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NCT Number: NCT06688058

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

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.

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

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

Loading trial locations.

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

V540D

Biological

Experimental vaccine and adjuvant administered via intramuscular (IM) injection

GARDASIL®9

Biological

Suspension administered via IM injection

Other names: G9, V503

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. Number of Participants Who Experience 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 Experience Unsolicited AEs

    Time frame: Up to approximately 7 months

    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.

  5. Number of Participants Who Experience a Serious Adverse Event (SAE)

    Time frame: Up to approximately 18 months

    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.

  6. Number of Participants Who Experience a Medically-Attended AE (MAAE)

    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 MAAEs. Examples of routine visits include physical examination, wellness visits, or vaccinations.

  7. Number of Participants Who Experience an Event of Clinical Interest (ECI)

    Time frame: Up to approximately 18 months

    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

    GMR of titers for participants vaccinated with V540D versus those who received GARDASIL®9 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 Trial to Evaluate, Tolerability, and Immunogenicity of V540D in Healthy Adults.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 14, 2024
Registry last updated
Mar 13, 2026

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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