Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: A pooled analysis of 11 clinical trials

Human Papilloma Virus. New Opportunities for Vaccination

“…Наиболее частой побочной реакцией является боль в месте инъекции, в большинстве случаев непродолжи-тельная, легкой и средней степени тяжести. Усталость, головная боль и боль в мышцах оказались наиболее распространенными ожидаемыми общими симптомами [26]. Первые данные о влиянии программ вакцинации на эпидемиологию ВПЧ появились после иммунизации девочек школьного возраста в Англии и Шотландии.…”

Neue Impfstoffkonzepte auf Basis moderner Erkenntnisse der Immunologie

“…Eine neue Generation von Adjuvanzien, die oft spezifische Schaltstellen des angeborenen Immunsystems ansteuern, ist derzeit in der Entwicklung. Ein neuer HPV-Impfstoff, der einen TLR-Agonisten enthält ist derzeit weltweit im Registrierungsprozess [38], weitere TLR-Agonisten sind in der klinischen Prüfung. Ein Beispiel ist IC31®, das in einem neuen TB-Proteinimpfstoff klinische Prüfungen durchläuft.…”

Update on Human Papillomavirus (HPV) Vaccines

“…There was no increase in adverse events with successive vaccine doses (PI, USA). (120) 10 to 14 years (146) 15 to 25 years (146) >25 years (146) Table 15 presents the rates of these outcomes from the pooled data bases; there are no differences in the development of these adverse events (MSC, NOAD, NOCD, SAE, and deaths) between HPV2 and control vaccine recipient. As Cervarix™ employs a new adjuvant, one pooled study extensively examined the risk of developing autoimmune disease.…”

“…(146,147) Table 16 presents data on 1737 pregnancies among women and girls who received at least one dose of the HPV2 vaccine or one of three controls [(Al(OH) 3 or hepatitis A vaccine (720 or 360 EU)] reported in 11 trials. (146) Overall there was no difference in pregnancy outcomes between the HPV vaccine and control arms (HAV360, HAV720, and Al(OH) 3 ). (147) The miscarriage rate in HPV2 vaccine recipients and control vaccine recipients was 11.5% and 10.2%.…”

“…(80,146,147) These studies were designed to evaluate risk of serious adverse events (SAE) (146) , medically significant conditions (MSC) (146) , new onset chronic disease (NOCD), (146) new onset autoimmune disease (NOAD) (80,146) , and adverse pregnancy outcomes. (146,147) Table 14 provides incidence of adverse events in Cervarix™ recipients >9 years of age. Cervarix™ administration resulted in a higher rate of solicited local (pain, redness, and swelling) and systemic reactions (fatigue, arthralgia and myalgia) within seven days of vaccine administration.…”