A Clinical Study of V540A in Healthy Female Participants (V540A-005)

Merck Sharp & Dohme (MSD)

Status and phase: Begins enrollment in 5 months; Phase 2

Conditions: Healthy

Treatments: Biological: GARDASIL®9; Biological: V540A-3; Biological: V540A-2

Study type: Interventional

Funder types: Industry

Identifiers

NCT07224477

2024-518805-16-00 (Registry Identifier)

V540A-005

U1111-1314-2250 (Registry 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.

A standard vaccine to prevent HPV-related cancers is V503. V503 protects against 9 types of HPV. V540A is a study vaccine designed to protect against the same (shared) 9 HPV types plus other (unique) HPV types.

Researchers want to learn if V540A:

• Is safe and if people tolerate it
• Works as well as V503 to cause an immune response (the body's response to protect against infections and illnesses) to the shared HPV types.

Enrollment: 525 estimated patients

Sex: Female

Ages: 16 to 26 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

• Is in good health
• Has a lifetime history of 0 to 4 sexual partners of any sex/gender
• A participant assigned female sex at birth is eligible to participate if not breastfeeding during the study intervention period and for at least 30 days after the last dose of study intervention

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

• Has a history of severe allergic reaction (e.g., swelling of the mouth and throat, difficulty breathing, hypotension, or shock) that required medical intervention
• Has known or history of functional or anatomic asplenia
• Is currently immunocompromised or has been diagnosed as having congenital or acquired immunodeficiency, human immunodeficiency virus infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition
• Has thrombocytopenia or other coagulation disorder
• Has had a positive test for human papillomavirus (HPV)
• Has a history of recurrent respiratory papillomatosis or HPV-related head and neck cancer, or HPV-related anal lesions or anal cancer
• Has a history of an abnormal cervical biopsy result
• Has a history of HPV-related external genital lesions or external genital cancer, HPV-related vaginal lesions or vaginal cancer
• Has received a dose of any HPV vaccine before study entry
• Has received within 12 months before the Day 1 vaccination, is receiving, or plans to receive during the study, immunosuppressive therapies or other therapy known to interfere with the immune response
• Is currently receiving systemic steroid therapy or has received 2 or more courses of high-dose corticosteroids lasting at least 1 week in duration in the year prior to Day 1 vaccination
• Has received within the 3 months before the Day 1 vaccination, is receiving, or plans to receive during the study any immune globulin product

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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525 participants in 3 patient groups

V540A-2

Experimental group

Description:

Participants will receive vaccinations of V540A-2.

Treatment:

Biological: V540A-2

V540A-3

Experimental group

Description:

Participants will receive vaccinations of V540A-3.

Treatment:

Biological: V540A-3

GARDASIL®9

Active Comparator group

Description:

Participants will receive vaccinations of V503.

Treatment:

Biological: GARDASIL®9