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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-12

Study Completion Date

2026-11-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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GARDASIL®9 (G9)

Participants will receive vaccinations with G9.

Group Type ACTIVE_COMPARATOR

GARDASIL®9 (G9)

Intervention Type BIOLOGICAL

Suspension administered via intramuscular (IM) injection

V540B

Participants will receive vaccinations with V540B.

Group Type EXPERIMENTAL

V540B

Intervention Type BIOLOGICAL

Experimental vaccine and adjuvant administered via IM injection

Interventions

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GARDASIL®9 (G9)

Suspension administered via intramuscular (IM) injection

Intervention Type BIOLOGICAL

V540B

Experimental vaccine and adjuvant administered via IM injection

Intervention Type BIOLOGICAL

Other Intervention Names

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V503

Eligibility Criteria

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Inclusion Criteria

* Is in good health based on medical history, physical examination, vital sign (VS) measurements and electrocardiograms (ECGs) performed before randomization.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes