Immunogenicity and Safety of BNT162b2 Homologous Booster Vaccination in People Living with HIV under Effective cART

Abstract

Data on COVID-19 boosting vaccination in people living with HIV (PLWH) are scant. We investigated the immunogenicity and safety of the BNT162b2 homologous boosting vaccination. Anti-SARS-CoV-2 spike antibodies (LIAISON® SARS-CoV-2 S1/S2 IgG test, DiaSorin®), CD4+, CD8+ and viraemia were monitored at T0 (pre-vaccination), T1 (4 weeks after the second dose), T2 (pre-booster) and T3 (4 weeks after the booster dose). Humoral responses were evaluated according to sex, age, BMI, nadir and baseline CD4+ counts, as well as type of cART regimen. Forty-two subjects were included: the median age was 53 years (IQR: 48–61); the median time since HIV was 12.4 years (IQR: 6.5–18.3); the median nadir and baseline CD4+ counts were 165 (IQR: 104–291) and 687 cells/mm3 (IQR: 488–929), respectively. The booster dose was administered at a median of 5.5 months after the second dose. Median anti-SARS-CoV-2 IgG concentration had significantly decreased at T2 compared to T1 (107 vs. 377, p < 0.0001). Antibody levels elicited by the booster dose (median: 1580 AU/mL) were significantly higher compared with those of all the other time points (p < 0.0001). None of the investigated variables significantly affected antibody response induced by the booster dose. Local and systemic side-effects were referred by 23.8% and 14.3% of the subjects, respectively. One patient developed sensorineural hearing loss (SNHL) 24 h after boosting. He recovered auditory function upon endothympanic administration of corticosteroids. The BNT162b2 boosting vaccination in PLWH is safe and greatly increased the immune response with respect to the primary vaccination.

COVID-19 vaccine immunogenicity in people with HIV

“…Similarly to our study, a fewer proportion of individuals with lower CD4 + cell counts mounted detectable antibody responses, but this proportion increased with increasing vaccine doses [ 10 ]. Furthermore, we did not find that ability to mount antibody responses was affected by sex, age, baseline CD4 + cell count, a finding which is in keeping with other studies [ 11 ].…”

“…In our study, age did not influence COVID-19 vaccine response. Similar to findings of other reports [ 10 , 11 , 12 ], our data suggest that PWH may retain antibodies for a shorter duration of time following initial vaccination when compared with controls, with a 3rd vaccine dose resulting in improved levels of immune response. We believe that our data support timely, serial booster administration to PWH.…”

“…There is evidence for sex-based differences in humoral immune response with certain types of vaccinations in HIV-negative populations [29]. However, we and others have not observed any sex difference in the context of COVID-19 vaccination [10–12,19].…”

Humoral Response after Two Doses of BNT162b2 mRNA Vaccine Has a Role in Predicting Response after Three Doses That Is Related to Plasma HIV Viremia and Nadir CD4+ Cell Count in HIV-Positive Patients

“…A few works reported data for HIV patients receiving mRNA-based vaccines; the efficacy of the third dose was confirmed in all reports, but the study designs differed from ours in terms of patient characteristics, the interval between third dose, and antibody testing. HIV patients had a median CD4+ cell count <200 cell/mm 3 and/or a previous AIDS diagnosis at the first vaccine dose per protocol in the work of Vergori et al [ 19 ] and a median CD4+ cell count >600 cells/mm 3 in the other studies [ 20 , 21 ]. The time from the third dose was lower (range 2–8 weeks) [ 19 , 20 , 21 ], and the humoral response was assessed with anti-S/RBD tests or with antitrimeric spike-protein-specific IgG [ 19 , 20 ].…”

“…HIV patients had a median CD4+ cell count <200 cell/mm 3 and/or a previous AIDS diagnosis at the first vaccine dose per protocol in the work of Vergori et al [ 19 ] and a median CD4+ cell count >600 cells/mm 3 in the other studies [ 20 , 21 ]. The time from the third dose was lower (range 2–8 weeks) [ 19 , 20 , 21 ], and the humoral response was assessed with anti-S/RBD tests or with antitrimeric spike-protein-specific IgG [ 19 , 20 ].…”