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

NCT02568566 | Active Not Recruiting Phase 2 Results DMC

• 6 other identifiers: NCI-2015-01645N01CN00031N01-CN-2012-000311512261519UAZ2015-05-01P30CA023074
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Human Papillomavirus-Related Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in the Antibody Titer of Other Carcinogenic HPV Types 31/33/45/52/58 and Non-carcinogenic HPV 6/11

  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

Study Arms (1)

Prevention (Gardasil 9)

EXPERIMENTAL

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

Other: Laboratory Biomarker Analysis; Biological: Recombinant Human Papillomavirus Nonavalent Vaccine

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Prevention (Gardasil 9)

Recombinant Human Papillomavirus Nonavalent Vaccine BIOLOGICAL

Given IM

Also known as: Gardasil 9, Nonavalent HPV VLP Vaccine, Recombinant HPV Nonavalent Vaccine, Recombinant Human Papillomavirus 9-valent Vaccine

Prevention (Gardasil 9)

Eligibility Criteria

• Age: 9 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

Banner University Medical Center - Tucson

Tucson, Arizona, 85719, United States

Location

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• 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.

  PMID: 30935375 DERIVED

MeSH Terms

Interventions

Human Papillomavirus Recombinant Vaccine nonavalent

Results Point of Contact

• Title: Sherry Chow, PhD
• Organization: University of Arizona

schow@azcc.arizona.edu

520-626-3358

Study Officials

• Hsiao-Hui (Sherry) Chow

  The University of Arizona Medical Center-University Campus

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2015
• First Posted: October 6, 2015
• Study Start: May 19, 2016
• Primary Completion: February 6, 2020
• Study Completion (Estimated): January 10, 2027
• Last Updated: April 13, 2026
• Results First Posted: April 5, 2022

Record last verified: 2026-01

Locations

US (2)