An Exploratory Open-Label Clinical Trial Evaluating the Immunogenicity of the 9-valent 2-dose HPV Vaccination Regimen
NCT ID: NCT04206813
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
352 participants
INTERVENTIONAL
2020-12-01
2026-06-30
Brief Summary
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Detailed Description
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Participants opting-in will be called and interviewed with the study recruitment script and eligibility will be determined. Eligible participants who agree to participate (in-person or over the phone), will be scheduled to come to the Boston University (BU) General Clinical Research Unit (GCRU) to complete the consent process. At the baseline visit participants will be assigned into the appropriate group (control vs. intervention) based on their age.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Intervention group
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)
Gardasil 9 2 dose regimen
a 2-dose regimen of Gardasil 9 at 0 and 6 months
Gardasil 9 rescue dose
A rescue dose of Gardasil 9 will be given at 12 months
Control group
120 eligible women will receive the standard 3-dose regimen of Gardasil 9 at (0, 2, 6 months)
Gardasil 9 3 dose regimen
standard 3-dose regimen of Gardasil 9 at 0, 2, 6 months
Interventions
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Gardasil 9 2 dose regimen
a 2-dose regimen of Gardasil 9 at 0 and 6 months
Gardasil 9 3 dose regimen
standard 3-dose regimen of Gardasil 9 at 0, 2, 6 months
Gardasil 9 rescue dose
A rescue dose of Gardasil 9 will be given at 12 months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Prior HPV vaccination
* A history of severe allergic reaction, including known allergy to any vaccine component, specially severe allergic to yeast
* Immunocompromised/previous immunosuppressive therapy
* Thrombocytopenia or other coagulation disorder
* Currently breastfeeding
16 Years
45 Years
FEMALE
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Boston Medical Center
OTHER
Responsible Party
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Principal Investigators
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Carl G Streed, MD MPH
Role: PRINCIPAL_INVESTIGATOR
Boston Medical Center, Internal Medicine
Locations
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Boston Medical Center
Boston, Massachusetts, United States
Countries
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References
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Meites E, Kempe A, Markowitz LE. Use of a 2-Dose Schedule for Human Papillomavirus Vaccination - Updated Recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep. 2016 Dec 16;65(49):1405-1408. doi: 10.15585/mmwr.mm6549a5.
Joura EA, Giuliano AR, Iversen OE, Bouchard C, Mao C, Mehlsen J, Moreira ED Jr, Ngan Y, Petersen LK, Lazcano-Ponce E, Pitisuttithum P, Restrepo JA, Stuart G, Woelber L, Yang YC, Cuzick J, Garland SM, Huh W, Kjaer SK, Bautista OM, Chan IS, Chen J, Gesser R, Moeller E, Ritter M, Vuocolo S, Luxembourg A; Broad Spectrum HPV Vaccine Study. A 9-valent HPV vaccine against infection and intraepithelial neoplasia in women. N Engl J Med. 2015 Feb 19;372(8):711-23. doi: 10.1056/NEJMoa1405044.
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.
Giuliano AR, Isaacs-Soriano K, Torres BN, Abrahamsen M, Ingles DJ, Sirak BA, Quiterio M, Lazcano-Ponce E. Immunogenicity and safety of Gardasil among mid-adult aged men (27-45 years)--The MAM Study. Vaccine. 2015 Oct 13;33(42):5640-5646. doi: 10.1016/j.vaccine.2015.08.072. Epub 2015 Sep 4.
Romanowski B, Schwarz TF, Ferguson LM, Peters K, Dionne M, Schulze K, Ramjattan B, Hillemanns P, Catteau G, Dobbelaere K, Schuind A, Descamps D. Immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine administered as a 2-dose schedule compared with the licensed 3-dose schedule: results from a randomized study. Hum Vaccin. 2011 Dec;7(12):1374-86. doi: 10.4161/hv.7.12.18322. Epub 2011 Dec 1.
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.
Meites E, Szilagyi PG, Chesson HW, Unger ER, Romero JR, Markowitz LE. Human Papillomavirus Vaccination for Adults: Updated Recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep. 2019 Aug 16;68(32):698-702. doi: 10.15585/mmwr.mm6832a3.
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.
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.
Van Damme P, Olsson SE, Block S, Castellsague X, Gray GE, Herrera T, Huang LM, Kim DS, Pitisuttithum P, Chen J, Christiano S, Maansson R, Moeller E, Sun X, Vuocolo S, Luxembourg A. Immunogenicity and Safety of a 9-Valent HPV Vaccine. Pediatrics. 2015 Jul;136(1):e28-39. 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
Related Links
Access external resources that provide additional context or updates about the study.
Centers for Disease Control and Prevention, Human Papillomavirus (HPV) facts.
Centers for Disease Control and Prevention, on how many cancers are linked with HPV each year.
Merck Sharp \& Dohme Corp. An Open-Label Phase III Clinical Trial to Study the Immunogenicity and Tolerability of GARDASIL®9 (A Multivalent Human Papillomavirus \[HPV\] L1 Virus-Like Particle Vaccine) in Adult Women Compared to Young Adult Women
Food and Drug Administration. Prescribing information \[package insert\]. Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant).
Luxembourg A. 9vHPV immunogenicity and safety trial in mid-adult females. Advisory Committee on Immunization Practices (ACIP).
Implementing Constrained or Balanced-Across-the-Centers Randomization with SAS v8 Procedure PLAN Song CQ.
Other Identifiers
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H-39051
Identifier Type: -
Identifier Source: org_study_id
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