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HPV InfectionPhase 4NCT04206813

An Exploratory Open-Label Clinical Trial Evaluating the Immunogenicity of the 9-valent 2-dose HPV Vaccination Regimen

A Phase 4 study testing Gardasil 9 2 dose regimen, Gardasil 9 3 dose regimen and Gardasil 9 rescue dose in people with HPV Infection, run by Boston Medical Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this study is to explore and evaluate whether a 2-dose schedule of Gardasil 9 among young and mid-adult women 16-45 years of age is generally safe and immunogenic, with an antibody response that is not inferior to that observed of a 3-dose schedule of Gardasil 9 among women aged 16-26 years old. Read more about this study

Who is it for?
Ages 16 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
HPV Infection
What is being tested?
Gardasil 9 2 dose regimen, Gardasil 9 3 dose regimen and Gardasil 9 rescue dose
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
352 participants
Where
1 siteUnited States
Study dates
1 Dec 2020to Oct 2026
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Women receiving care at Boston Medical Center

Who cannot join

  • Currently pregnant
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Boston Medical Center

    Boston, Massachusetts, 02118

Other trials in United States

About this study

Official title: An Open-Label Clinical Trial Evaluating the Immunogenicity of the 9vHPV Vaccination Regimen Over 6 Months Among Women Aged 16 to 45 Years Old, An Exploratory Immunogenicity Study

The goal of this study is to explore and evaluate whether a 2-dose schedule of Gardasil 9 among young and mid-adult women 16-45 years of age is generally safe and immunogenic, with an antibody response that is not inferior to that observed of a 3-dose schedule of Gardasil 9 among women aged 16-26 years old. The investigators thought that having a 2-dose vaccination regimen for individuals 16 to 45 would provide a more robust dataset than those of 27 to 45 years old.

Read the detailed description

The investigators will identify potential eligible subjects from the Boston Medical Center (BMC) Clinical Data Warehouse from the following BMC clinics: Pediatrics, Adolescent Medicine, Family Medicine, Obstetric/ Gynecology (OB/GYN), and Women's Health/Adult Primary Care. The research team will mail a recruitment opt-out letter signed by the principal investigator to the participant along with a study flyer. The recruitment letter will inform the participant that a research member may contact them via phone within two week to provide more information regarding the study.

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
HPV Infection
Being tested
Gardasil 9 2 dose regimen, Gardasil 9 3 dose regimen, Gardasil 9 rescue dose
Keywords
Gardasil, Immunogenicity, 9-valent 2-dose HPV vaccination, 9-valent 3-dose HPV vaccination
Medical subject headings
Papillomavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Gardasil 9 2 dose regimenDrug

    Also called Human Papillomavirus 9-valent Vaccine, Recombinant

    a 2-dose regimen of Gardasil 9 at 0 and 6 months

  • Gardasil 9 3 dose regimenDrug

    Also called Human Papillomavirus 9-valent Vaccine, Recombinant

    standard 3-dose regimen of Gardasil 9 at 0, 2, 6 months

  • Gardasil 9 rescue doseDrug

    Also called Human Papillomavirus 9-valent Vaccine, Recombinant

    A rescue dose of Gardasil 9 will be given at 12 months

Study groups in NCT04206813
Study groupRoleWhat they receive
Intervention groupExperimental240 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)
Receives: Drug: Gardasil 9 2 dose regimen; Drug: Gardasil 9 rescue dose
Control groupActive comparator120 eligible women will receive the standard 3-dose regimen of Gardasil 9 at (0, 2, 6 months)
Receives: Drug: Gardasil 9 3 dose regimen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in immunogenicity of Gardasil 9

    Immunogenicity will be measured by serum antibodies assessed by ELISA to the nine HPV types (anti-HPV 6/11/16/18/31/33/45/ 52/58 where positive anti-HPV serum levels are defined as >30, >16, >20, >24, >10, >8, >8, >8, or >8 milli Merck units (mMU)/mL respectively).

    Measured: baseline and 7 months

  2. Change in geometric mean titers ratios

    The geometric mean titers (GMT) ratios will be determined by a post-vaccination geometric mean titer (GMT) ratio with a pre-stated analysis of variance model (95% Confidence Interval lower bound >0.5).

    Measured: baseline and 7 months

Secondary outcomes (2)

  1. Number of participants with HPV seropositivity at day 1

    The number of participant who test positive in mili Unit (nMU) which will be will be defined as anti-HPV 6/11/16/18/31/33/45/ 52/58 positive if her anti-HPV serum level is >30, >16, >20, >24, >10, >8, >8, >8, or >8 milli Merck units (mMU)/mL for the 9 types, respectively. The serum testing will be under the direction of Merck research lab.

    Measured: day 1

  2. Number of participants with HPV seropositivity at month 7

    The number of participant who test positive in mili Unit (nMU) which will be will be defined as anti-HPV 6/11/16/18/31/33/45/ 52/58 positive if her anti-HPV serum level is >30, >16, >20, >24, >10, >8, >8, >8, or >8 milli Merck units (mMU)/mL for the 9 types, respectively. The serum testing will be under the direction of Merck research lab.

    Measured: month 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2019
  2. Study start1 Dec 2020
  3. Primary completion15 Apr 2026
  4. Study completionOct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
The control group will have 120 subjects will receive a 3-dose regimen as recommended by Center for Disease Control (CDC) given at 0, 2 and 6 months. The intervention group will have 240 subjects who will receive a modified 3-dose regimen given at 0, 6, and 12 months. Both groups will have HPV titers drawn at Visit 1 (pre-vaccination) and Visit 7 (after three doses for the Control group and 2 doses for the Intervention group).
Masking
None (open label)
Enrolment
352 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04206813
Sponsor's protocol ID
H-39051
Status last verified
Apr 2026
First submitted
15 Dec 2019
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27977643

  • 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.

    PubMed 25693011

  • 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.

    PubMed 21629249

  • 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.

    PubMed 26343499

  • 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.

    PubMed 22048171

  • 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.

    PubMed 30711698

  • 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.

    PubMed 31415491

  • 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.

    PubMed 26211489

  • 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.

    PubMed 17079588

  • 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.

    PubMed 26101366

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Gardasil 9 2 dose regimen, Gardasil 9 3 dose regimen and Gardasil 9 rescue dose in people with HPV Infection, run by Boston Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in immunogenicity of Gardasil 9 (time frame: baseline and 7 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04206813, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.

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