Immunogenicity and safety of Gardasil among mid-adult aged men (27-45 years)--The MAM Study

Vaccine
Anna R GiulianoEduardo Lazcano-Ponce

Abstract

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. 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. 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. The immune response to HPV vaccination in men ages 27-45 was comparable to that observed in younge...Continue Reading

References

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Citations

Dec 28, 2017·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Anastasia PhillipsKristine Macartney
Dec 7, 2017·Oncoimmunology·Stefano PieriniLorenzo Galluzzi
May 6, 2019·Human Vaccines & Immunotherapeutics·Mary Roz TimbangMichael G Moore
Mar 11, 2020·Journal of Cutaneous Medicine and Surgery·Alex DerstenfeldIvan V Litvinov
Aug 31, 2019·Epidemiology and Infection·Reyna Lizette Pacheco-DomínguezMalaquías López-Cervantes
May 10, 2018·The Cochrane Database of Systematic Reviews·Marc ArbynPierre Pl Martin-Hirsch
May 14, 2021·Patient Education and Counseling·Christopher W WheldonErika L Thompson
May 26, 2021·Human Vaccines & Immunotherapeutics·J HoesH E de Melker
Jun 29, 2021·Reumatología clinica·Íñigo Rúa-Figueroa Fernández de LarrinoaMaría Correyero Plaza

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