Safety and Immunogenicity of V540B in Healthy Adults (V540B-002).

A Phase 1, Randomized, Double-Blind, Comparator-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of V540B in Healthy Adults.

Researchers are looking for new ways to prevent cancers related to human papillomavirus (HPV). HPV is a common virus that can cause an infection. There are many different types of HPV. Most people's immune system can fight HPV infection and it goes away without treatment. For some people, HPV infections can last longer and may cause cancer years later.

A standard vaccine to prevent HPV-related cancers is GARDASIL®9 (G9). G9 protects against 9 types of HPV but it does not protect against other types of HPV. The study vaccine (called V540B) is designed to protect against the same HPV types that G9 protects against plus other HPV types. The main goal of this study is to learn about the safety of V540B in healthy adults and if people tolerate it.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy
• Intervention / Treatment: Biological: GARDASIL®9 (G9); Biological: V540B

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials ( Site 0002)
    • Glendale, California, United States, 91206
      • California Clinical Trials Medical Group managed by PAREXEL ( Site 0008)
  • Florida
    • Hallandale Beach, Florida, United States, 33009
      • Velocity Clinical Research, Hallandale Beach ( Site 0003)
    • Hollywood, Florida, United States, 33024
      • Research Centers of America ( Hollywood ) ( Site 0001)
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • Velocity Clinical Research, Omaha ( Site 0005)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: GARDASIL®9 (G9); Participants will receive vaccinations with G9.	Biological: GARDASIL®9 (G9); Suspension administered via intramuscular (IM) injection; Other Names: V503
Experimental: V540B; Participants will receive vaccinations with V540B.	Biological: V540B; Experimental vaccine and adjuvant administered via IM injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Experience a Solicited Injection-Site Adverse Event (AE)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	Up to approximately 6 months
Number of Participants Who Experience a Solicited Systemic AE	Solicited systemic AEs include headache, fatigue, nausea, dizziness, muscle aches, joint pain.	Up to approximately 6 months
Immediate Reactions Occurring Within 30 Minutes After Any Vaccination	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.	Up to approximately 6 months
Number of Participants Who Experienced a Serious Adverse Event	Serious adverse events (SAEs) include adverse events that result in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect.	Up to approximately 18 months
Number of Participants Who Experienced an Event of Clinical Interest	Events of clinical interest (ECIs) are defined as an overdose of Sponsor's product, drug-induced liver injury events, or potential immune-mediated diseases (pIMDs).	Up to approximately 18 months
Number of Participants Who Experienced Unsolicited AEs	An unsolicited AE is an AE that was not solicited using a vaccine report card (VRC) and that is communicated by a participant (or their legally acceptable representative, if applicable). Unsolicited AEs include serious and nonserious AEs.	Up to approximately 7 months
Number of Participants Who Experienced a Medically-Attended AE	AEs in which medical attention is received during an unscheduled, non-routine outpatient visit, such as an emergency department visit, office visit, or an urgent care visit with any medical personnel for any reason. Routine visits are not considered medically-attended adverse events (MAAEs). Examples of routine visits include physical examination, wellness visits, or vaccinations.	Up to approximately 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Immunoglobulin G (IgG) Geometric Mean Ratios (GMRs) for anti-HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58	Geometric mean ratio (GMR) of titers for participants vaccinated with V540B versus those who received G9 alone will be calculated.	Up to approximately 7 months

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2024
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): November 20, 2026

Study Registration Dates

• First Submitted: September 30, 2024
• First Submitted That Met QC Criteria: September 30, 2024
• First Posted (Actual): October 2, 2024

Study Record Updates

• Last Update Posted (Actual): August 3, 2025
• Last Update Submitted That Met QC Criteria: August 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: V540B-002 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No