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• W4285490623 abstract "We read with interest the findings by Xu et al.[1] regarding lower levels of antispike immunoglobulin G (IgG) produced by people with HIV (PWH) immunized with mRNA BNT162b2 vaccine against SARS-CoV-2 compared to healthy controls, especially observed in those with detectable HIV-RNA at baseline. Here, we used a two-dose prime-boost regimen to immunize with the BNT162b2 vaccine 63 PWH (median age: 53 years) on cART. We evaluated vaccine immunogenicity and safety, CD4+ T-cell count, CD8+ T-cell count, and viremia at baseline (day 0, first dose), day 21 (second dose), day 49, and day 77. Antispike antibodies were measured with LIAISON SARS-CoV-2 S1/S2 IgG test (DiaSorin). Statistical analyses were performed using MedCalc v.20.009 (MedCalc Software Ltd., Ostend, Belgium). Table 1(A) reports the characteristics of the study population. Overall, 34 individuals (53.9%) had a diagnosis of AIDS. Except for two patients, all subjects had an undetectable HIV-RNA level at baseline (61; 96.8%). Table 1 - (A) Baseline characteristics of the HIV-infected individuals who received two doses of the anti-COVID BTN162b2 mRNA vaccine; (B) geometric mean concentration (GMC) of the anti SARS-CoV-2 S1/S2 IgG at four time points. BTN162b2 immunizedHIV-infected individuals, N = 63 (A) Variable n (%) Sex Male 54 (85.7) Female 9 (14.3) BMI (kg/m2) 18.5–24.9 (normal-weight) 21 (33.3) 25–29.9 (over-weight) 32 (50.8) ≥30 (obese) 10 (15.9) Dual therapy 19 (30.2) INSTI regimen 25 (39.7) Undetectable HIV-RNA viral loada 61 (96.8) Median (IQR) Time since HIV (years) 12.6 (6.6–18.1) Nadir CD4+ T-cell count 170 (97–291) Zenith HIV-RNA viral load, log10 5.37 (5.04–5.55) Baseline CD4+ T-cell count 678 (501–909) Baseline CD8+ T-cell count 694 (514–963) (B) Time pointb GMC (95% CI) Day 1 4.38 (3.83–5.01) Day 21 44.94 (33.43–60.42) Day 49 376.72 (296.91–477.98) Day 77 158.85 (117.94–213.95) aLimit of quantification: 30 copies/ml.bTime points: day 1, pre-vaccination, first dose; day 21: second dose; day 49: 4 weeks after second dose; day 77: 8 weeks after second dose.BMI, body mass index; CI, confidence interval; GMC, geometric mean concentration; INSTI, integrase strand transfer inhibitor; IQR, interquartile range. Excluding two patients that were already reactive for antispike IgG at day 0, the responder rate was 86.9% (53/61) at day 21 and 100% (61/61) at day 49 (P = 0.008). The geometric mean concentration (GMC) of the antispike IgG at each time point is shown in Table 1(B). Compared with day 0, GMC significantly increased at days 21, 49 and 77 (P < 0.0001 for all comparisons). The highest GMC was reached at day 49, followed by a significant decrease at day 77 (P < 0.0001). This suggests a progressive weakening of the humoral protection from SARS-CoV-2 infection, and supports current recommendations for booster doses in PWH. The level of antibodies measured at day 21 in our patients was similar to that of healthy healthcare workers (HCW) immunized with the BNT162b2 vaccine in our Institute and analyzed using our same serological assay [2]. At day 49, antibody response was even higher in PWH than in HCW [2]. These findings stand in contrast with that by Xu et al.[1], who observed lower antispike IgG levels in PWH than controls. In our study, antibody levels did not differ significantly when stratifying according to sex, age (≤43 vs. >43 years), INSTI-based regimen, and dual therapy. In line with the results by Xu et al.[1], no significant differences in the antispike IgG levels after the second dose were found when we stratified according to body mass index (normal weight, overweight, and obese) and baseline CD4+ (≤500 vs. >500 cells/mm3), as confirmed in another two studies [3,4]. However, there is also some evidence that a baseline CD4+ count <200 cells/mm3 is associated with a significant decrease in the production of antibodies [5]. The antibody response measured up to day 49 was similar in all the patients irrespective of their nadir CD4+ count. Unexpectedly, at day 77, antibody levels were significantly higher in individuals with nadir CD4+ ≤200 compared to those with >200 cells/mm3. These two groups of patients did not significantly differ in terms of age and time since HIV diagnosis. Since others have reported no significant association between antibody response and nadir CD4+ in PWH immunized with anti-coronavirus disease 2019 (COVID-19) vaccines [6,7], caution is needed with regard to our results, especially given the low sample size. Nonetheless, it remains particularly important to establish whether and how nadir and current CD4+ counts may be predictors of anti-COVID-19 vaccination outcome. Notably, in the only two patients who were viremic at baseline, antibody levels after the second dose were in the lowest quartile, similarly to what reported by Xu et al.[1]. Importantly, we found that neither CD4+ nor CD8+ counts significantly varied following the anti-SARS-CoV-2 immunization. Conversely, significant declines in CD4+ have been described by others [8]. Two patients had a viral blip at day 21 and day 49, respectively, but HIV-RNA level returned to be undetectable at the last time point, confirming findings by Xu et al.[1] regarding lack of vaccine-induced viral blips. Only mild adverse events were observed. Mild pain at the injection site was the most common local adverse event (11/63; 17.5%). Asthenia, arthromyalgia and fever (<38°C) were the most common systemic adverse events (25/63; 39.7%). In conclusion, we showed that the BNT162b2 vaccine is safe and immunogenic in PWH in stable suppression and good immune recovery. Noteworthy, given the correlation between anti-S1/S2 IgG measured with LIAISON and neutralizing antibodies [9], protection from SARS-CoV-2 infection is inferable in our patients. The BNT162B2 vaccine induced limited adverse events, and had no effect on CD4+, CD8+ and viremia. Longer follow-up would be useful to monitor the humoral response over time. Acknowledgements The authors are thankful to Silvia Foracappa, Andrea Levi and Fulvia Roscini for their support in conducting the study. The authors thank Michael Kenyon for his review of the English language. Conflicts of interest There are no conflicts of interest. Funding: No specific funding was available for this study." @default.
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• W4285490623 title "High seroconversion rate after vaccination with mRNA BNT162b2 vaccine against SARS-CoV-2 among people with HIV – but HIV viremia matters?" @default.
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• W4285490623 doi "https://doi.org/10.1097/qad.0000000000003239" @default.
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