Gardasil for HPV

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
The Hope Clinic of Emory University, Atlanta, GA
HPV
Gardasil - Biological
Eligibility
18 - 65
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a vaccine can help prevent HPV infections in people with dementia.

See full description

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

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.

Day 30
Number of participants with a minimum four-fold rise in post-vaccination HPV-16 and HPV-18 neutralizing antibody titers
Day 730
Change in number of HPV-specific memory B cell (Bmem) response from Baseline
Change in titers of binding antibody isotypes: IgA, IgM, IgG in serum from Baseline

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

3 Treatment Groups

Group 3: Lymph node sampling at D-30, D194 and D210
1 of 3
Group 2: Lymph node sampling at D-30, D74 and D90
1 of 3
Group 1: Lymph node sampling at D-30, D14 and D30
1 of 3
Experimental Treatment

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.

Group 3: Lymph node sampling at D-30, D194 and D210Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180. Group 3 will have lymph node sampling D-30, D194 and D210. Bone marrow sampling will be done for all groups at D730.
Group 2: Lymph node sampling at D-30, D74 and D90Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180. Group 2 will have lymph node sampling doneD-30, D74 and D90. Bone marrow sampling will be done for all groups at D730.
Group 1: Lymph node sampling at D-30, D14 and D30Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180. Group 1 will have lymph node sampling done D-30, D14 and D30 after the first dose. Bone marrow sampling will be done for all groups at D730.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Human papillomavirus type 6 L1 capsid protein antigen
FDA approved
Lidocaine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (day 0), day 14, day 30, day 60, day 67, day 90, day 180, day 187, day 210, day 365, day 730 post-intervention
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline (day 0), day 14, day 30, day 60, day 67, day 90, day 180, day 187, day 210, day 365, day 730 post-intervention for reporting.

Who is running the study

Principal Investigator
E. S.
Prof. Erin Scherer, Assistant Professor
Emory University

Closest Location

The Hope Clinic of Emory University - Atlanta, GA

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The participant must be in good health, as judged by the physical examination, vital signs, medical history, and the investigator's clinical judgment. show original
The text discusses lab tests that should be performed on subjects who are having a bone marrow aspiration done show original
Must be available and willing to participate for the duration of this study
Must be willing to have a lymph node biopsy and a bone marrow biopsy. show original
The person must be willing to allow the future use of any leftover samples or specimens. show original
Individuals between the ages of 18 and 45 can get the HPV vaccine. show original
BMI ≤ 32.
If available, the patient's platelet count should be ≥ 150,000/mm3. show original
If your INR was less than 1.2 in the past month, it is likely that you are not taking your Warfarin medication as prescribed. show original
Understands and consents to treatment (provided in American English). show original

Patient Q&A Section

Can hpv be cured?

"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

Unverified Answer

What are common treatments for hpv?

"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

Unverified Answer

What are the signs of hpv?

"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

Unverified Answer

What is hpv?

"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

Unverified Answer

How many people get hpv a year in the United States?

"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

Unverified Answer

What does gardasil usually treat?

"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

Unverified Answer

Is gardasil typically used in combination with any other treatments?

"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

Unverified Answer

How serious can hpv be?

"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

Unverified Answer

Who should consider clinical trials for hpv?

"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

Unverified Answer

Is gardasil safe for people?

"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

Unverified Answer

Have there been other clinical trials involving gardasil?

"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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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