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Trial Outcomes & Findings for Study of Gardasil in Mid-Adult Males (MAM) (NCT NCT01432574)

NCT ID: NCT01432574

Last Updated: 2021-09-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

150 participants

Primary outcome timeframe

7 Months

Results posted on

2021-09-16

Participant Flow

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.

Participant milestones

Participant milestones
Measure
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).
Overall Study
STARTED
150
Overall Study
COMPLETED
147
Overall Study
NOT COMPLETED
3

Reasons for withdrawal

Reasons for withdrawal
Measure
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).
Overall Study
Moved
2
Overall Study
Not interested
1

Baseline Characteristics

Study of Gardasil in Mid-Adult Males (MAM)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Gardasil Vaccine
n=150 Participants
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).
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
150 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
Age, Continuous
36 years
n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
Sex: Female, Male
Male
150 Participants
n=5 Participants
Race/Ethnicity, Customized
White
68 participants
n=5 Participants
Race/Ethnicity, Customized
Black/African American
12 participants
n=5 Participants
Race/Ethnicity, Customized
Asian/Pacific Islander
3 participants
n=5 Participants
Race/Ethnicity, Customized
Native American/Alaskan
1 participants
n=5 Participants
Race/Ethnicity, Customized
More than one race
65 participants
n=5 Participants
Race/Ethnicity, Customized
Unknown
1 participants
n=5 Participants
Region of Enrollment
United States
75 participants
n=5 Participants
Region of Enrollment
Mexico
75 participants
n=5 Participants

PRIMARY outcome

Timeframe: 7 Months

Population: Participants who had specimens contributing to both Day 1 and Month 7 serum HPV antibody evaluations.

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.

Outcome measures

Outcome measures
Measure
Gardasil Vaccine - Month 7
n=145 Participants
Gardasil Vaccine - Month 7
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).
Percentage of Participants Seropositive at Month 7
HPV 11
100 percentage of participants
—
Percentage of Participants Seropositive at Month 7
HPV 6
100 percentage of participants
—
Percentage of Participants Seropositive at Month 7
HPV 16
100 percentage of participants
—
Percentage of Participants Seropositive at Month 7
HPV 18
100 percentage of participants
—

SECONDARY outcome

Timeframe: Points: Day 1 and Month 7

Population: Participants who had specimens contributing to both Day 1 and Month 7 serum HPV antibody evaluations.

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.

Outcome measures

Outcome measures
Measure
Gardasil Vaccine - Month 7
n=145 Participants
Gardasil Vaccine - Month 7
n=145 Participants
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).
Change in Antibody Titers
HPV 6
29.8 mMU/mL (geometric mean titer)
Interval 1.4 to 45.9
419.5 mMU/mL (geometric mean titer)
Interval 363.4 to 484.3
Change in Antibody Titers
HPV 11
40.1 mMU/mL (geometric mean titer)
Interval 11.1 to 144.5
516.6 mMU/mL (geometric mean titer)
Interval 454.7 to 586.8
Change in Antibody Titers
HPV 16
40.1 mMU/mL (geometric mean titer)
Interval 21.4 to 75.1
2228.6 mMU/mL (geometric mean titer)
Interval 2003.8 to 2478.5
Change in Antibody Titers
HPV 18
16.2 mMU/mL (geometric mean titer)
Interval 11.8 to 22.2
300.0 mMU/mL (geometric mean titer)
Interval 259.3 to 347.2

Adverse Events

Gardasil Vaccine

Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Gardasil Vaccine
n=150 participants at risk
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).
General disorders
Injection site reaction
12.7%
19/150 • Number of events 29 • 2 years, 3 months
Participants were asked to complete a vaccine report card to document any adverse events for 14 days following each of three doses of vaccine. Trial participants were provided thermometers to record their temperatures each day for five days following each dose of received vaccine.
Musculoskeletal and connective tissue disorders
Pain in extremity
7.3%
11/150 • Number of events 12 • 2 years, 3 months
Participants were asked to complete a vaccine report card to document any adverse events for 14 days following each of three doses of vaccine. Trial participants were provided thermometers to record their temperatures each day for five days following each dose of received vaccine.
Nervous system disorders
Headache
9.3%
14/150 • Number of events 15 • 2 years, 3 months
Participants were asked to complete a vaccine report card to document any adverse events for 14 days following each of three doses of vaccine. Trial participants were provided thermometers to record their temperatures each day for five days following each dose of received vaccine.

Additional Information

Anna Giuliano, Ph.D.

H. Lee Moffitt Cancer Center and Research Institute

Phone: 813-745-6820

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place