By: S. Blitshteyn Published February 2010 Postural tachycardia syndrome (POTS) is a heterogeneous disorder of the autonomic nervous system, consisting of orthostatic intolerance and an increase in heart rate of more than 30 bpm within 10 min of standing or head-up tilt [1]. Human Papillomavirus Quadrivalent Vaccine, Gardasil, has been approved for prevention of cervical […]
Gardasil – Update on National Marketing Experience
Published 11 November 2010 Adverse events reported through 31 October 2010 in Ireland The HSE human papillomavirus (HPV) School Immunisation Programme commenced in May 2010 and it is estimated that 60,000 doses of Gardasil have been distributed and approximately 45,000 doses have been administered up to the end of October 2010. The Irish Medicines […]
PATIENT INFORMATION ABOUT GARDASIL
What important information about GARDASIL should I know? You should continue to get routine cervical cancer screening. GARDASIL may not fully protect everyone who gets the vaccine. GARDASIL will not protect against HPV types that you already have. Who should not get GARDASIL? You should not get GARDASIL if you have, or have had: […]
Gardasil Safety: Post-marketing Experience
CONTRAINDICATIONS Hypersensitivity, including severe allergic reactions to yeast (a vaccine component), or after a previous dose of GARDASIL. WARNINGS AND PRECAUTIONS Syncope Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following vaccination […]
Safety and Immunogenicity of the Quadrivalent Human Papillomavirus Vaccine in HIV-1-Infected Men.
Pubmed
J Infect Dis. 2010 Sep 2
Wilkin T, Lee JY, Lensing SY, Stier EA, Goldstone SE, Berry JM, Jay N, Aboulafia D, Cohn DL, Einstein MH, Saah A, Mitsuyasu RT, Palefsky JM.
Abstract
Background. Human immunodeficiency virus type 1 (HIV-1)-infected men are at increased risk for anal cancer. Human papillomavirus (HPV) vaccination may prevent anal cancer caused by vaccine types. Methods. AIDS Malignancy Consortium Protocol 052 is a single-arm, open-label, multicenter clinical trial to assess the safety and immunogenicity of the quadrivalent HPV (types 6, 11, 16, and 18) vaccine in HIV-1-infected men. Men with high-grade anal intraepithelial neoplasia or anal cancer by history or by screening cytology or histology were excluded. Men received 0.5 mL intramuscularly at entry, week 8, and week 24. The primary end points were seroconversion to vaccine types at week 28, in men who were seronegative and without anal infection with the relevant HPV type at entry, and grade 3 or higher adverse events related to vaccination. Results. There were no grade 3 or greater adverse events attributable to vaccination among the 109 men who received at least 1 vaccine dose. Seroconversion was observed for all 4 types: type 6 (59 [98%] of 60), type 11 (67 [99%] of 68), type 16 (62 [100%] of 62), and type 18 (74 [95%] of 78). No adverse effects on CD4 counts and plasma HIV-1 RNA levels were observed. Conclusions. The quadrivalent HPV vaccine appears safe and highly immunogenic in HIV-1-infected men. Efficacy studies in HIV-1-infected men are warranted. Clinical trials registration. NCT 00513526 .
PMID: 20812850 [PubMed – as supplied by publisher]
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