The safety and immunogenicity of a bivalent conjugate vaccine against Salmonella enterica Typhi and Paratyphi A in healthy Indian adults: a phase 1, randomised, active-controlled, double-blind trial.

BACKGROUND: Enteric fever caused by Salmonella enterica Typhi and Salmonella Paratyphi A is an important public health problem, especially in low-income and middle-income countries with limited access to safe water and sanitation. We present results from, to our knowledge, the first ever human study of a bivalent paratyphoid A-typhoid conjugate vaccine (Sii-PTCV). METHODS: In this double-blind phase 1 study, 60 healthy Indian adults were randomly assigned (1:1) to receive a single intramuscular dose of either Sii-PTCV or typhoid conjugate vaccine (Typbar-TCV). Safety was assessed by observing solicited adverse events for 1 week, unsolicited events for 1 month, and serious adverse events (SAEs) over 6 months. Immunogenicity at 1 month and 6 months was assessed by measuring anti-capsular polysaccharide antigen Vi (anti-Vi) IgG and IgA against Salmonella Typhi and anti-lipopolysaccharide (LPS) IgG against Salmonella Paratyphi A by ELISA, and functional antibodies using serum bactericidal assay (SBA) against Salmonella Paratyphi A. This study is registered with Clinical Trial Registry-India (CTRI/2022/06/043608) and is completed. FINDINGS: 60 participants were enrolled. Of these 60 participants, 57 (95%) participants were male and three (5%) participants were female. Solicited adverse events were observed in 27 (90%) of 30 participants who received Sii-PTCV and 26 (87%) of 30 participants who received Typbar-TCV. The most common local solicited event was pain in 27 (90%) participants who received Sii-PTCV and in 23 (77%) participants who received Typbar-TCV. The most common solicited systemic event was myalgia in five (17%) participants who received Sii-PTCV, whereas four (13%) participants who received Typbar-TCV had myalgia and four (13%) had headache. No vaccine-related unsolicited adverse events or SAEs were reported. The seroconversion rates on day 29 were 96·7% (95% CI 82·8-99·9) with Sii-PTCV and 100·0% (88·4-100·0) with Typbar-TCV for anti-Vi IgG; 93·3% (77·9-99·2) with Sii-PTCV and 100·0% (88·4-100·0) with Typbar-TCV for anti-Vi IgA; 100·0% (88·4-100·0) with Sii-PTCV and 3·3% (0·1-17·2) with Typbar-TCV for anti-LPS (paratyphoid); and 93·3% (77·9-99·2) with Sii-PTCV and 0% (0·0-11·6) with Typbar-TCV for SBA titres (paratyphoid). Paratyphoid anti-LPS immune responses were sustained at day 181. INTERPRETATION: Sii-PTCV was safe and immunogenic for both typhoid and paratyphoid antigens indicating its potential for providing comprehensive protection against enteric fever. FUNDING: Serum Institute of India.

A phase I clinical study to assess safety and immunogenicity of yellow fever vaccine.

Yellow fever, a mosquito-borne flavivirus infection, is an important public health problem in Africa and Latin America. A Yellow Fever vaccine (YFV) was developed and tested in a study in India. This was a Phase I, open-label, randomized, controlled study where healthy adults received SII YFV intramuscularly (SII YFV IM), SII YFV subcutaneously (SII YFV SC) or STAMARIL® (Sanofi-Pasteur) in 1:1:1 ratio. They were followed for solicited reactions for 10 days and unsolicited events for 28 days and serious adverse events for 3 months. YF-neutralizing antibodies were measured at baseline and on Days 10, 14, 28. A total of 60 adults were enrolled in the study. The proportion of participants with solicited reactions was 10%, 40%, and 25% in SII YFV SC, SII YFV IM, and STAMARIL® arms, respectively. No causally related unsolicited events or any serious adverse event was reported. After vaccination, the seroconversion was 94.44%, 100%, and 100%, in the three arms respectively. The post-vaccination geometric mean titers were similar in the study arms. The new YFV was found safe and immunogenic by IM as well as SC routes. The vaccine can be tested in further phases of clinical studies.

Adherence of Observational Studies Published in Indian Journals to STRO BE Statement.

PURPOSE AIM: Quality of reporting is very important in medical research. To ensure a uniform and detailed reporting of observational studies experts came out with a checklist of items, named 'Strengthening the Reporting of Observational Studies in Epidemiology' (STROBE). The present study examines the adherence of observational studies published in selected Indian journals from 2011-2015 to STROBE Statement. METHOD: 7 open access Indian journals, belonging to different specialities were selected. All the observational studies were assessed by 5 independent reviewers for the adherence to STROBE checklist as 'yes, partly and no'. The completeness of reporting was also assessed. RESULTS: A total of 271 articles were examined. Only 10 items (Abstract, Background/rationale, Objectives, Study Setting, Data sources/ measurement, Quantitative variables, number of Participants at each stage, Characteristics of study participants, Key results) out of the 22 items and their subdivisions of STROBE were adhered to, in more than 70% of articles. Other 10 items (bias, subgroup analysis, addressing missing data, sensitivity analysis, reason for nonparticipation, flow diagram, missing data) had adherence in less than 30% of the articles. The completeness of reporting was 50.5%, 49.12% and 43.06% in cross sectional, cohort and case control study, respectively. CONCLUSION: The overall reporting was suboptimal. The completeness of reporting did not differ in the three types of observational study designs.

Drug Utilization in Neonatal Intensive Care Unit of a Tertiary-care Hospital in Mumbai, India.

OBJECTIVE: To study the prescription pattern (using applicable WHO indicators), cost analysis and off-label use of drugs in neonatal intensive care unit (NICU) of a tertiary-care hospital. METHODS: The prescriptions of 460 neonates admitted to a NICU during July 2014-March 2015 were studied prospectively. RESULTS: Of 460 neonates, 54.8% were preterm and 73% were low birth weight (LBW). The mean (SD) prescription items per neonate were 5.7 (3.6). Overall off-label use was 12.3%, while 38% neonates received at least one off-label drug. Of 326 off-label drugs, antibiotics (69.6%) followed by non-steroid anti-inflammatory drugs (7%) were commonly used. Premature and LBW babies required more drugs with higher cost and longer stay, compared to full term and normal weight babies (P<0.01), while the pattern of off-label use was similar across both these categories (P>0.05). CONCLUSION: Off-label antibiotics use was common, and prescribing practices were uniform in NICU.

A cross-sectional study to assess the incompatible dietary behavior of patients suffering from skin diseases: A pilot study.

BACKGROUND: Ayurveda implies the importance of diet and dietary habits in various human diseases. Confirmatory evidence regarding role of diet and dietary practices in diseases of skin are lacking. OBJECTIVES: To assess incompatible dietary behavior in acne, psoriasis, fungal infections, and vitiligo patients using a questionnaire tool. MATERIALS AND METHODS: A questionnaire-based, cross-sectional case control study was conducted in the skin out-patient department of a tertiary care hospital. Patients were enrolled in each diseased group and their control groups. Perception of patients regarding the role of diet in skin diseases was evaluated. Study participants were subjected to 2 validated questionnaires to assess consumption of incompatible diet and incompatible dietary habits. RESULTS: Diet was perceived to be more important in patients of acne compared to their controls (P < 0.05). Mean composite score regarding the assessment of consumption of incompatible diet of acne (19.594 ± 4.613 vs. 16.719 ± 3.457, P = 0.006) and psoriasis (17.531 ± 2.688 vs. 16.281 ± 2.630, P = 0.0497) patients was higher than their controls. Mean composite score regarding assessment of incompatible dietary habits was higher in acne (19.031 ± 4.589 vs. 15.688 ± 4.645, P = 0.0054), psoriasis (18.875 ± 5.014 vs. 15 ± 3.069, P = 0.0009), and fungal infection (16.469 ± 3.538 vs. 14.5 ± 2.627, P = 0.0115) patients compared to controls. Mean composite scores of both the questionnaires in vitiligo patients were similar to controls. CONCLUSION: Scores for consumption of incompatible diet and dietary habits were found to be higher in acne and psoriasis patients compared to controls. Patients with fungal infections had higher scores for the presence of incompatible dietary habits but similar scores for the consumption of incompatible diet, whereas both scores in patients of vitiligo were similar to controls.