September 13, 2010
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HPV4 not associated with autoimmune conditions

Chao C. G1-203. Presented at: 50th Interscience Conference on Antimicrobial Agents and Chemotherapy; Sept. 12-15, 2010; Boston.

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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.

The researchers included the medical records of 189,629 girls and women in their surveillance of autoimmune conditions. Of these, 1,014 were deemed potential new cases of condition onset, and 719 had records available for review.

Results indicated that the proportion of new onset autoimmune cases was 31% for rheumatologic conditions, 40% for endocrine conditions and 32% for ophthalmologic or neurologic conditions. The researchers noted no trends in condition onset and vaccination timing, dose sequencing or age. – by Melissa Foster

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