Immunogenicity of 2 versus 3 dose HPV vaccination by HIV infection status in Eswatini.

BACKGROUND

There are limited immunogenicity data among people with HIV (PWH) following human papilloma virus (HPV) vaccination, particularly with fewer dose schedules. 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 PWH cohorts received 2-doses of 9vHPV at 0 and 6 months: 1) boys 9-14 years (n = 349); 2) girls 9-14 years (n = 352); 3) adolescent girls and young women (AGYW) 15-26 years (n = 350). A comparison cohort of AGYW without HIV received the reference standard 3-dose regimen at 0, 2 and 6 months. At 7 months, we measured HPV-6/11/16/18/31/33/45/52/58 antibodies by competitive Luminex Immunoassay. We assessed non-inferiority of anti-HPV geometric mean titer ratios (GMTR), lower-bound 95% confidence interval > 0.5, among PWH versus AGYW without HIV; and secondarily explored GMTRs by HIV viral load (VL) at baseline or 7 months.

RESULTS

PWH 2-dose completion was high: 95% boys, 97% girls and 93% AGYW. Among AGYW without HIV, 95% received the second dose and 84% completed the 3-doses. GMTR of boys and girls with HIV were non-inferior to AGYW without HIV 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. GMTR of AGYW with HIV were non-inferior to AGYW without HIV 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. Among PWH with VL > 50 copies/mL, titers for all HPV sub-types were lower, and GMTRs were not non-inferior.

CONCLUSION

We found overall non-inferior immunogenicity of 2-dose 9vHPV among PWH versus 3-doses in AGYW without HIV, but 2-dose immunogenicity among viremic PWH may be compromised. Resource-saving 2-dose vaccination is an appropriate option for PWH while sustaining their VL suppression.

TRIAL REGISTRATION NUMBER: clinicaltrials.govNCT04982614.