Immunogenicity and Safety of the 9-Valent Human Papillomavirus Vaccine in Solid Organ Transplant Recipients and Adults Infected With Human Immunodeficiency Virus (HIV)

Abstract

Background The burden of human papillomavirus (HPV) in HIV-infected persons and solid organ transplant (SOT) recipients is high. Clinical trials on HPV vaccines in HIV-infected persons and particularly in SOT recipients have been sparse to date, included low numbers of participants and none of them assessed the nine-valent HPV (9vHPV). We investigated the immunogenicity with respect to HPV types 6/11/16/18/31/33/45/52/58 and the safety of the 9vHPV vaccine in HIV-infected persons and recipients of a kidney, lung or heart transplant. Methods This is a phase III investigator-initiated study in 100 HIV-infected persons (age: 18-45 years) and 171 SOT recipients (age: 18-55 years). The 9vHPV vaccine was administered at day 1, month 2 and month 6. Primary outcome was seroconversion rates to the 9vHPV types at month 7. Secondary outcomes were geometric mean titers (GMTs) and frequency of adverse events (AEs). Results All HIV-infected participants seroconverted for all HPV types, but seroconversion ranged from 46% for HPV45 to 72% for HPV58 in SOT recipients. GMTs ranged from 180 to 2985 mMU/ml in HIV-positive participants and from 17 to 170 mMU/ml in SOT recipients, depending on the HPV type. Injection-site AEs occurred in 62% of participants but were mostly mild or moderate in intensity. None of the reported serious adverse events were deemed vaccine-related. No patients died during the study. Conclusion Immunogenicity of the 9vHPV vaccine is high in HIV-infected persons but suboptimal in SOT recipients. The vaccine is safe and well tolerated in both groups.

Antibody response to SARS-CoV-2 mRNA vaccine among kidney transplant recipients: a prospective cohort study

“…Similar low antibody response to mRNA COVID-19 vaccines among kidney transplant recipients was recently reported following one vaccine dose in a cohort from the US.Older age and use of anti-metabolite maintenance were significantly associated with seronegativity in this study, in line with our results. (5) Sub-optimal antibody response to other vaccines has also been previously reported among solid organ transplant recipients compared to healthy subjects (2,6,7). Factors associated with this reduced response included use of tacrolimus as well as mycophenolic acid, the latter inhibits B-cell function and has been documented to influence antibody response to influenza vaccine depending on dose.…”

Towards the elimination of cervical cancer: HPV epidemiology, real-world experiences and the potential impact of the 9-valent HPV vaccine

“…All the trials were consistent in indicating that, irrespective of the recipients' age, sex or nationality, the vaccine schedule, the concomitant administration of other vaccines, and concomitant clinical conditions, the 9-valent HPV vaccine was well tolerated and safe, and there were no reported vaccine-related deaths [33-44, 46-50, 52]. The most common adverse events related to the injection site, reported in percentages varying from 57.6% [49] to 90.7% [33]. Systemic adverse events occurred in percentages varying from 20.6% [49] to 55.8% [33].…”

“…Supplementary Table 1 (Ref. [33][34][35][36][37][38][39][40][41][42][43][44][45][46][47][48][49][50][51][52]) lists the articles in chronological order and summarizes their characteristics and findings.…”

“…A follow-up study then confirmed that, as seen for the 3-dose schedule [44], so too for the 2-dose schedule, the immune response persisted for at least 36 months after the last dose of vaccine [50]. One clinical trial investigated immune response to the 9-valent HPV vaccine in HIV-positive subjects aged 18 to 45 years, and in solid organ transplant recipients aged 18 to 55 years: the seroconversion rates were 100% in the former group and ranged between 46% and 72% in the latter [49].…”

Vaccines

“…Minor reactogenicity AEs and no SAEs were reported. The vaccine is well tolerated and safe in both groups, while efficacy is high for persons living with HIV and suboptimal in SOT patients ( Boey et al, 2020 ) [C]. A meta-analysis by Zhan et al shows that HPV vaccines are safe and efficacious for PLIH ( Zhan et al, 2019 ) [M].…”