Testing a new HPV vaccine in healthy adults
A Phase 1, Randomized, Double-Blind, Comparator-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of V540B in Healthy Adults.
This study is testing a new HPV vaccine in healthy adults to see if it is safe and works better than the current standard vaccine.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Locations | 5 sites (Anaheim, California and 4 other locations) |
| Trial ID | NCT06623409 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and immunogenicity of a new vaccine, V540B, designed to prevent cancers related to human papillomavirus (HPV) in healthy adults. The study compares V540B with the standard HPV vaccine, GARDASIL®9, which protects against nine types of HPV. Researchers aim to determine how well participants tolerate the new vaccine and its safety profile. The trial includes healthy adults who meet specific health criteria and excludes those with a history of HPV-related conditions or cancers.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults without a history of HPV-related conditions or cancers.
Not a fit: Patients with a history of HPV-related lesions or cancers will not benefit from this study.
Why it matters
Potential benefit: If successful, this vaccine could provide broader protection against HPV-related cancers beyond what is currently available.
How similar studies have performed: Other studies have shown success with HPV vaccines, but this specific approach with V540B is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: The key inclusion criteria include but are not limited to the following: * Is in good health based on medical history, physical examination, vital sign (VS) measurements and electrocardiograms (ECGs) performed before randomization. Exclusion Criteria: The key exclusion criteria include but are not limited to the following: * Has a history of abnormal Pap smears, HPV- related external genital lesions (eg,condyloma acuminate, vulval intraepithelial neoplasia (VIN), or prostatic intraepithelial neoplasia (PIN)) or external genital cancer (eg, penile cancer), HPV-related vaginal or anal lesions (eg, condyloma acuminata or vaginal intraepithelial neoplasia (VaIN)) or vaginal or anal cancer. * Has a history of cancer (malignancy). * Has received any HPV vaccine or is expected to receive any HPV vaccine during the study, outside the protocol.
Where this trial is running
Anaheim, California and 4 other locations
- Anaheim Clinical Trials ( Site 0002) — Anaheim, California, United States (Recruiting)
- California Clinical Trials Medical Group managed by PAREXEL ( Site 0008) — Glendale, California, United States (Recruiting)
- Velocity Clinical Research, Hallandale Beach ( Site 0003) — Hallandale Beach, Florida, United States (Recruiting)
- Research Centers of America ( Hollywood ) ( Site 0001) — Hollywood, Florida, United States (Recruiting)
- Velocity Clinical Research, Omaha ( Site 0005) — Omaha, Nebraska, United States (Recruiting)
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.com
- Phone: 1-888-577-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.