This trial is evaluating whether Gardasil will improve 1 primary outcome and 2 secondary outcomes in patients with HPV. Measurement will happen over the course of 30 days after receiving the third and final vaccine dose.
This trial requires 32 total participants across 3 different treatment groups
This trial involves 3 different treatments. Gardasil is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.
"Most cases of HPV that progress to squamous-cell carcinoma arise from a first infection. A few cases develop from non-HPV-related types. HPV, when not present or not present at all during the initial infection, is not a risk factor for developing LSIL or HSIL." - Anonymous Online Contributor
"Most cases of hr-HPV infections in the United States do not require immediate therapy. In cases in which the infection is diagnosed late, topical treatment with an FDA-approved vaccine or HPV vaccination may prevent disease progression. In cases in which the hpv is detected at a more advanced stage, no treatment is recommended. Treatment for HPV may be considered in patients with localized disease or those with a high-grade lesion." - Anonymous Online Contributor
"When looking at medical records the absence of genital symptoms does not necessarily indicate a negative result - it could indicate that the patient still has active infection in this area or that they had a non-active (asymptomatic) infection which cleared by the time they were seen. The absence of symptoms also does not necessarily mean that the person was not infected - the fact they may not have contracted active infection is why not symptomatic. The presence of symptoms does not, therefore, guarantee a positive result - there are signs if there is an active infection in your body and genital warts are not the only manifestations." - Anonymous Online Contributor
"Human papilloma virus (HPV) is one of the most common sexually transmitted infections and the cause of cervical, anal, vulvar, vaginal, penis, and some [head and neck cancer](https://www.withpower.com/clinical-trials/head-and-neck-cancer)s. It has been detected in 75 percent of all cancers in women. HPV is transmitted through close sexual contact between partners. HPV can be prevented through prevention of sexual activities with partners. More work needs to be done to raise awareness about the importance of HPV and its transmission." - Anonymous Online Contributor
"About 30% of US adults would have been infected with HPV if one were going to be screened for all sexually active males and females each year. Furthermore, one in twelve of these cases will have been infected by an existing non-neoplastic precancerous lesion. Thus, nearly 90% of people in the US could have received the HPV vaccine even if they were to be offered it every year as part of their routine checkups. Furthermore, the lifetime risk of developing HPV-related cancers or premalignant lesions (i.e., CIN) in the United States is estimated to be under 1%, which is a similar level to that observed in developed countries." - Anonymous Online Contributor
"Gardasil is effective in preventing HPV infections in women over 16 years of age; it is no more effective for cervical intraepithelial neoplasia or cervical cancer. For those who already have HPV, the evidence is less clear regarding the effectiveness of Gardasil. This vaccine only prevents some of the strains of HPV that are most likely to cause disease. Because of the lack of data regarding the risk of serious health problems with early cervical cancer, we do not recommend routine cervical smear screening for women who are vaccinated with Gardasil. It is still recommended for people who are susceptible to HPV and, who do not have immunity to HPV vaccination or who do not have access to cervical screening tests." - Anonymous Online Contributor
"Gardasil may be used in combination with other treatments e.g. in patients with a history of pre-existing cervical lesions. However, safety and tolerability of combining with other treatments should be evaluated in future clinical trials." - Anonymous Online Contributor
"The virus is both very contagious, but more serious than many think. It is a serious health risk. Most people, including this man, have contracted it by using a condom properly during sex - at least a full one. There are a few ways to prevent it, the most important of which is using latex condoms with at least a 3.4% nitrile rubber lining. Although there are a number of condom kinds, the latex is best because it is the thinest, weakest variety, and because it is easiest to adjust. Also, the more you use condoms, the more you are protected. The good news is that, with the use of latex condoms, the risk of developing HPV is minimal." - Anonymous Online Contributor
"While the majority of respondents thought that they would consider clinical trials for HPV, they did not have any specific beliefs that would benefit their own or their clinic's practice. Further study is necessary in this population to identify barriers to clinical trials for HPV." - Anonymous Online Contributor
"Gardasil could not be considered safe for injection into newborns. Gardasil is not'safe for all ages' nor is it'safe to inject into children'. There are few randomized controlled trials to show any benefit. Vaccines are only safe if the vaccine components are carefully chosen and their effects on all of us are clearly understood. The vaccine should only be given to a small proportion of women who really need it. What we need is a clear cut process for testing vaccines before making them available so that they can only be given to those who really need them in the right situations and to those at greatest risk." - Anonymous Online Contributor
"The data suggests this vaccine is safe and effective. There are some patients who have reported anaphylaxis, an adverse event that occurs even with the Gardasil vaccine. It is also important to note that adverse events can occur throughout the lifetime of vaccine usage even after one administration (which may only apply to the Gardasil-25 vaccine). Patients must be warned that such occurrences can continue for years after vaccination and must be given adequate medication when necessary. The FDA licensed the Gardasil vaccine for patients and healthcare professionals ages 9–25 in 2009. The FDA advisory committee supports the marketing of Gardasil to children aged 9 to 15 years old, with the approval of a black box warning." - Anonymous Online Contributor