Prospective safety surveillance study of ACAM2000 smallpox vaccine in deploying military personnel.

OBJECTIVES: To compare rates of myopericarditis, severe and serious dermatological or neurological events, and other adverse events in deploying US military personnel who received or did not receive ACAM2000® (Smallpox [Vaccinia] Vaccine, Live) vaccine and to evaluate potential risk factors for development of myopericarditis. METHODS: Prospective observational cohort study enrolling up to 15,000 ACAM2000 recipients (Cohort 1) and up to 5000 persons otherwise eligible for ACAM2000 vaccination but not vaccinated due to recency of vaccination or characteristics of their contacts (Cohort 2). Data and specimens were collected initially and 10 (6-17) days later. Those with clinical or laboratory evidence of possible myopericarditis were referred for further evaluation and adjudication by a blinded independent review committee. The adjusted odds ratio for myopericarditis was determined by a logistic regression model controlling for age, race, gender, and exercise regimen. RESULTS: 14,667 subjects provided initial data and specimens (Cohort 1, 10,825; Cohort 2, 3842); 12,110 (Cohort 1, 8945; Cohort 2, 3165) completed Visit 2 per-protocol. A total of 125 (Cohort 1, 111; Cohort 2, 14) were referred for myopericarditis adjudication, yielding 54 (Cohort 1, 44, Cohort 2, 10) subclinical myopericarditis, 5 suspected myocarditis, 1 confirmed myocarditis, and 1 suspected pericarditis. Unadjusted myopericarditis rates were: Cohort 1, 5.7/1000 (95% CI, 4.3-7.5); Cohort 2, 3.2/1000 (95% CI, 1.7-5.8). Unadjusted and adjusted odds ratios for myopericarditis were 1.8 (95% CI: 0.9-3.6) and 1.3 (95% CI: 0.6-2.6), respectively. One hundred seventeen subjects (1.1%) in Cohort 1 and 13 (0.3%) in Cohort 2 experienced at least 1 serious adverse event. No instances of serious and severe neurological or dermatological adverse events were reported. CONCLUSIONS: In this carefully screened, generally young and healthy service-member population, ACAM2000 vaccination was associated with modest non-significant increases in the risk of myopericarditis (adjusted OR, 1.3; unadjusted OR, 1.8); all but seven cases were subclinical. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov NCT00928577.

Morning Cortisol Is Associated With Stress and Sleep in Elite Military Men: A Brief Report.

INTRODUCTION: Accumulating evidence suggests that trends in salivary cortisol after awakening may be reliable biological predictors of morbidity and mortality. In a sample of elite military men, our lab recently established summary parameters of morning cortisol as well as their stability across 2 d of repeated sampling. MATERIALS AND METHODS: In this follow-on study, we evaluated summary parameters and their relationships to theoretically relevant demographic (i.e., age, body mass index) and biobehavioral correlates (i.e., blood pressure [BP], sleep parameters, fatigue, and perceived stress). Fifty-eight male active duty U.S. Navy SEALs self-collected salivary samples on 2 consecutive, midweek workdays upon waking (WAKE), WAKE+30 min, WAKE+60 min, 4 p.m., and 9 p.m. in a nondeployed, free-living setting. Resting BP was measured manually, and sleep-wake periods were objectively derived using actigraphy. Daily fatigue and perceived stress were measured by self-report. Summary parameters of morning cortisol magnitude (i.e., peak value [Peak], area under the curve in terms of ground [AUCG], and average of morning samples [AVE]) were assessed with respect to each demographic and biobehavioral item via correlational analyses. A subgroup of 29 participants was selected for compliance with salivary sampling in the morning across 2 d. RESULTS: Perceived stress was positively associated with Peak (r[27] = 0.437, p < 0.05), AUCG (r[25] = 0.500, p < 0.01), and AVE (r[25] = 0.506, p < 0.01). Total sleep time was also positively associated with Peak (r[26] = 0.378, p < 0.05). There were borderline associations between some summary parameters and diastolic BP, percent sleep, and wake after sleep onset. Age, systolic BP, body mass index, time in bed, sleep efficiency, and fatigue did not associate with morning cortisol. CONCLUSIONS: Preliminary evidence of morning cortisol summary parameters as biobehavioral indicators was established, and these parameters appeared to associate with stress and sleep in elite military men.