Human Papillomavirus
Conditions
Keywords
HPV
Brief summary
The purpose of this study is to test the effectiveness of the research study vaccine, Gardasil, in men ages 27-45 who have completed 4 years of observation in The Human Papillomavirus \[HPV\] infection in men (HIM) Study.
Detailed description
The MAM Study is a prospective pilot intervention trial to investigate patterns of human papillomavirus (HPV) vaccine immunogenicity in men, aged 27-45 years, in which the men will receive Gardasil. Gardasil was administered at 0, 2, and 6 months. Blood was drawn at 0 and 7 months to provide a quadrivalent HPV antibody serologic profile. Participants also completed surveys via computer-assisted interviews (CASI) at Day 1 and Month 7 to record sexual behavior. Our overall goal is to test the efficacy of Gardasil to reduce HPV 6, 11, 16, 18 persistent infection among men at the external genital epithelium, anal canal, and oral cavity, and to reduce lesions caused by these HPV types at the external genital epithelium and anal canal. The purpose of this Phase II trial is to establish the immunogenicity of Gardasil among mid-adult men and to establish the infrastructure with which to build the larger Phase III trial in the future.
Interventions
BIOLOGICALGardasil
The First Shot: Given on the day participants joined the study (Visit 1). The Second Shot: Given about 2 months later (Visit 2). The Third Shot: Given about 6 months after the first (Visit 3).
Sponsors
Merck Sharp & Dohme LLC
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
27 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Men that have completed 4 years of follow-up in the on-going international prospective natural history study of HPV in men (The HIM Study) * Willing to comply with 4 scheduled visits within a 7-month period
Exclusion criteria
* Have received an HPV vaccine * Have a prior diagnosis of penile or anal cancers * Have a prior diagnosis of high grade anal intraepithelial neoplasia * Have been diagnosed with human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS) * Have a history of anaphylaxis to vaccines * Have known impairment of the immune system * Have received any blood products within 6 months of enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Seropositive at Month 7 | 7 Months | Immune response was measured with a multiplex competitive Luminex immunoassay (anti-HPV-6, -11, -16, and -18 chemiluminescence immunoassay analyzer (cLIA); Merck) at Pharmaceutical Product Development (PPD). Briefly, this assay simultaneously quantitates neutralizing antibodies to HPV 6, 11, 16, and 18 in 50 μL of serum. The seronegative study population at Day 1 (no detectable HPV antibody titers at Day 1) were to be categorized as seroconverted due to increase in titer levels for each vaccine component at Month 7. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Antibody Titers | Points: Day 1 and Month 7 | Change in antibody titers 1 month post-dose 3 of vaccine. For each vaccine component, the geometric mean titers (GMT) and the corresponding 95% confidence intervals (CI) were calculated for antibody titers at each time-point (Day 1 and Month 7). For each participant, the difference in antibody titers between these 2 time-points (titers at Month 7 minus titers at Day 1) was calculated. The mean of antibody titer change and its 95% CI were calculated. Immune response was measured with a multiplex competitive Luminex immunoassay (anti-HPV-6, -11, -16, and -18 chemiluminescence immunoassay analyzer (cLIA); Merck) at Pharmaceutical Product Development (PPD). Briefly, this assay simultaneously quantitates neutralizing antibodies to HPV 6, 11, 16, and 18 in 50 μL of serum. mMU/ml is an arbitrary unit of measure derived after comparing relative inhibition of mAb-PE binding to a pooled standard reference serum using a four-parameter logistic curve fit and correcting for dilution. |
Countries
Mexico, United States
Participant flow
Recruitment details
HIM Study participants that met the eligibility criteria were invited and enrolled into this Phase II Trial at the US and Mexico clinical sites between February and October of 2013.
Participants by arm
| Arm | Count |
|---|---|
| Gardasil Vaccine Vaccine Administration: A total of 3 injections (shots) at 3 separate visits.
Gardasil: The First Shot: Given on the day participants joined the study (Visit 1). The Second Shot: Given about 2 months later (Visit 2). The Third Shot: Given about 6 months after the first (Visit 3). | 150 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Moved | 2 |
| Overall Study | Not interested | 1 |
Baseline characteristics
| Characteristic | Gardasil Vaccine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 150 Participants |
| Age, Continuous | 36 years |
| Race/Ethnicity, Customized Asian/Pacific Islander | 3 participants |
| Race/Ethnicity, Customized Black/African American | 12 participants |
| Race/Ethnicity, Customized More than one race | 65 participants |
| Race/Ethnicity, Customized Native American/Alaskan | 1 participants |
| Race/Ethnicity, Customized Unknown | 1 participants |
| Race/Ethnicity, Customized White | 68 participants |
| Region of Enrollment Mexico | 75 participants |
| Region of Enrollment United States | 75 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 150 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 38 / 150 |
| serious Total, serious adverse events | 0 / 150 |
Outcome results
Primary
Percentage of Participants Seropositive at Month 7
Immune response was measured with a multiplex competitive Luminex immunoassay (anti-HPV-6, -11, -16, and -18 chemiluminescence immunoassay analyzer (cLIA); Merck) at Pharmaceutical Product Development (PPD). Briefly, this assay simultaneously quantitates neutralizing antibodies to HPV 6, 11, 16, and 18 in 50 μL of serum. The seronegative study population at Day 1 (no detectable HPV antibody titers at Day 1) were to be categorized as seroconverted due to increase in titer levels for each vaccine component at Month 7.
Time frame: 7 Months
Population: Participants who had specimens contributing to both Day 1 and Month 7 serum HPV antibody evaluations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Gardasil Vaccine - Month 7 | Percentage of Participants Seropositive at Month 7 | HPV 6 | 100 percentage of participants |
| Gardasil Vaccine - Month 7 | Percentage of Participants Seropositive at Month 7 | HPV 11 | 100 percentage of participants |
| Gardasil Vaccine - Month 7 | Percentage of Participants Seropositive at Month 7 | HPV 16 | 100 percentage of participants |
| Gardasil Vaccine - Month 7 | Percentage of Participants Seropositive at Month 7 | HPV 18 | 100 percentage of participants |
Secondary
Change in Antibody Titers
Change in antibody titers 1 month post-dose 3 of vaccine. For each vaccine component, the geometric mean titers (GMT) and the corresponding 95% confidence intervals (CI) were calculated for antibody titers at each time-point (Day 1 and Month 7). For each participant, the difference in antibody titers between these 2 time-points (titers at Month 7 minus titers at Day 1) was calculated. The mean of antibody titer change and its 95% CI were calculated. Immune response was measured with a multiplex competitive Luminex immunoassay (anti-HPV-6, -11, -16, and -18 chemiluminescence immunoassay analyzer (cLIA); Merck) at Pharmaceutical Product Development (PPD). Briefly, this assay simultaneously quantitates neutralizing antibodies to HPV 6, 11, 16, and 18 in 50 μL of serum. mMU/ml is an arbitrary unit of measure derived after comparing relative inhibition of mAb-PE binding to a pooled standard reference serum using a four-parameter logistic curve fit and correcting for dilution.
Time frame: Points: Day 1 and Month 7
Population: Participants who had specimens contributing to both Day 1 and Month 7 serum HPV antibody evaluations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Gardasil Vaccine - Month 7 | Change in Antibody Titers | HPV 6 | 29.8 mMU/mL (geometric mean titer) |
| Gardasil Vaccine - Month 7 | Change in Antibody Titers | HPV 11 | 40.1 mMU/mL (geometric mean titer) |
| Gardasil Vaccine - Month 7 | Change in Antibody Titers | HPV 16 | 40.1 mMU/mL (geometric mean titer) |
| Gardasil Vaccine - Month 7 | Change in Antibody Titers | HPV 18 | 16.2 mMU/mL (geometric mean titer) |
| Gardasil Vaccine - Month 7 | Change in Antibody Titers | HPV 18 | 300.0 mMU/mL (geometric mean titer) |
| Gardasil Vaccine - Month 7 | Change in Antibody Titers | HPV 6 | 419.5 mMU/mL (geometric mean titer) |
| Gardasil Vaccine - Month 7 | Change in Antibody Titers | HPV 16 | 2228.6 mMU/mL (geometric mean titer) |
| Gardasil Vaccine - Month 7 | Change in Antibody Titers | HPV 11 | 516.6 mMU/mL (geometric mean titer) |