PHASE II SAFETY AND IMMUNOGENICITY STUDY OF QUADRIVALENT HUMAN PAPILLOMAVIRUS

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study is being done to evaluate the safety and effect of an investigational vaccine against human papilloma virus (HPV). The investigational vaccine is called Human Papillomavirus (Types 6, 11, 16, 18) L1 Virus-Like Particle [VLP] Vaccine (QHPV Vaccine, also known as GARDASIL¿). Both the vaccine and placebo used in this study will be provided by Merck Research Laboratories. The study will look at two things. First, this study will examine the safety and tolerability of the QHPV Vaccine. This will be done by asking about adverse (bad) effects experienced after each shot of the vaccine. The second thing that this study will examine is whether the QHPV vaccine, when given in 3 separate doses, can stimulate the body's defense system to form antibodies (substances the body make in response to an infection or vaccination to help fight off disease) to each HPV type contained in the vaccine. This study will also check to see how long these antibodies will last. HPV infection is the most common sexually transmitted infection (STI) in the United States and worldwide. HPV infection causes genital and rectal warts. It also causes cancer of the cervix (opening of the uterus) in women, and can also cause cancer around the rectum and penis. HPV infection is common in HIV-infected adolescent girls and boys. HPV infection can be more severe and harder to treat in HIV-infected people. This study is the first step in evaluating a vaccine that might protect HIV-infected girls and boys from infection with HPV. The QHPV Vaccine has not been approved by the FDA, but has been safely tested in healthy adults. It has also been tested in children without HIV infection. Since the vaccine is made with only part of a virus, it cannot cause the HPV disease.