NCT01432574

Study of Gardasil in Mid-Adult Males (MAM)

Completed Phase 2 Results posted Last updated 16 September 2021

What this trial tests

Phase 2 trial testing Gardasil in Human Papillomavirus in 150 participants. Completed in 3 November 2020.

Timeline

19 February 2013

Primary endpoint
23 May 2014

3 November 2020

Quick facts

Lead sponsor	H. Lee Moffitt Cancer Center and Research Institute
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	150
Start date	19 February 2013
Primary completion	23 May 2014
Estimated completion	3 November 2020
Sites	2 locations across United States, Mexico

Drugs / interventions tested

• Gardasil — full drug profile →

Conditions studied

• Human Papillomavirus — all drugs for Human Papillomavirus →

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Who can join

Adults 27 to 45, male only, with Human Papillomavirus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Seropositive at Month 7 Primary · 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.

HPV 6

Group	Value	95% CI
Gardasil Vaccine - Month 7	100

HPV 11

Group	Value	95% CI
Gardasil Vaccine - Month 7	100

HPV 16

Group	Value	95% CI
Gardasil Vaccine - Month 7	100

HPV 18

Group	Value	95% CI
Gardasil Vaccine - Month 7	100

Change in Antibody Titers Secondary · 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 analyze

HPV 6

Group	Value	95% CI
Gardasil Vaccine - Day 1	29.8	1.4 – 45.9
Gardasil Vaccine - Month 7	419.5	363.4 – 484.3

HPV 11

Group	Value	95% CI
Gardasil Vaccine - Day 1	40.1	11.1 – 144.5
Gardasil Vaccine - Month 7	516.6	454.7 – 586.8

HPV 16

Group	Value	95% CI
Gardasil Vaccine - Day 1	40.1	21.4 – 75.1
Gardasil Vaccine - Month 7	2228.6	2003.8 – 2478.5

HPV 18

Group	Value	95% CI
Gardasil Vaccine - Day 1	16.2	11.8 – 22.2
Gardasil Vaccine - Month 7	300.0	259.3 – 347.2

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 years, 3 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Gardasil Vaccine

Serious: 0/150 (0%)

Deaths: —

Other adverse events (3 terms — click to expand)

Reaction	System	Gardasil Vaccine
Injection site reaction	General disorders	—
Headache	Nervous system disorders	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—

Data from ClinicalTrials.gov NCT01432574 adverse events section.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Quadrivalent Human Papillomavirus (HPV) Vaccine Induces HPV-Specific Antibodies in the Oral Cavity: Results From the Mid-Adult Male Vaccine Trial.
   Pinto LA, Kemp TJ, Torres BN, Isaacs-Soriano K, et al · · 2016 · cited 53× · PMID 27511896 · DOI 10.1093/infdis/jiw359
2. Effectiveness, immunogenicity, and safety of the quadrivalent HPV vaccine in women and men aged 27-45 years.
   Maldonado I, Plata M, Gonzalez M, Correa A, et al · · 2022 · cited 23× · PMID 35853188 · DOI 10.1080/21645515.2022.2078626
3. HPV-specific antibodies at the oral cavity up to 30 months after the start of vaccination with the quadrivalent HPV vaccine among mid-adult aged men.
   Parker KH, Kemp TJ, Isaacs-Soriano K, Abrahamsen M, et al · · 2019 · cited 11× · PMID 31005426 · DOI 10.1016/j.vaccine.2019.03.064
4. Evaluation of HPV-16 and HPV-18 specific antibody measurements in saliva collected in oral rinses and merocel® sponges.
   Parker KH, Kemp TJ, Pan Y, Yang Z, et al · · 2018 · cited 11× · PMID 29631883 · DOI 10.1016/j.vaccine.2018.03.034
5. Increases in HPV-16/18 antibody avidity and HPV-specific memory B-cell response in mid-adult aged men post-dose three of the quadrivalent HPV vaccine.
   Miller CN, Kemp TJ, Abrahamsen M, Isaacs-Soriano K, et al · · 2021 · cited 4× · PMID 34373120 · DOI 10.1016/j.vaccine.2021.07.069