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Abstract: Using data from the D.C. Cohort Longitudinal HIV Study, we examined (a) diagnosed mental health and (b) cardiovascular, pulmonary, or cancer (CPC) comorbidity among adults with HIV who smoked. Among 8,581 adults, 4,273 (50%) smoked; 49% of smokers had mental health, and 13% of smokers had a CPC comorbidity. Among smokers, non-Hispanic Black participants had a lower risk for mental health (prevalence ratio [PR]: 0.69; 95% confidence interval [CI] [0.62-0.76]) but a higher risk for CPC (PR: 1.17; 95% CI [0.84-1.62]) comorbidity. Male participants had a lower risk for mental health (PR: 0.88; 95% CI [0.81-0.94]) and CPC (PR: 0.68; 95% CI [0.57-0.81]) comorbidity. All metrics of socioeconomic status were associated with a mental health comorbidity, but only housing status was associated with a CPC comorbidity. We did not find any association with substance use. Gender, socioeconomic factors, and race/ethnicity should inform clinical care and the development of smoking cessation strategies for this population., (Copyright © 2023 Association of Nurses in AIDS Care.)

To enable benchmarking of immunogenicity between candidate severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines, there is a need for standardized, validated immunogenicity assays. In this article, we report the design and criteria used to validate immunogenicity assays and the outcome of the validation of serologic and functional assays for the evaluation of functional immune response and antibody titers in human serum. A quantitative cell-based microneutralization (MNT) assay, utilizing a reference standard, for detecting anti-SARS-CoV-2 spike protein-neutralizing antibodies in human serum and Meso Scale Discovery's multiplex electrochemiluminescence (MSD ECL) assay for immunoglobulin G (IgG) antibodies to SARS-CoV-2 spike, nucleocapsid, and receptor-binding domain (RBD) proteins were assessed for precision, accuracy, dilutional linearity, selectivity, and specificity using pooled human serum from coronavirus disease 2019 (COVID-19)-confirmed recovered donors. Both assays met prespecified acceptance criteria for precision, relative accuracy, dilutional linearity, selectivity, and specificity. Both assays demonstrated high specificity for the different SARS-CoV-2 antigens or virus tested, and no significant cross-reactivity with seasonal coronaviruses. An evaluation to compare the neutralizing activity in the MNT assay to the IgG measured using the MSD ECL assay showed a strong correlation between the presence of neutralizing activity and amount of antibodies against the spike and RBD proteins in sera from both convalescent and vaccinated individuals. Finally, the MNT assay was calibrated to the WHO reference standard to enable reporting of results in international units, thus facilitating comparison of immunogenicity data generated by different assays and/or laboratories. The MSD ECL assay has previously been calibrated. In conclusion, these validated assays for the evaluation of functional immune response and antibody titers following SARS-CoV-2 vaccination could provide a relatively simple standardized approach for accurately comparing immune responses to different vaccines and/or vaccination regimens., Competing Interests: All authors are employees of PPD®, part of Thermo Fisher Scientific, located in Richmond, VA, USA and Wayne, PA, USA. They may own stock in PPD®, part of Thermo Fisher Scientific. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Gene therapy, cell therapy and vaccine research have led to an increased need to perform cellular immunity testing in a regulated environment to ensure the safety and efficacy of these treatments. The most common method for the measurement of cellular immunity has been Enzyme-Linked Immunospot assays. However, there is a lack of regulatory guidance available discussing the recommendations for developing and validating these types of assays. Hence, the Global CRO Council has issued this white paper to provide a consensus on the different validation parameters required to support Enzyme-Linked Immunospot assays and a harmonized and consistent approach to Enzyme-Linked Immunospot validation among contract research organizations.