Background
Human papilloma virus (HPV) vaccination protects against HPV-related disease outcomes like cervical cancer, but immune responses to vaccination among HIV positive (HIV+) persons may be compromised. We compared immunogenicity of 9-valent HPV vaccine (9vHPV) by HIV infection status in Eswatini.
Methods
In this multi-site, open-label, non-inferiority study, three HIV+ cohorts received a 2-dose regimen of 9vHPV at 0 and 6 months: 1) male children and adolescents (boys) 9-14 years (n=349); 2) female children and adolescents (girls) 9-14 years (n=352); 3) adolescent girls and young women (AGYW) 15-26 years (n=350). A comparison cohort of HIV negative (HIV-) AGYW (n=352) received the standard of care (SOC) 3-dose regimen of 9vHPV at 0, 2 and 6 months. At month 7, we measured HPV-6/11/16/18/31/33/45/52/58 antibodies by competitive Luminex IgG assay, assessed non-inferiority of anti-HPV geometric mean titers (GMT) among HIV+ cohorts compared to HIV-AGYW (non-inferiority defined as lower-bound 95% confidence interval of GMT ratio >0.5), and explored GMT ratios by HIV viral load (VL) at baseline or month 7.
Results
Completion of 2-dose regimens among HIV+ cohorts was 95% for HIV+ boys, 97% for HIV+ girls and 93% for HIV+AGYW. Among HIV-AGYW, 95% received the second dose and 84% completed the 3-dose regimen.
At month 7, GMT ratios among HIV+ boys and girls were non-inferior to HIV-AGYW for all HPV subtypes: boys ranged from 0.74 (0.60, 0.90) for HPV-45 to 1.30 (1.08, 1.56) for HPV-58; girls ranged from 0.70 (0.58, 0.86) for HPV-45 to 1.32 (1.10, 1.58) for HPV-58. GMT ratios for HIV+AGYW were non-inferior to HIV-AGYW for all subtypes except HPV-45; ranging from 0.66 (0.54, 0.81) for HPV-18 to 0.95 (0.78, 1.14) for HPV-11, and (0.40, 0.60) for HPV-45.
Of 81% HIV+ boys, 80% HIV+ girls and 66% HIV+AGYW, with VL measured, ≥80% had VL <50 copies/mL. In all HIV+ cohorts, HIV+ persons with VL ≥50 copies/mL had lower antibody titers for all HPV sub-types, and GMT ratios were not non-inferior (Fig 1).
Conclusions
We found overall non-inferior immunogenicity of 2-dose 9vHPV regimens among HIV+ cohorts versus SOC 3-dose vaccination among HIV-AGYW, but 2-dose immunogenicity among viremic HIV+ individuals may be compromised. The findings support the use of resource-saving 2-dose vaccination regimens for HIV+ persons while sustaining VL suppression.
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