragua University of North Carolina at Chapel Hill Chapel Hill, NC 27599-7595 MedicalResearch.com: What is the background for this study? What are the main findings?  Response: Pertussis (or whooping cough) is a respiratory infection caused by bacteria. It has been becoming more common in the US over the past two decades. Infants are more likely to be hospitalized and die of the disease. They are especially vulnerable in the first months of life because they have not yet had time to complete the DTaP vaccine series themselves. (Currently, infants receive 3 doses of DTaP at 2,4, and 6 months of age.) Immunizing mothers allows the mothers to pass antibodies against pertussis through the placenta and provide passive immunity to infants early in life. In early 2013, the CDC recommended that pregnant women receive a Tdap vaccine in every pregnancy. That recommendation was based on studies of the immune response to the vaccine, not real cases of pertussis. Our study examined clinical cases of pertussis in over 675,000 infants throughout the US. We found that in the first six months of life, infants of vaccinated mothers (those that received Tdap during pregnancy) had 75% less pertussis hospitalizations and 50% less pertussis cases overall.  (more…)
Author Interviews, PLoS, Vaccine Studies / 13.06.2018

MedicalResearch.com Interview with: “Syringe and Vaccine” by NIAID is licensed under CC BY 2.0Melissa S Nolan, PhD, MPH Assistant Professor of Epidemiology Department of Epidemiology and Biostats Arnold School of Public Health University of South Carolina Columbia, SC 2920 MedicalResearch.com: What is the background for this study? Response: As the CDC says, “vaccines are one of the greatest success stories in public health”. In the US, fifteen different vaccines are currently available and recommendations are based on age group and medical indication. Estimates suggest that the US childhood vaccination program has prevented 381 million infections and avoided 855,000 deaths. Despite these astounding public health successes, a movement opposing childhood vaccinations has been growing. Medical contraindications do exist, and these children rely on others to be fully vaccinated to provide herd immunity for children that cannot get vaccinations for medical reasons. In contrast to this important vulnerable clinical population, other reasons for non-vaccination include religious and philosophical beliefs. A major reason for philosophical belief-exemptions is based on the erroneous belief that vaccines cause autism. With philosophical-belief based non-vaccinated populations on the rise, our current study aimed to better understand why some parents seek exemptions for their children. (more…)
FDA, Infections, Vaccine Studies / 08.05.2018

MedicalResearch.com Interview with: Lisa Danzig, MD Chief Medical Office PaxVax MedicalResearch.com: Would you briefly explain what is meant by Chikungunya infection?  Whom does it primarily affect?  How is it transmitted and what the  complications? Response: Chikungunya is caused by the chikungunya virus (CHIKV), an arthropod-borne virus (arbovirus) spread by infected mosquitos. Infection with chikungunya virus results in severe, often debilitating joint pain in infected patients, known as arthralgia. Symptoms can include intense discomfort in joints, such as the wrists, fingers, ankles, and feet, in the knees and in the hips or shoulders. Those affected can also frequently suffer from headaches, fever, and severe muscle pain, rashes on the torso and limbs and swelling in one or more cervical lymph nodes. Individuals who are at a higher risk for contracting chikungunya include infants, elderly and those with chronic conditions. The virus is a small, spherical, enveloped, positive-strand RNA virus. The virus is transmitted by the Aedes aegypti and Aedes albopictus mosquito, which originated in Africa, first spreading to Asia and recently expanding to the western hemisphere.  Outbreaks are rapid and widespread.  In February 2005 a major outbreak of chikungunya occurred in the islands of the Indian Ocean after which over 1.9 million cases have been reported in India, Indonesia, Maldives, Myanmar and Thailand. Chikungunya spread has been identified in 45 countries in the Americas alone with more than 1.7 million suspected cases reported to the Pan American Health Organization since 2015, increasing the incidence of the disease and risk to U.S. travelers. In 2016 there were approximately 60,000 cases of chikungunya across India. Beyond the Indian subcontinent, the Caribbean, Central America and South America, inhabitants and travelers visiting sub-Saharan Africa and Southeast Asia are also at risk. (more…)
Author Interviews, Infections, Science, Vaccine Studies / 05.04.2018

MedicalResearch.com Interview with: Matthieu Domenech de Cellès PhD Department of Ecology and Evolutionary Biology University of Michigan, Ann Arbor, MI, USA. Biostatistics, Biomathematics, Pharmacoepidemiology, and Infectious Diseases Unit Institut Pasteur, Inserm, University of Versailles St-Quentin-en-Yvelines, Versailles, France. MedicalResearch.com: What is the background for this study? What are the main findings?   Response: Our main motivation was to elucidate an apparent paradox: Why has the US experienced a resurgence of pertussis (whooping cough) since the mid-1970s, despite persistently high vaccine coverage? A variety of hypotheses have been proposed to explain this resurgence, but most attention has focused on the potential shortcomings of the new generation of pertussis vaccines (called acellular pertussis vaccines). However, there remains considerable uncertainty about the degree and the mechanisms of protection conferred by pertussis vaccines. Via a collaboration with the local department of public health, we used detailed surveillance data in the state of Massachusetts to test a number of hypotheses about pertussis vaccines. We found that, although pertussis vaccines are imperfect (in the sense that they do not provide lifelong, 100% protection to 100% of children vaccinated), they are still highly efficacious. Specifically, we estimated that vaccine protection wanes over time, but slowly, with about 85% of children still protected 10 years after vaccination. Despite this high vaccine efficacy, we showed that the resurgence of pertussis was, in fact, to be expected. What happens is that the introduction of routine vaccination leads to an overall reduction in transmission, not only in vaccinated children but also in the population at large. Accordingly, those who escaped vaccination as children (as a consequence of incomplete vaccine coverage or imperfect vaccine protection) increasingly age having also avoided natural infection. As a result, the number of individuals susceptible to contract pertussis gradually increases. Because such people are the “fuel” of epidemics, this sets the stage for pertussis’ resurgence, with increasing incidence among older individuals. This overall effect is called the “end-of-honeymoon” and means that resurgence is therefore a predictable consequence of incomplete vaccination with efficacious, but imperfect, vaccines. Importantly, these results show that recent trends do not necessarily reflect recent changes in the epidemiology of pertussis. Rather, they may be interpreted as a legacy of past immunization practices, with long-to-manifest effects. This is a significant shift of perspective about pertussis epidemiology.  (more…)
Author Interviews, GSK, Herpes Viruses, Infections, Vaccine Studies / 10.03.2018

MedicalResearch.com Interview with: Anthony. L. Cunningham, MD The Westmead Institute for Medical Research Westmead, NSW University of Sydney, Sydney,   MedicalResearch.com: What is the background for this study? What are the main findings? Response: This study examines the reasons why the HZ subunit vaccine candidate (HZ/su vaccine) consisting of a single viral protein, varicella-zoster glycoprotein E, and and adjuvant (immunostimulant) combination AS01B is so effective as a vaccine to prevent shingles (>90%), especially in those over the age of 70 years and 80 years, as published in recent trials i.e. it combats the declining immunity in the aging which usually restricts vaccine efficacy to under 60% in these age groups.  (more…)
Author Interviews, Infections, Pediatrics, Vaccine Studies / 23.02.2018

MedicalResearch.com Interview with: Professor Julie Bines Inaugural Victor and Loti Smorgon Professor of Paediatrics and Deputy Head of Department of Paediatrics University of Melbourne. Murdoch Childrens Research Institute  MedicalResearch.com: What is the background for this study? Would you briefly explain the significance of Rotavirus infections? Diarrhoea is one of the leading causes of child illness and death, and rotavirus is the most common cause of severe diarrhoea. Globally rotaviruses cause approximately 215,000 deaths in children under five years. This disease doesn’t discriminate – it infects children worldwide under the age of five – irrespective of what environment you live in. The rotavirus vaccines that are currently available work very well in places like Australia, the US and Europe but they don’t seem to work as well in low income settings in Africa and Asia where severe gastroenteritis is common and many children die. In a world-first clinical trial conducted in Indonesia, the oral RV3-BB vaccine was administered to babies within their first five days of life. Current rotavirus vaccines can only be administered to children older than six weeks, which leaves newborn babies particularly vulnerable to rotavirus infection. In lower resource settings, birth is often the best contact between mother, baby and health services. The oral RV3-BB vaccine was developed from the human neonatal rotavirus strain RV3 identified in the stool of healthy newborn babies. It does not naturally cause diarrhoea like other rotaviruses. The RV3-BB vaccine program aims to take advantage of the characteristics of this novel strain to target a birth dose vaccination strategy.  (more…)
Addiction, Author Interviews, Opiods, Vaccine Studies / 22.02.2018

MedicalResearch.com Interview with: “Syringe and Vaccine” by NIAID is licensed under CC BY 2.0Candy Hwang, Ph.D. The Scripps Research Institute La Jolla, CA 92037 MedicalResearch.com: What is the background for this study? What are the main findings? Response: Our heroin vaccine is designed to stimulate antibodies to recognize and bind heroin, preventing passage of drug molecules to the brain. By essentially blocking the “high” from heroin, we believe this will assist recovering addicts from relapsing. Last year, we reported a heroin vaccine that was shown to be effective in both mouse and non-human primate models. In this current study, we were interested in enhancing our heroin vaccine by exploring different vaccine components and dosages. Once we discovered the most promising vaccine formulations, we wanted to see if our vaccines would be stable under different storage conditions. We found that our heroin vaccine was shelf stable under different temperatures and as a powder or in liquid form, meaning that the vaccine will remain stable for transport and storage. The best vaccine formulation from these studies showed protection against lethal doses of heroin. (more…)