Testing a new HPV vaccine in healthy adults
Official title: A Phase 1, Randomized, Double-Blind, Comparator-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of V540B in Healthy Adults.
Run by Merck Sharp & Dohme LLC · NCT06623409 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Enrollment | 124 (estimated) |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Locations | 4 sites (Anaheim, California and 3 other locations) |
| Status | Recruiting |
| Started | November 12, 2024 |
| Main results expected | May 31, 2028 |
| Study ends | May 31, 2028 |
| Registry record updated | October 8, 2026 |
| Trial ID | NCT06623409 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are healthy adults without a history of HPV-related conditions or cancers.
✕Probably not a fit
Patients with a history of HPV-related lesions or cancers will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown success with HPV vaccines, but this specific approach with V540B is novel.
Who can join: the full rules
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 it's running
-
Velocity Clinical Research, Hallandale Beach ( Site 0003)
Hallandale, Florida, United States Recruiting -
Research Centers of America ( Hollywood ) ( Site 0001)
Hollywood, Florida, United States Recruiting -
Anaheim Clinical Trials ( Site 0002)
Anaheim, California, United States Active not recruiting -
Velocity Clinical Research, Omaha ( Site 0005)
Omaha, Nebraska, United States Active not recruiting
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.com
- Phone: 1-888-577-8839
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.