Post-Marketing Surveillance of the World's First Novel Cocktail of Rabies Monoclonal Antibodies: TwinRab™ in Real \-World Setting.

Rabies presents with a high fatality rate, which imposes a significant global public health challenge, and therefore the use of post-exposure prophylaxis (PEP) is crucial for prevention. Monoclonal antibodies (mAbs) have emerged as a promising substitute for rabies immunoglobulins (RIGs) due to their high efficacy and standardized manufacturing process. A prospective, open-label, post-marketing surveillance study (PMS) was conducted at Byramjee Jeejeebhoy Medical College (BJMC), Pune. The study included patients aged more than 2 years who had recently sustained Category III-suspected rabid animal bite exposures. These patients were administered TwinRabTM at a dosage of 40 IU/kg in and around the wound as intralesional transfer, along with the anti-rabies vaccine (ARV). Adverse events (AEs) grading was performed with reference to the Food and Drug Administration (FDA) toxicity grading. In this study, 215 subjects received the TwinRabTM mAb with a 100% completion rate. Out of 215 patients, three (1.3%) patients in the range of 18 to 65 years of age showed solicited local AEs, which were resolved after the appropriate treatment intervention, but causality assessment was non-assessable. The overall tolerability assessment showed positive ratings from doctors (91.63%) and patients (67.91%) for the mAb cocktail. The PMS demonstrated the safety of TwinRabTM in patients who experienced Category III-suspected rabid animal bites, thereby supporting its potential as an alternative option for post-exposure prophylaxis in the management of animal bites for the prevention of rabies.

A case control study to assess effectiveness of measles containing vaccines in preventing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in children.

Currently, most licensed vaccines against SARS-CoV-2 infection are approved for adults and not for children. We conducted a test negative case-control study to assess the effectiveness of Measles Containing Vaccines (MCVs) against SARS-CoV-2 infection in Pune, India, in children who were ≥1 year and <18 years of age and were tested for SARS-CoV-2 infection by Reverse transcription polymerase chain reaction (RT-PCR). The enrolled participants included 274 SARS-CoV-2 positive cases (216 vaccinated and 58 unvaccinated) along with 274 SARS-CoV-2 negative controls (265 vaccinated and 9 unvaccinated). Of the 274 cases, 180 (65.7%) were asymptomatic while 94 (34.3%) were symptomatic, all with mild severity. The number of participants with symptomatic SARS-CoV-2 infection was significantly lower in the vaccinated group compared to the unvaccinated group (p < .0001). The unadjusted overall Vaccine Effectiveness (VE) in the vaccinated group compared to unvaccinated group was 87.4% (OR = 0.126, 95% CI of VE: 73.9-93.9) while the adjusted overall VE after adjusting for age and sex was 87.5% (OR = 0.125, 95% CI of VE: 74.2-94.0). MCVs reduced incidence of laboratory confirmed SARS-CoV-2 infection in children. Number of symptomatic cases were also lower in the vaccinated group compared to the unvaccinated group. Results of our study have provided strong preliminary evidence that MCVs have a good effectiveness against SARS-CoV-2 infection in the pediatric population, which needs to be confirmed further through prospective randomized clinical trials.

An epidemiological study of laboratory confirmed COVID-19 cases admitted in a tertiary care hospital of Pune, Maharashtra.

BACKGROUND: India has reported more than 70,000 cases and 2000 deaths. Pune is the second city in the Maharashtra state after Mumbai to breach the 1000 cases. Total deaths reported from Pune were 158 with a mortality of 5.7%. To plan health services, it is important to learn lessons from early stage of the outbreak on course of the disease in a hospital setting. OBJECTIVES: To describe the epidemiological characteristics of the outbreak of COVID-19 in India from a tertiary care hospital. METHODS: This was a hospital-based cross-sectional study which included all admitted laboratory confirmed COVID19 cases from March 31, to April 24, 2020. The information was collected in a predesigned pro forma which included sociodemographic data, duration of stay, family background, outcome, etc., by trained staff after ethics approval. Epi Info7 was used for data analysis. RESULTS: Out of the total 197 cases, majority cases were between the ages of 31-60 years with slight male preponderance. Majority of these cases were from the slums. Breathlessness was the main presenting symptom followed by fever and cough. More than 1/5th of patients were asymptomatic from exposure to admission. The case fatality rate among the admitted cases was 29.4%. Comorbidity was one of the significant risk factors for the progression of disease and death (odds ratio [OR] = 16.8, 95% confidence interval [CI] = 7.0 - 40.1, P < 0.0001). CONCLUSION: Mortality was higher than the national average of 3.2%; comorbidity was associated with bad prognosis.

Documentation of vaccine wastage in two different geographic contexts under the universal immunization program in India.

BACKGROUND: Government of India is introducing new and relatively costly vaccines under immunization program. Monitoring of vaccine wastage is needed to guide the program implementation and forecasting. Under pilot introduction of rotavirus vaccine in two districts both 5- and 10-doses vials were used, which was considered as an opportunity for documenting the wastage. The wastage rates for other routine vaccines were also documented. METHODS: A survey conducted in two districts (Kangra, Himachal Pradesh and Pune, Maharashtra) covered 49 vaccine stores, 34 sub-centres and 34 outreach sessions collected vaccine receipt, distribution and usage data for two complete years 2016 and 2017. RESULTS: The overall wastage rates for almost all vaccines were higher in Kangra district (BCG 37.1%, DPT 32.1%, Measles 32.2%, OPV 50.8%, TT 34.1% and pentavalent 18.4%) than Pune district (BCG 35.1%, DPT 25.4%, Measles 21.7%, OPV 14.3%, TT 23.1% and pentavalent 13.2%). Wastage for pneumococcal conjugate and measles-rubella vaccines in Kangra district were 27 and 40.5%, respectively. With transition from 5- to 10-doses vials for rotavirus vaccine, wastage at stores levels increased in both Kangra (29 to 33.2%) and Pune (17.8 to 25.7%) districts. With transition from intramuscular to intradermal fractional inactivated polio vaccine, the wastage increased from 36.1 to 54.8% in Kangra and 18.4 to 26.9% in Pune district. CONCLUSIONS: The observed vaccine wastage rates for several vaccines were relatively higher than program assumption for forecasting. The observed variations in the vaccine wastage indicates need for state or region based documentation and monitoring in India for appropriate programmatic action.

Profile of drug-resistant tuberculosis in Western Maharashtra.

CONTEXT: Drug-resistant tuberculosis (TB) strains have evolved mainly due to incomplete or improper treatment of TB patients and are one of the hurdles in controlling TB problem. It is better to understand the magnitude and comorbidities associated with drug-resistant TB. AIM AND OBJECTIVES: (1) To study some of the sociodemographic profile and history of TB treatment of drug-resistant TB cases. (2) To study their drug-resistance pattern and their comorbidity profile. SETTINGS AND DESIGN: It was a record-based study descriptive, cross-sectional study of drug-resistant TB cases that were referred to State TB Training and Demonstration Centre (STDC). MATERIALS AND METHODS: The data were collected by means of use of TB patient treatment register of those tested at STDC during first two quarters of the year 2012 (from January to June 2012). Sputum samples of all the cases were subjected to concentrated microscopy, and all positive samples were tested by GeneXpert and Line Probe Assay for drug susceptibility testing (DST) for isoniazid and rifampicin. STATISTICAL ANALYSIS: The findings were analyzed with Epi info7, using the mean, standard deviation, Chi-square test. RESULTS: The mean age of the patients was 35.65 ± 13.59 years, majority 71.87% were males. The majority of patients 72.91% had the previous history of TB. A majority 68.75% of the patients had acquired drug resistance, and 73.95% of cases were suffering from multidrug-resistant TB. A total of 28.13% patients had self-reported comorbidity. A majority 62.5% had failure as the treatment outcome for the current episode of TB and mortality was seen in 12.5% cases. CONCLUSIONS: Majority had failure as a treatment outcome due to advanced disease status or late diagnosis. Rapid diagnosis and DST for first- and second-line drugs will greatly improve the clinical outcome.