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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

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 effectiveness in preventing HPV infection and related diseases in various populations, including adolescents, adults, and patients with specific medical conditions. The studies aim to evaluate different dosing regimens, immunogenicity, safety, and efficacy in preventing persistent HPV infection and associated lesions.

Table of Contents

What is HPV?

Human papillomavirus (HPV) is a common virus that can cause several types of cancer and diseases. There are many different types of HPV. Some can lead to cervical cancer in women, as well as other cancers like anal, vaginal, vulvar, penile, and throat cancers. Other types can cause genital warts.[1]

About the HPV Vaccine

The HPV vaccine discussed in these clinical trials is called Gardasil 9. It 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.[2]

Gardasil 9 is what’s known as a recombinant vaccine. This means it’s made using pieces of HPV proteins, not the actual virus. These protein pieces are produced in yeast cells using genetic engineering techniques.[2]

How the Vaccine Works

The vaccine works by stimulating the body’s immune system to produce antibodies against the 9 types of HPV it targets. These antibodies help prevent future infections with these HPV types. The vaccine doesn’t treat existing HPV infections, but it can prevent new ones.[1]

Who Should Get Vaccinated

The HPV vaccine is typically recommended for:

  • Boys and girls aged 9-14 years[1]
  • Young women up to age 26[1]
  • Adult males aged 20-45 years (based on ongoing research)[3]

Some studies are also looking at the vaccine’s effectiveness in older adults and people with certain medical conditions.[4][5]

Dosing Schedule

The typical vaccination schedule involves:

  • For ages 9-14: Two doses, with the second dose given 6-12 months after the first[1]
  • For ages 15 and older: Three doses, with the second dose given 2 months after the first, and the third dose given 6 months after the first[1]

Some research is looking at extended dosing intervals to see if they provide similar protection.[1]

Effectiveness

Clinical trials have shown that the HPV vaccine is highly effective at preventing infections with the HPV types it targets. This includes preventing:

  • Persistent HPV infections[3]
  • Cervical precancers and early cervical cancers[6]
  • Genital warts[3]

Research is ongoing to determine how long protection lasts and whether booster doses might be needed in the future.[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
  • Muscle or joint pain[2]

Serious side effects are rare. As with any vaccine, there is a very small risk of a severe allergic reaction.[2]

Ongoing Research

Several clinical trials are currently investigating new uses for the HPV vaccine, including:

  • Vaccination for adult males to prevent oral HPV infections[3]
  • Use in women over 45 who have been treated for cervical lesions[4]
  • Effectiveness in treating difficult-to-treat warts[5]
  • Use before surgery for cervical lesions to reduce recurrence[6]

These studies aim to expand our understanding of how the HPV vaccine can be used to prevent HPV-related diseases in different populations.

Study Focus Population Key Objectives Main Outcomes
Extended 2-dose regimens Boys and girls 9-14 years, women 16-26 years Compare immunogenicity of extended 2-dose vs. standard 3-dose regimens Antibody responses, seroconversion rates
Immunocompromised patients Children and adolescents with HIV, SOT/HSCT, post-chemotherapy Evaluate immunogenicity in immunocompromised individuals Seroconversion, antibody titers, immune response markers
Oral persistent infection Adult males 20-45 years Assess efficacy in preventing oral HPV infection Incidence of HPV-related oral persistent infection
Vulvar HSIL treatment Women with vulvar HSIL Evaluate efficacy of adjuvant vaccination after HSIL treatment Recurrence rates, immune response, quality of life
Post-treatment of cervical lesions Women over 45 with high-grade cervical lesions Assess impact on HPV clearance and recurrence after treatment HPV clearance rates, recurrence of cervical lesions
Palmar/plantar warts Patients with difficult-to-treat warts Evaluate efficacy in treating recalcitrant warts Wart remission rates, quality of life, pain reduction

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, vulvar, vaginal, and anal cancers, as well as genital warts.
  • Who are the target populations for these clinical trials? The clinical trials target various populations, including boys and girls aged 9-14 years, women aged 16-26 years, adult males aged 20-45 years, immunocompromised children and adolescents, women with high-grade cervical lesions, and patients with difficult-to-treat palmar or plantar warts.
  • What are 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 HPV infection and related diseases, studying its effectiveness in specific patient groups (e.g., immunocompromised individuals), and exploring its potential 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 regimens vary among trials, with some studies comparing 2-dose schedules to 3-dose schedules, while others focus on the standard 3-dose regimen given over 6 months.
  • What are some of the key outcomes being measured in these trials? Key outcomes include antibody responses to HPV types, seroconversion rates, incidence of persistent HPV infection, recurrence rates of cervical or vulvar lesions, quality of life measures, and safety assessments such as the occurrence of adverse events following vaccination.

Ongoing Clinical Trials on 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

Glossary

  • HPV (Human Papillomavirus): A group of viruses that can cause various types of cancer and genital warts. There are many types of HPV, with some high-risk types associated with cancer development.
  • 9vHPV vaccine: The 9-valent HPV vaccine (Gardasil 9) that protects against nine types of HPV (6, 11, 16, 18, 31, 33, 45, 52, and 58).
  • 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 precancerous.
  • HSIL (High-grade Squamous Intraepithelial Lesion): A precancerous condition where abnormal cells are found on the surface of the cervix or other areas.
  • 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 diagnostic or treatment purposes.
  • Geometric Mean Titers (GMT): A measure of the average antibody levels in a group of individuals, used to assess immune response to vaccines.
  • Adverse Event (AE): Any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a medical treatment or procedure.

References

  1. http://clinicaltrials.eu/trial-id/2022-500256-37-00
  2. http://clinicaltrials.eu/trial-id/2022-501413-31-00
  3. http://clinicaltrials.eu/trial-id/2022-501974-21-00
  4. http://clinicaltrials.eu/trial/study-on-hpv-vaccine-after-treatment-for-high-grade-cervical-lesions-in-women-over-45/
  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/
  6. 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/