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Active, Not Recruiting

NCT Number: NCT06623409

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Trials ( Site 0002), Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GARDASIL®9 (G9)

Biological

Suspension administered via intramuscular (IM) injection

Other names: V503

V540B

Biological

Experimental vaccine and adjuvant administered via IM injection

Primary outcomes

  1. Number of Participants Who Experience a Solicited Injection-Site Adverse Event (AE)

    Time frame: 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.

  2. Number of Participants Who Experience a Solicited Systemic AE

    Time frame: Up to approximately 6 months

    Solicited systemic AEs include headache, fatigue, nausea, dizziness, muscle aches, joint pain.

  3. Immediate Reactions Occurring Within 30 Minutes After Any Vaccination

    Time frame: 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.

  4. Number of Participants Who Experienced Unsolicited AEs

    Time frame: 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.

  5. Number of Participants Who Experienced a Serious Adverse Event

    Time frame: 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.

  6. Number of Participants Who Experienced a Medically-Attended AE

    Time frame: 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.

  7. Number of Participants Who Experienced an Event of Clinical Interest

    Time frame: 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 outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 2, 2024
Registry last updated
Aug 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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