Recombinant Human Papillomavirus Nonavalent Vaccine in Preventing Human Papilloma Virus in Younger Healthy Participants
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|ClinicalTrials.gov Identifier: NCT02568566|
Recruitment Status : Active, not recruiting
First Posted : October 6, 2015
Results First Posted : April 5, 2022
Last Update Posted : October 19, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Human Papillomavirus-Related Carcinoma||Other: Laboratory Biomarker Analysis Biological: Recombinant Human Papillomavirus Nonavalent Vaccine||Phase 2|
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.
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.
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 (Clinical Trial)|
|Actual Enrollment :||201 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||March 30, 2016|
|Actual Primary Completion Date :||February 6, 2020|
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
Biological: Recombinant Human Papillomavirus Nonavalent Vaccine
- Change in Human Papilloma Virus (HPV)16/18 Antibody Titer [ Time Frame: Between 6 and 24 months after prime dose and prior to the administration of the second dose ]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.
- Change in the Antibody Titer of Other Carcinogenic HPV Types 31/33/45/52/58 and Non-carcinogenic HPV 6/11 [ Time Frame: Data are not available. The study team is working on analyzing the antibody titers of other HPV types. ]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.
- Incidence of Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 [ Time Frame: Up to 2 weeks post-treatment ]
- Vaccine Reactogenicity [ Time Frame: Up to 30 months ]
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|Ages Eligible for Study:||9 Years to 11 Years (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568566
|United States, Arizona|
|Banner University Medical Center - Tucson|
|Tucson, Arizona, United States, 85719|
|United States, California|
|UCLA / Jonsson Comprehensive Cancer Center|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Yi Zeng||The University of Arizona Medical Center-University Campus|
Documents provided by National Cancer Institute (NCI):
|Responsible Party:||National Cancer Institute (NCI)|
|Other Study ID Numbers:||
NCI-2015-01645 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
N01CN00031 ( U.S. NIH Grant/Contract )
1512261519 ( Other Identifier: Banner University Medical Center - Tucson )
UAZ2015-05-01 ( Other Identifier: DCP )
P30CA023074 ( U.S. NIH Grant/Contract )
|First Posted:||October 6, 2015 Key Record Dates|
|Results First Posted:||April 5, 2022|
|Last Update Posted:||October 19, 2022|
|Last Verified:||October 2022|
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