Quadrivalent HPV Vaccine Prevents High-Grade Squamous Intraepithelial Lesions Among HIV-Positive Men

Illustrative picture of human papillomavirus HPV vaccine
Researchers examined the efficacy and safety of the quadrivalent human papillomavirus vaccine for young men who have sex with men and are living with HIV.

Young adult men who have sex with men and are living with HIV were found to be protected from low-grade and high-grade squamous intraepithelial lesions after receiving the quadrivalent human papillomavirus (HPV) vaccine, according to the results of a study published in Clinical Infectious Diseases.

In a phase 2, open-label, multicenter trial, 144 young adult men who have sex with men and are living with HIV aged 18 to 26 years were recruited to undergo vaccination with the HPV 6/11/16/18 vaccine consisting of 3 injections at weeks 0, 8, and 24. Participants were followed through week 104 (n=106). After vaccination, time to incident infection and HPV-associated perianal and/or anal disease lesions were compared with 58 HIV-negative men who have sex with men. Suspected lesions were assessed by biopsy and for serology.

Study participants were 60% Black, 45% were current smokers, 55% had 2 or more sexual partners during the past 6 months, 37% reported consistent non-oral condom use, and 91% had less than 400 HIV copies/mL.

At baseline, 77% were seropositive and/or DNA-positive for HPV 6, 11, 16, or 18. The most prevalent infections were caused by HPV 6 (35%), followed by HPV 11 (10%), HPV 16 (10%), and HPV 18 (3%).

Stratified by prevaccine HPV exposure, no novel perianal low-grade and high-grade squamous intraepithelial lesions were observed among the HPV-naive cohort. Among the pre-exposed individuals, any grade HPV lesions were detected among 14 of them, corresponding with 14.6 events per 100 person-years (py) risk.

The HIV-negative control group had an incidence rate of perianal low-grade or high-grade squamous intraepithelial lesions of 5.8 per 100 py, which was significantly greater than the HPV-naive cohort (P =.008).

Persistent HPV 6 and 16 infections were detected among 1 (1.8 events per 100 py) and 3 (2.9 per 100 py) individuals who were HPV naive prior to vaccination, respectively. No persistent infections were detected among those previously exposed.

Adverse events were reported by 71.5% of participants, most commonly injection site reactions (25.7%), skin and subcutaneous tissue disorders (9.0%), decreased neutrophil count (6.9%), and cough (6.9%). Serious adverse events occurring among 5 individuals included skin infection, gum infection, vomiting, nausea, homicidal ideation, suicidal ideation, and suicide attempt.

This study was limited by its small proportion of HPV-naive individuals among the population of men who have sex with men and are living with HIV. This observation underlies the urgent need for widespread vaccination campaigns among the young population of men who have sex with men.

These data indicated the quadrivalent HPV vaccine was well tolerated and immunogenic, especially among the HPV-naive subpopulation of men who have sex with men and are living with HIV.

Disclosure: This research was supported by Merck & Co. Please see the original reference for a full list of disclosures.


Palefsky JM, Lensing SY, Belzer M, et al; AIDS Malignancy Consortium and Adolescent Medicine Trials Network for HIV/AIDS Interventions. High prevalence of anal high-grade squamous intraepithelial lesions, and prevention through human papillomavirus vaccination, in young men who have sex with men living with HIV. Clin Infect Dis. Published online May 15, 2021. doi:10.1093/cid/ciab434