Typhoid fever has the highest disease burden in countries in low- and middle-income countries, primarily located in Asia and Sub-Saharan Africa. Previous typhoid vaccines such as the live attenuated typhoid (Ty21a) vaccine and Vi (virulence) capsular polysaccharide vaccine had the limitation that they could not be administered with other standard childhood immunizations and were ineffective in children under two years of age. To address these shortcomings of the previous vaccines, typhoid conjugate vaccines (TCVs) were developed and prequalified by the World Health Organization. Cross-reacting material and tetanus toxoid are widely used as carrier proteins in TCVs. According to various studies, TCV has higher efficacy, has a more extended protection period, and is safe and immunogenic in infants as young as six months. This review article aims to comprehensively appraise the data available on TCVs' efficacy, duration of protection, safety, and immunogenicity in endemic regions.
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.
OBJECTIVES: Every year, 18,000-20,000 people die from rabies in India, with children younger than the age of 15 accounting for 30%-60% of all cases. Wound cleaning, vaccination, and rabies immunoglobulin (RIG) administration are all part of treatment. TwinRabTM, a unique combination of two monoclonal antibodies (mAbs), docaravimab and miromavimab, effectively neutralizes rabies and rabies-like viruses. We conducted this study to evaluate the safety of the cocktail in patients infected with category-III animal bites according to WHO guidelines. METHODS: This open-label observational study was conducted in patients with WHO category-III animal bites by suspected rabid animals. All participants were screened, enrolled, and were administered the TwinRabTM manufactured by Zydus Lifesciences Ltd. at the rate of 40 IU/kg by infiltration in and around the wound along with anti-rabies vaccine (ARVs). Participants were assessed at various intervals, and any adverse events (AEs) were documented and reported to the sponsor within 24 hours. RESULT: The study enrolled 401 participants, 55.61% (n = 223) male, whose median age was 34 years. Adults made up 69.83% (n = 280) of the participants. The most exposed sites were the lower parts of the body (60.6%, n = 243); 99.75% (n = 400) of the population showed normal cardiovascular, gastrointestinal, and central nervous systems. After seven days of the last postexposure prophylaxis (PEP) dose, 9.98% of the total study population experienced 80 mild local solicited AEs and were assessed and treated. CONCLUSION: The study concluded that TwinRabTM when given in a 40 IU/kg dose with Essen or the updated Thai Red Cross Vaccine regimen, provides safe and effective rabies prophylaxis in WHO category III patients exposed to suspected rabied animal bites.
Measles, mumps, and rubella (MMR) are highly infectious viral diseases affecting young children and have high secondary attack rates. Present MMR vaccines show consistent seroconversion rates for anti-measles and anti-rubella antibodies with variable responses for anti-mumps antibodies. Most common strains for MMR vaccines, currently available in India, are the Edmonston-Zagreb measles strain, Leningrad Zagreb (L-Z) mumps strain, and the RA 27/3 rubella strain. L-Z strain of mumps virus has been found to be associated with aseptic meningitis by different studies from different parts of the world including India. Recently, a novel freeze-dried MMR vaccine developed by Zydus Lifesciences (Zyvac MMR) contains Edmonston Zagreb measles strain, Hoshino mumps strain, and RA 27/3 rubella strain. The Hoshino strain is WHO approved and was found to induce interferon gamma production. This review article aims to provide a comprehensive appraisal of the data available on the safety and immunogenicity of the novel MMR vaccine.
Measles , Mumps , Rubella , Child , Humans , Infant , Child, Preschool , Mumps/prevention & control , Rubella Vaccine , Measles-Mumps-Rubella Vaccine/adverse effects , Measles/prevention & control , Rubella/prevention & control , Mumps virus , Antibodies, Viral , Measles Vaccine
Background Treatment of pain and inflammation form the mainstay of osteoarthritis (OA) management. Non-steroidal anti-inflammatory drugs (NSAIDs), due to their inflammation-blocking mechanism, are a highly effective class of drugs for chronic pain and inflammation in OA. However, this comes at a cost of increased risk for multiple adverse effects, including gastrointestinal bleeding, cardiovascular side effects, and NSAID-induced nephrotoxicity. To minimize the potential risk of an adverse event, numerous regulatory bodies and medical societies recommend using the lowest effective NSAID dose for the shortest time necessary. One potential strategy to achieve this is the use of disease-modifying osteoarthritis drugs (DMOADs) containing anti-inflammatory and analgesic properties instead of NSAIDs for the management of OA. This study focuses on the efficacy of Clagen™ [Aflapin (Boswellia serrata extract) + native type 2 collagen + Mobilee (hyaluronic acid (60-70%), polysaccharides (>10%), and collagen (>5%)) + CurQlife (Curcumin)] for the symptomatic improvement in OA patients as well as if this combination is effective in the long-term management of OA instead of NSAIDs. Methodology In this retrospective observational study, a total of 300 patients were screened, of whom 100 OA patients who fulfilled the criteria and agreed to be part of the study were enrolled. The data were analyzed to evaluate the efficacy of the nutraceutical formulation Clagen™ in patients with OA of the knee. From the baseline to two months, primary outcomes of improvement in the Visual Analog Scale (VAS) score, range of motion, and Knee Injury and Osteoarthritis Outcome Score (KOOS) were measured at monthly follow-up. Statistical analyses were performed according to the results obtained from the parameters. The tests were performed at a 5% significance level (p <0.05). The qualitative characteristics were described using absolute and relative frequencies, and the quantitative measures were described as summary measures (mean, standard deviation). Results Of the 100 patients enrolled in the study, 99 (64 males and 35 females) completed the study. The mean age of the patients was 50.6 ± 13.9 years, and the mean body mass index was 24.5 ± 3.5 kg/m2. The statistical analysis of the outcomes from the baseline to the two-month follow-up was analyzed using paired t-test. The difference in the mean of VAS pain score at baseline and two months was 3.3 ± 1.8 [t (97) = 18.2; p < 0.05], which showed a significant reduction in pain at two months. Moreover, the difference in the mean of the goniometer value of 7.3 ± 7.3 [t (98) = -10.0, p < 0.05] indicated statistically significant improvements in the range of motion. It was also observed that Clagen™ significantly improved the composite KOOS score by 10.8% at the end of two months. Similarly, KOOS scores for Symptoms, Function, and Quality of Life showed improvements of 9.6%, 9.8%, and 7.8%, respectively, and were statistically significant (p < 0.05). Conclusions Clagen™ exerted positive adjuvant effects in the management of OA. The combination not only improved the symptoms and quality of life but, in the light of future perspective, NSAIDs can be withdrawn in OA patients, considering their long-term negative effects. To validate these findings further long-term studies with a comparison arm of NSAIDs are needed.
Background This is an observational study conducted to determine the prevalence of osteoporosis and osteopenia in patients undergoing elective arthroplasty and spinal procedures in India. Methods This observational, multicentre study included both male and female patients. Their bone mineral density and fracture risk were measured using dual-energy x-ray absorptiometry (DEXA) and Fracture Risk Assessment Tool (FRAX®: Centre for Metabolic Bone Diseases, University of Sheffield, UK), respectively, in compliance with the guidelines for Good Epidemiological Practice (ISRCTN: 14543098). Results The study revealed that majority (76.4%; 97/127) of the patients had low BMD; over one-third had osteoporosis (39.4%; 50/127) or osteopenia (37%; 47/127). Among those undergoing total knee replacement (TKR)/total hip replacement (THR), majority (75.6%; 59/78) had low BMD (osteoporosis: 38.5% {30/78}; osteopenia: 37.2% {29/78}). Among the patients undergoing spinal procedures, all except two (93.10%; 27/29) had low BMD, two-thirds had osteoporosis (65.5%; 19/29), and around one-fourth had osteopenia (27.6%; 8/29). Radial BMD measurements showed higher prevalence of osteoporosis and osteopenia. Based on FRAX score, nearly 30% of patients were at a high risk of hip fracture in the next 10 years. As per National Osteoporosis Foundation (NOF) guidelines, most (59.79%; 58/97) patients with osteoporosis/osteopenia met criteria for pharmacological treatment. Conclusions Regular preoperative bone health evaluation should be adopted and osteoporosis/osteopenia patients should be adequately managed pharmacologically in India.
