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Cancer Vaccine

Gardasil9 for Human Papillomavirus (PPV Trial)

Phase 4

Waitlist Available

Led By Chailee Moss, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the end of the study, up to 2 years

Awards & highlights

PPV Trial Summary

This trial will study the HPV vaccine in women after giving birth, to see if it's effective and well-tolerated.

Eligible Conditions

Human Papillomavirus
Immunizations

PPV Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of the study, up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the end of the study, up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of the study, up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Immunogenicity of a Two-dose 9-valent HPV Vaccination as Assessed by Antibody Titer

Secondary outcome measures

Antibody Response to the Other 8 HPV Types

Percentage of Participants Who Complete 2-dose Vaccination

Percentage of Participants With Baseline Titers Suggestive of Natural Inoculation or Prior Vaccination to HPV 16

+2 more

PPV Trial Design

1Treatment groups

Experimental Treatment

Group I: Gardasil9Experimental Treatment1 Intervention

Two doses of the 9-valent HPV vaccine to be administered to participants at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gardasil9

2019

Completed Phase 4

~420

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,260 Previous Clinical Trials

14,820,555 Total Patients Enrolled

Merck Sharp & Dohme LLCIndustry Sponsor

3,888 Previous Clinical Trials

5,054,832 Total Patients Enrolled

Chailee Moss, MDPrincipal InvestigatorJohns Hopkins University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Gardasil9 for therapeutic use?

"The safety of Gardasil9 was rated at a 3 due to its Phase 4 trial status, signifying the treatment has been approved for use."

Answered by AI

Is there capacity for additional participants in this trial?

"In accordance with the information presented on clinicaltrials.gov, this specific trial is not presently recruiting participants. Although initially posted on August 3rd 2020 and edited as recently a October 3rd 2022, there are 103 other studies actively seeking patients at this time."

Answered by AI

Am I eligible to enroll in this investigation?

"This trial is recruiting 169 participants aged 15-45 who have had immunizations. Prerequisites for participation include: Female birth assignment and having given birth to a live infant in the last three days."

Answered by AI

Are participants of this clinical trial restricted to those aged 85 and below?

"This clinical trial is seeking participants between the ages of 15 and 45. For those younger than 18 or older than 65, there are 22 trials for minors and 63 studies for seniors respectively."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

HPV Vaccination Study in Postpartum Women

2020. "HPV Vaccination Study in Postpartum Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04274153.