Abstract

The prophylactic vaccines available to protect against infections by HPV are well tolerated and highly immunogenic. People with HIV have a higher risk of developing HPV infection and HPV-associated cancers due to a lower immune response, and due to viral interactions. We performed a systematic review of RCTs to assess HPV vaccines efficacy and safety on HIV-infected people compared to placebo or no intervention in terms of seroconversion, infections, neoplasms, adverse events, CD4+ T-cell count and HIV viral load. The vaccine-group showed a seroconversion rate close to 100% for each vaccine and a significantly higher level of antibodies against HPV vaccine types, as compared to the placebo group (MD = 4333.3, 95% CI 2701.4; 5965.1 GMT EL.U./ml for HPV type 16 and MD = 1408.8, 95% CI 414.8; 2394.7 GMT EL.U./ml for HPV type 18). There were also no differences in terms of severe adverse events (RR = 0.6, 95% CI 0.2; 1.6) and no severe adverse events (RR = 0.6, 95% CI 0.9; 1.2) between vaccine and placebo groups. Secondary outcomes, such as CD4 + T-cell count and HIV viral load, did not differ between groups (MD = 14.8, 95% CI − 35.1; 64.6 cells/µl and MD = 0.0, 95% CI − 0.3; 0.3 log10 RNA copies/ml, respectively). Information on the remaining outcomes was scarce and that did not allow us to combine the data. The results support the use of the HPV vaccine in HIV-infected patients and highlight the need of further RCTs assessing the effectiveness of the HPV vaccine on infections and neoplasms.

Highlights

  • Since we have included only RCTs in this review, our rating started from a high level of certainty and we eventually downgraded it by considering the following criteria: RoB of included studies, inconsistency and imprecision of relative effect estimates, indirectness of evidence and publication bias

  • U./ml for HPV 16 and 1404.8 Geometric Mean antibody Titre (GMT) EL.U./ml for HPV 18 (Fig. 3)

  • Publication bias was not a concern as, after searching on ClinicalTrials.gov registry, we did not find any completed studies before 2019 that have not yet been published

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Summary

Objectives

This review seeks to evaluate the efficacy and safety of vaccines to prevent HPV infections and correlated lesions in cervical, vulvar, vaginal, penile, anal or oral districts in HIV-infected patients by metaanalysing the results of randomised controlled trials (RCTs)

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