Evaluation of a single dose of diphtheria toxoid among adults in the Republic of Georgia, 1995: immunogenicity and adverse reactions

To determine the immunogenicity and safety of a single dose of diphtheria toxoid among adults, blood samples for detecting serum antitoxin levels were obtained from 18- to 59-year-old subjects (n=248) before and 30 days after immunization with Td (tetanus-diphtheria toxoids; manufactured by Serum Institute of India). By day 30, the seroprevalence of antitoxin levels >/=0.1 IU/mL increased from 22.6% to 81.5%; median antitoxin levels increased from 0.01 to 4.0 IU/mL. These parameters were lowest among subjects who were 40-59 years old, especially among those 40-49 years old. Adverse reactions (local redness, swelling, induration, fever>39 degrees C) were reported by 5.3% of participants. Our findings suggest that, in general, one dose of the Indian-produced Td vaccine is efficacious and safe in inducing an adequate immune response against diphtheria in adults; however, in Georgia, persons 40-59 years old, especially those 40-49 years old, will require additional doses of toxoid to achieve protective levels of antitoxin.     

Depression and adverse drug reactions among hospitalized older adults

BACKGROUND: Depression is a common disorder among hospitalized older adults, and it has been associated with adverse outcomes during hospital stays, including increased risk of morbidity and mortality and reduced recovery rates from illness and disability. The aim of this study was to assess whether depression may be a risk factor for adverse drug reactions (ADRs) among hospitalized older adults. METHODS: A total of 3134 older patients admitted to 23 hospitals throughout Italy between May 1 and June 30 and September 1 and October 31, 1998, entered the study. Patients with a short-form Geriatric Depression Scale score of 5 or greater were considered depressed. Adverse drug reactions observed during hospital stays and classified as definite or probable on the basis of the Naranjo algorithm were considered for this study. RESULTS: During the hospital stays, 192 ADRs were identified in 183 patients (5.8% of the sample). Cardiovascular and arrhythmic complications (20.3% of all ADRs) were the most frequent ADRs, followed by gastrointestinal (18.8%), dermatologic and allergic (12.5%), hemorrhagic (11.5%), and electrolyte (9.9%) disturbances. Adverse drug reactions were recorded in 101 (7.4%) of 1363 depressed patients and in 82 (4.6%) of 1771 nondepressed patients (P =.001). After adjusting for potential confounders, depression was associated with a significantly higher rate of ADRs (odds ratio, 1.58; 95% confidence interval, 1.14-2.20; P =.006). This effect seemed more pronounced in women (odds ratio, 1.85; 95% confidence interval, 1.16-2.95) than in men (odds ratio, 1.38; 95% confidence interval, 0.85-2.34). CONCLUSION: In older hospitalized patients, depression seems to be associated with a greater occurrence of ADRs.     

Assessment of vaccination coverage among adults 30-49 years of age following a mass diphtheria vaccination campaign: Ukraine, April 1995

Ukraine has been experiencing epidemic diphtheria since 1991. In efforts to control this epidemic, a mass vaccination campaign was held in April 1995. Persons not vaccinated in the previous 3 years were considered eligible for vaccination with tetanus-diphtheria toxoids (Td). Two cluster sample surveys were conducted to determine vaccination coverage achieved. In the urban and rural survey areas, respectively, 628 and 618 persons 30-49 years of age were interviewed. Fifty-nine percent of urban and 58% of rural participants were eligible for vaccination. During the vaccination campaign, 58% (95% confidence interval [95% CI], 47.1-69.2) of eligible persons received Td in the urban area, compared with 92% (95% CI, 89.2-95.3) in the rural area. Apparent barriers to vaccination included misconceptions about the safety, efficacy, and need for booster doses of Td. Future vaccination campaigns should include targeted information and education messages. Mass vaccination campaigns can be successful in vaccinating large numbers of adults; however, in urban areas, additional efforts may be required to achieve levels of coverage adequate to confer herd immunity and interrupt the diphtheria epidemic.     

Population-based incidence of pertussis among adolescents and adults, Minnesota, 1995-1996

To estimate the incidence of pertussis, a prospective study was done among members of a managed care organization in Minneapolis/St. Paul, Minnesota. Of 212 patients 10-49 years old enrolled from January 1995 through December 1996, 8 were found to be culture positive, 10 were found to be positive by polymerase chain reaction assay, 13 had a > or =2-fold increase in IgG or IgA to pertussis toxin (PT), and 18 had IgG to PT in a single serum specimen > or =3 SD above the mean of an age-matched control group. At least 1 positive laboratory test result for pertussis infection was found in 27 (13%) patients, among whom the duration of cough illness was a median of 42 days (range, 27-66 days). On the basis of any positive laboratory result, the estimated annual incidence of pertussis was 507 cases per 100,000 person-years (95% confidence interval, 307-706 cases). Bordetella pertussis infection may be a more common cause of cough illness among adolescents and adults than was recognized previously.     

Evaluation of a single daily dose of naproxen in osteoarthritis

A six-week double-blind randomized cross-over trial comparing the safety and efficacy of 250 mg naproxen administered twice daily and 500 mg naproxen administered as a single dose at night in osteoarthritic patients stabilized on naproxen 250 mg twice daily is reported. There was no significant difference between the two regimens. This study provides evidence that naproxen can be given to patients with osteoarthritis on a single-daily-dose regimen without any loss of anti-inflammatory/analgesic activity.     

Varicella among adults: data from an active surveillance project, 1995-2005

We report detailed population-based data on varicella among adults. In 2 US varicella active surveillance sites with high vaccine coverage among young children, the incidence of varicella among adults declined 74% during 1995-2005. A low proportion (3%) of adults with varicella had been vaccinated, with no improvement over the decade of program implementation, suggesting that the decline was likely secondary to herd-immunity effects. Compared with children, adults had more severe varicella in terms of both clinical presentation and frequency of complications. However, <30% of adults with varicella were treated with acyclovir. Among adolescents, illness severity was intermediate between that in children and adults. Varicella cases are preventable through vaccination. As we enter the second decade of the varicella vaccination program in the United States, we need to ensure that susceptible adolescents and adults are adequately protected from varicella by vaccination and that those who acquire varicella are appropriately treated with effective antiviral treatment.     

Longitudinal perspective: adverse childhood events, substance use, and labor force participation among homeless adults

OBJECTIVES: We examined the long-term effects of adverse childhood events on adulthood substance use, social service utilization, and subsequent labor force participation. METHODS: A county-wide probability sample of 397 homeless adults was interviewed three times in a 15-month period. By using a path model, literature-based relationships between adverse childhood events and labor force participation with the mediating effects of adulthood substance use and service use were tested. RESULTS: Adverse childhood events were precursors to adulthood alcohol and drug use. Consistent substance use was negatively associated with long-term labor force participation and with social service utilization among homeless adults. Adverse events at childhood, however, were positively associated with service use. CONCLUSIONS: Adverse childhood events may contribute to negative adulthood consequences, including consistent substance use and reduced labor force participation. Agencies that are involved in halting the abuse or neglect also should participate in more preventive interventions. Job-related assistance is particularly important to facilitate employment and labor force participation among homeless adults.     

Modification of psychic, autonomic and metabolic reactions during examinations by a single dose of beta-receptor blockers

18 students of human medicine were checked during their state examinations when they were or were not administered the beta-receptor blocker Propranolol. In the present examinations under psychic stress Propranolol has no ascertaining influence on the experience parameters, but on somatic reactions in the cardio-circulatory system, the haematological system as well as in the influence on a series of laboratory-chemical parameters. While slighter heart rate, lower blood pressure, a slighter decrease of the absolute number of lymphocytes and a lower plasma cortisol level refer to less distinct reactions of demand under influence of Propranolol, in the region of the lipid parameters HDL-cholesterol and LDL-cholesterol changes develop in the sense of an at least situational increased atherogenic risk.     

High Percentage of Recent HIV Infection Leading to Onward Transmission in Odessa,Ukraine Associated with Young Adults

The proportion of new HIV diagnoses between May and December 2009 across Odessa recently-infected was estimated using the BED-CEIA assay. Logistic regression models were used to explore factors associated with testing as recent. Of 1,313 newly-diagnosed individuals, 321 (24 %) were classified as recent. Recent infection was less likely among older adults [odds ratio (OR) = 0.70 per 10-year increase, 95 % CI 0.60–0.82]. Compared to men residing in Odessa city, women in rural Odessa and non-resident men were more likely to be recently-infected (OR 1.85, 1.26–2.71 and 2.83, 1.15–6.97, respectively). Reason for test was not associated with recent infection. In sensitivity analysis, after excluding individuals tested due to clinical indications, the proportion recently-infected and the association with age remained virtually unchanged. Our findings suggest a high risk of onward transmission, particularly in younger age groups. These findings highlight the need for tailored prevention strategies and ongoing RITA testing to monitor and evaluate effectiveness of prevention programmes.     

Unexpected frequency, duration and spectrum of adverse events after therapeutic dose of mefloquine in healthy adults.

The frequency and spectrum of adverse events associated with the antimalarial therapeutic regimen of mefloquine (MQ) (750 and 500 mg at an interval of 6 h) was assessed in 22 healthy volunteers who were monitored for 21 days following drug administration. An unexpected high frequency of side effects of any grade were reported by all 22 subjects. The most commonly reported symptoms were vertigo (96%), followed by nausea (82%) and headache (73%). Participants suffering from severe (grade 3) vertigo (73%) required bed rest and specific medication for 1 to 4 days. More females than males reported severe adverse reactions. The majority (77.3%) of the participants (f: 8/12, m: 9/10) showed symptom resolution within 3 weeks (510 h) after drug administration. Biochemical and haematological findings stayed within the normal range of values, but showed nevertheless a significant rise of Na, Cl, Ca, bilirubin, GGT and LDH. The unexpectedly high frequency and severity of adverse reactions after normal therapeutic dosage of MQ in healthy subjects may influence future recommendations regarding the use of MQ for stand-by treatment of suspected malaria in travellers.     

Clinical efficacy and adverse effects of weekly single dose leflunomide in refractory rheumatoid arthritis

AimTo study the clinical efficacy and adverse events of weekly single dose of leflunomide in patients with refractory rheumatoid arthritis in comparison with conventional daily regimen.MethodsPatients with refractory rheumatoid arthritis were taken up for the study; 91 patients were enlisted of whom 3 became non-compliant and were excluded. A concurrent parallel study was designed with the patients divided into two groups and efficacy and adverse events recorded at third and sixth months.ResultsA total of 88 patients were included in the study and were divided into two groups. At the end of 6 months, in the daily group 37 (82.2%) out of 45 patients had disease activity score (DAS) less than 3.2 indicating a low disease activity and 8 patients (17.8%) had moderate disease activity. None had high disease activity. In the weekly group, 36 (83.7%) out of 43 patients had low disease activity and 7 (16.3%) had moderate disease. None had high disease activity. Four (8.9%) patients developed adverse reactions in the daily group. One patient (2.2%) had alopecia and the other (2.2%) had diarrhoea and were withdrawn from the study. Two (4.4%) patients had elevated liver enzymes and the drug was stopped at 6 months. None in the weekly group reported any adverse events.ConclusionsWeekly regimen was found to be better in terms of compliance and had a lower adverse effect profile. The result was statistically significant. Clinical efficacy of weekly therapy was found to be similar to that of conventional therapy in terms of DAS.     

Human-rhesus reassortant rotavirus vaccines: safety and immunogenicity in adults, infants, and children

Human-rhesus reassortant rotavirus vaccines derived from rhesus rotavirus and human rotavirus serotypes 1, 2, or 4 were administered to adults, children, and infants after they had been given sodium bicarbonate buffer. Over 70% of infants and children developed antibody responses to or shed the candidate vaccine viruses. Individuals with prevaccination serum neutralization antibody titers less than or equal to 1:160 had significantly (P less than .0001) higher response rates than did individuals with prevaccination titers greater than or equal to 1:320. Similarly, shedding of vaccine viruses occurred significantly (P = .03) more often in children than adults and was inversely correlated with prevaccination antibody titers. No illnesses were observed in adults, and the vaccines were well tolerated in children. An increased rate of low-grade, transient fever (38.0-38.8 C) was noted only in children given serotype 2 vaccine, compared with controls (P = .006). No significant differences in the average number of unformed stools passed during the seven days after vaccination were noted in vaccinees versus controls. These vaccine strains are currently undergoing further evaluation in expanded clinical trials.     

Respiratory viral infections among hospitalized adults: experience of a single tertiary healthcare hospital

Background

Following the 2009 H1N1 pandemic, there have been a large number of studies focusing on the epidemiology and outcomes of influenza A infection; however, there have been fewer studies focused on other respiratory viral infections.

Objectives

To define the epidemiology and outcomes of non-influenza respiratory viral infections in hospitalized adults.

Patients/Methods

Data on all patients ≥18 years of age with a positive molecular respiratory viral assay who were hospitalized at a single tertiary healthcare system in Chicago, IL, from retrospectively collected and analyzed.

Results

Over the study period, 503 of 46 024 (1·1%) admitted patients had a positive RVP result. Human rhinovirus was the most commonly detected virus followed by influenza A, human metapneumovirus, respiratory syncytial virus, and parainfluenza virus, adenovirus, and influenza B, respectively. Infection in immunocompromised patients was associated with a higher rate of progression to pneumonia and death.

Conclusions

Non-influenza respiratory viral infections are commonly detected among adults admitted to the hospital and can cause serious illness. The data can inform the prioritization of research into novel antiviral therapies for these infections.     

Hepatitis A seroprevalence in children and adults in Kiev City, Ukraine

Summary.  Ukraine is a zone of moderate hepatitis A endemicity. The changing epidemiology of the disease because of improved hygiene has shifted the burden of Hepatitis A to older age groups where the disease is more severe. Outbreaks have also become more common as more of the population has become susceptible to hepatitis A virus (HAV). To help guide decisions regarding use of hepatitis A vaccine in Ukraine, we examined the presence of antibody to HAV (anti-HAV) in 1001 persons aged 1 to 85 years, visiting four municipal healthcare centres in the Ukrainian capital, Kiev. Overall, the anti-HAV prevalence was 31.9%. Anti-HAV seropositivity increased with age from 9.2% among children aged 1–5 years to 81.7% among persons over 50 years, but less than 50% of subjects less than 50 years were HAV seropositive. No children under 2 years were seropositive. HAV seropositivity was twice as high in children aged 5–11 years old in the low socio-economic status group (income less than 150 US$ per family member per month) than in the middle/high group (11.1% compared to 6.3%) but this disparity disappeared by adolescence. The prevalence of anti-HAV antibodies in adults was not different with respect to district of residence within the city. Considering the proportion of HAV seronegative subjects in all age groups under 50 years, routine vaccination against HAV of children aged 1–2 years old would appear to be an effective schedule for hepatitis A prophylaxis in Kiev.     

The safety and immunogenicity of a CETP vaccine in healthy adults

A cholesterol ester transfer protein (CETP) vaccine (CETi-1) that induces auto-antibodies that specifically bind and inhibit activity of endogenous CETP has been demonstrated in rabbits to significantly increase HDL-C and reduce the development of atherosclerosis. In a Phase I human trial with CETi-1, one patient at the highest dose (250 mg) out of a total of 36 patients who received a single injection developed anti-CETP antibodies. In an extension study of 23 patients, 53% (8/15) who received a second injection of the active vaccine developed anti-CETP antibodies compared with 0% (0/8) in the placebo group. The vaccine was well tolerated and no significant laboratory abnormalities occurred. CETi-1 is a feasible therapy in humans to induce CETP auto-antibodies. Future research will determine if repeat inoculations will induce a sufficient anti-CETP antibody response to inhibit CETP and increase HDL levels.     

Skin testing and adverse reactions in fluorescein: a prospective study.

Sodium fluorescein (SF) is widely used to assess chorioretinal disorders. Adverse reactions are well documented but the underlying mechanism is still uncertain. The aim of this study was the evaluation of skin testing to predict SF reaction, the identification of possible predisposing factors, and the objective record of the reported reactions. All patients with adequate indication for SF angiography (SFA) during an 18-month period were evaluated as follows: (a) detailed personal history of atopy, diabetes, previous SFA, and/or diagnostic procedures with radiocontrast media (RCM) and possible side effect; (b) skin testing with SF 10% diluted preparations; (c) SFA with 5 mL of SF, objective record of any reaction. Two hundred twenty-four patients (108 men and 116 women) with a mean age of 65.2 years (SD, 12.86; range, 16-92 years) underwent SFA. The overall rate of adverse reactions was 3.6% (8/224), which consists of 5 (2.2%) individuals with transient mild nausea; 2 (0.9%) subjects with face and upper trunk flushing that appeared in one case after 60 minutes and in the other case 24 hours later and both resolved without treatment, and I subject with transient bilateral frontal headache and dizziness. None of the 224 patients had positive skin or intradermal testings. One hundred thirty-six of 224 (60.7%) patients stated no previous SFA and 74.1% had not performed RCM injection. None of the recorded variables correlated with increased risk of reaction. SFA is a safe procedure with minor adverse effects. Although in vivo testing can not identify reactors it may help to exclude an underlying IgE-mediated mechanism in susceptible individuals.     

Mycobacterium leprae DNA associated with type 1 reactions in single lesion paucibacillary leprosy treated with single dose rifampin, ofloxacin, and minocycline

Leprosy affects skin and peripheral nerves, and acute inflammatory type 1 reactions (reversal reaction) can cause neurologic impairment and disabilities. Single skin lesion paucibacillary leprosy volunteers (N = 135) recruited in three Brazilian endemic regions, treated with single-dose rifampin, ofloxacin, and minocycline (ROM), were monitored for 3 years. Poor outcome was defined as type 1 reactions with or without neuritis. IgM anti-phenolic glycolipid I, histopathology, Mitsuda test, and Mycobacterium leprae DNA polymerase chain reaction (ML-PCR) were performed at baseline. chi(2) test, Kaplan-Meir curves, and Cox proportional hazards were applied. The majority of volunteers were adults with a mean age of 30.5 +/- 15.4 years; 44.4% were ML-PCR positive. During follow-up, 14.8% of the patients had a poor clinical outcome, classified as a type 1 reaction. Older age (> or = 40 years), ML-PCR positivity, and lesion size > 5 cm were associated with increased risk. In multivariate analysis, age (> or = 40 years) and ML-PCR positivity remained baseline predictors of type 1 reaction among monolesion leprosy patients.