Immunogenicity and safety of Gardasil among mid-adult aged men (27-45 years)--The MAM Study.
BACKGROUND
The quadrivalent (types 6/11/16/18) human papillomavirus (HPV) vaccine, Gardasil, has demonstrated efficacy against persistent HPV infection and associated anogenital disease in males. The goal of this Phase II trial was to establish the immunogenicity and safety of Gardasil among mid-adult men ages 27-45 years.


METHODS
One hundred and fifty men from Tampa, FL, US, and Cuernavaca, Mexico who met eligibility criteria (male, 27-45 years old, completed four years of follow-up in the HPV Infection in Men (HIM) natural history study) were enrolled. Subjects completed four visits over seven months, with Gardasil administered at Day 1 and Months 2 and 6. Sera were collected at Day 1 (pre-vaccination) and Month 7 (one month post-dose three). Anti-HPV6, 11, 16, and 18 IgG levels were determined by competitive Luminex immunoassay.


RESULTS
100% of men seroconverted to each of the four HPV vaccine components, and the vaccine was generally well-tolerated. Antibody responses to vaccine did not differ by age group or sexual orientation, regardless of HPV type, and were significantly higher at Month 7 among men who entered the trial seropositive for HPV 6 or 11.


CONCLUSIONS
The immune response to HPV vaccination in men ages 27-45 was comparable to that observed in younger men, in whom clinical efficacy was demonstrated. Further trials to assess the efficacy of HPV vaccines to prevent persistent HPV infections in mid-adult men are needed.


BACKGROUND
Merck & Co. Inc. was the main sponsor of this trial (IISP39256) and provided the study product.
Center for Infection Research in Cancer, H. Lee Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, Tampa, FL 33612, United States. Electronic address: Anna.Giuliano@moffitt.org.
Anna R
AR
Giuliano
Center for Infection Research in Cancer, H. Lee Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, Tampa, FL 33612, United States.
Kimberly
K
Isaacs-Soriano
Center for Infection Research in Cancer, H. Lee Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, Tampa, FL 33612, United States.
B Nelson
BN
Torres
Center for Infection Research in Cancer, H. Lee Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, Tampa, FL 33612, United States.
Martha
M
Abrahamsen
Center for Infection Research in Cancer, H. Lee Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, Tampa, FL 33612, United States.
Donna J
DJ
Ingles
Center for Infection Research in Cancer, H. Lee Moffitt Cancer Center and Research Institute, 12902 Magnolia Drive, Tampa, FL 33612, United States.
Bradley A
BA
Sirak
Instituto Nacional de Salud Publica, Av. Universidad 655, Col. Santa Maria Ahuacatitlan, 62508 Cuernavaca, MOR, Mexico.
Manuel
M
Quiterio
Instituto Nacional de Salud Publica, Av. Universidad 655, Col. Santa Maria Ahuacatitlan, 62508 Cuernavaca, MOR, Mexico.
Eduardo
E
Lazcano-Ponce
D000328:Adult; D057134:Antibodies, Neutralizing / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D000917:Antibody Formation; D005431:Florida; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007074:Immunoglobulin G / Q000097:blood; D008297:Male; D008800:Mexico; D008875:Middle Aged; D030361:Papillomavirus Infections / Q000517:prevention & control*
D057134:Antibodies, Neutralizing; D000914:Antibodies, Viral; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D007074:Immunoglobulin G
HPV; Human papillomavirus; Mid-adult men; Vaccine