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Human Papillomavirus Type 31 L1 Protein – Adsorbed – In The Form Of Virus-Like Particles Produced In Yeast Cells (Saccharomyces Cerevisiae Canade 3C-5 (Strain 1895)) By Rdna

This article summarizes several clinical trials investigating the use of the 9-valent human papillomavirus (HPV) vaccine, also known as Gardasil 9, for different indications. The trials explore the vaccine’s efficacy, safety, and immunogenicity in various populations, including children, adolescents, adults, and immunocompromised individuals. The studies aim to evaluate different dosing regimens, assess the vaccine’s potential in preventing HPV-related diseases, and examine its use in therapeutic settings for conditions like cervical lesions and warts.

Table of Contents

What is the HPV Vaccine?

The HPV vaccine, also known as Gardasil 9, is a vaccine that helps protect against infections caused by human papillomavirus (HPV). HPV is a very common virus that can lead to several types of cancer and genital warts.[1]

Gardasil 9 is a 9-valent vaccine, meaning it protects against 9 different types of HPV. Specifically, it targets HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.[1]

How the HPV Vaccine Works

The vaccine contains proteins that resemble parts of the HPV virus. These proteins are called L1 proteins and are produced using recombinant DNA technology in yeast cells. When injected, these proteins stimulate the body’s immune system to produce antibodies against HPV, providing protection against future HPV infections.[1]

The vaccine is given as an injection into the muscle, usually in the upper arm or thigh. It does not contain any live virus, so it cannot cause HPV infection.[1]

Who Should Get the HPV Vaccine?

The HPV vaccine is recommended for the following groups:

  • Boys and girls aged 9-14 years[1]
  • Young women aged 16-26 years[1]
  • Adult males aged 20-45 years[2]

Some studies are also investigating the use of the vaccine in other populations, such as:

  • Women over 45 years who have been treated for high-grade cervical lesions[3]
  • Women with vulvar high-grade squamous intraepithelial lesions (vHSIL)[4]
  • Immunocompromised children and adolescents[5]

Dosing Schedule

The typical dosing schedule for the HPV vaccine is:

  • For individuals 9-14 years old: 2 doses, with the second dose given 6-12 months after the first dose[1]
  • For individuals 15 years and older: 3 doses, with the second dose given 2 months after the first, and the third dose given 6 months after the first[1]

Some studies are investigating extended dosing intervals to see if they provide similar protection with fewer doses.[1]

Effectiveness

The HPV vaccine has been shown to be highly effective in preventing HPV infections and related diseases. It can help prevent:

  • Cervical, vaginal, and vulvar cancers in women
  • Anal cancer in both men and women
  • Genital warts in both men and women
  • Potentially, oral HPV infections and related cancers[2]

Studies have shown that the vaccine can produce a strong immune response, with high levels of antibodies against the targeted HPV types.[1]

Safety and Side Effects

The HPV vaccine has been extensively tested and is considered safe. Common side effects may include:

  • Pain, redness, or swelling at the injection site
  • Fever
  • Headache
  • Nausea
  • Dizziness[1]

Serious side effects are rare. As with any vaccine, there is a very small risk of a severe allergic reaction.[1]

Ongoing Research

Several clinical trials are currently underway to further investigate the HPV vaccine’s potential uses and benefits. These include:

  • Studying its effectiveness in preventing oral HPV infections in adult males[2]
  • Evaluating its use in women treated for high-grade cervical lesions or early cervical cancer[4]
  • Investigating its potential in treating difficult-to-treat palmar or plantar warts[6]
  • Assessing its efficacy in preventing recurrence of vulvar high-grade lesions[4]

These studies aim to expand our understanding of the vaccine’s potential benefits and optimize its use in various populations.

Trial Number Population Main Objective Key Endpoints
2022-500256-37-00 Boys and girls 9-14 years, women 16-26 years Evaluate safety and immunogenicity of extended 2-dose regimens Antibody GMTs, seroconversion rates, adverse events
2022-501413-31-00 Immunocompromised children and adolescents Assess immunogenicity in immunocompromised individuals Seroconversion rates, antibody titers
2022-501974-21-00 Adult males 20-45 years Evaluate efficacy in preventing oral persistent HPV infection Incidence of HPV-related oral persistent infection
2023-506792-94-00 Women with vulvar HSIL Assess efficacy in preventing recurrence after treatment Recurrence rate of vulvar HSIL
2024-513081-19-00 Women over 45 with high-grade cervical lesions Evaluate HPV clearance after treatment and vaccination HPV-negative status within 2 years
2024-513671-40-00 Patients with difficult-to-treat palmar or plantar warts Assess efficacy in treating resistant warts Complete remission of warts
2024-513704-34-00 Women undergoing LEEP for high-grade cervical lesions Evaluate impact of pre-surgical vaccination on recurrence Reduction in disease recurrence

FAQ

  • What is the 9-valent HPV vaccine? The 9-valent HPV vaccine, also known as Gardasil 9, is a vaccine that protects against nine types of human papillomavirus (HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58). It is designed to prevent HPV-related diseases such as cervical cancer, genital warts, and other HPV-associated cancers.
  • Who are the target populations for these clinical trials? The clinical trials target various populations, including children and adolescents aged 9-14 years, adult males aged 20-45 years, women over 45 years with high-grade cervical lesions, immunocompromised children and adolescents, and individuals with difficult-to-treat palmar or plantar warts.
  • What are the main objectives of these clinical trials? The main objectives vary across trials but generally include evaluating the vaccine's efficacy in preventing HPV infections and related diseases, assessing its safety and immunogenicity, studying different dosing regimens, and exploring its potential therapeutic use in treating existing HPV-related conditions.
  • How is the vaccine administered in these trials? The vaccine is typically administered as an intramuscular injection. The dosing schedules vary between trials, with some studies evaluating 2-dose regimens with extended intervals, while others use the standard 3-dose regimen.
  • What are some of the potential benefits being studied? The trials are investigating potential benefits such as reduced incidence of HPV infections, prevention of HPV-related diseases, improved immune responses, reduction in recurrence of cervical lesions, and possible therapeutic effects on existing HPV-related conditions like warts.

Ongoing Clinical Trials on Human Papillomavirus Type 31 L1 Protein – Adsorbed – In The Form Of Virus-Like Particles Produced In Yeast Cells (Saccharomyces Cerevisiae Canade 3C-5 (Strain 1895)) By Rdna

Glossary

  • HPV (Human Papillomavirus): A group of viruses that can cause various types of cancer and genital warts. There are many types of HPV, and some are considered high-risk for causing cancer.
  • 9-valent HPV vaccine: A vaccine that protects against nine types of HPV (6, 11, 16, 18, 31, 33, 45, 52, and 58), offering broader protection than earlier versions of the vaccine.
  • Immunogenicity: The ability of a substance, such as a vaccine, to provoke an immune response in the body.
  • Seroconversion: The development of detectable antibodies in the blood directed against an infectious agent, indicating an immune response.
  • CIN (Cervical Intraepithelial Neoplasia): Abnormal cell growth on the surface of the cervix, which can be a precursor to cervical cancer.
  • LEEP (Loop Electrosurgical Excision Procedure): A procedure used to remove abnormal tissue from the cervix using a thin wire loop heated by electric current.
  • Conization: A surgical procedure to remove a cone-shaped piece of tissue from the cervix for examination or treatment of abnormal cells.
  • Geometric Mean Titers (GMT): A measure of the average concentration of antibodies in the blood, used to assess the immune response to a vaccine.
  • Recombinant vaccine: A vaccine produced using genetic engineering techniques to create proteins that trigger an immune response.
  • Placebo-controlled trial: A study in which some participants receive an inactive substance (placebo) instead of the treatment being tested, allowing researchers to compare results.

References

  1. http://clinicaltrials.eu/trial-id/2022-500256-37-00
  2. http://clinicaltrials.eu/trial-id/2022-501974-21-00
  3. http://clinicaltrials.eu/trial/study-on-hpv-vaccine-after-treatment-for-high-grade-cervical-lesions-in-women-over-45/
  4. http://clinicaltrials.eu/trial/study-on-hpv-vaccine-for-women-with-vulvar-hsil-evaluating-the-effectiveness-of-nonavalent-hpv-vaccine-in-preventing-recurrence-of-vulvar-high-grade-lesions/
  5. http://clinicaltrials.eu/trial-id/2022-501413-31-00
  6. http://clinicaltrials.eu/trial/study-on-the-effectiveness-of-the-nonavalent-hpv-vaccine-in-treating-hard-to-treat-palmar-or-plantar-warts-in-patients-who-have-not-responded-to-two-previous-treatments/