Clinical trial NCT06688058: A Trial to Evaluate Tolerability and Immunogenicity of V540D in Healthy Adults (V540D-004)
Official title: A Phase 1, Randomized, Double-Blind, Comparator-Controlled, Dose-Escalation Trial to Evaluate, Tolerability, and Immunogenicity of V540D in Healthy Adults.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-11-14
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Experience a Solicited Injection-Site Adverse Event (AE)
timeFrame: Up to approximately 6 months
measure: Number of Participants Who Experience a Solicited Systemic AE
timeFrame: Up to approximately 6 months
measure: Number of Participants Who Experience Immediate Reactions Occurring Within 30 Minutes After Any Vaccination
timeFrame: Up to approximately 6 months
measure: Number of Participants Who Experience Unsolicited AEs
timeFrame: Up to approximately 7 months
measure: Number of Participants Who Experience a Serious Adverse Event (SAE)
timeFrame: Up to approximately 18 months
measure: Number of Participants Who Experience a Medically-Attended AE (MAAE)
timeFrame: Up to approximately 18 months
measure: Number of Participants Who Experience an Event of Clinical Interest (ECI)
timeFrame: Up to approximately 18 months
Secondary outcomes:
measure: Total Immunoglobulin G (IgG) Geometric Mean Ratios (GMRs) for anti-HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58
timeFrame: Up to approximately 7 months
Other outcomes:
Locations:
city: Hollywood
country: United States
facility: Research Centers of America ( Hollywood ) ( Site 0001)
state: Florida
city: Savannah
country: United States
facility: Velocity Clinical Research, Savannah ( Site 0005)
state: Georgia
city: Kansas City
country: United States
facility: Alliance for Multispecialty Research, LLC ( Site 0003)
state: Missouri
city: Knoxville
country: United States
facility: Alliance for Multispecialty Research, LLC ( Site 0004)
state: Tennessee
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: