ABSTRACT
Candidate HIV vaccines are designed to induce antibodies to various components of the HIV virus. An unintended result of these antibodies is that they may also be detected by commercial HIV diagnostic kits designed to detect an immune response to HIV acquisition. This phenomenon is known as Vaccine-Induced Seropositivity/Reactivity (VISP/R). In order to identify the vaccine characteristics associated with VISP/R, we collated the VISP/R results from 8,155 participants from 75 phase 1/2 studies and estimated the odds of VISP/R by multivariable logistic regression and 10-year estimated probability of persistence in relation to vaccine platform, HIV gag and envelope (env) gene inserts, and protein boost. Recipients of viral vectors, protein boosts, and combinations of DNA and viral-vectored vaccines had higher odds of VISP/R compared to those who received DNA-only vaccines (odds ratio, OR = 10.7, 9.1, 6.8, respectively, p<0.001). Recipients of gp140+ env gene insert (OR = 7.079, p<0.001) or gp120 env (OR = 1.508, p<0.001) had higher odds of VISP/R compared to those participants who received no env. Recipients of gp140 protein had higher odds of VISP/R than those that did not receive protein (OR = 25.155, p<0.001), and recipients of gp120 protein, had lower odds of VISP/R than those that did not receive protein (OR = 0.192, p<0.001). VISP/R persisted at 10 years in more recipients of env gene insert or protein compared to those who did not (64% vs 2%). The inclusion of gag gene in a vaccine regimen had modest effects on these odds and was confounded by other covariates. Participants receiving gp140+ gene insert or protein were most often reactive across all serologic HIV tests. Conclusions from this association analysis will provide insight into the possible impact of vaccine design on the HIV diagnostic landscape and vaccinated populations.
ABSTRACT
BACKGROUND: There is limited data on the difference in the clinical characteristics and outcomes of patients with severe coronavirus disease 2019 (COVID-19) infection in the summer compared to the fall surge. AIM: To compare the sociodemographic, clinical characteristics, and outcomes among mechanically ventilated patients with severe COVID-19 infection admitted to the intensive care unit (ICU) during the summer and fall surges in the year 2020. METHODS: We included patients admitted to the ICU and treated with invasive mechanical ventilation for COVID-19 associated respiratory failure between April 1 and December 31, 2020. Patients were categorized into summer surge for ICU admissions between June 15, 2020, and August 15, 2020, and fall surge between October 15, 2020, and December 31, 2020. We compared patients' characteristics and outcomes using descriptive and inferential statistics. RESULTS: A total of 220 patients were admitted to the Grady Memorial Hospital ICU and mechanically ventilated for COVID-19 associated hypoxemic respiratory failure during the period considered (125 during the summer surge and 95 during the fall surge). More women were admitted in the fall compared to summer (41.1% vs 36.8%, difference, 4.3%; 95%CI: 1.2, 7.5). Patients admitted in the fall had fewer comorbidities (chronic obstructive pulmonary disease, stroke, diabetes mellitus, obstructive sleep apnea and body mass index ≥ 35 kg/m2). Overall, patients in the fall had a lower ICU mortality rate (27.4% vs 38.4%, difference, -11.0; 95%CI: -6.4, -18.2), shorter length of stay on the mechanical ventilator (7 d vs 11 d, difference, 4 d; 95%CI: 2.1, 6.6) and shorter ICU length of stay (9 d vs 14 d, difference, 5 d; 95%CI: 2.7, 9.4). CONCLUSION: Patients admitted with severe COVID-19 infection requiring mechanical ventilation had better outcomes in the fall than summer. This difference observed is likely attributable to a better understanding of the condition and advances in treatment strategies.
ABSTRACT
BACKGROUND: Experimental human immunodeficiency virus (HIV)-1 vaccines frequently elicit antibodies against HIV-1 that may react with commonly used HIV diagnostic tests, a phenomenon known as vaccine-induced seropositivity/seroreactivity (VISP/VISR). We sought to determine, under clinic conditions, whether a patient-controlled HIV test, OraQuick ADVANCE Rapid HIV-1/2 Antibody Test, detected HIV-1 vaccine-induced antibodies. METHODS: Plasma assessment of HIV-1 cross-reactivity was examined in end-of-study samples from 57 healthy, HIV-uninfected participants who received a candidate vaccine that has entered Phase 2B and 3 testing. We also screened 120 healthy, HIV-uninfected, unblinded HIV-1 vaccine participants with VISP/VISR for an assessment using saliva. These participants came from 21 different parent vaccine protocols representing 17 different vaccine regimens, all of which contained an HIV-1 envelope immunogen. OraQuick ADVANCE was compared with results from concurrent blood samples using a series of commercial HIV screening immunoassays. RESULTS: Fifty-seven unique participant plasma samples were assayed in vitro, and only 1 (1.8%) was reactive by OraQuick ADVANCE. None of the 120 clinic participants (0%; 95% confidence interval, 0% to 3.7%) tested positive by OraQuick ADVANCE, and all were confirmed to be uninfected by HIV-1 viral ribonucleic acid testing. One hundred eighteen of the 120 (98.3%) participants had a reactive HIV test for VISP/VISR: 77 (64%) had at least 1 reactive fourth-generation HIV-1 diagnostic test (Pâ <â .0001 vs no reactive OraQuick ADVANCE results), and 41 (34%) only had a reactive test by the less specific third-generation Abbott Prism assay. CONCLUSIONS: These data suggest that this widely available patient-controlled test has limited reactivity to HIV-1 antibodies elicited by these candidate HIV-1 vaccines.
