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Human Papillomavirus Type 52 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, specifically focusing on the active substance Human Papillomavirus Type 52 L1 Protein. These trials explore the vaccine’s efficacy, safety, and immunogenicity in different populations and for various indications, including prevention of HPV infection and treatment of HPV-related conditions. The studies cover diverse groups such as children, adolescents, adults, and immunocompromised individuals, providing valuable insights into the potential applications of this vaccine beyond its current approved uses.

Table of Contents

What is the HPV Type 52 Vaccine?

The HPV Type 52 vaccine is part of a 9-valent human papillomavirus (HPV) vaccine that helps protect against several types of HPV, including type 52. It contains Human Papillomavirus Type 52 L1 protein in the form of virus-like particles produced in yeast cells using recombinant DNA technology.[1] This vaccine is also known by the brand name Gardasil 9.

The vaccine works by stimulating the body’s immune system to produce antibodies against HPV type 52 and other included HPV types. These antibodies help prevent infection if a person is later exposed to these viruses.

How Does It Work?

The vaccine contains proteins that mimic the outer shell of the HPV virus. When injected, these proteins trigger an immune response, causing the body to produce antibodies specific to HPV type 52 and other included types. If a vaccinated person is later exposed to the actual virus, their immune system can quickly recognize and neutralize it before an infection takes hold.[2]

Who Is It For?

The HPV Type 52 vaccine is approved for use in:

  • Girls and women aged 9 to 45 years old
  • Boys and men aged 9 to 45 years old
It is most effective when given before potential exposure to HPV through sexual activity.[1]

The vaccine may also be beneficial for:

  • Women treated for high-grade cervical lesions or early cervical cancer[3]
  • Women with vulvar high-grade squamous intraepithelial lesions (vHSIL)[4]
  • Immunocompromised children and adolescents[5]

Effectiveness

Clinical trials have shown the 9-valent HPV vaccine to be highly effective at preventing infection and disease caused by HPV type 52 and other included types. In one study, it demonstrated:

  • Nearly 100% effectiveness in preventing cervical, vulvar, and vaginal precancers caused by the 9 HPV types
  • 97% effectiveness in preventing genital warts caused by HPV types 6 and 11
The vaccine has also shown effectiveness in reducing recurrence of high-grade cervical and vulvar lesions after treatment.[3][4]

Dosing and Administration

The typical dosing schedule for the HPV Type 52 vaccine is:

  • 3 doses given over 6 months
  • 0.5 mL per dose, injected intramuscularly
  • Doses given at 0, 2, and 6 months
Some studies are investigating extended dosing intervals or 2-dose schedules in certain age groups.[1]

Safety and Side Effects

The HPV Type 52 vaccine has been shown to be generally safe and well-tolerated. Common side effects may include:

  • Pain, swelling, or redness at the injection site
  • Headache
  • Fever
  • Nausea
  • Dizziness
Serious side effects are rare but can include severe allergic reactions.[2]

Ongoing Research

Several clinical trials are currently underway to further study the HPV Type 52 vaccine, including:

  • Extended dosing intervals in children and adolescents[1]
  • Effectiveness in preventing oral HPV infections in adult males[2]
  • Use as adjuvant therapy for women treated for cervical or vulvar lesions[3][4]
  • Efficacy in immunocompromised populations[5]
  • Potential use in treating recalcitrant warts[6]

These ongoing studies aim to expand our understanding of the vaccine’s potential uses and optimize its effectiveness in preventing HPV-related diseases.

Trial Focus Population Key Objectives Duration
Extended dosing intervals Children and adolescents 9-14 years, women 16-26 years Evaluate safety and immunogenicity of 2-dose regimens with extended intervals Up to 36 months post-vaccination
Immunocompromised patients Immunocompromised children and adolescents over 9 years Assess immunogenicity in HIV-infected, transplant recipients, and post-chemotherapy patients Up to 12 months post-vaccination
Oral persistent infection Adult males 20-45 years Evaluate efficacy in preventing oral persistent HPV infection Up to 24 months
Vulvar HSIL treatment Women with vulvar high-grade squamous intraepithelial lesion Assess efficacy in preventing recurrence after treatment Up to 24 months, with long-term follow-up to 10 years
Post-treatment for cervical lesions Women over 45 with high-grade cervical lesions Evaluate efficacy in clearing HPV infection after treatment Up to 24 months
Palmar/plantar warts Patients ≥15 years with difficult-to-treat warts Assess efficacy in treating resistant palmar or plantar warts 7 months
Pre-surgical vaccination Women with high-grade cervical lesions or early cervical cancer Evaluate impact on reducing post-surgical disease recurrence Not specified

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 contains virus-like particles produced in yeast cells for each of these HPV types.
  • What populations are being studied in these clinical trials? The clinical trials are studying 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 patients with difficult-to-treat palmar or plantar warts.
  • What are some of the main objectives of these trials? The main objectives vary across trials but generally include evaluating the vaccine's efficacy in preventing HPV infections, assessing its immunogenicity, studying its effectiveness in treating HPV-related conditions, and investigating its safety profile in different populations.
  • Are there any trials looking at non-traditional uses of the HPV vaccine? Yes, some trials are exploring non-traditional uses of the HPV vaccine. For example, one study is investigating its efficacy in treating difficult-to-treat palmar or plantar warts, while another is looking at its use in preventing recurrence of vulvar high-grade squamous intraepithelial lesions.
  • How long do these clinical trials typically last? The duration of these clinical trials varies, but many of them involve follow-up periods ranging from 6 months to several years. Some studies even include long-term follow-up plans for up to 5 or 10 years to assess the vaccine's long-term efficacy and safety.

Ongoing Clinical Trials on Human Papillomavirus Type 52 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, 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), offering broader protection than earlier HPV vaccines.
  • 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.
  • LEEP (Loop Electrosurgical Excision Procedure): A treatment for abnormal cells on the cervix, where a small electrical wire loop is used to remove the affected tissue.
  • Conization: A surgical procedure to remove a cone-shaped piece of tissue from the cervix for examination or treatment of abnormal cells.
  • Persistent infection: An infection that continues for a longer period than expected, often defined as lasting more than 6-12 months in the context of HPV.
  • Recurrence: The return of a disease or condition after a period of improvement or remission.
  • HSIL (High-grade Squamous Intraepithelial Lesion): A precancerous condition characterized by abnormal cell changes on the surface of the cervix or other areas.
  • Colposcopy: A medical procedure to closely examine the cervix, vagina, and vulva for signs of disease using a special instrument called a colposcope.
  • 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.

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/