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

Merck Sharp & Dohme (MSD)

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Biological: V540B; Biological: GARDASIL®9 (G9)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06623409

V540B-002 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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72 participants in 2 patient groups

GARDASIL®9 (G9)

Active Comparator group

Description:

Participants will receive vaccinations with G9.

Treatment:

Biological: GARDASIL®9 (G9)

V540B

Experimental group

Description:

Participants will receive vaccinations with V540B.

Treatment:

Biological: V540B