Evaluating a new HPV vaccine in healthy adults
A Phase 1, Randomized, Double-Blind, Comparator-Controlled, Dose-Escalation Trial to Evaluate, Tolerability, and Immunogenicity of V540D in Healthy Adults.
PHASE1 · Merck Sharp & Dohme LLC · NCT06688058
This study is testing a new HPV vaccine called V540D in healthy adults to see if it is safe and can help protect against more types of HPV than the current GARDASIL®9 vaccine.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Merck Sharp & Dohme LLC (industry) |
| Locations | 4 sites (Hollywood, Florida and 3 other locations) |
| Trial ID | NCT06688058 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and tolerability of a new vaccine called V540D in healthy adults. The vaccine is designed to protect against various types of human papillomavirus (HPV), including those not covered by the existing GARDASIL®9 vaccine. Participants will receive the V540D vaccine, and researchers will monitor their health and immune response to determine the vaccine's safety profile. The study is crucial for understanding how well this new vaccine can prevent HPV-related 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 than current vaccines.
How similar studies have performed: While there have been successful studies on HPV vaccines, this specific approach with V540D is novel and untested.
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
Hollywood, Florida and 3 other locations
- Research Centers of America ( Hollywood ) ( Site 0001) — Hollywood, Florida, United States (RECRUITING)
- Velocity Clinical Research, Savannah ( Site 0005) — Savannah, Georgia, United States (RECRUITING)
- Alliance for Multispecialty Research, LLC ( Site 0003) — Kansas City, Missouri, United States (RECRUITING)
- Alliance for Multispecialty Research, LLC ( Site 0004) — Knoxville, Tennessee, 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.
Conditions: Healthy