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Study on Reducing HPV Infectivity in HPV-Positive Women Using 9vHPV Vaccine

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the vaccine called Gardasil 9, which is used to protect against the Human Papillomavirus (HPV). HPV is a common virus that can lead to certain types of cancers and other diseases. The vaccine is designed to target nine different types of HPV, including types 16 and 18, which are known to cause the majority of HPV-related cancers. The purpose of this study is to assess how well the vaccine reduces the ability of the virus to infect and spread in women who are already positive for HPV types 16 and/or 18.

Participants in the study will receive the Gardasil 9 vaccine in three doses. The study will collect samples from different parts of the body, such as the cervix, anus, vulva, urine, and mouth, before and after each vaccine dose. These samples will help researchers understand how the vaccine affects the virus's ability to infect and spread. The study will also look for the presence of antibodies, which are proteins made by the body to fight infections, in these samples. This will help determine if the vaccine is effective in reducing the virus's ability to cause infection.

The study is open-label, meaning that both the participants and the researchers know which treatment is being given. It is non-randomized, so all participants will receive the Gardasil 9 vaccine rather than being randomly assigned to different groups. The study aims to provide valuable information on how well the vaccine works in reducing the spread of HPV in women who are already infected with certain types of the virus. This information could be important for understanding how to better prevent HPV-related diseases in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial Visit and Screening
Upon joining the study, an initial visit is conducted to confirm eligibility. This includes a review of medical history, a physical examination, and laboratory tests to ensure no major health conditions are present.
Participants must provide written consent to participate in the study.
Step 2
First Vaccine Dose
The first dose of the Gardasil 9 vaccine is administered. This vaccine is a suspension for injection and is given intramuscularly.
Samples from cervical, anal, vulvar, urine, and oral areas are collected to evaluate the presence of HPV before vaccination.
Step 3
Second Vaccine Dose
The second dose of the Gardasil 9 vaccine is administered. The timing of this dose follows the schedule provided by the study protocol.
Additional samples are collected from the same areas to assess changes in HPV presence and antibody levels.
Step 4
Third Vaccine Dose
The third and final dose of the Gardasil 9 vaccine is administered.
Final samples are collected to evaluate the reduction in HPV infectivity and the presence of antibodies.
Step 5
Follow-Up and Evaluation
Participants are monitored for any side effects and the effectiveness of the vaccine in reducing HPV infectivity is evaluated.
The study aims to demonstrate a reduction in the infective capacity of body fluids after the complete vaccination regimen.

Who can join the trial?

11 criteria

Must be a woman aged 18 years or older.
Must be attending a routine cervical cancer screening or gynecological visit.
Must test positive for **HPV 16** and/or **HPV 18**. **HPV** stands for Human Papillomavirus, a common virus that can affect the skin and the moist membranes lining your body.
Must have been diagnosed with HPV positivity within the last 10 months.
For the first group: Must be a non-vaccinated adult woman, positive for HPV 16 and/or 18 on the cervix, with no visible cervical lesion or with a mild cervical lesion called **CIN 1/2**. **CIN** stands for Cervical Intraepithelial Neoplasia, which is a term for abnormal cells on the surface of the cervix.
For the second group: Must be a non-vaccinated adult woman, positive for HPV 16 and/or 18 on an anal test, with no visible anal lesions or with anal lesions that can be treated conservatively.
Alternatively, must be a non-vaccinated adult woman, positive for HPV 16 and/or 18 on a cervical test, with a vulvar premalignant lesion or **condylomas**. **Condylomas** are growths on the skin caused by HPV.
Must not have any major health conditions that could affect the ability to follow the study procedures, as determined by the study doctor.
Must provide written consent to participate in the study.
Must provide a reliable contact number and an alternative way to be contacted, like another phone number or email, for follow-up purposes.
Must plan to stay in the area near the study site for the entire duration of the study to attend study visits conveniently.

Who cannot join the trial?

2 criteria

Participants must not be male. Only females are eligible for this study.
Participants must not be part of a vulnerable population. This means they should not be in a situation where they are unable to protect their own interests.

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Verified sites

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Bellvitge University Hospital
Verified
L'hospitalet De Llobregat, Spain
Hospital Clinic De Barcelona
Verified
Barcelona, Spain

Trial locations

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Investigated drugs

9vHPV: This is a vaccine designed to protect against nine types of human papillomavirus (HPV), including types 16 and 18, which are known to cause cervical and other types of cancers. The vaccine works by stimulating the body's immune system to produce antibodies that can prevent HPV infection. In this study, the vaccine is given in three doses to women who are already positive for HPV types 16 and/or 18, with the aim of reducing the virus's ability to infect and be transmitted through body fluids.

Human Papillomavirus Type 6 L1 Protein - Adsorbed - In The Form Of Virus-Like Particles Produced In Yeast Cells (Saccharomyces Cerevisiae Canade 3C-5 (Strain 1895)) By Rdna

What is already known about the treatment

9vHPV Vaccine – This vaccine is administered through an injection, typically given in a three-dose regimen. It is currently used in medical practice to prevent infections caused by certain types of human papillomavirus (HPV), particularly types 16 and 18, which are known to cause cervical and other cancers. The main therapeutic indication is to reduce the infectivity and transmission of HPV in individuals who are already positive for these virus types. At the molecular level, the vaccine works by stimulating the immune system to produce antibodies against the virus-like particles, preventing the virus from infecting cells. It is classified as a prophylactic vaccine, designed to prevent disease rather than treat it.

Investigated diseases

Human Papillomavirus Infection – Human Papillomavirus (HPV) infection is a common viral infection that affects the skin and mucous membranes. It is caused by the human papillomavirus, which has many different types, some of which can lead to health problems like warts and cancers. The virus is primarily spread through intimate skin-to-skin contact, often during sexual activity. In many cases, the infection does not cause any symptoms and may resolve on its own. However, certain types of HPV can persist and lead to the development of genital warts or cancers, such as cervical cancer. The progression of the infection can vary, with some individuals clearing the virus naturally, while others may experience persistent infection leading to more serious health issues.