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Cancer Vaccine

Gardasil 9 Vaccination Regimen for HPV

Phase 4
Recruiting
Led By Natalie Joseph, MD MPH
Research Sponsored by Boston Medical Center
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 month 7
Awards & highlights

Study Summary

This trial is testing a 2-dose schedule of the HPV vaccine Gardasil 9 in women aged 16-45, to see if it is safe and produces an immune response.

Who is the study for?
This trial is for women aged 16-45 who are patients at Boston Medical Center and have not been vaccinated against HPV. They must not be pregnant, breastfeeding, have blood clotting disorders, severe allergies (especially to yeast), or a compromised immune system.Check my eligibility
What is being tested?
The study tests if two doses of Gardasil 9 provide the same immune response in women aged 16-45 as three doses do in those aged 16-26. It also explores the safety of this reduced-dose regimen compared to the standard three-dose schedule.See study design
What are the potential side effects?
Possible side effects include pain at injection site, headache, fever, nausea, dizziness. Rarely there may be allergic reactions which could be serious.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 7
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in geometric mean titers ratios
Change in immunogenicity of Gardasil 9
Secondary outcome measures
Number of participants with HPV seropositivity at day 1
Number of participants with HPV seropositivity at month 7

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention groupExperimental Treatment2 Interventions
240 eligible women will receive a 2-dose regimen of Gardasil 9 at (0 and 6 months, followed by a rescue 3rd dose at month 12)
Group II: Control groupActive Control1 Intervention
120 eligible women will receive the standard 3-dose regimen of Gardasil 9 at (0, 2, 6 months)

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,054,697 Total Patients Enrolled
Boston Medical CenterLead Sponsor
383 Previous Clinical Trials
870,789 Total Patients Enrolled
Natalie Joseph, MD MPHPrincipal InvestigatorBoston Medical Center
1 Previous Clinical Trials
100 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
British Journal of CancerJournal
End-of-study Safety, Immunogenicity, and Efficacy of Quadrivalent HPV (types 6, 11, 16, 18) Recombinant Vaccine in Adult Women 24–45 Years of Age
Castellsagué, X, N Muñoz, P Pitisuttithum, D Ferris, J Monsonego, K Ault, J Luna, et al.. 2011. “End-of-study Safety, Immunogenicity, and Efficacy of Quadrivalent HPV (types 6, 11, 16, 18) Recombinant Vaccine in Adult Women 24–45 Years of Age”. British Journal of Cancer. Springer Science and Business Media LLC. doi:10.1038/bjc.2011.185.
MMWR. Morbidity and Mortality Weekly ReportJournal
Use of a 2-dose Schedule for Human Papillomavirus Vaccination — Updated Recommendations of the Advisory Committee on Immunization Practices
Meites, Elissa, Allison Kempe, and Lauri E. Markowitz. 2016. “Use of a 2-dose Schedule for Human Papillomavirus Vaccination — Updated Recommendations of the Advisory Committee on Immunization Practices”. MMWR. Morbidity and Mortality Weekly Report. Centers for Disease Control MMWR Office. doi:10.15585/mmwr.mm6549a5.
Papillomavirus ResearchJournal
Two-dose Recommendation for Human Papillomavirus Vaccine Can Be Extended up to 18 Years – Updated Evidence from Indian Follow-up Cohort Study
Basu, Partha, Richard Muwonge, Neerja Bhatla, Bhagwan M. Nene, Smita Joshi, Pulikottil O. Esmy, Usha Rani Reddy Poli, et al.. 2019. “Two-dose Recommendation for Human Papillomavirus Vaccine Can Be Extended up to 18 Years – Updated Evidence from Indian Follow-up Cohort Study”. Papillomavirus Research. Elsevier BV. doi:10.1016/j.pvr.2019.01.004.
MMWR. Morbidity and Mortality Weekly ReportJournal
Human Papillomavirus Vaccination for Adults: Updated Recommendations of the Advisory Committee on Immunization Practices
Meites, Elissa, Peter G. Szilagyi, Harrell W. Chesson, Elizabeth R. Unger, José R. Romero, and Lauri E. Markowitz. 2019. “Human Papillomavirus Vaccination for Adults: Updated Recommendations of the Advisory Committee on Immunization Practices”. MMWR. Morbidity and Mortality Weekly Report. Centers for Disease Control MMWR Office. doi:10.15585/mmwr.mm6832a3.
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~32 spots leftby Sep 2024
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