Concomitant administration of zoster and pneumococcal vaccines in adults ≥60 years old.

This study evaluated safety & immunogenicity of ZOSTAVAX® (zoster vaccine: ZV) administered concomitantly versus nonconcomitantly with PNEUMOVAX® 23 (pneumococcal vaccine: PPV23). This randomized, double-blind, placebo-controlled study enrolled 473 subjects ≥60 years old in 1:1 ratio to receive ZV & PPV23 concomitantly (Day 1) or nonconcomitantly (PPV23 Day 1, ZV Week 4). Blood samples obtained for pneumococcal polysaccharide (PnPs) antibody (Ab) testing by enzyme-linked immunosorbent assay (ELISA) and varicella-zoster virus (VZV) Ab testing by glycoprotein ELISA. Subjects followed for adverse experiences (AEs) for 28 days postvaccination. Mean baseline VZV geometric mean titers (GMT) in nonconcomitant group were lower than concomitant group. Four weeks postvaccination with ZV, VZV Ab response in concomitant group was not similar to nonconcomitant group; estimated VZV GMT ratio [concomitant/nonconcomitant] was 0.70 (95% CI, 0.61-0.80). VZV Ab response was acceptable in concomitant group; estimated geometric mean foldrise (GMFR) from baseline was 1.9 (95% CI, 1.7-2.1). PnPs serotype-specific Ab responses were similar in both groups. All 6 reported serious AEs were deemed not related to study vaccine. Postvaccination of ZV, incidence of injection-site AEs was similar in both groups; clinical AEs were numerically but not significantly higher in nonconcomitant group. In summary, VZV GMT Ab response induced by ZV administered concomitantly with PPV23 was inferior to that induced nonconcomitantly. These results indicate that, to avoid a potential decrease in ZV immunogenicity, ZV & PPV23 should not be given concomitantly. Concomitant administration did not affect response to PPV23 serotypes tested. When administered concomitantly, ZV & PPV23 vaccines were generally well tolerated.

Safety and efficacy of inactivated varicella zoster virus vaccine in immunocompromised patients with malignancies: a two-arm, randomised, double-blind, phase 3 trial.

BACKGROUND: Patients who are immunocompromised because of malignancy have an increased risk of herpes zoster and herpes zoster-related complications. We aimed to investigate the efficacy and safety of an inactivated varicella zoster virus (VZV) vaccine for herpes zoster prevention in patients with solid tumour or haematological malignancies. METHODS: This phase 3, two-arm, randomised, double-blind, placebo-controlled, multicentre trial with an adaptive design was done in 329 centres across 40 countries. The trial included adult patients with solid tumour malignancies receiving chemotherapy and those with haematological malignancies, either receiving or not receiving chemotherapy. Patients were randomly assigned (1:1) to receive four doses of VZV vaccine inactivated by γ irradiation or placebo approximately 30 days apart. The patients, investigators, trial site staff, clinical adjudication committee, and sponsor's clinical and laboratory personnel were masked to the group assignment. The primary efficacy endpoint was herpes zoster incidence in patients with solid tumour malignancies receiving chemotherapy, which was assessed in the modified intention-to-treat population (defined as all randomly assigned patients who received at least one dose of inactivated VZV vaccine or placebo). The primary safety endpoint was serious adverse events up to 28 days after the fourth dose in patients with solid tumour malignancies receiving chemotherapy. Safety endpoints were assessed in all patients who received at least one dose of inactivated VZV vaccine or placebo and had follow-up data. This trial is registered (NCT01254630 and EudraCT 2010-023156-89). FINDINGS: Between June 27, 2011, and April 11, 2017, 5286 patients were randomly assigned to receive VZV vaccine inactivated by γ irradiation (n=2637) or placebo (n=2649). The haematological malignancy arm was terminated early because of evidence of futility at a planned interim analysis; therefore, all prespecified haematological malignancy endpoints were deemed exploratory. In patients with solid tumour malignancies in the modified intention-to-treat population, confirmed herpes zoster occurred in 22 of 1328 (6·7 per 1000 person-years) VZV vaccine recipients and in 61 of 1350 (18·5 per 1000 person-years) placebo recipients. Estimated vaccine efficacy against herpes zoster in patients with solid tumour malignancies was 63·6% (97·5% CI 36·4 to 79·1), meeting the prespecified success criterion. In patients with solid tumour malignancies, serious adverse events were similar in frequency across treatment groups, occurring in 298 (22·5%) of 1322 patients who received the vaccine and in 283 (21·0%) of 1346 patients who received placebo (risk difference 1·5%, 95% CI -1·7 to 4·6). Vaccine-related serious adverse events were less than 1% in each treatment group. Vaccine-related injection-site reactions were more common in the vaccine group than in the placebo group. In the haematological malignancy group, VZV vaccine was well tolerated and estimated vaccine efficacy against herpes zoster was 16·8% (95% CI -17·8 to 41·3). INTERPRETATION: The inactivated VZV vaccine was well tolerated and efficacious for herpes zoster prevention in patients with solid tumour malignancies receiving chemotherapy, but was not efficacious for herpes zoster prevention in patients with haematological malignancies. FUNDING: Merck & Co, Inc.

High-risk drinking among college fraternity members: a national perspective.

This survey, with its 85% response rate, provides an extensive profile of drinking behaviors and predictors of drinking among 3,406 members of one national college fraternity, distributed across 98 chapters in 32 states. Multiple indexes of alcohol consumption measured frequency, quantity, estimated blood alcohol concentration levels (BACs), and related problems. Among all members, 97% were drinkers, 86% binge drinkers, and 64% frequent binge drinkers. On the basis of self-reports concerning the 4 weeks preceding the time of survey, the authors found that members drank on an average of 10.5 days and consumed an average of 81 drinks. Drinkers had an average BAC of 0.10, reaching at least 0.08 on an average of 6 days. These fraternity members appear to be heavier drinkers than previously studied fraternity samples, perhaps because they were more representative and forthright. All 6 preselected demographic attributes of members and 2 chapter characteristics were significantly related to the drinking behaviors and levels of risk, identifying possible targets for preventive interventions.

Contemporaneous relationship between substance abuse treatment and poly-substance use: evidence from the Persistent Effect of Treatment Studies.

Data from the Persistent Effect of Treatment Studies (PETS) are used to explore the relationship between duration of substance use treatment and simultaneous poly-substance using behaviors. Studying such contemporaneous relationships is especially important given the chronic nature of the substance-using population (McLellan, 2002) in the PETS study. Data were collected at intake to treatment programs and follow-up interviews were performed periodically at treatment program sites. One of the features of the analysis was the development of a poly-substance scale to measure multiple substance use. Multilevel models were implemented to examine the relationship between three levels of care (i.e., intensive outpatient, outpatient, and residential) and simultaneous poly-substance use. Contemporaneous effects of treatment were obtained such that higher duration of treatment was associated with drops in substance-using behaviors. This result supports the need for sustaining treatment for a population of chronic substance abusers.

The role of intent and harm in judgments of prejudice and discrimination.

Four experiments examined how an actor's intent and the harm experienced by a target influence judgments of prejudice and discrimination. The presence of intent increased the likelihood that participants judged an actor as prejudiced and the actor's behavior as discriminatory. When intent was uncertain, harm influenced judgments of the behavior, which in turn influenced judgments of the actor, and participants were more cautious in their judgments about an actor than an actor's behavior. Harm also played a stronger role in targets' than observers' judgments. Understanding the role of intent and harm on perceptions of prejudice can help explain variations in targets' versus observers', and possibly targets' versus actors', judgments of discrimination and prejudice.

Alcohol risk-reduction skills training in a national fraternity: a randomized intervention trial with longitudinal intent-to-treat analysis.

OBJECTIVE: The potential effectiveness of two group-administered social-skills training interventions for reducing high-risk drinking behavior was evaluated through a prospective randomized intervention trial with 3,406 members of a national college fraternity. METHOD: Ninety eight of 99 chapters of a national fraternity were randomly assigned, within three strata, to receive (1) a 3-hour baseline intervention, (2) the same baseline intervention plus two booster sessions, or (3) assessments only. The current article emphasizes a rigorous intent-to-treat analysis model that compares outcomes among members assigned to receive study interventions (vs assessment-only sites) regardless of whether they actually did receive them; it also includes individuals at intervention sites even if they did not participate. This model allows us to address a social policy issue regarding the effect that introducing such an intervention may have in changing the high-risk normative drinking environment of the fraternity itself. RESULTS: Frequent heavy drinkers (64.2% of members) assigned to either intervention showed significant reductions at a 6-month follow-up in their frequency of drinking, heavy drinking, and drinking to intoxication; plus, they reported consuming fewer drinks overall. At 12 and 18 months postbaseline, these positive outcomes had largely dissipated. Additionally, there was an increase in drinking among lower-risk members 18 months postbaseline, which may be the result of factors other than differential attrition. CONCLUSIONS: Findings suggest that introducing such a brief intervention can effectively reduce risky drinking behavior on a short-term basis in high-risk members of a national fraternity. Future studies may wish to focus on strategies for sustaining positive outcomes for longer, plus would benefit, in general, from learning more about mechanisms of change.