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

Human Papillomavirus-Related Carcinoma Clinical Trial

Official title:

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 Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02568566
• Other study ID #: NCI-2015-01645
• Secondary ID: NCI-2015-01645N0
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 30, 2016
• Est. completion date: February 6, 2025

Study information

• Verified date: February 2024
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 201
• Est. completion date: February 6, 2025
• Est. primary completion date: February 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Human Papillomavirus-Related Carcinoma

Intervention

Other:
• Laboratory Biomarker Analysis
Correlative studies

Biological:
• Recombinant Human Papillomavirus Nonavalent Vaccine
Given IM

Locations

Country	Name	City	State
United States	UCLA / Jonsson Comprehensive Cancer Center	Los Angeles	California
United States	Banner University Medical Center - Tucson	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	Vaccine Reactogenicity		Up to 30 months