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Study on the Safety and Immune Response of 9vHPV Vaccine in Preventing HPV in Boys and Girls Aged 9-14 Compared to Young Women Aged 16-26

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 prevention of persistent anogenital infection and disease caused by the Human Papillomavirus (HPV). The study involves the use of a vaccine called Gardasil 9, which is designed to protect against nine types of HPV: types 6, 11, 16, 18, 31, 33, 45, 52, and 58. The vaccine is administered as a suspension for injection, which means it is given as a liquid shot into the muscle.

The purpose of the study is to evaluate the safety and immune response of different dosing schedules of the Gardasil 9 vaccine. The study compares a 2-dose regimen given to boys and girls aged 9 to 14 years with a standard 3-dose regimen given to young women aged 16 to 26 years. The study also looks at the immune response in boys and girls aged 10 to 15 years who have already received one dose of the vaccine at least a year before joining the study. Participants will receive the vaccine at different intervals, and their immune response will be measured to see how well the vaccine works over time.

Throughout the study, participants will be monitored for any side effects or adverse reactions to the vaccine. The study aims to ensure that the vaccine is safe and effective in preventing HPV-related diseases. Participants will receive the vaccine through an intramuscular injection, which means the shot is given directly into a muscle. The study will help determine the best dosing schedule for the Gardasil 9 vaccine to provide optimal protection against HPV.

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 vaccination
Upon joining the study, participants will receive the first dose of the Gardasil 9 vaccine. This vaccine is administered as an intramuscular injection, which means it is given as a shot into a muscle.
The vaccine is designed to help prevent infections caused by certain types of the human papillomavirus (HPV).
Step 2
Second vaccination
Participants aged 9 to 14 will receive a second dose of the Gardasil 9 vaccine after a specified interval, which varies depending on the cohort they are in. The intervals are 12, 24, 36, or 60 months after the first dose.
Participants aged 16 to 26 will receive their second dose 2 months after the first dose.
Step 3
Third vaccination (if applicable)
Only participants aged 16 to 26 will receive a third dose of the Gardasil 9 vaccine. This dose is administered 6 months after the first dose.
Step 4
Follow-up and monitoring
Participants will be monitored for any side effects or reactions to the vaccine. This includes checking for any injection-site reactions or other symptoms.
Regular follow-up visits will be scheduled to assess the immune response to the vaccine. Blood samples may be taken to measure the levels of antibodies against HPV.
Step 5
Final assessment
At the end of the study period, a final assessment will be conducted to evaluate the overall safety and effectiveness of the vaccine regimen.
Participants will be informed about the results of their participation and any relevant findings from the study.

Who can join the trial?

4 criteria

Boys and girls aged 9 to 15 years must not have started any sexual activity and do not plan on becoming sexually active during the vaccination period.
Women aged 16 to 26 years who have never had a Papanicolaou (Pap) test or only have had normal Pap test results. A Pap test is a procedure to test for cervical cancer in women.
Women aged 16 to 26 years with a lifetime history of 0 to 4 male and/or female sexual partners.
Participants in Cohort 0 must have received 1 dose of the 9-valent HPV (9vHPV) vaccine at least 1 year before joining the study and did not receive a second dose of any HPV vaccine. The 9vHPV vaccine is designed to protect against nine types of human papillomavirus (HPV).

Who cannot join the trial?

7 criteria

Participants who have a current or past infection with any of the **HPV types** included in the study. HPV stands for Human Papillomavirus, a virus that can cause certain diseases.
Participants who have received any **HPV vaccine** before, except for those specified in the study.
Participants with a known allergy to any component of the **HPV vaccine**.
Participants with a weakened immune system, which means their body has a reduced ability to fight infections and diseases.
Participants who are pregnant or planning to become pregnant during the study period.
Participants who have any medical condition that, in the opinion of the study doctor, might interfere with the study results or pose a risk to the participant.
Participants who are currently participating in another clinical trial or have participated in another trial within a certain time frame before this study.

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Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu
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Wroclaw, Poland

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Investigated drugs

9vHPV Vaccine is a vaccine designed to protect against nine types of human papillomavirus (HPV). HPV is a common virus that can lead to certain types of cancer and other diseases. The vaccine works by stimulating the body's immune system to produce antibodies against these virus types, helping to prevent infection. In this clinical trial, the vaccine is being tested in different age groups and dosing schedules to evaluate its safety and how well it triggers an immune response. The study aims to find out if a two-dose schedule in younger participants is as effective as a three-dose schedule in older participants.

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 given as an injection to prevent persistent infections and diseases caused by certain types of human papillomavirus (HPV), specifically types 6, 11, 16, 18, 31, 33, 45, 52, and 58. It is currently being studied in a clinical trial to assess its safety and effectiveness when given in two doses to young boys and girls, compared to the standard three-dose regimen in young women. The vaccine works by stimulating the body's immune system to produce antibodies that fight off the virus, preventing infection. It is classified as a vaccine in the field of pharmacology.

Investigated diseases

Human Papillomavirus Infection – Human Papillomavirus (HPV) infection is caused by a group of viruses that affect the skin and moist membranes lining the body, such as the cervix, anus, mouth, and throat. The virus is transmitted through direct skin-to-skin contact, often during sexual activity. HPV infection can lead to the development of warts in the anogenital region and other areas. Some types of HPV are associated with the development of certain cancers, such as cervical cancer. The infection often progresses without symptoms, making it difficult to detect without screening. Over time, persistent infection with high-risk HPV types can lead to cellular changes and the development of precancerous lesions.