GARDASIL 9: 3 Dose vs. 2 Dose With Delayed 3rd Dose

NCT03943875 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: 19-0058RP190022
• Study Type: interventional
• Target: 767
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are evaluating whether 15-26 year old males and females need a 3rd dose of the human papillomavirus (HPV) vaccine, or whether 2 doses provide similar protection as 3 doses from the 9 types of HPV that it protects against.

Conditions

Immunization; Efficacy; Human Papilloma Virus

Keywords

HPV vaccination; Gardasil 9; vaccine efficacy

Outcome Measures

Primary Outcomes (18)

• Short-term Human Papillomavirus (HPV) Type-specific Antibody Response for Type HPV-6

  Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 6, measured as % of participants who seroconvert

  Month 7

• Short-term HPV Type-specific Antibody Response for Type HPV-11

  Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 11, measured as measured as % of participants who seroconvert.

  Month 7

• Short-term HPV Type-specific Antibody Response for Type HPV-16

  Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 16, measured as % of participants who seroconvert

  Month 7

• Short-term HPV Type-specific Antibody Response for Type HPV-18

  Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 18, measured as % of participants who seroconvert

  Month 7

• Short-term HPV Type-specific Antibody Response for Type HPV-31

  Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 31, measured as % of participants who seroconvert

  Month 7

• Short-term HPV Type-specific Antibody Response for Type HPV-33

  Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 33, measured as % of participants who seroconvert

  Month 7

• Short-term HPV Type-specific Antibody Response for Type HPV-45

  Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 45, measured as % of participants who seroconvert

  Month 7

• Short-term HPV Type-specific Antibody Response for Type HPV-52

  Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 52, measured as % of participants who seroconvert

  Month 7

• Short-term HPV Type-specific Antibody Response for Type HPV-58

  Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 58, measured as % of participants who seroconvert

  Month 7

• HPV Type-specific Antibody Response for Type HPV-6

  Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 6, measured as % of participants who seroconvert

  Month 12

• HPV Type-specific Antibody Response for Type HPV-11

  Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 11, measured as % of participants who seroconvert

  Month 12

• HPV Type-specific Antibody Response for Type HPV-16

  Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 16, measured as % of participants who seroconvert

  Month 12

• HPV Type-specific Antibody Response for Type HPV-18

  Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 18, measured as % of participants who seroconvert

  Month 12

• HPV Type-specific Antibody Response for Type HPV-31

  Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 31, measured as % of participants who seroconvert

  Month 12

• HPV Type-specific Antibody Response for Type HPV-33

  Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 33, measured as % of participants who seroconvert

  Month 12

• HPV Type-specific Antibody Response for Type HPV-45

  Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 45, measured as % of participants who seroconvert

  Month 12

• HPV Type-specific Antibody Response for Type HPV-52

  Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 52, measured as % of participants who seroconvert

  Month 12

• HPV Type-specific Antibody Response for Type HPV-58

  Yes/No for seroconversion, defined as changing from seronegative (no detectable antibodies) to seropositive (antibodies at or exceeding natural immunity levels) to HPV type 58, measured as % of participants who seroconvert

  Month 12

Study Arms (4)

Females, 3 dose standard

ACTIVE COMPARATOR

Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.

Biological: 9-valent HPV vaccine, 3 doses standard timing

Females, 2 dose with delayed 3rd dose

EXPERIMENTAL

Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.

Biological: 9-valent HPV vaccine, 2 dose efficacy

Males, 3 dose standard

ACTIVE COMPARATOR

Three doses of the 9-valent HPV vaccine to be administered to the comparison group (15-26 years of age) at 0, 2, and 6 months.

Biological: 9-valent HPV vaccine, 3 doses standard timing

Males, 2 dose with delayed 3rd dose

EXPERIMENTAL

Two doses of the 9-valent HPV vaccine to be administered to the experimental group (15-26 years of age) at 0 and 6 months. Additional HPV vaccine dose will be offered after final blood draw at 12 months.

Biological: 9-valent HPV vaccine, 2 dose efficacy

Interventions

9-valent HPV vaccine, 2 dose efficacy BIOLOGICAL

Evaluate the efficacy of 2 doses of the HPV vaccine across a 12 month period following the 1st dose among 15-26 year old males and females.

Females, 2 dose with delayed 3rd dose; Males, 2 dose with delayed 3rd dose

9-valent HPV vaccine, 3 doses standard timing BIOLOGICAL

Will be comparison group for 2 dose efficacy group.

Females, 3 dose standard; Males, 3 dose standard

Eligibility Criteria

• Age: 15 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Males and females 15-26 years old.
• Ability to give informed consent. All participants under 18 years of age must have the informed consent of a parent and must assent to participation.
• Has not received any prior doses of the HPV vaccine. Investigators will ask the patient and his/her parent (if \<18) about prior vaccination and check the state registry (Immtrac), as well as the UTMB electronic medical record (if previously seen at UTMB), investigators will check with their primary care provider, if feasible, for patients who are not a previously established UTMB patient.
• Identified source of funding for vaccine which may include Texas Vaccines for Children (VFC) program, Medicaid, the Children's Health Insurance Plan (CHIP), Texas Healthy Women program or other public or private health insurance.
• Reliable telephone access.
• Participant and parent/ guardian (if \<18) can read and speak either English or Spanish.

You may not qualify if:

• For females, currently pregnant or plans to become pregnant or donate eggs in next 12 months. Sexually active females must report that they use regular birth control. All female subjects will be required to take a urine pregnancy test before each Gardasil 9 dose, unless it can be verified that she gave birth within the last week. Any subjects with positive tests at the initial visit will be disqualified from the study and advised to seek prenatal care. If a subject is pregnant when her follow-up visit window closes, she will be removed from the study.
• History of 6 or more lifetime sexual partners.
• History of any immunodeficiencies (HIV+, chemotherapy treatment, status splenectomy) or autoimmune disorders (lupus, thyroid disorder, psoriasis).
• History of bleeding or platelet disorders such as hemophilia.
• Currently taking medication which can suppress immune function including systemic corticosteroids, radiation therapy, cyclophosphamide, azathioprine, methotrexate, cyclosporine, leflunomide, TNF-alpha antagonists, monoclonal antibody therapies, or intravenous immunoglobulin treatment.
• Known allergies to any components of the vaccine, including aluminum, yeast or Benzonase.
• Febrile at ≥100°F in the 24 hours prior to vaccination. This will be reviewed before each Gardasil 9 dose.
• Received any non-study inactive vaccines within the past 14 days or any live vaccines within the past 30 days. Those excluded for this reason will be re-screened under the same study number at a later date.
• Plan to move out of the Galveston/Houston area in the 13 months following study entry.

Sponsors & Collaborators

• Cancer Prevention Research Institute of Texas: collaborator
• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Related Publications (2)

• Bergman H, Henschke N, Arevalo-Rodriguez I, Buckley BS, Crosbie EJ, Davies JC, Dwan K, Golder SP, Loke YK, Probyn K, Petkovic J, Villanueva G, Morrison J. Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. Cochrane Database Syst Rev. 2025 Nov 24;11(11):CD015364. doi: 10.1002/14651858.CD015364.pub2.

  PMID: 41276263 DERIVED

• Berenson AB, Panicker G, Unger ER, Rupp RE, Kuo YF. Immunogenicity of 2 or 3 Doses of 9vHPV Vaccine in U.S. Female Individuals 15 to 26 Years of Age. NEJM Evid. 2024 Feb;3(2):EVIDoa2300194. doi: 10.1056/EVIDoa2300194. Epub 2024 Jan 23.

  PMID: 38320488 DERIVED

Results Point of Contact

• Title: Abbey Berenson
• Organization: University of Texas Medical Branch

abberens@utmb.edu

409-772-2417

Study Officials

• Abbey B Berenson, MD, PhD

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Vials submitted for assay will be de-identified and labeled only with the study ID number.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 9, 2019
• Study Start: June 17, 2019
• Primary Completion: January 13, 2025
• Study Completion: January 13, 2025
• Last Updated: April 16, 2026
• Results First Posted: February 17, 2026

Record last verified: 2026-04

Locations

US (1)