About this trial

The goal of this clinical trial is to compare a 2-dose and 3-dose series of 9vHPV vaccine among 27-45-year-old females to assess if 2 doses elicit a noninferior immune response. Participants will be randomized 1:1 to either the 2-dose group or the 3-dose group and asked to provide 4 blood samples over a period of 12 months. All 2-dose participants will be offered a 3rd dose after the final blood draw,12 months after their initial vaccination.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Females 27-45 years old.

Ability to give informed consent.

Has not received any prior doses of the HPV vaccine. This will be verified by the person and state registry (Immtrac), as well as the person's electronic medical record.

Reliable telephone access for the duration of the project.

Disqualifiers

Currently pregnant or plans to become pregnant or donate eggs in the next 13 months. Any subjects with positive pregnancy tests at the initial visit will be disqualified from the study and advised to seek prenatal care.

Has an immunodeficiency or autoimmune disease such as HIV infection, lymphoma, leukemia, lupus, rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition.

Currently receiving treatment or medication that can suppress immune function including radiation therapy, chemotherapy, cyclosporin, leflunomide (Arava), TNF-α antagonists, monoclonal antibody therapies (including rituximab [Rituxan]), intravenous gamma globulin (IVIG), antilymphocyte sera, other therapy known to interfere with the immune response, or systemic corticosteroids (by mouth or intramuscular injection). Those using or have used steroids that are inhaled, placed in the eye, applied on the skin, or injected into the joint/soft tissue will be considered eligible for the study.

History of splenectomy

Trial design

Design model

Parallel

Treatments tested in this trial

9-valent HPV vaccine, 2 doses alternate timing
Biological/Vaccine
Evaluate 2 doses of the 9-valent HPV vaccine across a 12-month period following the 1st dose among 27-45-year-old females.
9-valent HPV vaccine, 3 doses standard timing
Biological/Vaccine
This will be the comparison group for the 2-dose group.

Treatment groups

618 Participants

are divided into 2 treatment groups

Group A: Females, 3-dose standardActive comparator 1 intervention

Group B: Females, 2-dose alternativeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Short-term human papillomavirus (HPV) type-specific antibody response for type HPV-6

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-6, measured as number of participants.

Time frame

Month 1

2

Short-term human papillomavirus (HPV) type-specific antibody response for type HPV-6

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-6, measured as number of participants.

Time frame

Month 7

3

Short-term human papillomavirus (HPV) type-specific antibody response for type HPV-6

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-6, measured as number of participants.

Time frame

Month 12

4

Short-term HPV type-specific antibody response for type HPV-11

Yes/No for seroconversion, defined as changing from seronegative (antibody titer below established threshold) to seropositive (antibody titer above established threshold) for HPV-11, measured as number of participants.

Time frame

Month 1

Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts