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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain

Other Sites

Site Name	City	Country	Status
Hospital Clinic De Barcelona	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	09.09.2022

Trial locations

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 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.

Trial ID:

2024-515228-36-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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

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