WEAB0202 - Oral Abstract
Immunogenicity of the HPV-6, -11, -16, -18 vaccine in HIV-positive young women
Presented by Jessica Kahn (United States).
J. Kahn1, J. Xu2, B. Kapogiannis3, B. Rudy4, N. Liu2, R. Gonin2, C. Wilson5, C. Worrell3, K. Squires6
1Cincinnati Children's Hospital Medical Center, Pediatrics, Cincinnati, United States, 2Westat Inc., Rockville, United States, 3NICHD/PAMAB, Rockville, United States, 4New York University, New York, United States, 5University of Alabama at Birmingham - School of Public Health, Birmingham, United States, 6Jefferson Medical College, Philadelphia, United States
Background: The objective of this study was to examine the immunogenicity of the HPV-6, -11, -16, -18 vaccine in HIV-infected young women.
Methods: This phase II, open-label, multi-center trial was conducted through the Adolescent Trials Network for HIV/AIDS Interventions. Participants were 16-23 year-old women behaviorally infected with HIV. Two groups were enrolled: Group A (ART naïve or had not received HAART for at least six months prior to study entry) and Group B (had received HAART for at least 6 months, with two HIV-1 RNA plasma viral loads < 400 copies/mL). Participants received the HPV-6, -11, -16, -18 vaccine at baseline and study weeks 8 and 24; immunogenicity testing was performed before the first dose and 4 weeks after the third dose. Immunogenicity was measured by 1) mean geometric mean titers (GMTs) and 2) seroconversion rates for HPV-6, -11, -16, and -18, among those seronegative and HPV DNA negative for each type at baseline. One sample t-tests and one-arm comparisons were used to compare mean GMTs and seroconversion rates, respectively, of participants vs. historical controls (N=276) who were HIV-negative (Villa et al., 2006).
Results: The mean age of the 99 subjects was 21.4 years, and 80% were Non-Hispanic Black. At baseline, 85% had a CD4+ count > 350 cells/mm3, 40% had a HIV viral load < 400 copies/mL, 56% were seronegative and HPV DNA negative for HPV-16, and 74% were seronegative and HPV DNA negative for HPV-18. Mean GMTs and seroconversion rates for subjects and controls are shown in the Table.
| ||Mean GMTs||Seroconversion rates (1)|
| ||Group A
(N=99)||Controls / P value (2)||Group A
(N=99)||Controls / P value (2)|
| ||mean||mean||mean||mean / P value||%||%||%||% / P value|
|HPV-6||547||1139||739||582 / 0.28||96.3||100||97.5||100 / 0.16|
|HPV-11||655||1454||896||697 / 0.17||95.5||100||96.8||100 / 0.07|
|HPV-16||2176||5037||2961||3892 / 0.05||94.6||100||96.1||100 / 0.08|
|HPV-18||445||963||577||801 / 0.03||90.0||100||92.5||100 / 0.01|
|(1) Proportion with GMTs to HPV-6, -11, -16, and -18 of at least 20, 16, 20, and 24 mMU/mL, respectively.|
|(2) P value assesses differences in mean GMTs or seroconversion rates 4 weeks after the third vaccine dose for all subjects vs. controls. When GMTs and seroconversion rates for Group A and Group B participants were compared to those of controls, the only significant differences were in Group A subjects vs. controls for HPV-18; no differences were found in Group B subjects vs. controls.|
Conclusions: Among HIV-infected young women who were HPV DNA and HPV seronegative at the time of vaccination, HPV type-specific immune responses to vaccination were generally robust. Subjects not on HAART vs. controls had significantly lower mean GMTs and seroconversion rates for HPV-18 only; no differences were found between subjects on HAART and controls.
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