Gardasil HPV Vaccine for Human Papillomavirus

(PROTECT Trial)

This trial tests the Gardasil9 vaccine to evaluate its effectiveness in boosting the immune system against the human papillomavirus (HPV). The focus is on individuals born male who have used or are using hormone treatments, such as androgen blockers or estrogen, including those living with HIV and those without. Participants will receive the vaccine and have their immune response assessed after the final dose. Suitable candidates for this trial are HIV-positive or HIV-negative individuals, born male, who have used hormone treatments or have had sexual contact with a person with a penis in the past year. As a Phase 2 trial, this research aims to measure the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant medical advancements.

The trial does not specify if you need to stop taking your current medications. However, if you are on treatments like systemic chemotherapy or certain immune-affecting drugs, you may not be eligible to participate.

Research has shown that Gardasil9, the HPV vaccine being tested, is generally safe. Common side effects include pain, redness, and swelling at the injection site. Some individuals might also experience mild reactions such as headaches or dizziness. These effects resemble those caused by other vaccines and are usually not serious. Serious side effects, such as fainting, occur rarely. No evidence links the vaccine to infertility or other long-term health problems. The vaccine's approval for use in other groups suggests a good safety record.¹²³⁴⁵

Unlike other treatments for human papillomavirus (HPV) prevention, Gardasil9 is noteworthy because it covers nine different HPV strains, offering broader protection compared to earlier vaccines that cover fewer strains. Researchers are particularly excited about this treatment for its potential to protect individuals with unique health backgrounds, such as those with past exposure to hormone treatments, who may have different immune responses. This expanded protection could significantly reduce HPV-related health issues in these populations, making Gardasil9 a promising advancement in HPV prevention.

Research has shown that the Gardasil9 vaccine effectively protects against HPV, a common virus. Over 98% of recipients develop an immune response to the virus. This trial will administer the Gardasil9 vaccine to participants in different groups. One group includes people born male with current or past exposure to androgen blockers or estrogen, while another group includes HIV-negative individuals who are either in the same category or are men who have had sex with a person with a penis. The vaccine can prevent up to 90% of infections from certain types of HPV linked to cancers and genital warts. It has been proven to lower the risk of several diseases related to HPV. The vaccine is safe and provides strong protection for many people.⁶⁷⁸⁹¹⁰