A Trial to Evaluate Tolerability and Immunogenicity of V540D in Healthy Adults (V540D-004)

A Phase 1, Randomized, Double-Blind, Comparator-Controlled, Dose-Escalation Trial to Evaluate, Tolerability, and Immunogenicity of V540D 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 V540D) 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 V540D in healthy adults and if people tolerate it.

Study Overview

• Status: Active, not recruiting
• Conditions: Healthy
• Intervention / Treatment: Biological: V540D; Biological: GARDASIL®9

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

Contacts and Locations

Study Locations

• United States
  • Florida
    • Hollywood, Florida, United States, 33024
      • Research Centers of America ( Hollywood ) ( Site 0001)
  • Georgia
    • Savannah, Georgia, United States, 31406
      • Velocity Clinical Research, Savannah ( Site 0005)
  • Missouri
    • Kansas City, Missouri, United States, 64114
      • Alliance for Multispecialty Research, LLC ( Site 0003)
  • Tennessee
    • Knoxville, Tennessee, United States, 37920
      • Alliance for Multispecialty Research, LLC ( Site 0004)

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: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: V540D; Participants will receive vaccinations with V540D.	Biological: V540D; Experimental vaccine and adjuvant administered via intramuscular (IM) injection
Active Comparator: GARDASIL®9; Participants will receive vaccinations with GARDASIL®9.	Biological: GARDASIL®9; Suspension administered via IM injection; Other Names: V503; G9

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
Number of Participants Who Experience 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 Experience Unsolicited AEs	An unsolicited AE is an event that is not predefined as a solicited AE or is predefined as a solicited AE but reported at any time outside the solicited time period.	Up to approximately 7 months
Number of Participants Who Experience a Serious Adverse Event (SAE)	SAEs include AEs that result in any of the following outcomes: death, a life-threatening AE, 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 Experience a Medically-Attended AE (MAAE)	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 MAAEs. Examples of routine visits include physical examination, wellness visits, or vaccinations.	Up to approximately 18 months
Number of Participants Who Experience an Event of Clinical Interest (ECI)	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

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	GMR of titers for participants vaccinated with V540D versus those who received GARDASIL®9 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): December 20, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: November 12, 2024
• First Submitted That Met QC Criteria: November 12, 2024
• First Posted (Actual): November 14, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neu1 protein, mouse
• Other Study ID Numbers: V540D-004

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