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    • Despite the increased risk for infections

    2021-12-09

    Despite the increased risk for infections and the widespread availability of vaccines, reported vaccine coverage rates among HIV-infected adult patients are low [17], [18], [19], [20], [21]. Data from two studies in the United States suggested that influenza vaccination coverage among HIV-infected patients ranged between 25% and 43%, and that patients with a lower CD4+ T-cell count and higher HIV RNA viral load were less likely to have received influenza vaccine [19], [20]. Reasons for the low vaccine coverage rates among HIV-infected patients are likely multifactorial [22], including fear of side effects and adverse impact on HIV disease [23]. However, there are no substantive data to support the notion that influenza, pneumococcal, and SBI-0206965 vaccines adversely affect the overall health of HIV patients or accelerate disease progression [24], [25], [26], [27], [28], [29], [30]. Currently, safety data for tetanus-diphtheria and tetanus-diphtheria-acellular pertussis vaccines (Td/Tdap) are not available among HIV-infected adults. Furthermore, most of the previous vaccine safety studies among HIV-infected patients had small sample sizes and were not powered to detect rare adverse events (AEs). Those previous studies used HIV-uninfected populations as a comparison group, thus estimated risk ratio of vaccine induced AEs is subject to confounding by the effect of impaired immune response in HIV-infected patients because the underlying risks in HIV-infected individuals are expected to be different from that in HIV-uninfected patients.
    Methods
    Results Among all patients receiving any type of vaccine of interest, a small elevated risk for cellulitis and infection in the 1–7 days following vaccination was detected (RR: 1.18, 95% CI: 1.03–1.35) (Table 1). There was no significant increased risk for other AEs following vaccination. In analyses stratified by whether patients received more than one type of vaccine on the same day (i.e., concomitant vaccination, n = 11156, 9% of the total sample), a slightly elevated risk for cellulitis and infection was also observed among patients who did not receive concomitant vaccine (RR: 1.17, 95% CI: 1.02–1.34); while the point estimate of the relative risk among those who received concomitant vaccination was slightly higher, but it was not statistically significant (RR: 1.35, 95% CI: 0.86, 2.11). In stratified analyses by vaccine type (influenza, HBV, or bacterial vaccines including PPSV23/PCV13 and Td/Tdap), an elevated risk for cellulitis and infection was only observed among patients who received bacterial vaccines (RR: 1.88, 95% CI: 1.48–2.40), while there was no significant risk detected after either influenza vaccination or HBV vaccination. We did not observe an elevated risk of any other AE regardless of concomitant vaccination or the type of vaccine. Baseline CD4+ T-cell count was < 200 cells/mm3 in 8% of patients and ≥500 cells/mm3 in 53% of patients. In analyses stratified by baseline CD4+ T-cell count, a small but statistically significant risk for cellulitis was observed among patients with baseline CD4+ T-cell count ≥ 500 cells/mm3 (RR: 1.25, 95% CI: 1.03–1.52). We also observed a small risk of cellulitis among patients with baseline CD4+ T-cell count < 200 cells/mm3 (RR: 1.11, 95% CI: 0.75–1.65), but the association did not reach statistical significance, potentially due to the small sample size of this subgroup (n = 9,216). No significant elevated risk was identified for other AEs in analyses stratified by baseline CD4+ T-cell count; however, we observed a non-statistically significant elevated risk for stroke and cerebrovascular diseases (adjusted RR: 1.79, 95% CI: 0.65–4.91) among patients with a baseline CD4+ T-cell count < 200 cells/mm3. In stratified analyses by HIV RNA viral load, we detected a significantly elevated risk for stroke and cerebrovascular diseases (RR: 3.94, 95% CI: 1.32–11.72) among patients with a baseline viral load greater than 10,000 copies/ml, based on data from 11,339 unique vaccination dates (Table 2). There was no elevated risk among those with a baseline viral load < 10,000 copies/ml. When we further stratified the analysis by vaccine type among those who had a baseline HIV RNA viral load greater than 10,000 copies/ml, we observed elevated risks for stroke and cerebrovascular diseases following influenza vaccine, HBV vaccine, and PPSV23/PCV13, but the estimates for adjusted RRs were not statistically significant and the confidence intervals were wide (Table 3). The adjusted RR for stroke and cerebrovascular diseases following Td/Tdap vaccine among those with viral load greater than 10,000 copies/ml was not estimated, as there were no cases identified during the comparison window.