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

Giuliano, Anna R.; Isaacs-Soriano, Kimberly; Torres, B. Nelson; Abrahamsen, Martha; Ingles, Donna J.; Sirak, Bradley; Quiterio, Manuel; Lazcano‐Ponce, Eduardo

doi:10.1016/j.vaccine.2015.08.072

Cited by 52 publications

(48 citation statements)

References 17 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…We have shown that a delayed fourth dose of vaccine generates a higher peak titer in antibodies to HPV 16 and 18 but not to HPV 6 and 11. For HPV 16, the titers 4 weeks after the fourth dose in our study was similar to the titers observed in heterosexual HIV-uninfected males aged 16–23 years and 27–45 years after they are vaccinated with three doses (2422 mMU/mL compared to 2622 mMU/mL and 2285 mMU/mL, respectively) [23], [24]. The antibody titer needed for maintenance of protection is not clear.…”

Section: Discussionsupporting

confidence: 57%

A delayed dose of quadrivalent human papillomavirus vaccine demonstrates immune memory in HIV-1-infected men

Ellsworth

Lensing

Ogilvie

et al. 2018

Papillomavirus Research

View full text Add to dashboard Cite

Section: Discussionsupporting

confidence: 57%

A delayed dose of quadrivalent human papillomavirus vaccine demonstrates immune memory in HIV-1-infected men

Ellsworth

Lensing

Ogilvie

et al. 2018

Papillomavirus Research

View full text Add to dashboard Cite

“…On the other hand, there is no established relationship between antibody titres and vaccine efficacy in EGL, anal intra-epithelial neoplasia, and cervix, vulva or vaginal cancer [25, 26]. The response rates in this study were lower than previously reported [33], though they were obtained in an older population and using a different assay technique. Possible causes for a lower antibody titre include prior infection not detectable by anal HPV DNA testing or serology [26], and being MSM [34].…”

Section: Discussioncontrasting

confidence: 68%

Safety and immunogenicity of the quadrivalent human papillomavirus (qHPV) vaccine in HIV-positive Spanish men who have sex with men (MSM)

et al. 2017

View full text Add to dashboard Cite

BackgroundSafety and immunogenicity of the quadrivalent human papillomavirus (qHPV) vaccine were evaluated in HIV-positive Spanish MSM. The prevalence of High Squamous Intraepithelial Lesions (HSIL) and genotypes of high-risk human papillomavirus (HR-HPV) were also determined, as well as risk factors associated with the presence of HR-HPV in anal mucosa.MethodsThis is a randomised, double blind, placebo-controlled trial of the quadrivalent HPV (qHPV) vaccine. The study enrolled from May 2012 to May 2014. Vaccine and placebo were administered at 0, 2 and 6 months (V1, V2, V3 clinical visits). Vaccine antibody titres were evaluated at 7 months. Cytology (Thin Prep® Pap Test), HPV PCR genotyping (Linear Array HPV Genotyping Test), and high-resolution anoscopy (Zeiss 150 fc© colposcope) were performed at V1.ResultsPatients (n = 162; mean age 37.9 years) were screened for inclusion; 14.2% had HSIL, 73.1% HR-HPV and 4.5% simultaneous infection with HPV16 and 18. Study participants (n = 129) were randomized to qHPV vaccine or placebo. The most common adverse event was injection-site pain predominating in the placebo group [the first dose (83.6% vs. 56.1%; p = 0.0001]; the second dose (87.8% vs. 98.4%; p = 0.0001); the third dose (67.7% vs. 91.9%; p = 0.0001). The vaccine did not influence either the viral load of HIV or the levels of CD4. Of those vaccinated, 76% had antibodies to HPV vs. 30.2% of those receiving placebo (p = 0.0001). In the multivariate analysis, Older age was associated with lower HR-HPV infection (RR 0.97; 95% CI 0.96–0.99), and risk factor were viral load of HIV >200 copies/µL (RR 1.42 95% CI 1.17–1.73) and early commencement of sexual activity (RR 1.35; 95% CI 1.001–1.811).ConclusionsThis trial showed significantly higher anti-HR-HPV antibody titres in vaccinated individuals than in unvaccinated controls. There were no serious adverse events attributable to the vaccine. In our cohort, 1 of every 7 patients had HSIL and the prevalence of combined infection by genotypes 16 and 18 was low. This suggests that patients could benefit from receiving qHPV vaccine. Older age was the main protective factor against HR-HPV infection, and non-suppressed HIV viremia was a risk factor.Clinical trial registration: ISRCTN14732216 (http://www.isrctn.com/ISRCTN14732216).

show abstract

“…To date, very few countries have gender‐neutral national HPV vaccination policies, including the United States, Israel, Australia, and Austria. More recently, the immunogenicity and safety of Gardasil 9, which protects against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, has been demonstrated in adolescent and young adult males . Licensure of Gardasil 9 for adolescent males ages 9 to 15 years occurred in 2014, with the expectation that FDA licensure for young adult males ages 16 to 26 years will occur in the near future.…”

Section: Prevention Of Penile Cancer and Preneoplastic Lesionsmentioning

confidence: 99%

“…More recently, the immunogenicity and safety of Gardasil 9, which protects against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, has been demonstrated in adolescent and young adult males. 82,83 Licensure of Gardasil 9 for adolescent males ages 9 to 15 years occurred in 2014, with the expectation that FDA licensure for young adult males ages 16 to 26 years will occur in the near future. To maintain consistent vaccine recommendations, the Advisory Committee on Immunization Practice has extended its male vaccination recommendation (males ages 9-21 years) to Gardasil 9 in 2015 with an increase in the upper age range to 26 years for high-risk and immunocompromised males.…”

Section: Prevention Of Penile Cancer and Preneoplastic Lesionsmentioning

confidence: 99%

Pathophysiological basis of human papillomavirus in penile cancer: Key to prevention and delivery of more effective therapies

Spiess

Dhillon

Baumgarten

et al. 2016

CA A Cancer J Clinicians

Self Cite

View full text Add to dashboard Cite

Answer questions and earn CME/CNE Squamous cell carcinoma (SCC) of the penis is a rare malignancy in the United States, with a significantly higher incidence-up to 20 to 30 times greater-in areas of Africa and South America. This can be explained in part by the significantly greater prevalence of sexually transmitted diseases among high-risk males often having unprotected sex with multiple sexual partners. Human papillomavirus (HPV) has been implicated as the infectious pathway by which several these penile neoplasms originate from precursor lesions. In this regard, a fundamental understanding of HPV in penile carcinogenesis can have meaningful implications in understanding 1) the diagnosis of HPV-related precursor penile lesions, 2) targeting HPV-specific molecular pathways, and 3) cancer prevention. Using vaccination programs not only may improve patient outcomes but also may minimize the need for highly aggressive and often debilitating surgical resection. CA Cancer J Clin 2016. © 2016 American Cancer Society.

show abstract

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

Cited by 52 publications

References 17 publications

A delayed dose of quadrivalent human papillomavirus vaccine demonstrates immune memory in HIV-1-infected men

A delayed dose of quadrivalent human papillomavirus vaccine demonstrates immune memory in HIV-1-infected men

Safety and immunogenicity of the quadrivalent human papillomavirus (qHPV) vaccine in HIV-positive Spanish men who have sex with men (MSM)

Pathophysiological basis of human papillomavirus in penile cancer: Key to prevention and delivery of more effective therapies

Contact Info

Product

Resources

About