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

NCT06623409 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: V540B-002
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (7)

• 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 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 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 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

• 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

Secondary Outcomes (1)

• Total Immunoglobulin G (IgG) Geometric Mean Ratios (GMRs) for anti-HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58

  Up to approximately 7 months

Study Arms (2)

GARDASIL®9 (G9)

ACTIVE COMPARATOR

Participants will receive vaccinations with G9.

Biological: GARDASIL®9 (G9)

V540B

EXPERIMENTAL

Participants will receive vaccinations with V540B.

Biological: V540B

Interventions

GARDASIL®9 (G9) BIOLOGICAL

Suspension administered via intramuscular (IM) injection

Also known as: V503

GARDASIL®9 (G9)

V540B BIOLOGICAL

Experimental vaccine and adjuvant administered via IM injection

V540B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is in good health based on medical history, physical examination, vital sign (VS) measurements and electrocardiograms (ECGs) performed before randomization.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (5)

Anaheim Clinical Trials ( Site 0002)

Anaheim, California, 92801, United States

Location

California Clinical Trials Medical Group managed by PAREXEL ( Site 0008)

Glendale, California, 91206, United States

Location

Velocity Clinical Research, Hallandale Beach ( Site 0003)

Hallandale, Florida, 33009, United States

Location

Research Centers of America ( Hollywood ) ( Site 0001)

Hollywood, Florida, 33024, United States

Location

Velocity Clinical Research, Omaha ( Site 0005)

Omaha, Nebraska, 68134, United States

Location

Related Links

• Merck Clinical Trials Information

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2024
• First Posted: October 2, 2024
• Study Start: November 12, 2024
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): November 20, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (5)