Safety and Immunogenicity of V540B in Healthy Adults (V540B-002).
ConditionHealthy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorMerck Sharp & Dohme LLC
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Is in good health based on medical history, physical examination, vital sign (VS) measurements and electrocardiograms (ECGs) performed before randomization.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
GARDASIL®9 (G9)
Biological/VaccineSuspension administered via intramuscular (IM) injection
V540B
Biological/VaccineExperimental vaccine and adjuvant administered via IM injection
Treatment groups
124 Participants
are divided into 2 treatment groupsGroup A: GARDASIL®9 (G9)Active comparator 1 intervention
Group B: V540BExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants Who Experience a Solicited Injection-Site Adverse Event (AE)
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.
Time frame
Up to approximately 6 months2
Number of Participants Who Experience a Solicited Systemic AE
Solicited systemic AEs include headache, fatigue, nausea, dizziness, muscle aches, joint pain.
Time frame
Up to approximately 6 months3
Immediate Reactions Occurring Within 30 Minutes After Any Vaccination
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.
Time frame
Up to approximately 6 months4
Number of Participants Who Experienced Unsolicited AEs
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.
Time frame
Up to approximately 7 monthsSecondary outcomes
1
Total Immunoglobulin G (IgG) Geometric Mean Ratios (GMRs) for anti-HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Geometric mean ratio (GMR) of titers for participants vaccinated with V540B versus those who received G9 alone will be calculated.
Time frame
Up to approximately 7 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov