A randomized non-inferiority clinical study to assess post-exposure prophylaxis by a new purified vero cell rabies vaccine (Rabivax-S) administered by intramuscular and intradermal routes.

BACKGROUND: Rabies is a 100% fatal disease but preventable with vaccines and immunoglobulins. We have developed a new purified vero cell rabies vaccine (Rabivax-S) and evaluated its safety and immunogenicity in post-exposure prophylaxis by intramuscular (IM) and intradermal (ID) routes. METHODS: This was a randomized active-controlled non-inferiority study in 180 individuals (age 5years and above) with suspected rabies exposure (90 each with WHO Category II and Category III exposures). The participants received either Rabivax-S (1mL IM; five doses), Rabivax-S (0.1mL ID; eight doses) or purified chick embryo cell vaccine (PCEC, Rabipur®) (1mL IM; five doses). The IM doses were given on Day 0, 3, 7, 14 and 28 while the ID doses were given on days 0, 3, 7 and 28. Category III patients also received a human rabies immunoglobulin (HRIG) on Day 0. Adverse events (AEs) were recorded with diary cards till day 42. Rabies neutralizing antibody levels were measured on day 0, 7, 14, 28 and 42. RESULTS: In both the category II and III patients, the geometric mean concentration (GMC) ratios of Rabivax-S IM and Rabivax-S ID groups to PCEC IM were more than 1, thus proving the non-inferiority. GMCs were similar or higher in Rabivax-S groups at all the time points. Seroresponse against rabies (RFFIT titre⩾0.5IU/mL) was achieved in all participants. Mostly mild local and systemic adverse events were reported across the three groups and all resolved without sequelae. CONCLUSIONS: Rabivax-S was well tolerated and showed immunogenicity comparable to a licensed rabies vaccine by both IM and ID routes in post-exposure prophylaxis. Registry No.: CTRI/2012/11/003135.

A study on morbidity among automobile service and repair workers in an urban area of South India.

INTRODUCTION: Service sector in Indian industrial growth has obtained significant numbers. Automobile service industry is one of the largest in the world with a majority of the workers in unorganized sector of the industry. This study was carried out among auto service industry workers in Vellore urban area to assess possible occupation related morbidity. MATERIALS AND METHODS: A cross-sectional observation study was carried out among 106 automobile repair shop workers. RESULTS: Half (47%) suffered work related stress, 32 (30.2%) reported exposure to dust, 81 (76%) to heat, and 50 (17%) to hazardous chemicals and heavy metals. More than 90% reported over exposure to petroleum products. A third reported cough for more than 2 weeks, more than a quarter reported gastrointestinal symptoms associated with work. Half of them reported musculoskeletal complaints associated with work with a quarter reporting un-intentional work place injuries. A tenth of them were found to have reduced pulmonary function on testing and nearly half had impaired sensory functions in peripheries. Reduced pulmonary function was found to be significantly associated with heavy metal exposure (P = 0.001). Peripheral neuropathy was significantly associated with years of occupation (P = 0.001), exposure to petroleum products (P = 0.03) and exposure to heavy metals (P = 0.018). DISCUSSION: Half of the workers were unaware of health problems associated with their occupational exposures and thereby the use of personal protection is abysmally low. A very high proportion of workers had symptoms of cough, breathlessness, abdominal pain, abdominal discomfort and muscle aches. Almost a quarter of the workers had un-intentional occupational injuries in the last 6 months. Though they work in a high-risk environment with chances of fire hazard, falls and chemical exposures, none of the workshops had fire-extinguishers, first aid kits or any such safety devices.

Kikuchi-fujimoto disease: clinical and laboratory characteristics and outcome.

INTRODUCTION: Kikuchi-Fujimoto disease is an uncommon disorder with worldwide distribution, characterized by fever and benign enlargement of the lymph nodes, primarily affecting young adults. Awareness about this disorder may help prevent misdiagnosis and inappropriate investigations and treatment. The objective of the study was to evaluate the clinical and laboratory characteristics of histopathologically confirmed cases of Kikuchi's disease from a tertiary care center in southern India. MATERIALS AND METHODS: Retrospective analysis of all adult patients with histopathologically confirmed Kikuchi's disease from January 2007 to December 2011 in a 2700-bed teaching hospital in South India was done. The clinical and laboratory characteristics and outcome were analyzed. RESULTS: There were 22 histopathologically confirmed cases of Kikuchi's disease over the 5-year period of this study. The mean age of the subjects' was 29.7 years (SD 8.11) and majority were women (Male: female- 1:3.4). Apart from enlarged cervical lymph nodes, prolonged fever was the most common presenting complaint (77.3%). The major laboratory features included anemia (54.5%), increased erythrocyte sedimentation rate (31.8%), elevated alanine aminotransferase (27.2%) and elevated lactate dehydrogenase (LDH) (31.8%). CONCLUSION: Even though rare, Kikuchi's disease should be considered in the differential diagnosis of young individuals, especially women, presenting with lymphadenopathy and prolonged fever. Establishing the diagnosis histopathologically is essential to avoid inappropriate investigations and therapy.