Safety and Immunogenicity of V540B in Healthy Adults (V540B-002).
- 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.
- Short title
- Safety and Immunogenicity of V540B in Healthy Adults (V540B-002).
- Official title
- A Phase 1, Randomized, Double-Blind, Comparator-Controlled, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Immunogenicity of V540B in Healthy Adults.
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2028-05-31
- First posted
- 2024-10-02
- Registry last updated
- 2026-10-08
- Primary completion date
- 2028-05-31
- Start date
- 2024-11-12
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Merck Sharp & Dohme LLC
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06623409
- ClinicalTrials.gov ID
- NCT06623409
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Sequential
- Purpose
- Prevention
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Number of Participants Who Experience a Solicited Injection-Site Adverse Event (AE)
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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).
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
Geometric mean ratio (GMR) of titers for participants vaccinated with V540B versus those who received G9 alone will be calculated.
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 45 Years
- Healthy volunteers
- Yes
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.
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.
- Anaheim Clinical Trials ( Site 0002)Anaheim, United StatesActive, not recruiting
- Velocity Clinical Research, Hallandale Beach ( Site 0003)Hallandale, United StatesRecruiting
- Research Centers of America ( Hollywood ) ( Site 0001)Hollywood, United StatesRecruiting
- Velocity Clinical Research, Omaha ( Site 0005)Omaha, United StatesActive, not recruiting
- Related resource (www.merckclinicaltrials.com)
Other registry identifiers
- V540B-002