Mechanisms of aluminum adjuvant toxicity and autoimmunity in pediatric populations

Tomljenovic L1, Shaw CA.

Abstract

Immune challenges during early development, including those vaccine-induced, can lead to permanent detrimental alterations of the brain and immune function. Experimental evidence also shows that simultaneous administration of as little as two to three immune adjuvants can overcome genetic resistance to autoimmunity. In some developed countries, by the time children are 4 to 6 years old, they will have received a total of 126 antigenic compounds along with high amounts of aluminum (Al) adjuvants through routine vaccinations. According to the US Food and Drug Administration, safety assessments for vaccines have often not included appropriate toxicity studies because vaccines have not been viewed as inherently toxic. Taken together, these observations raise plausible concerns about the overall safety of current childhood vaccination programs. When assessing adjuvant toxicity in children, several key points ought to be considered: (i) infants and children should not be viewed as “small adults” with regard to toxicological risk as their unique physiology makes them much more vulnerable to toxic insults; (ii) in adult humans Al vaccine adjuvants have been linked to a variety of serious autoimmune and inflammatory conditions (i.e., “ASIA”), yet children are regularly exposed to much higher amounts of Al from vaccines than adults; (iii) it is often assumed that peripheral immune responses do not affect brain function. However, it is now clearly established that there is a bidirectional neuro-immune cross-talk that plays crucial roles in immunoregulation as well as brain function. In turn, perturbations of the neuro-immune axis have been demonstrated in many autoimmune diseases encompassed in “ASIA” and are thought to be driven by a hyperactive immune response; and (iv) the same components of the neuro-immune axis that play key roles in brain development and immune function are heavily targeted by Al adjuvants. In summary, research evidence shows that increasing concerns about current vaccination practices may indeed be warranted. Because children may be most at risk of vaccine-induced complications, a rigorous evaluation of the vaccine-related adverse health impacts in the pediatric population is urgently needed.

Access article via this link.

From Human Papillomavirus (HPV) Detection to Cervical Cancer Prevention in Clinical Practice

Sin Hang Lee, Jessica S. Vigliotti, Veronica S. Vigliotti and William Jones

Abstract:

The newly gained knowledge of the viral etiology in cervical carcinogenesis has prompted industrial interests in developing virology-based tools for cervical cancer prevention. Due to the long incubation period from viral infection to developing an invasive cancer, a process whose outcome is influenced by numerous life-style and genetic factors, the true efficacy of the genotype-specific human papillomavirus (HPV) vaccines in cervical cancer prevention cannot be determined for another 30 years. Most HPV DNA test kits designed to replace the traditional Papanicolaou (Pap) smears for precancer detection lack the analytical sensitivity and specificity to comprehensively detect all potentially carcinogenic HPVs and to perform reliable genotyping. The authors implemented the classic nested PCR and Sanger DNA-sequencing technology for routine HPV testing. The results showed a true negative HPV PCR invariably indicates the absence of precancerous cells in the cytology samples. However, 80.5% of single positive HPV-16 tests and 97.3% of single positive HPV-18 tests were associated with a negative or a largely self-reversible Pap cytology. Routine sensitive and reliable HPV type-specific or perhaps even variant-specific methods are needed to address the issues of persistence of HPV infection if a virology-based primary cervical screen is used to replace the Pap cytology screening paradigm.

This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

 

The HPV vaccine: injuries and treatment

By Stig Gerdes, Guest Author

SaneVax-FeaturedThe HPV vaccine Gardasil was introduced into the childhood vaccination program in Denmark in 2009. The decision was made already in 2006 by the former Minister of Health Lars Løkke Rasmussen.

In the spring of 2013 there came reports in the Danish press and on Facebook that young girls/women had developed some symptoms characterized by damage to the skin, nervous system, immune system, etc. These symptoms were associated to the Gardasil vaccine.

It was claimed that the vaccination was stopped in Denmark and that the injured were diagnosed and treated for all the many serious damages which were described. The problem is that many did not know and still do not know, the strange symptoms they experienced after Gardasil injections are vaccine injuries.

The health authorities responded by promoting the vaccine and saying the serious injuries of the HPV vaccine was Functional disorders, caused by psychological reasons. The Danish Health and Medicines Authority however would increase surveillance of the HPV vaccine, but nothing was communicated about this, and the doctors did not get any information about the strong suspicion, and they were not informed about the contraindications for the HPV vaccine, it was quite obvious that The Danish Health and Medicines Authority, SSI and The Danish Cancer Society had a financial interest in promoting the vaccine.

At one point, however it was admitted that the HPV vaccine can injure the youngsters. The Minister of Health Nick Hækkerup therefore answers:

“The Danish Health and Medicines Authority consider it important to ensure that patients receive a comprehensive diagnose and treatment, and there is a particular challenge for The Regions to ensure that for patients with severe and unexplained symptoms  this requires collaboration across specialties.”

Subsequently, it was asked for an expert committee to assist The Regions in diagnosing and treating the injured. The Regions thought this was a good idea, but The Danish Health and Medicines Authority refused.

It is important to keep in mind that new HPV injured patients will continue to emerge, because we continue to vaccinate!

Since then, the focus has raised on the HPV vaccine safety outside Denmark, due to healthcare professionals and people around the world linking the severe injuries and possible deaths to the HPV vaccine.

India has cancelled the HPV vaccine trials after 7 deaths and multiple adverse events after vaccine administration.

Japan has pulled the government recommendation for HPV vaccines and replaced their top three government health officials after discovering the high incidence of adverse reactions after HPV vaccine administration.

Spain has scheduled trials.

France discusses the pros and cons.

England’s vaccination victims have been speaking in The Parliament.

Columbia is in turmoil due to deaths and severe injuries ……

The association of HPV Update has held two meetings convened by The Ministry of Health. The Regions and the Danish Health and Medicines Authority were also invited to discuss the frequency and severity of injuries caused by the HPV vaccine.

A worldwide non-profit organization was founded in 2010, SaneVax (Safe affordable, necessary and effective vaccines) in response to the HPV vaccine controversy. This is the link www.sanevax.org

In Denmark, the pressure on the Health Authorities has been so strong that the Minister of Health, Nick Hækkerup, has put diagnosing and treatment in the hands of the Regions.

To make sure that ordinary people and professionals can recognize the HPV vaccine damages, I have summarized these as they are mentioned in the manufacturer Merck’s “leaflet.” The Danish Authorities have not translated adequately, and therefore many of the adverse events are not on the Danish translation. It is a big mistake!

The adverse events are listed below. It must be remembered that the individual injured can have many symptoms at the same time. Most HPV vaccine injured have over 15 symptoms simultaneously.

  • Anaphylactic reaction
  • Autoimmune diseases
  • Inflammation of the pancreas
  • Inflammation of the stomach / intestines
  • Inflammation in other tissues, such as muscles and tendons
  • Inflammation of the sinuses
  • Inflammation of the bladder
  • Inflammation of the lungs
  • Inflammation of the brain
  • Inflammation of the kidney / pelvic
  • Chest pain, they are as violent as by a blood clot in the heart or lungs.
  • Fainting
  • Cell changes in the cervix (if at the time of vaccination, the HP virus in the blood).
  • Death
  • Diarrhoea
  • Fever
  • Guillain-Barre syndrome
  • Headache
  • Cough
  • Swollen lymph nodes
  • Hypersensitivity
  • Flu-like symptoms
  • Weakness
  • Chills (fever)
  • Jaw Pain
  • Nausea
  • Paralysis
  • Joint pain
  • Muscle pain
  • Hives
  • Vomiting
  • POTS (high heart rate, low blood pressure)
  • Insomnia
  • Spasms in the lungs bronchi
  • Dizziness
  • Toothache
  • Fatigue

If you have many of these symptoms, consult your doctor. Bring this article with you, so he can diagnose HPV vaccine injury, and invalidate the diagnosis Functional suffering – and therefore refer you to one of The Region’s hospitals or orthomolecular doctors who can provide you proper treatment paid by The Region.

The characteristic of the HPV injured is that they largely tell the same history of severe tiredness, general aches and pain throughout the body, headache, fainting, seizures, etc.., so that they spend most of their time in bed, and are unable to carry out their schooling, work or household responsibilities. In short term, their functional and work are reduced from 100% to below 30%.

It is encouraging that there is now a symptomatic and perhaps curative treatment!

The reason for the HPV vaccine injuries is finding mitochondria (the cellular powerhouses) at the cellular level destroyed by metals such as lead, mercury, aluminium and artificial HPV DNA.

The treatment is well known in the form of intravenous vitamin C and Glutathione, as well as supplement of vitamins and salts, and to avoid foods that contain metals and allergens.

Several young women have been treated successfully. How long the treatment should continue, is yet unknown, but it seems that intravenous therapy improves symptoms rapidly (i.e. after 6-12 treatments) and may be discontinued after a period, so the injured can continue taking antioxidants, vitamins and salts by mouth.

It should be strongly emphasized that the treated relapse if treatment is stopped and the good effect returns when treatment is resumed.

The good thing about the treatment is that it has been used for many years for other disorders – with good effect, although not recognized by The Health Authorities in Denmark.

One big advantage is this treatment has great effect and no adverse events; unlike HPV vaccines which have plenty of adverse events and has no effect!

The intravenous treatment may be performed by the patient’s GP, but when The Minister of Health has handed over the responsibility for the diagnosis and treatment to The Regions, it must be the hospitals around The Regions that are responsible for treating the HPV vaccine injured when the diagnosis is made. The diagnosis is currently clinically, but safe laboratory tests are under development.

Treatment Protocol:

The intravenous treatment consists of vitamin C administered 2 times a week and Glutathione 1 time per week. Start example is: IV. Vitamin C  25 grams in 250-500 ml of Ringer’s Lactate administered over 3-4 hours, for example, Monday and Friday. Iv. Glutathione Wednesdays, 200-1.200 mg administered in 100-250 ml of saline over 1-1 ½ hours. Vitamin C is gradually increased to 50 grams after 4 infusions. Glutathione increased from 200-1.200 mg after some infusions.

It’s worth knowing:

By IV. Vitamin C the patient are recommended to drink at least 1 ½ litres of water.

The rest of the day the patient are recommended to continue to drink much water.

In order to strengthen the intravenous treatment it is recommended to make a vitamin and mineral plan for supplements. A significant and effective action is seen by the following vitamin and mineral combinations by mouth:

Vitamin C in large doses, Vitamin E, Selenium, Q10, Omega 3, Magnesium, Vitamin D3, Vitamin B complex, Vitamin B12 (Methylcobalamin), Lime, Zinc, Alpha Lipoic acid and N-Acetyl Cysteine.

The dosage and selection of the above should be performed by a specialist in the area. Intravenous treatments should be performed by physicians with adequate experience in the field. The patients’ safety comes first.

Insomnia is a known adverse event after the HPV vaccine. In order to improve sleep it is recommended to take Melatonin which is released over 6 hours.

Avoid food and drinks containing sugar, avoid light products too.

E-numbers and aluminium are found everywhere – try to avoid it. E171, E173 and E621 and aluminium should be avoided completely. There are aluminium (E173) and titanium dioxin (171) everywhere. Baking soda, white flour, white sugar, toothpaste, deodorants, cosmetics, candy, seasoning and often in pills…

The HPV vaccine provides food intolerance frequently. Pay attention to the quality of food. Until the immune system is in place and the nervous system damages are restored, all food is recommended to be organic. This also applies to dietary supplements.


 

On the relationship between human papilloma virus vaccine and autoimmune diseases

Authors: Paolo Pellegrinoa, Carla Carnovalea, Marco Pozzib, Stefania Antoniazzic, Valentina Perronea, Dionigi Salvatia, Marta Gentilia, Tatiana Brusadellia, Emilio Clementib, d, , , Sonia Radicea

Abstract

The human papilloma virus (HPV) vaccines were introduced to reduce the incidence of cervical cancer. The bivalent vaccine is effective against HPV-16, -18, -31, -33 and -45 while the quadrivalent vaccine is effective against HPV-16, 18, 31, 6 and 11 types. The immunisation, recommended for adolescent females, has led to high vaccine coverage in many countries.

Along with the introduction of the HPV vaccines, several cases of onset or exacerbations of autoimmune diseases following the vaccine shot have been reported in the literature and pharmacovigilance databases, triggering concerns about its safety. This vaccination programme, however, has been introduced in a population that is at high risk for the onset of autoimmune diseases, making it difficult to assess the role of HPV vaccine in these cases and no conclusive studies have been reported thus far.

We have thus analysed and reviewed comprehensively all case reports and studies dealing with either the onset of an autoimmune disease in vaccinated subject or the safety in patients with autoimmune diseases to define the role of the HPV vaccines in these diseases and hence its safety. A solid evidence of causal relationship was provided in few cases in the examined studies, and the risk vs. benefit of vaccination is still to be solved. The on-going vigilance for the safety of this vaccine remains thus of paramount importance.

Access the full article here (fee applies).

Peripheral Sympathetic Nerve Dysfunction in Adolescent Japanese Girls Following Immunization with the Human Papillomavirus Vaccine

Authors: Tomomi Kinoshita1), Ryu-ta Abe1), Akiyo Hineno1), Kazuhiro Tsunekawa2), Shunya Nakane3), Shu-ichi Ikeda1)

Objective To investigate the causes of neurological manifestations in girls immunized with the human papillomavirus (HPV) vaccine.

Methods During the past nine months, 44 girls visited us complaining of several symptoms after HPV vaccination. Four patients with other proven disorders were excluded, and the remaining forty subjects were enrolled in this study.

Results The age at initial vaccination ranged from 11 to 17 years, and the average incubation period after the first dose of the vaccine was 5.47±5.00 months. Frequent manifestations included headaches, general fatigue, coldness of the legs, limb pain and weakness. The skin temperature examined in 28 girls with limb symptoms exhibited a slight decrease in the fingers (30.4±2.6°C) and a moderate decrease in the toes (27.1±3.7°C). Digital plethysmograms revealed a reduced height of the waves, especially in the toes. The limb symptoms of four girls were compatible with the Japanese clinical diagnostic criteria for complex regional pain syndrome (CRPS), while those in the other 14 girls were consistent with foreign diagnostic criteria for CRPS. The Schellong test identified eight patients with orthostatic hypotension and four patients with postural orthostatic tachycardia syndrome. The girls with orthostatic intolerance and CRPS commonly experienced transient violent tremors and persistent asthenia. Electron-microscopic examinations of the intradermal nerves showed an abnormal pathology in the unmyelinated fibers in two of the three girls examined.

Conclusion The symptoms observed in this study can be explained by abnormal peripheral sympathetic responses. The most common previous diagnosis in the studied girls was psychosomatic disease. The social problems of the study participants remained unresolved in that the severely disabled girls stopped going to school.

Access complete study here.

Copyright © 2014 by The Japanese Society of Internal Medicine

Cervarix dosage unrelated to protection?

[SaneVax: A study published this month in the Journal of the National Cancer Institute indicates that the protection afforded by the HPV vaccine Cervarix is unrelated to dosage. In other words, it appears that one injection is as good as three. What does this mean for all of the people who suffered adverse reactions after challenging their immune system three times with a vaccine that may provide the same protection with only one injection? If the findings in the study below are correct, why are government health authorities opting to promote two doses instead of one? What is wrong with this picture?

Proof-of-Principle Evaluation of the Efficacy of Fewer Than Three Doses of a Bivalent HPV16/18 Vaccine

Aimée R. KreimerAna Cecilia RodriguezAllan HildesheimRolando HerreroCarolina PorrasMark SchiffmanPaula GonzálezDiane SolomonSilvia JiménezJohn T. SchillerDouglas R. LowyWim QuintMark E. ShermanJohn SchusslerSholom Wacholder and for the CVT Vaccine Group

Abstract

Background Three-dose regimens for human papillomavirus (HPV) vaccines are expensive and difficult to complete, especially in settings where the need for cervical cancer prevention is greatest.

Methods We evaluated the vaccine efficacy of fewer than three doses of the HPV16/18 vaccine Cervarix in our Costa Rica Vaccine Trial. Women were randomly assigned to receive three doses of the HPV16/18 vaccine or to a control vaccine and were followed for incident HPV16 or HPV18 infection that persisted in visits that were 10 or more months apart (median follow-up 4.2 years). After excluding women who had no follow-up or who were HPV16 and HPV18 DNA positive at enrollment, 5967 women received three vaccine doses (2957 HPV vaccine vs 3010 control vaccine), 802 received two doses (422 HPV vs 380 control), and 384 received one dose (196 HPV vs 188 control). Reasons for receiving fewer doses and other pre- and post-randomization characteristics were balanced within each dosage group between women receiving the HPV and control vaccines.

Results Incident HPV16 or HPV18 infections that persisted for 1 year were unrelated to dosage of the control vaccine. Vaccine efficacy was 80.9% for three doses of the HPV vaccine (95% confidence interval [CI] = 71.1% to 87.7%; 25 and 133 events in the HPV and control arms, respectively), 84.1% for two doses (95% CI = 50.2% to 96.3%; 3 and 17 events), and 100% for one dose (95% CI = 66.5% to 100%; 0 and 10 events).

Conclusion Four years after vaccination of women who appeared to be uninfected, this nonrandomized analysis suggests that two doses of the HPV16/18 vaccine, and maybe even one dose, are as protective as three doses.

Access the entire paper here.

PP26 Efficacy of HPV vaccines: a review of the evidence used by the WHO

S Scharer1,2AM Pollock1P Sevcikova1

+ Author Affiliations


  1. 1Centre for Primary Care and Public Health, Queen Mary University of London, London, UK

  2. 2Institute of General Practice, Family Medicine and Preventive Medicine, Paracelsus Medical University, Salzburg, Austria

Abstract

Background In 2009 the World Health Organisation (WHO) recommended the inclusion of routine human papilloma virus (HPV) vaccines in national immunisation programmes to reduce the global burden of cervical cancer. The aim of this review was to critically appraise the evidence of efficacy of HPV vaccines in the studies used by the WHO in support of its recommendation.

Methods The efficacy-publications were retrieved from the WHO Immunisation, Vaccines and Biologicals webpage and each publication was appraised against the Critical Appraisal Skills Programme (CASP) framework and compared with WHO Strategic Group of Experts’ GRADE-evaluation of evidence with special focus on outcome measures, length of follow-up and general applicability of the results.

Results The WHO based its decision on three phase III trials and two phase II trials. The age range of enrolled females (15–26 years) was not compatible with the recommended vaccine age (9–13 years). All five studies used surrogate endpoints, namely cervical intraepithelial neoplasia (CIN) stadia I, II and III and Adenocarcinoma in situ (AIS). The direct effect of HPV vaccines on the natural history of cervical cancer was not assessed. Gardasil’s® efficacy for the prevention of cervical lesions associated with all known HPV types was very low and not statistically significant for CIN 3 and AIS. Gardasil® and Cervarix® proved efficacious only when all endpoints were grouped and when a subgroup analysis was undertaken of HPV 16 and or 18 naïve women. Individual endpoints were measured in two trials only and the number of cases was small and confidence intervals were wide. Grouping endpoints is problematic because of different rates of progression and regression especially for CIN 1, which is also the most prevalent cervical lesion. The percentage of cervical lesions associated with HPV types 16 and or 18 was lower than the 70% reported in medical literature. Maximum follow up was 6.4 years with only two trials examining participants for more than 4 years. General applicability of results is not clear due to lack of data on recruitment and composition of country samples.

Conclusion WHO’s recommendation to include routine HPV vaccination in national immunisation programmes is based on weak evidence namely surrogate outcome measures, which are very likely to regress spontaneously. Data on long-term efficacy are lacking.

Access entire article here.

High prevalence of hpv multiple genotypes in women with persistent chlamydia trachomatis infection

Silva Seraceni1, Francesco De Seta12, Claudia Colli3, Rossella Del Savio1, Giuliano Pesel1, Valentina Zanin1, Pierlanfranco D’Agaro12,Carlo Contini4 and Manola Comar12*

Abstract

Background

Chlamydia trachomatis interaction with HR-HPV types has highlighted a central role in cervical cancer development. The aim of this study was to investigate HPV prevalence and genotypes distribution in women at risk for C. trachomatisinfection and negative for intraepithelial lesion or malignancy.

Methods

1071 cervical swabs were tested for C. trachomatis by Real Time PCR and genotyping by ompA gene sequencing. Additionally, a quantitative Real time-PCR was performed to assess the expression of the C. trachomatis Hsp60–encoding gene (Ct604 portion), linked to a persistent status of infection. HPV infection and genotypes was investigated in C. trachomatis positive women using Luminex technology.

Results

C. trachomatis infection was detected in 53 out of 1071 (4.5%) samples, of which the 53% resulted positive for Hsp60 gene expression. The overall prevalence of HPV infection in C. trachomatis positive samples was of 60.4% (32/53): in 37.5% of samples was present a single genotype, while multiple genotypes infections were found in the 62.5% of them. Among women with a C. trachomatis chronic infection, 68% were HPV co-infected and the 79% showed multiple genotypes. Should be noted that levels of C. trachomatis Hsp60 expression in HPV co-infected women were significantly lower compared to women infected only with C. trachomatis. The C. trachomatis serotype F was found in the majority of samples, independently of HPV infection.

Conclusions

A high prevalence of HPV multiple infections have been found in young women affected with a C. trachomatis chronic infection. These observations suggested that the expression of CHSP60-1, interfering with both apoptotic and cellular senescence pathways, may promote a favourable local microenvironment for HPV infection.

Access entire article here.

© 2014 Seraceni et al.; licensee BioMed Central Ltd.

This is an Open Access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited.

The levels of anti-HPV16/18 and anti-HPV31/33/35/45/52/58 antibodies among AS04-adjuvanted HPV16/18 vaccinated and non-vaccinated Ugandan girls aged 10–16 years

Miriam Nakalembe1*, Cecily Banura2, Proscovia B Namujju34 and Florence M Mirembe1

Abstract

Background

Data on Human Papilloma virus (HPV) vaccine immune response in sub-Saharan Africa is still sparse yet such knowledge is critical for optimal implementation and monitoring of HPV vaccines. Our primary objective was to evaluate levels of anti-HPV-16/18 antibodies and six other ‘high risk’ HPV (hrHPV) types among the vaccinated and unvaccinated Ugandan girls.

Methods

We conducted a cross sectional study among AS04-adjuvanted HPV-16/18 vaccinated and unvaccinated school girls aged 10–16 years in Western Uganda using purposive sampling. The vaccinated girls were at 18 months post vaccination. After consenting and assenting, data was collected using interviewer administered questionnaires for demographics and sexual history. Blood was drawn from which serum samples were analysed by the multiplex HPV serology technology to determine anti-HPV antibody levels to HPV-16/18 and six other hrHPV types (31, 33, 35, 45, 52 and 58). The antibody levels were expressed as Median Fluorescent Intensity (MFI).

A total of 207 vaccinated [mean age 13.1 years (SD 1.5); range 10-16 years] and 197 unvaccinated girls [mean age 13.6 years (SD 1.3); range 10-16 years] participated in the study. Sexual activity was self reported among 14/207 (6.8%) vaccinated and 5/197 (2.5%) unvaccinated girls. The MFI levels for HPV-16 and HPV-18 were 15 and 20 times higher respectively in the vaccinated girls than in the unvaccinated girls. HPV-16 mean MFI level was 4691(SD 1812; 95% CI: 4438-4958) among the vaccinated compared to 218 (SD 685; 95% CI: 190-252) among the unvaccinated girls. For HPV-18 the mean MFI level was 1615 (SD 1326; 95% CI: 1470-1776) among the vaccinated compared to MFI 103 (SD 506; 95% CI: 88 -121) among unvaccinated girls.

In addition antibody levels to non vaccine hrHPV types (31, 33, 35, 45, 52 and 58) were all significantly higher in the vaccinated group than in the unvaccinated group (p<0.01).

Conclusion

The AS04-Adjuvanted HPV-16/18 vaccinated girls showed a higher level of antibodies to HPV-16/18 and other non-vaccine hrHPV types compared to the unvaccinated girls. This may translate into protection against HPV-16/18 and other hrHPV types.

Read the entire paper here.

© 2014 Nakalembe et al.; licensee BioMed Central Ltd.

This is an Open Access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited.

Monitoring the Impact of a National HPV Vaccination Program in Japan (MINT Study): Rationale, Design and Methods

Koji Matsumoto1,*, Nobuo Yaegashi2, Takashi Iwata3, Kazuya Ariyoshi4, Kiyoshi Fujiwara5, Yuko Shiroyama6, Tomoka Usami7, Yoshiaki Kawano8, Koji Horie9, Kouichiro Kawano10, Kiichiro Noda11 and Hiroyuki Yoshikawa1 for MINT Study Group

Abstract

We have developed a collaborative hospital-based approach to monitoring the impact of a human papillomavirus vaccine on cervical cancer, its precursor lesions and human papillomavirus type-specific prevalence in Japan. The monitoring will be conducted for a total period of 21 years on women aged <40 who are newly diagnosed with invasive cervical cancer, cervical intraepithelial neoplasia or adenocarcinoma in situ at 21 participating institutes. Women are monitored to determine their vaccine history and will be human papillomavirus-genotyped each year. The primary endpoint is the human papillomavirus16/human papillomavirus18-positive rate in women aged 16–25 who are diagnosed with invasive cervical cancer, cervical intraepithelial neoplasia grade 2/3 and adenocarcinoma in situ. The major secondary endpoints are the number of women aged <40 who are diagnosed with invasive cervical cancer, cervical intraepithelial neoplasia grade 2/3 and adenocarcinoma in situ, the human papillomavirus type-specific prevalence, and the number of deaths from invasive cervical cancer in women aged <40. Long-term surveillance for human papillomavirus-associated cervical diseases in young females is important for the development of future strategies for cervical cancer prevention in Japan.

Key words

human papillomavirus, vaccination, cervical intraepithelial neoplasia, cervical cancer

© The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Access complete article here.