Westat (United States)

Surveillance of COVID-19 vaccine effectiveness (VE) was extensive upon vaccine introduction; however, it declined after the withdrawal of pandemic status in May 2023. Continued monitoring of updated vaccine formulations is needed to ensure the maintenance of VE in the face of evolving viral strains. The Booster Epidemiological Evaluation of Health, Illness and Vaccine Efficacy (BEEHIVE) study (NCT06065176), a randomized trial with a hybrid design, was developed to assess the real-world VE of the 2023-2024 Pfizer-BioNTech and Novavax COVID-19 vaccine formulations targeting the XBB.1.5 SARS-CoV-2 variant. This study was designed to enroll approximately 1500 participants aged ≥18 years from the Salt Lake City, Utah, area who had previously received ≥2 doses of an authorized messenger RNA (mRNA)-based COVID-19 vaccine but had not received a dose of the 2023-2024 formulation. The study used a randomized, hybrid design comprising 2 blinded groups assigned to receive the 2023-2024 formula of either the Novavax COVID-19 vaccine or the Pfizer-BioNTech COVID-19 vaccine and a nonrandomized, observational control group of volunteers who chose not to receive a 2023-2024 vaccine dose during the study. Follow-up lasted 24 weeks and included symptom surveys and self-administered COVID-19 antigen testing, both occurring weekly. The primary aim was to compare VE (defined as prevention of symptomatic SARS-CoV-2 infection) between study-vaccinated participants and the control group. The secondary aim was to determine the relative VE of the Pfizer-BioNTech mRNA and Novavax 2023-2024 COVID-19 vaccines. Secondary objectives included assessing how the number of previous COVID-19 vaccinations impacted VE of the 2023-2024 COVID-19 vaccines; identifying predictors and associated factors for asymptomatic versus symptomatic infection and/or prolonged or severe illness; examining factors associated with post-COVID-19 conditions; and evaluating participants' knowledge, attitudes, and practices related to COVID-19 vaccination. Participant engagement was maintained via online and text-based reminders and surveys, as well as researcher follow-up. Participants were recruited from November 2023 through March 2024, with 452 and 457 participants randomized to the Novavax and Pfizer-BioNTech vaccine groups, respectively, and 279 participants enrolled in the control group. SARS-CoV-2 variants from the XBB, JN.1, KP.2, and KP.3 lineages were in circulation in the United States and the Utah region during data collection. The study ended on September 9, 2024, with results expected to be published in 2026. Data from this study will provide valuable real-world VE data for a dose of the Novavax COVID-19 vaccine or the Pfizer-BioNTech COVID-19 vaccine after an mRNA-based COVID-19 primary series. ClinicalTrials.gov NCT06065176; https://www.clinicaltrials.gov/study/NCT06065176. RR1-10.2196/80858.

Abstract Background Respiratory syncytial virus (RSV) caused approximately 100,000-160,000 hospitalizations annually in adults aged ≥60 years in the United States (US) before RSV vaccine introduction. In 2023, two vaccines were recommended for prevention of severe RSV disease in adults aged ≥60 years using shared clinical decision making. In 2024, a third product was licensed, and all three available vaccines were recommended for all adults aged ≥75 years and for adults aged 60-74 years at increased risk of severe RSV disease. We assessed post-licensure vaccine effectiveness (VE) to inform future recommendations and public communications. Methods VISION is a multi-site electronic health record-based study including >200 hospitals in the US. Adults aged ≥60 years hospitalized with RSV-like illness and tested for RSV were included. Cases had a positive molecular or antigen RSV test; controls had a negative molecular RSV test. Critical illness included admission to the intensive care unit or in-hospital death. VE against hospitalization and critical illness was calculated using a test negative design as (1-adjusted odds ratio) x 100% where the odds ratio compares odds of vaccination in cases and controls after adjusting for confounders. Results were stratified by time since RSV vaccination, age group, and immunocompromised status. Results Among 83,652 hospitalizations during October 2023-March 2024 and October 2024-March 2025, VE was 62% (95% CI: 56-67%, Table) against RSV-associated hospitalization, median 279 days after RSV vaccination. VE was 83% (95% CI: 73-89%) at 14-59 days after vaccination and 42% (95% CI: 30-53%) at least 1 year after vaccination (median 429 days). VE against RSV-associated critical illness was 69% (95% CI: 55-78%), median 277 days after vaccination. VE was similar by age group and among those with and without immunocompromising conditions. Conclusion RSV vaccines are effective at preventing severe RSV and have the potential to reduce the burden of RSV-associated hospitalizations among older adults, although waning protection was apparent during the second season after vaccination. Ongoing monitoring of RSV VE is warranted to ensure vaccines are working as expected, to understand duration of protection, and to inform policy decisions. Disclosures All Authors: No reported disclosures

Abstract Background The integration of biomeasures into social surveys has grown rapidly, enabling new insights into biosocial processes by combining probability-based survey data with biological indicators. However, biomeasure collection outside clinical settings introduces unique sources of error that are not fully addressed by traditional survey methodology frameworks. This paper adapts the Total Survey Error (TSE) framework to account for the distinctive challenges of biomeasure data collection in surveys. Methods We review the stages of biomeasure data collection in social surveys and systematically map them onto the TSE framework. We extend the framework to identify new error sources, including biomeasure nonresponse, data loss during transmission, laboratory and batch effects, and interviewer-related biases. The discussion draws on evidence from large-scale biosocial surveys and methodological studies, highlighting trade-offs between different sources of error and the implications for study design, data processing, and analysis. Results Our extended framework demonstrates that biomeasure collection adds multiple new opportunities for error across both selection and measurement processes. On the selection side, additional nonresponse mechanisms—such as refusal to consent to biological collection or ineligibility due to physical characteristics—can create systematic biases. On the measurement side, issues such as interviewer variability, shipment and storage conditions, laboratory practices, and batch effects can significantly influence data quality. Trade-offs emerge between maximizing measurement precision and minimizing participation bias, between standardization in clinical contexts and ecological validity in household settings, and between cost constraints and optimal data integrity. Conclusions The adapted TSE framework provides a structured approach to evaluating and minimizing errors in biomeasure data collection in social surveys. Recognizing and addressing new sources of error is essential for producing valid and generalizable biosocial research. Future work should focus on developing standardized protocols, improving interviewer and nurse training, expanding feasible self-collection methods, and quantifying the relative magnitude of different error sources. By systematically incorporating biomeasures into probability-based surveys while accounting for these challenges, researchers can strengthen the reliability and policy relevance of biosocial findings.

Disclosure: K.J. Patterson: None. H.B. Chin: None. M.A. Adgent: None. A. Kelly: None. V.A. Stallings: None. S. Patchel: None. W.J. Rogan: None. D.M. Umbach: None. N. Shaw: None. M. Goldberg: None.Background: Boys experience accelerated somatic and reproductive organ growth during minipuberty of infancy, the transient postnatal activation of the hypothalamic-pituitary-gonadal axis that is associated with increased testosterone production. Previous studies have observed positive associations of testosterone levels with linear growth velocity and penile length in infant boys. Most studies reported relatively weak associations; however, many were based on cross-sectional data. In addition, while testosterone is the standard treatment to increase penile length in infant boys with micropenis, this treatment may lead to supra-physiological levels; as such, it may not be relevant to penile growth in healthy infant boys. Thus, whether penile and somatic growth are influenced by testosterone levels that fall within the normal range in infant boys remains unclear. Hypothesis: Higher testosterone levels will be positively correlated with rate of growth in length, weight, and stretched penile length (SPL) during the first 3 months of life in healthy infant boys. Methods: We used data from 129 infant boys in the Infant Feeding and Early Development Study, a prospective cohort of reproductive development in term, singleton infants enrolled during 2010-2013 from the Philadelphia area. We measured serum testosterone (ng/dL) at the 2-week study visit via mass spectrometry. We measured length (cm), weight (kg), and SPL (cm) at the neonatal (0-3 days of age) and 12-week visits. We calculated the average rate of growth per day by subtracting the neonatal measure from the 12-week measure and dividing by the difference in age in days between the two assessments. We assessed associations of testosterone concentrations with rates of penile and somatic growth using Pearson correlation coefficients (r). We further examined the association of testosterone with penile growth rate using linear regression models adjusted for SPL at the neonatal visit, neonatal weight, or rate of weight gain. Results: Most infants were Black (69%) and fed either soy formula (36%) or cow’s milk formula (36%). The mean testosterone at the 2-week visit was 197 ng/dL (SD=103). Mean SPL was 3.6 cm (SD=0.5) at the neonatal visit and increased to 4.4 cm (SD=0.5) at the 12-week visit. Testosterone was not correlated with rate of growth in length (r=-0.05, p=0.56), weight (r=-0.07, p=0.44), or SPL (r=0.06, p=0.51). Results for penile growth were also null in adjusted models. Conclusions: In this longitudinal cohort of healthy infant boys, testosterone was not associated with somatic growth or growth of the penis. These data may indicate that the testosterone level per se is not critical for normal growth as long as a critical threshold is exceeded. Other factors such as genetics, environment, and androgen receptor activity may have a greater influence on somatic and/or reproductive growth during infancy and deserve further study.Presentation: Sunday, July 13, 2025

This study examined the main and interactive effects of sex, cigarette smoking status, cigarette pack-years, and second-hand smoke exposure on COPD prevalence and incidence. COPD prevalence was estimated for US adults aged 40+ years from Wave 1 of the Population Assessment of Tobacco and Health Study (n = 12 296). Incidence analyses included adults from the initial sample without a COPD diagnosis (n = 6611). Multivariable Poisson regressions assessed prevalence and incidence based on self-reported sex and cigarette smoking, adjusted for covariates. COPD prevalence was 7.4% and 9.4% and incident COPD was 5.0% and 8.7% for males and females, respectively. The adjusted prevalence ratio (aPR) for COPD for females was 1.26 [95% CI = 1.11, 1.44], and the adjusted risk ratio (aRR) for incident COPD was 1.73 [1.41, 2.12]. Stratified by smoking status, female (vs. male) sex was associated with aPRs of 1.26 [1.10, 1.44] and 1.35 [0.98, 1.84] and aRRs of 1.32 [1.00, 1.75] and 2.58 [1.79, 3.72] for adults who ever or never smoked, respectively. Smoking status (p= .003) and pack-years (p= .006) increased risk of COPD incidence for both males and females, but to a greater extent for males. Female sex was associated with significantly higher COPD incidence, which was not explained by cigarette smoking, second-hand smoke exposure, e-cigarette use, or other covariates. Cigarette-related COPD risk factors increased risk of COPD incidence for both males and females but to a greater extent for males. Future research can include examining alternative risk factors or diagnostic biases contributing to higher incident COPD among females. Prior studies show that COPD prevalence has been increasing for women in the United States, but the basis for this change remains unclear. This study shows how female (vs. male) sex is associated with significantly increased risk for COPD prevalence and incidence among a nationally representative sample of older (aged ≥40 years) US adults using data from 2013 to 2019, which was not accounted for by cigarette smoking, second-hand smoke exposure, e-cigarette use, or other covariates. Work is needed on alternative COPD risk factors or diagnostic biases contributing to higher incident COPD among females.

Health coaching is a field that is growing in popularity. Health coaching is not regulated and there is no standard for background, education, or training for those acting as health coaches. The purpose of this study was to investigate the burgeoning field of health coaching: who is performing it and common practices. A total of 560 health coaching websites were reviewed to record educational backgrounds, recommendations for supplements, and the sale of supplements and/or other wellness products. Multivariable logistic regression was used to test associations between characteristics of health coaches and whether they recommend supplements, sell supplements, or sell other wellness products. The sample was mostly female without an applicable associate or bachelor's degree listed practicing without national board certification. Twenty-nine percent recommended supplements, approximately 17% sold supplements, and 17% sold other wellness products. Of those without national board certification, nearly a quarter sold supplements. Multivariable logistic regression was used to identify associations between characteristics and supplement recommendations or selling supplements or other wellness products. As health coaching develops, it is important to understand who is practicing as a health coach and common health coaching practices in the field.