Trial Information

A Phase II Study to Evaluate the Immunogenicity and Safety of a Quadrivalent Human Papillomavirus Vaccine in HIV-1-Infected Females

HPV is a DNA virus that affects both men and women. Approximately 90 types of HPV have been
identified, 30 of which are sexually transmitted. The most common forms of HPV are types 6,
11, 16, and 18. The quadrivalent HPV vaccine that will be tested in this study has been
shown in previous studies to be effective in preventing infection with HPV 6, 11, 16, and 18
in healthy young women. According to a report by the Centers for Disease Control and
Prevention (CDC), 80% of women will have acquired HPV by the age of 50. HIV infected women
have been reported to have a higher prevalence and persistence of HPV infection, as well as
an increased risk for abnormal Pap smears and cervical cancer. HPV types 16 and 18 cause the
majority of cervical cancers worldwide, and types 6 and 11 are responsible for the majority
of cases of genital warts. Vaccinations for preventable infections are particularly
important among HIV infected people because people with HIV have compromised immune systems;
therefore, any infection is very serious and can potentially be fatal. However, standard
vaccination series have not been very successful because a compromised immune system may not
produce the desired immune response to a vaccine. The HPV vaccine is designed to protect
against infection with HPV types 6, 11, 16, and 18 and has been approved by the FDA for use
in women between the ages of 9 and 26. The purpose of this study is to determine whether the
quadrivalent HPV vaccine is safe, tolerable, and effective in producing antibodies to HPV in
HIV infected females.

This study will last 72 weeks. Participants will receive their first dose of the HPV vaccine
by intramuscular injection. The HPV vaccine will be administered again at Weeks 8 and 24.
Following each injection, participants will remain at the clinic for 30 minutes of
observation for adverse events. A phone call from or a home visit by study staff will occur
within 2 days following each injection.

Participants will return to the clinic for visits at Weeks 4, 8, 12, 24, 28, 52, and 72.
Most study visits will include a physical exam, medication review, blood and urine
collection, and answering questions about signs and symptoms since study screening. Some
visits will include measurement of HIV viral load in the cervix, a cervical brush, an anal
swab, and an oral exam. Some participants will be asked to provide additional blood samples.