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.
Eligible Conditions
- Human Papillomavirus
Treatment Effectiveness
Effectiveness Progress
This is further along than 93% of similar trials
Study Objectives
2 Primary · 2 Secondary · Reporting Duration: month 7
baseline and 7 months
Change in geometric mean titers ratios
Change in immunogenicity of Gardasil 9
day 1
Number of participants with HPV seropositivity at day 1
month 7
Number of participants with HPV seropositivity at month 7
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
Control group
1 of 2
Intervention group
1 of 2
Active Control
Experimental Treatment
360 Total Participants · 2 Treatment Groups
Primary Treatment: Gardasil 9 2 dose regimen · No Placebo Group · Phase 4
Intervention groupExperimental Group · 2 Interventions: Gardasil 9 2 dose regimen, Gardasil 9 rescue dose · Intervention Types: Drug, Drug
Control group
Drug
ActiveComparator Group · 1 Intervention: Gardasil 9 3 dose regimen · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: month 7
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,706 Previous Clinical Trials
4,963,697 Total Patients Enrolled
Boston Medical CenterLead Sponsor
362 Previous Clinical Trials
875,176 Total Patients Enrolled
Natalie Joseph, MD MPHPrincipal InvestigatorBoston Medical Center
1 Previous Clinical Trials
100 Total Patients Enrolled
Eligibility Criteria
Age 16 - 45 · Female Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are a woman currently receiving medical care at Boston Medical Center.
References
- 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.
- 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.
- 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.
- 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.
- Block, Stan L., Terry Nolan, Carlos Sattler, Eliav Barr, Katherine E.D. Giacoletti, Colin D. Marchant, Xavier Castellsagué, et al.. 2006. “Comparison of the Immunogenicity and Reactogenicity of a Prophylactic Quadrivalent Human Papillomavirus (types 6, 11, 16, and 18) L1 Virus-like Particle Vaccine in Male and Female Adolescents and Young Adult Women”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2006-0461.
- Joura, Elmar A., Anna R. Giuliano, Ole-Erik Iversen, Celine Bouchard, Constance Mao, Jesper Mehlsen, Edson D. Moreira Jr., et al.. 2015. “A 9-valent HPV Vaccine Against Infection and Intraepithelial Neoplasia in Women”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1405044.
- Giuliano, Anna R., Kimberly Isaacs-Soriano, B. Nelson Torres, Martha Abrahamsen, Donna J. Ingles, Bradley A. Sirak, Manuel Quiterio, and Eduardo Lazcano-Ponce. 2015. “Immunogenicity and Safety of Gardasil Among Mid-adult Aged Men (27–45 Years)—the MAM Study”. Vaccine. Elsevier BV. doi:10.1016/j.vaccine.2015.08.072.
- Romanowski, Barbara, Tino F. Schwarz, Linda M. Ferguson, Klaus Peters, Marc Dionne, Karin Schulze, Brian Ramjattan, et al.. 2011. “Immunogenicity and Safety of the HPV-16/18 As04-adjuvanted Vaccine Administered as a 2-dose Schedule Compared to the Licensed 3-dose Schedule”. Human Vaccines. Informa UK Limited. doi:10.4161/hv.7.12.18322.
- Hernández-Ávila, Mauricio, Leticia Torres-Ibarra, Margaret Stanley, Jorge Salmerón, Aurelio Cruz-Valdez, Nubia Muñoz, Rolando Herrero, Ignacio F Villaseñor-Ruíz, and Eduardo Lazcano-Ponce. 2015. “Evaluation of the Immunogenicity of the Quadrivalent HPV Vaccine Using 2 Versus 3 Doses at Month 21: An Epidemiological Surveillance Mechanism for Alternate Vaccination Schemes”. Human Vaccines & Immunotherapeutics. Informa UK Limited. doi:10.1080/21645515.2015.1058458.
- Van Damme, Pierre, Sven Eric Olsson, Stanley Block, Xavier Castellsague, Glenda E. Gray, Teobaldo Herrera, Li-Min Huang, et al.. 2015. “Immunogenicity and Safety of a 9-valent HPV Vaccine”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2014-3745.
- Yifan Huang, Jason C. Hsu, Hochberg's Step-Up Method: Cutting Corners Off Holm's Step-Down Method, Biometrika, Volume 94, Issue 4, December 2007, Pages 965-975, https://doi.org/10.1093/biomet/asm067
- Block SL, Nolan T, Sattler C, Barr E, Giacoletti KE, Marchant CD, Castellsague X, Rusche SA, Lukac S, Bryan JT, Cavanaugh PF Jr, Reisinger KS; Protocol 016 Study Group. Comparison of the immunogenicity and reactogenicity of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in male and female adolescents and young adult women. Pediatrics. 2006 Nov;118(5):2135-45. doi: 10.1542/peds.2006-0461.
- Basu P, Muwonge R, Bhatla N, Nene BM, Joshi S, Esmy PO, Poli URR, Joshi G, Verma Y, Zomawia E, Shastri SS, Pimple S, Anantharaman D, Prabhu PR, Hingmire S, Sauvaget C, Lucas E, Pawlita M, Gheit T, Jayant K, Malvi SG, Siddiqi M, Michel A, Butt J, Sankaran S, Rameshwari Ammal Kannan TP, Varghese R, Divate U, Willhauck-Fleckenstein M, Waterboer T, Muller M, Sehr P, Vashist S, Mishra G, Jadhav R, Thorat R, Tommasino M, Pillai MR, Sankaranarayanan R; Indian HPV vaccine study group. Two-dose recommendation for Human Papillomavirus vaccine can be extended up to 18 years - updated evidence from Indian follow-up cohort study. Papillomavirus Res. 2019 Jun;7:75-81. doi: 10.1016/j.pvr.2019.01.004. Epub 2019 Jan 31.
- Hernandez-Avila M, Torres-Ibarra L, Stanley M, Salmeron J, Cruz-Valdez A, Munoz N, Herrero R, Villasenor-Ruiz IF, Lazcano-Ponce E. Evaluation of the immunogenicity of the quadrivalent HPV vaccine using 2 versus 3 doses at month 21: An epidemiological surveillance mechanism for alternate vaccination schemes. Hum Vaccin Immunother. 2016;12(1):30-8. doi: 10.1080/21645515.2015.1058458. Epub 2015 Jul 25.
- Castellsague X, Munoz N, Pitisuttithum P, Ferris D, Monsonego J, Ault K, Luna J, Myers E, Mallary S, Bautista OM, Bryan J, Vuocolo S, Haupt RM, Saah A. 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. Br J Cancer. 2011 Jun 28;105(1):28-37. doi: 10.1038/bjc.2011.185. Epub 2011 May 31.
- 2020. "An Exploratory Open-Label Clinical Trial Evaluating the Immunogenicity of the 9-valent 2-dose HPV Vaccination Regimen". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04206813.