Effectiveness of an inactivated virus-based SARS-CoV-2 vaccine, BBV152, in India: a test-negative, case-control study.

BACKGROUND: BBV152 is a whole-virion inactivated SARS-CoV-2 vaccine that has been deployed in India. The results of the phase 3 trial have shown clinical efficacy of BBV152. We aimed to evaluate the effectiveness of BBV152 against symptomatic RT-PCR-confirmed SARS-CoV-2 infection. METHODS: We conducted a test-negative, case-control study among employees of the All India Institute of Medical Sciences (a tertiary care hospital in New Delhi, India), who had symptoms suggestive of COVID-19 and had an RT-PCR test for SARS-CoV-2 during the peak of the second wave of the COVID-19 pandemic in India between April 15 and May 15, 2021. Cases (test-positives) and controls (test-negatives) were matched (1:1) on the basis of age and gender. The odds of vaccination with BBV152 were compared between cases and controls and adjusted for level of occupational exposure (to COVID-19), previous SARS-CoV-2 infection, and calendar time, using conditional logistic regression. The primary outcome was effectiveness of two doses of BBV152 (with the second dose received at least 14 days before testing) in reducing the odds of symptomatic RT-PCR-confirmed SARS-CoV-2 infection, expressed as (1 - odds ratio) × 100%. FINDINGS: Between April 15 and May 15, 2021, 3732 individuals had an RT-PCR test. Of these, 2714 symptomatic employees had data on vaccination status, and 1068 matched case-control pairs were available for analysis. The adjusted effectiveness of BBV152 against symptomatic COVID-19 after two doses administered at least 14 days before testing was 50% (95% CI 33-62; p<0·0001). The adjusted effectiveness of two doses administered at least 28 days before testing was 46% (95% CI 22-62) and administered at least 42 days before testing was 57% (21-76). After excluding participants with previous SARS-CoV-2 infections, the adjusted effectiveness of two doses administered at least 14 days before testing was 47% (95% CI 29-61). INTERPRETATION: This study shows the effectiveness of two doses of BBV152 against symptomatic COVID-19 in the context of a huge surge in cases, presumably dominated by the potentially immune-evasive delta (B.1.617.2) variant of SARS-CoV-2. Our findings support the ongoing roll-out of this vaccine to help control the spread of SARS-CoV-2, while continuing the emphasis on adherence to non-pharmacological measures. FUNDING: None. TRANSLATION: For the Hindi translation of the abstract see Supplementary Materials section.

Post COVID-19 sequelae: A prospective observational study from Northern India.

Post COVID-19 sequelae are a constellation of symptoms often reported after recovering from COVID-19. There is a need to better understand the clinical spectrum and long-term course of this clinical entity. The aim of this study is to describe the clinical features and risk factors of post COVID-19 sequelae in the North Indian population. This prospective observational study was conducted at a tertiary healthcare centre in Northern India between October 2020 and February 2021. Patients aged >18 years with laboratory-confirmed COVID-19 were recruited after at least two weeks of diagnosis, and details were captured. A total of 1234 patients were recruited and followed up for a median duration of 91 days (IQR: 45-181 days). Among them, 495 (40.1%) had persistent symptoms post-discharge or recovery. In 223 (18.1%) patients, the symptoms resolved within four weeks; 150 (12.1%) patients had symptoms till 12 weeks, and 122 (9.9%) patients had symptoms beyond 12 weeks of diagnosis/symptom-onset of COVID-19. Most common symptoms included myalgia (10.9%), fatigue (5.5%), shortness of breath (6.1%), cough (2.1%), insomnia (1.4%), mood disturbances (0.48%) and anxiety (0.6%). Patients who were hospitalized were more likely to report fatigue as a feature of long COVID. Hypothyroidism (OR: 4.13, 95% CI: 2.2-7.6, p-value < 0.001) and hypoxia (SpO2 ≤ 93%) (OR: 1.7, 95% CI: 1.1-2.4, p-value 0.012) were identified as risk factors for long COVID sequelae. In conclusion, long COVID symptoms were common (22%), and 9.9% had the post COVID-19 syndrome. Myalgias, fatigue and dyspnoea were common symptoms. Patients with hypothyroidism and hypoxia during acute illness were at higher risk of long COVID.

Evaluation of the dose-effect association between the number of doses and duration since the last dose of COVID-19 vaccine, and its efficacy in preventing the disease and reducing disease severity: A single centre, cross-sectional analytical study from India.

AIMS: To evaluate the dose-effect association between COVID-19 vaccination and probability of turning RT-PCR positive and to assess the correlation between disease severity and vaccination status. METHODS: A single centre cross-sectional study was conducted amongst 583 individuals presenting to COVID-19 testing clinic and 55 hospitalized COVID-19 patients. Vaccination status was assessed by the number of doses and duration since the last dose. Disease severity was evaluated by the requirement of hospitalisation and ICU admission/death. The association between the vaccination status and development of disease and its severity were statistically analyzed. RESULTS: The mean age of the population was 36.6 years and 82.6% had no comorbidities. The odds of turning RT-PCR positive was 0.17(95% CI: 0.11-0.27) among the clinical suspects who had taken both doses of the vaccine at least 14 days before (fully vaccinated). The odds of hospitalisation was 0.12(95% CI: 0.03-0.45) and ICU admission/death was 0.07(95% CI: 0.01-0.36) among fully vaccinated individuals. The protective role of vaccination was observed to start 14 days after receiving the first dose. CONCLUSIONS: COVID-19 vaccination provides dose-dependent protection against the development of the disease. It also lowers the risk of hospitalisation and ICU admission/death in RT-PCR positive patients in a dose-dependent manner.

Clinicomycological overview of brain abscess in a tertiary care center: A 38 year retrospection: Fungal brain abscess.

INTRODUCTION: Brain abscesses (BA) form approximately 8% of intracranial masses in developing and 1-2% in western countries. Fungal BA (FBA) are aggressive and represent a catastrophic manifestation compared to protozoan and bacterial BA. Diagnosis of FBA is rare and usually done postmortem. OBJECTIVES: The present retrospective study analyses the clinico-mycological aspects of FBA presented to our neurosurgical services over a period of 38 years, from January 1979 to April 2017. MATERIALS AND METHODS: Patients diagnosed as definitive cases of FBA were included in the study. Clinico- demographic and microbiological data were collected from medical records. BA pus was examined for fungal etiology using standard microbiological procedures. RESULTS: During the period of 38 years out of total 2,916 brain abscesses, 29 cases of FBA were diagnosed with an overall incidence rate of 0.99% per year. Cladophialophora bantiana (44%) was the most predominant isolate followed by Aspergillus spp and others. Male preponderance was seen with a male:female ratio of 4.8:1. There was no predilection for any age group. Headache, limb weakness and fever were the most common presentations. Amphotericin B was given in 44.8% of cases. Craniotomy with excision (48.2%) was the predominant surgical management. Outcome was fatal in 62% of the cases. CONCLUSION: Neurotropic C. bantiana is the predominant isolate causing fungal brain abscess. The incidence and trends of fungi causing brain abscess do not show significant change. Young immunocompetent outdoor working males were predominantly susceptible to fungal infection. Advance in the diagnostic modalities show promising in diagnosis of FBA. High index of suspicion with early diagnosis, prompt antifungal therapy and aggressive surgical management is required as FBA are associated with high mortality rate.

Streptococcus pluranimalium: Emerging Animal Streptococcal Species as Causative Agent of Human Brain Abscess.

BACKGROUND: Streptococcus pluranimalium is a new and emerging animal streptococcal species associated with primary infection in bovine and avian species. Data in the literature regarding its pathogenic significance in human beings are limited. We hereby report a case of brain abscess caused by S. pluranimalium in a healthy adult male. S. pluranimalium, a causative agent of brain abscess, was unanticipated, and to the best of our knowledge, this is one of the rare cases reported in the medical literature. CASE DESCRIPTION: A 44-year-old male presented with headache and occasional episodes of vomiting for 2 weeks, weakness of the left upper and lower limbs for 1 week, and 1 episode of generalized tonic clonic seizure 2 days back. He was afebrile and had no history of loss of consciousness or head trauma. His physical and neurologic examination was unremarkable. Magnetic resonance imaging of the brain revealed a focal ring enhancing lesion in right posterior parietal lobe, suggestive of infective etiology. The patient underwent right parietooccipital craniotomy and excision of cerebral abscess, from which S. pluranimalium was isolated. The patient responded to treatment with intravenous ceftriaxone, vancomycin, and metronidazole without any residual neurologic sequelae. CONCLUSION: Clinical data regarding epidemiology, pathogenic mechanisms, and zoonotic potential of S. pluranimalium in human beings are lacking. The number of cases of human infections with S. pluranimalium are steadily increasing. Hence further detailed study of the pathogenesis of S. pluranimalium in human beings is warranted, which may help to develop new strategies to prevent and treat infection with this bacterium.

Rotavirus Infection in Children with Acute Gastroenteritis in Aurangabad, Central Maharashtra.

OBJECTIVE: To determine the prevalence of rotavirus diarrhea and its genotypes in children from Aurangabad, India. METHODS: Stool samples collected during 2012-2013 from 168 children, aged ?3 years, were tested by ELISA to detect rotavirus. Rotavirus strains were genotyped by multiplex reverse-transcription polymerase chain reaction. RESULTS: Stool samples from 20 (11.9%) children tested positive for rotavirus. Rotavirus positivity was higher among the children aged 0-12 months than those in 13-24 and 25-36 months. Severity of disease was moderate in both rotavirus-infected and uninfected children. Genotype G1P[8] combination was detected predominantly in circulation. CONCLUSIONS: Rotavirus diarrhea was caused mainly by G1P[8] strains during 2012-2013 in Aurangabad, Central Maharashtra, India.

Microfilaria in human subcutaneous dirofilariasis: a case report.

Human subcutaneous dirofilariasis, a rare zoonosis is being increasingly reported from various parts of the world. Most of the reported cases have lesions in and around the eye. The adult female dirofilariae release microfilaria into the definitive host's blood. Various mosquitoes that serve as intermediate hosts such as Culex, Aedes and Anopheles take up the microfilariae (mf-L1) while feeding on an infected host. Microfilariae develop in the mosquitoes. The transmission to dogs or other hosts including humans occurs through mosquito bite during subsequent blood meal. Humans may be infected as aberrant (accidental) hosts, mainly by D. repens and D. immitis. D. repens usually resides subcutaneously, while D. immitis frequently ends up in the human lung. In human infections usually just one larva develops, which does not reach sexual maturity. In India, almost all reported cases of dirofilariasis in humans have involvement of face in the form of ocular dirofilariasis with a few reports on subcutaneous dirofilariasis. We report a case of human subcutaneous dirofilariasis, from western India, involving leg and showing microfilaria in tissue indicating presence of gravid female dirofilaria (sexual maturity). To the best of our knowledge, it is among rare cases of subcutaneous dirofilariasis wherein microfilariae have developed in human host.