Recombinant Human Papillomavirus Nonavalent Vaccine in Preventing Human Papilloma Virus in Younger Healthy Participants

A Prospective, Single-arm, Open-label, Non-randomized, Phase IIA Trial of a Nonavalent Prophylactic HPV Vaccine to Assess Immunogenicity of a Prime and Deferred-booster Dosing Schedule Among 9-11 Year-old Girls and Boys

Human papillomavirus (HPV) is a common sexually-transmitted virus which causes infections that usually last only a few months, but sometimes can last a long time and cause cancers of the cervix, vagina, vulva, anus or oropharynx over many years among adults. This phase IIA trial studies how well does the nonavalent HPV vaccine (which can prevent nine different types of HPV) work when given in an alternative dosing schedule to heathy young research participants.

Study Overview

• Status: Active, not recruiting
• Conditions: Human Papillomavirus-Related Carcinoma
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Biological: Recombinant Human Papillomavirus Nonavalent Vaccine

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the persistence and stability of serologic geometric mean titer (GMT) of HPV 16/18 between 6, 12, 18, and 24 months after the prime dose and prior to the administration of the second dose.

SECONDARY OBJECTIVES:

I. To determine the persistence and stability of serologic GMT of HPV types 6/11/31/33/45/52/58 between 6, 12, 18, and 24 months after prime dose and prior to the administration of the second dose.

II. To assess safety and reactogenicity to each vaccine dose.

OUTLINE:

Participants receive recombinant human papillomavirus nonavalent vaccine intramuscularly (IM) at baseline (priming injection) and at 24 and 30 months (booster injections).

After completion of study, participants are followed up for 2 weeks.

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85719
      • Banner University Medical Center - Tucson
  • California
    • Los Angeles, California, United States, 90095
      • UCLA / Jonsson Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 11 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy, medically well girls and boys
• Ability to understand and the willingness to sign a written informed consent document by the legal representative(s) of the participant
• Ability to understand and the willingness to sign a written assent document by the participant

Exclusion Criteria:

• Previous vaccination against HPV
• The use of any investigational agent within 30 days preceding the first dose of the study vaccine or subsequent participation in another clinical trial at any time during the study period, in which the subject will be exposed to an investigational product
• Chronic administration of immunosuppressive agents or other immune-modifying drugs or chemotherapeutic agents within six months prior to the first vaccine dose; use of inhaled steroids, nasal sprays, and topical creams for small body areas is allowed
• Receiving active treatment for cancer or an autoimmune condition
• Confirmed or suspected immunosuppressive or immunodeficient condition
• Known bleeding disorders that preclude intramuscular injection (e.g., on anticoagulants or thrombocytopenia)
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal dysfunction, which in the opinion of the investigator precludes administration of the study vaccine
• History of allergic reactions attributed to compounds of similar chemical or biologic composition of GARDASIL 9 (recombinant human papillomavirus nonavalent vaccine), including yeast allergy
• Are pregnant

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prevention (Gardasil 9); Patients receive recombinant human papillomavirus nonavalent vaccine IM at baseline (priming injection) and at 24 and 30 months (booster injections).	Other: Laboratory Biomarker Analysis; Correlative studies; Biological: Recombinant Human Papillomavirus Nonavalent Vaccine; Given IM; Other Names: Gardasil 9; Nonavalent HPV VLP Vaccine; Recombinant HPV Nonavalent Vaccine; Recombinant Human Papillomavirus 9-valent Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Human Papilloma Virus (HPV)16/18 Antibody Titer	Difference in the log-transformed HPV 16/18 antibody levels between 6 and 12 months, between 12 and 18 months, and between 18 and 24 months after prime dose.	Between 6 and 24 months after prime dose and prior to the administration of the second dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Antibody Titer of Other Carcinogenic HPV Types 31/33/45/52/58 and Non-carcinogenic HPV 6/11	Difference in the log-transformed HPV type-specific antibody levels between 6 and 12 months, between 12 and 18 months, and between 18 and 24 months after prime dose.	Data are not available. The study team is working on analyzing the antibody titers of other HPV types.
Incidence of Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0		Up to 2 weeks post-treatment
Vaccine Reactogenicity		Up to 30 months

Collaborators and Investigators

• Sponsor: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Hsiao-Hui (Sherry) Chow, The University of Arizona Medical Center-University Campus

Publications and helpful links

General Publications

• Zeng Y, Moscicki AB, Sahasrabuddhe VV, Garcia F, Woo H, Hsu CH, Szabo E, Dimond E, Vanzzini S, Mondragon A, Butler V, DeRose H, Chow HS. A prospective, single-arm, open-label, non-randomized, phase IIa trial of a nonavalent prophylactic HPV vaccine to assess immunogenicity of a prime and deferred-booster dosing schedule among 9-11 year-old girls and boys - clinical protocol. BMC Cancer. 2019 Apr 1;19(1):290. doi: 10.1186/s12885-019-5444-4.

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2016
• Primary Completion (Actual): February 6, 2020
• Study Completion (Estimated): January 10, 2027

Study Registration Dates

• First Submitted: October 5, 2015
• First Submitted That Met QC Criteria: October 5, 2015
• First Posted (Estimated): October 6, 2015

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immunologic Factors; Physiological Effects of Drugs; Human Papillomavirus Recombinant Vaccine nonavalent
• Other Study ID Numbers: NCI-2015-01645 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); P30CA023074 (U.S. NIH Grant/Contract); N01-CN-2012-00031; N01CN00031 (U.S. NIH Grant/Contract); 1512261519 (Other Identifier: Banner University Medical Center - Tucson); UAZ2015-05-01 (Other Identifier: DCP)