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Human Papillomavirus Type 18 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 examine the vaccine’s efficacy, safety, and immunogenicity in various populations, including children, adolescents, adults, and immunocompromised individuals. The studies explore different dosing regimens, extended intervals between doses, and the vaccine’s potential in preventing or treating HPV-related conditions such as cervical lesions, vulvar lesions, and persistent oral infections.

Table of Contents

What is the HPV Type 18 L1 Protein Vaccine?

The Human Papillomavirus (HPV) Type 18 L1 Protein vaccine is part of a 9-valent HPV vaccine that protects against nine types of HPV, including type 18[1]. It contains virus-like particles (VLPs) of the L1 protein from HPV type 18, produced using recombinant DNA technology in yeast cells[1]. This vaccine is also known by the brand name Gardasil 9.

How Does it Work?

The vaccine works by stimulating the body’s immune system to produce antibodies against HPV type 18 and other included HPV types. These antibodies help prevent future infections by these HPV types. The vaccine contains no live virus, only proteins that mimic the outer shell of the virus[1].

What Does it Treat and Prevent?

The HPV type 18 L1 protein vaccine, as part of the 9-valent HPV vaccine, helps prevent:

  • Persistent anogenital HPV infection
  • Cervical, vulvar, vaginal, and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58
  • Genital warts caused by HPV types 6 and 11
  • Precancerous or dysplastic lesions caused by the 9 HPV types covered by the vaccine[1]

How is it Administered?

The vaccine is typically given as a series of intramuscular injections. The standard regimen involves:

  • 3 doses for individuals 15 years and older
  • 2 doses for children 9-14 years old[1]

Current research is also investigating extended dosing intervals and their effectiveness[1].

Effectiveness

Clinical trials have shown the 9-valent HPV vaccine, which includes the HPV type 18 L1 protein, to be highly effective. It induces a strong immune response, with high rates of seroconversion (development of antibodies) to the HPV types covered by the vaccine[1].

Safety and Side Effects

The vaccine has been shown to have a good safety profile in clinical trials. Common side effects may include:

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

Serious allergic reactions are rare but possible. Patients should inform their healthcare provider of any allergies before receiving the vaccine.

Who Should Get Vaccinated?

The HPV vaccine is recommended for:

  • Girls and boys aged 9-14 years (2-dose schedule)
  • Individuals aged 15-26 years who haven’t been previously vaccinated (3-dose schedule)
  • Some adults aged 27-45 years may benefit from vaccination after discussing with their healthcare provider[2]

The vaccine is not recommended for pregnant women or individuals with severe allergies to vaccine components.

Ongoing Research

Several clinical trials are currently investigating new applications and dosing regimens for the 9-valent HPV vaccine, including:

  • Extended dosing intervals in children and adolescents[1]
  • Effectiveness in immunocompromised children and adolescents[3]
  • Prevention of oral HPV infections in adult males[2]
  • Use in women with high-grade cervical lesions or early cervical cancer[4]
  • Efficacy in treating difficult-to-treat palmar or plantar warts[5]

These ongoing studies aim to expand our understanding of the vaccine’s potential uses and optimize its effectiveness in different populations.

Study Focus Population Key Objectives Notable Aspects
Extended dosing intervals Children/adolescents 9-14 years, women 16-26 years Safety and immunogenicity of 2-dose vs 3-dose regimens Evaluates dosing intervals up to 60 months apart
Immunocompromised patients Children/adolescents with HIV, transplants, post-chemotherapy Immunogenicity in special populations Compares response to healthy controls
Oral HPV prevention Males 20-45 years Efficacy in preventing persistent oral HPV infection First study on oral HPV prevention in adult males
Vulvar HSIL treatment Women with vulvar high-grade lesions Efficacy in preventing recurrence after treatment Investigates adjuvant vaccination post-treatment
Cervical lesion treatment Women over 45 with high-grade cervical lesions Efficacy in clearing HPV and preventing recurrence Focuses on older women with chronic HPV
Wart treatment Patients with difficult-to-treat palmar/plantar warts Efficacy in treating resistant warts Novel application for treatment-resistant cases

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 cancers affecting the genitals and throat.
  • Who are the target populations for these clinical trials? The clinical trials target various populations, including children and adolescents aged 9-14 years, adults aged 16-26 years, males aged 20-45 years, immunocompromised children and adolescents, women with high-grade cervical lesions, and individuals with difficult-to-treat palmar or plantar warts.
  • What are some of the main objectives of these clinical trials? The main objectives of these trials include evaluating the safety and immunogenicity of different dosing regimens, assessing the vaccine's efficacy in preventing persistent oral HPV infections, studying its effectiveness in treating high-grade cervical lesions, and investigating its potential in managing difficult-to-treat warts.
  • Are there any studies focusing on special populations? Yes, there are studies focusing on special populations. For example, one trial is investigating the immunogenicity of the 9-valent HPV vaccine in immunocompromised children and adolescents, including those with HIV infection, solid organ transplants, and post-chemotherapy patients.
  • What are some of the potential benefits being studied in these trials? The potential benefits being studied include improved protection against HPV-related diseases, reduced recurrence of high-grade cervical and vulvar lesions, prevention of persistent oral HPV infections, and possible treatment effects on difficult-to-treat warts. Some trials also aim to optimize vaccination schedules and explore the vaccine's impact on quality of life and healthcare costs.

Ongoing Clinical Trials on Human Papillomavirus Type 18 L1 Protein – Adsorbed – In The Form Of Virus-Like Particles Produced In Yeast Cells (Saccharomyces Cerevisiae Canade 3C-5 (Strain 1895)) By Rdna

Glossary

  • Human Papillomavirus (HPV): A group of viruses that can cause various types of cancer and genital warts. There are many types of HPV, some of which are targeted by the 9-valent vaccine.
  • 9-valent HPV vaccine: A vaccine that protects against nine types of HPV (6, 11, 16, 18, 31, 33, 45, 52, and 58), also known as Gardasil 9.
  • 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 changes in the cells on the surface of the cervix that could potentially lead to cervical cancer if left untreated.
  • HSIL (High-grade Squamous Intraepithelial Lesion): A precancerous condition where abnormal cells are found on the surface of the cervix or vulva.
  • LEEP (Loop Electrosurgical Excision Procedure): A procedure used to remove abnormal tissue from the cervix using a thin wire loop heated by electric current.
  • Persistent infection: An infection that continues for a longer period than would normally be expected, often defined as lasting 6 months or more in the context of HPV.
  • Geometric Mean Titers (GMT): A measure of the average concentration of antibodies in a group of subjects, used to assess the immune response to a vaccine.
  • Competitive Luminex Immunoassay (cLIA): A laboratory test used to measure antibody levels in response to vaccination.

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-id/2022-501413-31-00
  4. http://clinicaltrials.eu/trial/study-on-the-effectiveness-of-hpv-9-valent-vaccine-in-women-undergoing-leep-for-high-grade-cervical-lesions-or-early-cervical-cancer/
  5. 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/