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Inovio Pharmaceuticals Achieves Unprecedented T-Cell Immune Responses in Human Trial of DNA Vaccine for Cervical Dysplasia and Cancer Caused by HPV

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DNA Vaccine Delivered Using Electroporation Shows Potential to Treat Cervical Cancer and Precursor Dysplasias; Vaccine to Start Phase II in Early 2011
Market Watch

BLUE BELL, Pa., Sep 13, 2010 (BUSINESS WIRE) — Inovio Pharmaceuticals, Inc. /quotes/comstock/14*!ino/quotes/nls/ino (INO 1.11, 0.00, 0.00%) , a leader in the development of therapeutic and preventive vaccines against cancers and infectious diseases, announced today that it has achieved best-in-class immune responses in its Phase I dose escalation study of VGX-3100, its DNA vaccine to treat pre-cancerous cervical dysplasias and cervical cancers caused by human papillomavirus (HPV) types 16 and 18. This vaccine targets HPV E6 and E7 proteins and is delivered via in vivo electroporation. All dose groups developed significant antibody and T-cell immune responses; however, more notably, in the third and final dose group, five of six (83%) patients developed unprecedented T-cell responses not achieved by any other non-replicating vaccine platform in humans. Inovio is planning to start a Phase II clinical study in the first quarter of 2011.

Gardasil and Seizures: is VAERS now taking a connection seriously?

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Gardasil Side Effects

September 13, 2010

Theresa E was floored when she got a phone call from VAERS, the FDA’s vaccine adverse event reporting system. Yes, the caller said, investigators did indeed feel that Theresa’s daughter’s seizures could be a serious reaction to Merck’s anti-HPV vaccine, Gardasil.

Although Theresa had had a hunch that her daughter’s intermittent seizures could have been triggered by the Gardasil vaccine, doctors completely pooh-poohed the idea.

But eventually, encouraged by information from Nina Kenney, whose daughter had also begun suffering seizures post-vaccine, she insisted on filing a VAERS report. Her doctor had for months been “too busy” to get around to the paperwork, she said, “and when I took the almost-completed form to him to finish he was a little shocked that I was serious.”

HPV4 not associated with autoimmune conditions

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Infectious Disease News

Posted September 13, 2010

BOSTON — The quadrivalent human papillomavirus vaccine did not raise the risk for developing autoimmune conditions, according to data presented here at the 50th Interscience Conference on Antimicrobial Agents and Chemotherapy.

In a study sponsored by Merck and conducted on behalf of the Gardasil Safety Team, researchers investigated the safety of the quadrivalent HPV vaccine (HPV4; Gardasil, Merck). The researchers honed in on identifying 16 prespecified rheumatologic, endocrine and neurologic or ophthalmologic autoimmune conditions.

During the post-licensure, observational study, the researchers monitored girls and women in managed care organizations who received at least one dose of HPV4 between August 2006 and March 2008. Follow-up lasted for 6 months after administration of each dose.

The researchers found 11 conditions among a random sample of girls and women who had at least a 12-month health care plan before HPV4 vaccination. Clinicians reviewed medical records to verify diagnosis and determine time of disease onset. Incidence rates for each condition were also established for vaccinated and unvaccinated participants during case identification and review.

Más mercado (y víctimas) de la vacuna VPH

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Publicado por Miguel Jara el

Spain
13 de Septiembre de 2010

La campaña para expandir la polémica vacunación contra el virus del papiloma humano toma fuerza. Hasta ahora sólo se podía vacunar a las niñas pero la Comisión Europea ha extendido su administración a mujeres de hasta 45 años.

Hay algunas cosas que llaman la atención. La primera de ellas es que antes decían que esta vacuna estaba indicada para las jóvenes que no habían iniciado relaciones sexuales ya que según un estudio realizado con una de las marcas del preparado, Gardasil, del laboratorio Merck, si la joven estaba infectada había un 44,6% de posibilidades de contraer cáncer de útero. Ahora parece que obvian este estudio. Desde la Asociación de Afectadas por la Vacuna contra el Papiloma opinan:

“Creemos que este dato no se puede obviar y todas las mujeres deberían hacerse una citología o pruebas antes de recibir la vacuna para ver si están infectadas, de lo contrario en lugar de prevenir la hipotética posibilidad de contraer cáncer de útero, incrementarían esta posibilidad en un 44,6%“.

Cigarette smoking and human papillomavirus in patients with reported cervical cytological abnormality.

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Pubmed
BMJ. 1993 Mar 20;306(6880):749-52.

Burger MP, Hollema H, Gouw AS, Pieters WJ, Quint WG.

Department of Obstetrics and Gynaecology, University Hospital, Groningen, Netherlands.

Comment in:

BMJ. 1993 May 8;306(6887):1269.
BMJ. 1993 May 8;306(6887):1269.
BMJ. 1993 May 8;306(6887):1268-9.

Abstract
OBJECTIVE: To assess the relation between two risk factors for cervical neoplasia: smoking and infection with oncogenic human papillomavirus. It has been suggested that smoking causes a local immunological defect, which could facilitate the infection and persistence of human papillomavirus.

DESIGN: Cross sectional epidemiological study. Completion of a structured questionnaire by the patients, analysis of cervical scrapes for human papillomavirus, and morphological examination of biopsy specimens.

SETTING: Outpatient gynaecological clinic.

SUBJECTS: 181 women with a report of cervical cytological abnormality.

MAIN OUTCOME MEASURES: Prevalence of infection with oncogenic human papillomavirus and smoking habits.

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