The purpose of this study is to evaluate the efficacy, immunogenicity and safety of the 9vHPV vaccine in men 20 to 45 years of age. The primary hypothesis tested after the primary database lock is that administration of a 3-dose regimen of 9vHPV vaccine will reduce the incidence of human papillomavirus (HPV) 16/18/31/33/45/52/58-related oral persistent infection (6 months or longer) compared with placebo. There will also be an Extension Study to offer an opportunity to complete the 3 dose regimen of 9vHPV vaccine for participants who received placebo in the Base Study, or received less than 3 doses of 9vHPV vaccine in the Base Study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
6,033
9vHPV is an aluminum-adjuvanted recombinant protein vaccine prepared from the highly purified virus-like particles of the recombinant major capsid (L1) protein of HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 given as a 0.5 mL intramuscular injection.
0.9% sodium chloride given as a 0.5-mL intramuscular injection
Valley Clinical Trials Inc. ( Site 0002)
Northridge, California, United States
Inland Empire Clinical Trials, LLC ( Site 0025)
Rialto, California, United States
Alta California Medical Group ( Site 0031)
Simi Valley, California, United States
Encompass Clinical Research ( Site 0028)
Spring Valley, California, United States
Diablo Clinical Research, Inc ( Site 0042)
Walnut Creek, California, United States
Incidence of HPV 16/18/31/33/45/52/58-related 6-month Persistent Oral Infection
A 6-month persistent infection is defined to have occurred if a participant, after completion of the Month 7 visit, is positive for the same HPV type by the HPV polymerase chain reaction (PCR) assay to at least 1 common gene in Oral Rinse and Gargle (ORG) samples obtained at 2 or more consecutive visits at 6 months (+/-1 month visit window) apart.
Time frame: Up to Month 90
Incidence of HPV 6/11-related 6-month Persistent Oral Infection
A 6-month persistent infection is defined to have occurred if a participant, after completion of the Month 7 visit, is positive for the same HPV type by the HPV PCR assay to at least 1 common gene in ORG samples obtained at 2 or more consecutive visits at 6 months (+/-1 month visit window) apart.
Time frame: Up to Month 90
Geometric Mean Titers to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 Antibodies
Serum antibodies to HPV types are measured with competitive Luminex immunoassay (cLIA). Geometric mean titers of antibodies to HPV types will be calculated by exponentiating the mean estimates of natural logarithm of the anti-HPV titers.
Time frame: 1 month postdose 3 (Month 7)
Percentage of Participants who Seroconvert to HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58
Seroconversion is defined as changing a participant's serostatus from seronegative at Day 1 to seropositive by 4 weeks postdose 3. A participant with anti-HPV cLIA titer at or above the serostatus cutoff of the cLIA for a given HPV type is considered seropositive for that HPV type.
Time frame: 1 month postdose 3 (Month 7)
Percentage of Participants with at Least 1 Solicited Injection-site Adverse Event (AE)
An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. Solicited injection-site AEs such as redness/erythema, swelling, and tenderness/pain at the injection site will be recorded.
Time frame: Up to 5 days after any vaccination
Percentage of Participants with Elevated Temperature (Fever)
Participants are asked to record oral body temperatures. The percentage of participants with elevated temperature (≥37.8°C or 100.0°F) will be assessed.
Time frame: Up to 5 days after any vaccination
Percentage of Participants Who Report at Least 1 Systemic AE
An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the study vaccine. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study vaccine or a protocol-specified procedure, whether or not considered related to the study vaccine or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study vaccine or protocol-specified procedure is also an AE. Systemic AEs are those not categorized as injection-site AEs.
Time frame: Up to 15 days after any vaccination
Percentage of Participants Who Experience at Least 1 Serious Adverse Event (SAE)
A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect, or is another important medical event deemed such by medical or scientific judgment.
Time frame: Up to 15 days after any vaccination
Percentage of Participants who Experience at Least 1 Serious Vaccine-Related AE
A SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect, or is another important medical event deemed such by medical or scientific judgment. An SAE that is considered by an investigator (a qualified physician) to be vaccine-related will be reported during entire study period.
Time frame: Up to Month 90
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Clinical Research of South Florida ( Site 0036)
Coral Gables, Florida, United States
Acevedo Clinical Research Associates ( Site 0001)
Miami, Florida, United States
Moffitt Cancer Center ( Site 0017)
Tampa, Florida, United States
Augusta University ( Site 0010)
Augusta, Georgia, United States
Solaris Clinical Research, LLC ( Site 0003)
Meridian, Idaho, United States
...and 93 more locations