A study of a human papillomavirus (HPV) virus-like particle (VLP) vaccine in a cohort of human immunodeficiency virus (HIV) positive girls and women

Women's Health Research Institute (WHRI) (Canada)0 个研究点目标入组 500 人开始时间: 2008年8月21日最近更新: 2019年4月29日

适应症

试验速览

•1. HIV positive
•2. Aged greater than or equal to 9 years
•3. Able to give fully informed consent or assent
•4. Not pregnant (as determined by a negative urine pregnancy test) and willing to avoid pregnancy for the duration of the vaccination phase. Subjects at the time of the study entry must be abstinent or must be using an effective method of birth control for 30 days prior to vaccination and throughout the study up to one month following the last vaccination. Effective methods of birth control include: birth control pill, intra-uterine device (IUD), depo provera, male or female condom and spermicidal, diaphragm or sponge with spermicidal, abstinence.
•5. Able to attend the clinic for all of the study visits

•1. Allergy to the vaccine or its components
•2. Prior use of an HPV vaccine
•3. Current enrolment in any clinical trial which used an investigational vaccine or drug
•4. Female planning to become pregnant or likely to become pregnant prior to 30 days post-last vaccine (visit 4)
•5. Any condition (physical or psychosocial) that the site investigator deems exclusionary (for example, poor prognosis, extreme immunocompromisation; an individual may be enrolled into the study after the above have resolved)

发起方

Women's Health Research Institute (WHRI) (Canada)