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

Phase 1

Recruiting

• Conditions: Healthy
• Interventions: Biological: GARDASIL®9 (G9); Biological: V540B

• Registration Number: NCT06623409
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-30
• Study First Submitted QC: 2024-09-30
• Study First Posted: 2024-10-02
• Study Start: 2024-11-12
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-13
• Primary Completion: 2026-11-20
• Study Completion: 2026-11-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
GARDASIL®9 (G9)	GARDASIL®9 (G9)	Participants will receive vaccinations with G9.
V540B	V540B	Participants will receive vaccinations with V540B.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experience a Solicited Injection-Site Adverse Event (AE)	Up to approximately 6 months	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.
Number of Participants Who Experience a Solicited Systemic AE	Up to approximately 6 months	Solicited systemic AEs include headache, fatigue, nausea, dizziness, muscle aches, joint pain.
Immediate Reactions Occurring Within 30 Minutes After Any Vaccination	Up to approximately 6 months	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.
Number of Participants Who Experienced Unsolicited AEs	Up to approximately 7 months	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.
Number of Participants Who Experienced a Serious Adverse Event	Up to approximately 18 months	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.
Number of Participants Who Experienced a Medically-Attended AE	Up to approximately 18 months	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.
Number of Participants Who Experienced an Event of Clinical Interest	Up to approximately 18 months	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).

Secondary Outcome Measures

Name	Time	Method
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	Geometric mean ratio (GMR) of titers for participants vaccinated with V540B versus those who received G9 alone will be calculated.

Trial Locations

Locations (5)

Anaheim Clinical Trials ( Site 0002); 🇺🇸 Anaheim, California, United States

California Clinical Trials Medical Group managed by PAREXEL ( Site 0008); 🇺🇸 Glendale, California, United States

Velocity Clinical Research, Hallandale Beach ( Site 0003); 🇺🇸 Hallandale Beach, Florida, United States

Research Centers of America ( Hollywood ) ( Site 0001); 🇺🇸 Hollywood, Florida, United States

Velocity Clinical Research, Omaha ( Site 0005); 🇺🇸 Omaha, Nebraska, United States