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Gardasil and Cervarix: Reasons for Caution Still Exist

May 6, 2012 By Leave a Comment

[SaneVax: In 2008, Dr. Charlotte Haug urged caution when considering implementation of HPV (human papillomavirus) vaccination programs. Not many people in the medical establishment appeared to listen. Four years later, those reasons for caution still exist, with a few new ones added. Please take a few minutes to read Dr. Haug's letter to the editor of the New England Journal of Medicine. Educate yourself before consenting to any medical intervention, including HPV vaccines.]

Human Papillomavirus Vaccination – Reasons for Caution

By Charlotte Haug, MD, PhD, (N Engl J Med 2008; 359:861-862 August 21, 2008)

HPV Vaccination Concerns

Despite great expectations and promising results of clinical trials, we still lack sufficient evidence of an effective vaccine against cervical cancer. Several strains of human papillomavirus (HPV) can cause cervical cancer, and two vaccines directed against the currently most important oncogenic strains (i.e., the HPV-16 and HPV-18 serotypes) have been developed. That is the good news. The bad news is that the overall effect of the vaccines on cervical cancer remains unknown. As Kim and Goldie1 point out in this issue of the Journal, the real impact of HPV vaccination on cervical cancer will not be observable for decades.

Although it was licensed for use in the United States in June 2006, the first phase 3 trials of the HPV vaccine with clinically relevant end points — cervical intraepithelial neoplasia grades 2 and 3 (CIN 2/3) — were not reported until May 2007, first in the Journal 2 and 1 month later in theLancet.3,4 The vaccine was highly successful in reducing the incidence of precancerous cervical lesions caused by HPV-16 and HPV-18, but a number of critical questions remained unanswered.5,6 For instance, will the vaccine ultimately prevent not only cervical lesions, but also cervical cancer and death? How long will protection conferred by the vaccine last? Since most HPV infections are easily cleared by the immune system, how will vaccination affect natural immunity against HPV, and with what implications? How will the vaccine affect preadolescent girls, given that the only trials conducted in this cohort have been on the immune response? The studies with clinical end points (i.e., CIN 2/3) involved 16- to 24-year-old women. How will vaccination affect screening practices? Since the vaccines protect against only two of the oncogenic strains of HPV, women must continue to be screened for cervical lesions. Vaccinated women may feel protected from cervical cancer and may be less likely than unvaccinated women to pursue screening. How will the vaccine affect other oncogenic strains of HPV? If HPV-16 and HPV-18 are effectively suppressed, will there be selective pressure on the remaining strains of HPV? Other strains may emerge as significant oncogenic serotypes.

Read the entire letter here.

Filed Under: HPV, HPV Science, Immunization Practices, World News Tagged With: , , , ,

Incident HPV 51 Infection After Prophylactic Quadrivalent Human Papillomavirus (Types 6, 11, 16, and 18) L1 Virus-Like Particle Vaccine Gardasil/Silgard®

May 3, 2012 By Leave a Comment

Philippe Halfon,1,2 Sophie Ravet,3 Hacène Khiri,1 Guillaume Penaranda,1,2,3 and Carole Lefoll2

1 Laboratoire Alphabio, Marseille, France
2 Hopital Ambroise Paré, Marseille, France
3 CDL Pharma, Marseille, France
Corresponding author email: philippe.halfon@alphabio.fr
This is an open access article. Unrestricted non-commercial use is permitted provided the original work is properly cited.

Abstract

We report the case of a 19-year-old woman who received a complete vaccine program by Gardasil. After one year, Greiner HPV test revealed HPV51 positivity. This case report highlights the limits of the vaccine, and the need to have a clinical follow up of patients despite the vaccination program.

Access entire article here.

Filed Under: Gardasil/Silgard Vaccine, Human Papillomavirus Research Tagged With: , ,

Effect of the human papillomavirus (HPV) quadrivalent vaccine in a subgroup of women with cervical and vulvar disease: retrospective pooled analysis of trial data

April 2, 2012 By Leave a Comment

Abstract

Objectives To determine the effect of human papillomavirus (HPV) quadrivalent vaccine on the risk of developing subsequent disease after an excisional procedure for cervical intraepithelial neoplasia or diagnosis of genital warts, vulvar intraepithelial neoplasia, or vaginal intraepithelial neoplasia.

Design Retrospective analysis of data from two international, double blind, placebo controlled, randomised efficacy trials of quadrivalent HPV vaccine (protocol 013 (FUTURE I) and protocol 015 (FUTURE II)).

Setting Primary care centres and university or hospital associated health centres in 24 countries and territories around the world.

Participants Among 17 622 women aged 15–26 years who underwent 1:1 randomisation to vaccine or placebo, 2054 received cervical surgery or were diagnosed with genital warts, vulvar intraepithelial neoplasia, or vaginal intraepithelial neoplasia.

Intervention Three doses of quadrivalent HPV vaccine or placebo at day 1, month 2, and month 6.

Main outcome measures Incidence of HPV related disease from 60 days after treatment or diagnosis, expressed as the number of women with an end point per 100 person years at risk.

Results A total of 587 vaccine and 763 placebo recipients underwent cervical surgery. The incidence of any subsequent HPV related disease was 6.6 and 12.2 in vaccine and placebo recipients respectively (46.2% reduction (95% confidence interval 22.5% to 63.2%) with vaccination). Vaccination was associated with a significant reduction in risk of any subsequent high grade disease of the cervix by 64.9% (20.1% to 86.3%). A total of 229 vaccine recipients and 475 placebo recipients were diagnosed with genital warts, vulvar intraepithelial neoplasia, or vaginal intraepithelial neoplasia, and the incidence of any subsequent HPV related disease was 20.1 and 31.0 in vaccine and placebo recipients respectively (35.2% reduction (13.8% to 51.8%)).

Conclusions Previous vaccination with quadrivalent HPV vaccine among women who had surgical treatment for HPV related disease significantly reduced the incidence of subsequent HPV related disease, including high grade disease.

Trial registrations NCT00092521 and NCT00092534

  1. Authors: Elmar A Joura, associate professor1,  Suzanne M Garland, director, professor2, Jorma Paavonen, professor, physician in chief3, Daron G Ferris, professor4, Gonzalo Perez, professor5, Kevin A Ault, associate professor6, Warner K Huh, associate professor7, Heather L Sings, director of Global Scientific and Medical Publications8, Margaret K. James, senior biometrician8, Richard M Haupt, executive director of clinical research8 for the FUTURE I and II Study Group

Author Affiliations

  1. Correspondence to: E A Joura elmar.joura@meduniwien.ac.at
  • Accepted 13 January 2012, BMJ 2012;344:e1401

Access entire article here.

Filed Under: Gardasil/Silgard Efficacy, Human Papillomavirus Research Tagged With: , ,

Mass psychogenic illness after vaccination

January 23, 2012 By 1 Comment

 

 

PubMed.gov

Drug Saf. 2003;26(9):599-604.

Source

Department of Vaccines and Immunisation, World Health Organization, Geneva, Switzerland. ClementsCJ@telstra.com

Abstract

When vaccines are administered to groups, the physical reactions of the recipients may be similar, causing a form of mass reaction, the mechanism for which is the same as that for mass reactions from other causes. These phenomena have been categorised as mass psychogenic illness (MPI), and have been defined as the collective occurrence of a constellation of symptoms suggestive of organic illness but without an identified cause in a group of people with shared beliefs about the cause of the symptom(s). A review of the literature shows that such outbreaks have been reported in differing cultural and environmental settings including developing and industrialised countries, in the work place, on public transport, in schools, and the military. The perceived threats have been against agents such as food poisoning, fire and toxic gases. Whatever the place or perceived threat, the response seems to be similar. The symptoms generally included headache, dizziness, weakness, and loss of consciousness. Once under way, MPIs are not easy to stop. Incidents reported in the literature show that they can quickly gather momentum and can be amplified by the press who disseminate information rapidly, escalating the events. Management of such mass events can be extremely difficult. Should the public health official in charge continue to try and determine the cause, or should this person call off the entire investigation? It is suggested here that once vaccines are identified as a probable cause of the phenomenon, a dismissive approach may actually be harmful. Unless the spokesperson has already earned a high level of trust, the public are not likely to be convinced easily that nothing was wrong with the vaccine until it has been tested. An increased awareness of MPIs on the part of organisers of future mass vaccination campaigns seems appropriate. Immunisation managers should be aware that mass immunisation campaigns could generate such mass reactions. It is therefore essential that surveillance/reporting systems for reporting adverse events be improved before such campaigns. A mass campaign using a smallpox vaccine should be accompanied by a surveillance system capable of distinguishing between multiple cases of conventionally understood vaccine reactions and outbreaks of mass psychogenic illness.

PMID:
12814329
[PubMed - indexed for MEDLINE]

 

 

Read More…

Filed Under: United States, Vaccine Related Research, Vaccine Science, Vaccines Tagged With: , , , ,

Systemic lupus erythematosus following HPV immunization or infection?

January 16, 2012 By Leave a Comment

Author: Soldevilla, H., Briones, S., Navarra, S.
Publication: Lupus
Volume: 21, Issue: 2, Pages: 158 to 161Date: Tuesday, January 10, 2012

Background and purpose: The link between autoimmunity and infectious agents has been strongly suggested by reports of lupus or lupus-like syndromes following immunization. This report describes three patients with either newly diagnosed systemic lupus erythematosus (SLE) or SLE flare, following vaccination for human papilloma virus (HPV).

Case 1: A 17-year-old female completed two doses of HPV vaccine uneventfully. Two months later, she developed arthralgias with pruritic rashes on both lower extremities, later accompanied by livedo reticularis, bipedal edema with proteinuria, anemia, leucopenia, hypocomplementemia and high titers of anti-nuclear antibody (ANA) and anti-double-stranded DNA (anti-dsDNA). Kidney biopsy showed International Society of Nephrology/Renal Pathology Society Class III lupus nephritis. She was started on high dose steroids followed by pulse cyclophosphamide therapy protocol for lupus nephritis, and subsequently went into remission.

Case 2: A 45-year-old housewife, previously managed for 11 years as having rheumatoid arthritis, had been in clinical remission for a year when she received two doses of HPV immunization. Four months later, she developed fever accompanied by arthritis, malar rash, oral ulcers, recurrent ascites with intestinal pseudo-obstruction, and behavioral changes. Cranial MRI showed vasculitic lesions on the frontal and parietal lobes. Laboratory tests showed anemia with leucopenia, hypocomplementemia, proteinuria, ANA positive at 1:320, and antibodies against dsDNA, Ro/SSA, La/SSB and histone. She improved following pulse methylprednisolone with subsequent oral prednisone combined with hydroxychloroquine.

Case 3: A 58-year-old housewife diagnosed with SLE had been in clinical remission for 8 years when she received two doses of HPV immunization. Three months later, she was admitted to emergency because of a 1-week history of fever, malar rash, easy fatigability, cervical lymph nodes, gross hematuria and pallor. Laboratory exams showed severe anemia, thrombocytopenia, active urine sediments, and hypocomplementemia. Despite pulse steroid therapy, blood transfusions, intravenous immunoglobulin and aggressive resuscitative measures, she expired a day after hospital admission.

Summary: These cases narrate instances of the onset or exacerbation of lupus following HPV immunization suggesting adjuvant-induced autoimmunity. On the other hand, there are reports of higher incidence of HPV infection in SLE, with the infection per se possibly contributing to disease activity. Thus, the benefit of HPV immunization may still outweigh the risk among these individuals.

Access entire article via this link.

Filed Under: Autoimmune Disorders, Human Papillomavirus Research, Vaccine Related Research Tagged With: , ,

Autoimmune encephalitis: a case series and comprehensive review of the literature

January 9, 2012 By Leave a Comment

Wingfield T, McHugh C, Vas A, Richardson A, Wilkins E, Bonington A, Varma A.

Source

The Monsall Unit, Department of Infectious Diseases and Tropical Medicine, North Manchester General Hospital, Manchester, UK. tomwingfield@hotmail.co.uk

Abstract

Encephalitic syndromes are a common medical emergency. The importance of early diagnosis and appropriate treatment is paramount. If initial investigations for infectious agents prove negative, other diagnoses must be considered promptly. Autoimmune encephalitides are being increasingly recognized as important (and potentially reversible) non-infectious causes of an encephalitic syndrome. We describe four patients with autoimmune encephalitis–3 auto-antibody positive, 1 auto-antibody negative–treated during the last 18 months. A comprehensive review of the literature in this expanding area will be of interest to the infectious diseases, general medical and neurology community.

PMID:  21784780 [PubMed - in process]

Access entire paper via this link.

Filed Under: Vaccine Related Research Tagged With: , ,

Human papillomavirus (HPV) vaccine policy and evidence-based medicine: Are they at odds?

January 7, 2012 By 8 Comments

Ann Med. 2011 Dec 22. [Epub ahead of print]

Tomljenovic L, Shaw CA.

Source

Neural Dynamics Research Group, Department of Ophthalmology and Visual Sciences, University of British Columbia , 828 W. 10th Ave, Vancouver, BC, V5Z 1L8 , Canada.

Abstract

All drugs are associated with some risks of adverse reactions. Because vaccines represent a special category of drugs, generally given to healthy individuals, uncertain benefits mean that only a small level of risk for adverse reactions is acceptable. Furthermore, medical ethics demand that vaccination should be carried out with the participant’s full and informed consent. This necessitates an objective disclosure of the known or foreseeable vaccination benefits and risks. The way in which HPV vaccines are often promoted to women indicates that such disclosure is not always given from the basis of the best available knowledge. For example, while the world’s leading medical authorities state that HPV vaccines are an important cervical cancer prevention tool, clinical trials show no evidence that HPV vaccination can protect against cervical cancer. Similarly, contrary to claims that cervical cancer is the second most common cancer in women worldwide, existing data show that this only applies to developing countries. In the Western world cervical cancer is a rare disease with mortality rates that are several times lower than the rate of reported serious adverse reactions (including deaths) from HPV vaccination. Future vaccination policies should adhere more rigorously to evidence-based medicine and ethical guidelines for informed consent.

PMID:  22188159 [PubMed - as supplied by publisher]
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Filed Under: Human Papillomavirus Research, Immunization Practices Tagged With: , , ,

Adverse Events following 12 and 18 Month Vaccinations: a Population-Based, Self-Controlled Case Series Analysis

December 26, 2011 By 1 Comment

By Kumanan Wilson1,2,3,4*, Steven Hawken2, Jeffrey C. Kwong5, Shelley Deeks6, Natasha S. Crowcroft6, Carl Van Walraven1,2,3, Beth K. Potter2,3, Pranesh Chakraborty4,8,Jennifer Keelan7, Michael Pluscauskas4, Doug Manuel2,3,9

Abstract:

Background

Live vaccines have distinct safety profiles, potentially causing systemic reactions one to 2 weeks after administration. In the province of Ontario, Canada, live MMR vaccine is currently recommended at age 12 months and 18 months.

Methods

Using the self-controlled case series design we examined 271,495 12 month vaccinations and 184,312 18 month vaccinations to examine the relative incidence of the composite endpoint of emergency room visits or hospital admissions in consecutive one day intervals following vaccination. These were compared to a control period 20 to 28 days later. In a post-hoc analysis we examined the reasons for emergency room visits and the average acuity score at presentation for children during the at-risk period following the 12 month vaccine.

Results

Four to 12 days post 12 month vaccination, children had a 1.33 (1.29–1.38) increased relative incidence of the combined endpoint compared to the control period, or at least one event during the risk interval for every 168 children vaccinated. Ten to 12 days post 18 month vaccination, the relative incidence was 1.25 (95%, 1.17–1.33) which represented at least one excess event for every 730 children vaccinated. The primary reason for increased events was statistically significant elevations in emergency room visits following all vaccinations. There were non-significant increases in hospital admissions. There were an additional 20 febrile seizures for every 100,000 vaccinated at 12 months.

Conclusions

There are significantly elevated risks of primarily emergency room visits approximately one to two weeks following 12 and 18 month vaccination. Future studies should examine whether these events could be predicted or prevented.

Access entire article here.

Citation: Wilson K, Hawken S, Kwong JC, Deeks S, Crowcroft NS, et al. (2011) Adverse Events following 12 and 18 Month Vaccinations: a Population-Based, Self-Controlled Case Series Analysis. PLoS ONE 6(12): e27897. doi:10.1371/journal.pone.0027897

Editor: Shabir Ahmed Madhi, University of Witwatersrand, South Africa

Received: August 5, 2011; Accepted: October 27, 2011; Published: December 12, 2011

Copyright: © 2011 Wilson et al. 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 author and source are credited.

Funding: This study was supported by the Canadian Foundation for Innovation, the Population Health Improvement Research Network (PHIRN), and by the Institute for Clinical Evaluative Sciences (ICES), which is funded by an annual grant from the Ontario Ministry of Health and Long-Term Care (MOHLTC). The opinions, results and conclusions reported in this paper are those of the authors and are independent from the funding sources. No endorsement by ICES, Ontario MOHLTC or PHIRN is intended or should be inferred. Dr. Wilson holds the Canada Research Chair in Public Health Policy. Dr. Manuel holds the CIHR Chair in Applied Public Health. Dr. Kwong and Professor Keelan are supported by a Career Scientist award from the Ontario Ministry of Health and Long-Term Care. Dr Kwong is also supported by a Clinician Scientist award from the Department of Family and Community Medicine, University of Toronto. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing interests: The authors have declared that no competing interests exist.

 

Filed Under: Immunization Practices, Vaccine Injuries, Vaccine Safety, Vaccine Science Tagged With: , , ,

Assuring the Quality, Safety, and Efficacy of DNA Vaccines

November 27, 2011 By Leave a Comment

Robertson JS, Griffiths E

Source

National Institute for Biological Standards and Control, Herts, UK.

Methods Mol Med. 2006;127:363-74.

Abstract

Scientists in academia whose research is aimed at the development of a novel vaccine or approach to vaccination may not always be fully aware of the regulatory process by which a candidate vaccine becomes a licensed product. It is useful for such scientists to be aware of these processes, as the development of a novel vaccine could be problematic as a result of the starting material often being developed in a research laboratory under ill-defined conditions. This chapter examines the regulatory process with respect to the development of a DNA vaccine. DNA vaccines present unusual safety considerations which must be addressed during nonclinical safety studies, including adverse immunopathology, genotoxicity through integration into a vaccinee’s chromosomes and the potential for the formation of anti-DNA antibodies.

Access entire article via this link.

Filed Under: Vaccine Related Research, Vaccine Safety Tagged With: , , , ,

Human papillomavirus DNA detected in peripheral blood samples from healthy Australian male blood donors

November 21, 2011 By Leave a Comment
J Med Virol. 2009 Oct;81(10):1792-6

Chen AC, Keleher A, Kedda MA, Spurdle AB, McMillan NA, Antonsson A.

The University of Queensland, Diamantina Institute for Cancer, Immunology and Metabolic Medicine, Princess Alexandra Hospital, Woolloongabba, Brisbane, QLD, Australia.

Abstract

Recent studies have shown that human papillomavirus (HPV) DNA can be found in circulating blood, including peripheral blood mononuclear cells (PBMCs), sera, plasma, and arterial cord blood. In light of these findings, DNA extracted from PBMCs from healthy blood donors were examined in order to determine how common HPV DNA is in blood of healthy individuals. Blood samples were collected from 180 healthy male blood donors (18-76 years old) through the Australian Red Cross Blood Services. Genomic DNA was extracted and specimens were tested for HPV DNA by PCR using a broad range primer pair. Positive samples were HPV-type determined by cloning and sequencing. HPV DNA was found in 8.3% (15/180) of the blood donors. A wide variety of different HPV types were isolated from the PBMCs; belonging to the cutaneous beta and gamma papillomavirus genera and mucosal alpha papillomaviruses. High-risk HPV types that are linked to cancer development were detected in 1.7% (3/180) of the PBMCs. Blood was also collected from a healthy HPV-positive 44-year-old male on four different occasions in order to determine which blood cell fractions harbor HPV. PBMCs treated with trypsin were negative for HPV, while non-trypsinized PBMCs were HPV-positive. This suggests that the HPV in blood is attached to the outside of blood cells via a protein-containing moiety. HPV was also isolated in the B cells, dendritic cells, NK cells, and neutrophils. To conclude, HPV present in PBMCs could represent a reservoir of virus and a potential new route of transmission.

Access entire paper here.

Filed Under: Human Papillomavirus Research Tagged With: , ,
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