Browsing by Author "Anup Singh"

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A clinical trial to evaluate the safety and immunogenicity of the LEISH-F1+MPL-SE vaccine for use in the prevention of visceral leishmaniasis
(2011) Jaya Chakravarty; Subodh Kumar; Sonali Trivedi; Vijay K. Rai; Anup Singh; Jill A. Ashman; Elsa M. Laughlin; Rhea N. Coler; Stuart J. Kahn; Anna Marie Beckmann; Karen D. Cowgill; Steven G. Reed; Shyam Sundar; Franco M. Piazza
Healthy Indian adult volunteers, with or without a history of leishmaniasis, were evaluated for evidence of previous infection with Leishmania donovani based on the direct agglutination test (DAT). Three cohorts of 6 DAT-negative and 6 DAT-positive subjects were enrolled in an open-label, dose-escalating, uncontrolled clinical trial and received three injections of the LEISH-F1+MPL-SE vaccine (consisting of 5μg, 10μg, or 20μg recombinant Leishmania polyprotein LEISH-F1 antigen+25μg MPL®-SE adjuvant). The study injections were given subcutaneously on days 0, 28, and 56, and the subjects were followed through day 168 for safety and immunological endpoints. The vaccine was safe and well-tolerated in DAT-negative and DAT-positive subjects and induced T-cell production of IFN-γ and other cytokines in response to stimulation with the LEISH-F1 antigen. This clinical trial shows that the LEISH-F1+MPL-SE vaccine is safe and immunogenic in healthy subjects with and without history of previous infection with Leishmania donovani. © 2011 Elsevier Ltd.
A prospective observational safety study on ChAdOx1 nCoV-19 corona virus vaccine (recombinant) use in healthcare workers- first results from India
(Elsevier Ltd, 2021) Upinder Kaur; Bisweswar Ojha; Bhairav Kumar Pathak; Anup Singh; Kiran R. Giri; Amit Singh; Agniva Das; Anamika Misra; Ashish Kumar Yadav; Sangeeta Kansal; Sankha Shubhra Chakrabarti
Background: We provide the first post-approval safety analysis of COVISHIELD in health care workers (HCWs) in northern India. Methods: This continuing prospective observational study (February 2021 to May 2022) enrolled participants ≥18 years receiving COVISHIELD vaccination. Primary outcome was safety and reactogenicity. Categories (FDA toxicity grading) and outcomes of adverse events following immunization (AEFIs) were recorded, causality assessment performed, and risk factors analysed. Findings: We present the results of an interim analysis of 804 participants. AEFIs following first dose were reported in 321 (40%; systemic involvement in 248). Among 730 participants who completed a 7-day follow-up post second dose, AEFIs occurred in 115 (15.7%; systemic in 99). Majority of AEFIs were mild-moderate and resolved spontaneously. Serious AEFIs, leading to hospitalization was noticed in 1 (0.1%) participant with suspicion of immunization stress related response (ISRR). AEFIs of grade 3 severity (FDA) were recorded in 4 participants (0.5%). No deaths were recorded. Regression analysis showed increased risk of AEFIs in younger individuals, a two times higher odds in females, those with hypertension or with history of allergy; and three times higher odds in individuals with hypothyroidism. Interpretation: COVISHIELD carries an overall favourable safety profile with AEFI rates much less than reported for other adenoviral vaccines. Females, those with hypertension, individuals with history of allergy and hypothyroidism may need watchful vaccine administration. This being an interim analysis and based on healthcare workers who may not reflect the general population demographics, larger inclusive studies are warranted for confirming the findings. Funding: No funding support. © 2021 The Author(s)
An elaborative NMR based plasma metabolomics study revealed metabolic derangements in patients with mild cognitive impairment: a study on north Indian population
(Springer, 2021) Umesh Kumar; Abhai Kumar; Smita Singh; Payal Arya; Sandeep Kumar Singh; Rameshwar Nath Chaurasia; Anup Singh; Dinesh Kumar
Mild cognitive impairment (MCI) is transition phase between cognitive decline and dementia. The current study aims to investigate altered metabolic pattern in plasma of MCI for potential biomarkers. MCI (N = 50) and healthy controls (HC, N = 50) age group 55–75 years were screened based on Mini Mental State Examination Test (MMSE) and diffusion tensor imaging (DTI imaging). The MMSE score of MCI was significantly lower (25.74 ± 1.83) compared to healthy control subjects (29 ± 1). The MCI patients exhibit significant changes in white matter integrity in the right frontal lobe, right temporal lobe, left frontal lobe, forcep major, fornix, corpus callosum. Further, the plasma samples of twenty seven MCI patients (N = 27) and twenty HC subjects (N = 20; having no significant differences in any demographics) were analyzed using 1H NMR based metabolomics approach. Consistent with many previous reports, the levels of several plasma metabolites were found to be elevated in MCI patients compared to healthy controls. Further univariate and multivariate ROC curve analyses provided three plasma metabolites as a diagnostic panel of biomarker for MCI; which are lysine, glycine, and glutamine. Overall, the results of this study will help to improve the diagnostic and prognostic strategies of MCI in addition to improving our understanding about disease pathogenesis. We believe that the over-nutritional metabolic phenotype of MCI needs to be targeted for developing future dietary interventions so that the progression of MCI can be limited. Graphical abstract: Metabolic derangements associated with Mild Cognitive Impairment [Figure not available: see fulltext.] © 2021, The Author(s), under exclusive licence to Springer Science+Business Media, LLC part of Springer Nature.
Atypical Presentation Of Rickettsial Spotted Fever
(2017) Uday Prabhakar; Anup Singh
Acute febrile illness is a common entity in tropics and often is challenging due a host of pathogenic bacteria, viruses and fungi. Extensive work up is required for better management. Rickettsiosis is uncommon and hence comes lower down in the differentials of multiorgan failure being superseded by the more common diseases as malaria, enteric fever and Dengue. We document a case of young male presenting with high grade fever, multiorgan dysfunction (hepatic, renal, neurological and respiratory involvement), conjunctival suffusion, retiform rash and without lymphadenopathy. The diagnosis was further challenging because the rashes appeared late at 8th day in the course of illness, unlike the typical disease where rashes come on early in day 3-6 of the disease. Patient responded to timely treatment with doxycycline. Thus, a high index of suspicion is needed to diagnose Rickettsiosis in geographical areas apparently free of the disease.
Cerebellar dysfunction in an elderly male after a brief course of metronidazole
(Bentham Science Publishers B.V., 2019) Upinder Kaur; Ishan Kumar; Anup Singh; Mukesh Kumar; Sankha Shubhra Chakrabarti
Background: Metronidazole, a widely used antibacterial and antiprotozoal drug, is often the drug of choice in amoebic liver abscess. The drug, otherwise safe, can cause serious central nervous disturbances in rare circumstances. Case Report: Here, we report a case of cerebellar dysfunction in the form of slurring of speech and episodes of falls, in an elderly male following a three-week course of metronidazole therapy. Results and Conclusion: The patient manifested classic radiologic features of metronidazole neurotoxicity. Marked improvement in clinical symptoms was seen following drug discontinuation. © 2019, Bentham Science Publishers B.V.. All rights reserved.
Chemotherapeutics of visceral leishmaniasis: Present and future developments
(Cambridge University Press, 2018) Shyam Sundar; Anup Singh
Treatment of Visceral Leishmaniasis (VL), a neglected tropical disease, is very challenging with few treatment options. Long duration of treatment and drug toxicity further limit the target of achieving VL elimination. Chemotherapy remains the treatment of choice. Single dose of liposomal amphotericin B (LAmB) and multidrug therapy (LAmB + miltefosine, LAmB + paromomycin (PM), or miltefosine + PM) are recommended treatment regimen for treatment of VL in Indian sub-continent. Combination therapy of pentavalent antimonials (Sbv) and PM in East Africa and LAmB in the Mediterranean region/South America remains the treatment of choice. Various drugs having anti-leishmania properties are in preclinical phase and need further development. An effective treatment and secondary prophylaxis of HIV-VL co-infection should be developed to decrease treatment failure and drug resistance. © 2018 Cambridge University Press.
Comparison of patients with ankylosing spondylitis and non-radiographic axial spondyloarthritis-a cross sectional study
(Journal of Clinical and Diagnostic Research, 2018) Uday Prabhakar; Anup Singh
Introduction: The Assessment of Spondylo Arthritis International Society (ASAS) classification criteria for Axial Spondyloarthropathy (axSpA) published in 2009 aimed to achieve a greater sensitivity in diagnosing patients of axial spondyloarthritis. Whether the radiographic form Ankylosing Spondylitis (AS) and the Non Radiographic Axial Spondyloarthritis (nr-axSpA) form, are subgroups or different phases of the same disease is a pertinent question because this could have affected the pharmacological management of the two subgroup. Whether a distinction between AS and nr-axSpA in clinical practice is useful, remains unknown. Therefore, the present study was undertaken with the following aim. Aim: To investigate the differences in clinical presentation and disease activity between nr-axSpA and AS. Materials and Methods: A cross sectional study was conducted in Division of Rheumatology, Banaras Hindu University, Varanasi, India from January 2016 to June 2017. All the patients presenting with history of chronic back pain for ≥3 months and age at onset ≤45 years after taking written informed consent were included in the study. Using the ASAS criteria, patients were then classified into two groups of 50 patients each, patients having AS (if there was sacroilitis on radiographs as defined in modified New York criteria) and nr-axSpA diagnosed using ASAS criteria. The various SpA related variables were then compared including gender, age, duration of illness, enthesitis, dactylitis, uveitis, peripheral arthritis, psoriasis, family history, Human Leucocyte Antigen (HLA) B27 positivity, baseline C-Reactive Protein (CRP), baseline Erythrocyte Sedimentation Rate (ESR), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Bath Ankylosing Spondylitis Functional Index (BASFI). Results: Patients with AS, as compared with nr-axSpA had a longer disease duration {4.5(1.875-8.250) vs. 2.0(1.000-4.000); p-value 0.023} and had a significantly higher levels of objective markers of inflammation i.e., CRP {4.7(2.325-6.525) vs. 2.20(0.588-4.125); p-value<0.001)} and ESR {(41.98±16.936 vs. 34.20±14.552; p-value 0.015)}. No statistically significant difference was found in age of onset, male: female ratio, enthesitis, dactylitis, uveitis, peripheral arthritis, psoriasis, family history and HLAB27 positivity. Neither any statistically significant difference was noted between the mean BASDAI and BASFI in the two groups. Conclusion: Other than elevated levels of markers of inflammation (CRP/ESR) and a longer disease duration in AS, most other features do not vary significantly between the two groups. Thus, the two groups might represent same disease in different phases. © 2018, Journal of Clinical and Diagnostic Research. All rights reserved.
Correlative study of serum hepcidin levels and serum iron reserve parameters in preeclampsia and HELLP syndrome
(National Institute of Science Communication and Information Resources (NISCAIR), 2018) Tapan Kumar; Kulsoom Zahra; Tulika Dey; Anup Singh; Uma Pandey; S.P. Mishra
HELLP syndrome is described as a special group of severe preeclampsia characterized by haemolysis (H), elevated liver enzymes (EL) and low platelets (PL), whereas preeclampsia is a disease of unknown etiology characterized by hypertension and proteinuria after the 20th week of gestation. The objective of the study was to evaluate the level of hepcidin in the serum of the patient suffering from HELLP syndrome and preeclampsia. It was done by competitive sandwich ELISA which assesses the serum level of hepcidin in the forty patients suffering from preeclampsia and HELLP syndrome (as cases) and forty healthy individuals (as control). The results of our study showed that serum hepcidin levels were significantly increased among the cases (P =0.00171) in comparison to control (P <0.05) and transferrin saturation levels were significantly decreased (P <0.05) among the cases (P =0.001) in comparison to controls. The decrease in transferrin saturation indicates that there is low serum iron level among the cases. It was concluded that increased hepcidin level may be the cause of anemia among the cases. © 2018, National Institute of Science Communication and Information Resources (NISCAIR). All rights reserved.
Determinants of COVID-19 Breakthrough Infections and Severity in ChAdOx1 nCoV-19–Vaccinated Priority Groups
(American Society of Tropical Medicine and Hygiene, 2022) Upinder Kaur; Sapna Bala; Bisweswar Ojha; Bhairav Kumar Pathak; Aditi Joshi; Ashish Kumar Yadav; Anup Singh; Sangeeta Kansal; Sankha Shubhra Chakrabarti
The current analysis is a part of an ongoing observational study that began in February 2021 in the Sir Sunder Lal Hospital (Varanasi, Uttar Pradesh) in northern India and is expected to continue until June 2022. This analysis aimed to delineate the clinical presentation and risk factors of occurrence and severity of COVID-19 in vaccinated individuals. The study enrolled health-care workers and the elderly receiving the COVID-19 vaccine at one of three centers linked to the study hospital. The participants received the ChAdOx1 nCoV-19 (Oxford-AstraZeneca) vaccine based on the chimpanzee adenovirus platform (manufactured in India by the Serum Institute of India). The adenovirus codes for the spike (S) protein of SARS-CoV-2. Participants were contacted by phone at pre-decided intervals and questioned about the occurrence of COVID-19, clinical presentation, severity, and persistence of symptoms. A logistic regression analysis was performed to predict the risk factors of occurrence and severity of COVID-19. Of the 1,500 participants included in the analysis, 418 developed COVID-19 (27.9%). Fever was the most common symptom (72%), followed by cough (34%) and rhinitis (26%). Cardiovascular involvement was seen in more than 2% of individuals, and 11% had post-COVID-19 complaints. Regression analysis showed 1.6 times greater odds of contracting the disease in females and in those younger than 40 years, 1.4 times greater odds in individuals who were overweight, and 2.9 times greater odds in those receiving only one dose, compared with respective comparators. Individuals receiving two doses at a gap of ≤ 30 days had 6.7 times greater odds of infection than those receiving at a > 60-day interval. There was no association between COVID-19 occurrence in the vaccinees and pre-vaccination history of SARS-CoV-2 infection. Males were at a 3.6 times greater risk, and persons with preexisting lung disease—mainly asthma—had a 5.9 times greater risk of experiencing moderate to severe COVID-19 than comparators. While an extended interval between the two vaccine doses seems to be a better strategy, gender differences and an association of asthma phenotypes with COVID-19 need to be explored. Copyright © 2022 The author(s)
Diffusion tensor imaging based white matter changes and antioxidant enzymes status for early identification of mild cognitive impairment
(Taylor and Francis Ltd, 2019) Abhai Kumar; Smita Singh; Anup Singh; Ashish Verma; Vijay Nath Mishra
Mild cognitive impairment (MCI) is an early stage of dementia. The changes in white matter integrity and antioxidant enzymes levels are crucial in onset and progression to Alzheimer’s disease (AD). To elucidate the changes in cognitive performance, white matter integrity, oxidative stress marker, for early detection of prodromal state of AD. Fifty cases of MCI and controls (55-75 years) were subjected to Mini Mental State Examination (MMSE), diffusion tensor imaging (DTI) followed by estimation of superoxide dismutase, glutathione peroxidase and lipid peroxidation in serum of MCI and control population. The MMSE scores of MCI subjects were (28±2 - 22.6±1) as compared with controls (28±1- 29±1). DTI metrics fractional anisotropy (FA) values in right and left frontal lobe, fornix, corpus callosum, while apparent diffusion coefficient (ADC) values in right temporal lobe, hippocampus head, corpus callosum right, and forcep major were significantly altered in MCI as compared with controls. Superoxide dismutase, glutathione peroxidase level were lower while lipid peroxidation marker malondialdehyde (MDA) was increased in patients with MCI as compared with controls. The study emphasized that changes in neuro-psychological performance, white matter integrity and antioxidant enzymes level provide early signature for diagnosis of MCI. © 2018, © 2018 Taylor & Francis.
Effectiveness of single-dose liposomal amphotericin b in visceral leishmaniasis in Bihar
(American Society of Tropical Medicine and Hygiene, 2019) Shyam Sundar; Anup Singh; Neha Agrawal; Jaya Chakravarty
Liposomal amphotericin B (LAmB) is recommended for treatment of Indian visceral leishmaniasis (VL), with a cure rate of more than 95% in the Indian subcontinent. A prospective observational study of 1,143 subjects was performed with a longer follow-up than prior studies (12 months) to evaluate the long-term effectiveness and safety of LAmB for the treatment of VL. Patients received a single dose of 10 mg/kg LAmB and were evaluated for initial cure at day 30 and final cure at 6 and 12 months to see the response to the therapy. Furthermore, predictors of relapse were also calculated. At day 30, the initial cure rate was 100%; however, at 6 months and 12 months, cure rates were 97.0% and 94.2% by per-protocol analysis and 96.9% and 93.9% by intension-to-treat analysis, respectively. Fever was the most common adverse event (AE). There were no deaths and serious AEs. Male gender, weight less than 30 kg, and spleen size more than 4 cmat the start of the treatment were significant risk factors of relapse. Liposomal amphotericinBwas found to be very effective and safe in the treatment of VL. A longer follow-up period of 12 months is recommended to pick up late relapses. © 2019 by The American Society of Tropical Medicine and Hygiene.
Efficacy and safety of miltefosine in treatment of post-kala-azar dermal leishmaniasis
(Hindawi Publishing Corporation, 2015) Shyam Sundar; Anup Singh; Jaya Chakravarty; Madhukar Rai
Background. Long regimens for the treatment of post-kala-azar dermal leishmaniasis (PKDL) result in noncompliance. A safe, effective, and acceptable regimen for the treatment of PKDL is still to be developed. Miltefosine has been found to be effective in the treatment of Visceral Leishmaniasis (VL). Hence, its efficacy was tested in patients of PKDL. Methods. In this exploratory study, 33 patients with PKDL aged 10 years and above were administered miltefosine (50 mg for those weighing <25 kg or 100 mg in divided doses for those ≥25 kg and 2.5 mg per kg for children) for 12 weeks and followed up for one year to find out the efficacy. Results. Out of 33 patients, 3 patients withdrew consent. Treatment was stopped due to adverse effect in 1 patient. 28 (96.6%) got cured with complete disappearance of lesion while 1 patient (3.4%) failed treatment by protocol analysis. Conclusion. Miltefosine was found to be effective and safe in the treatment of PKDL. © 2015 Shyam Sundar et al.
Efficacy of miltefosine in the treatment of visceral leishmaniasis in India after a decade of use
(2012) Shyam Sundar; Anup Singh; Madhukar Rai; Vijay K. Prajapati; Avinash K. Singh; Bart Ostyn; Marleen Boelaert; Jean-Claude Dujardin; Jaya Chakravarty
Background. Miltefosine is the only oral drug available for treatment of Indian visceral leishmaniasis (VL), which was shown to have an efficacy of 94% in a phase III trial in the Indian subcontinent. Its unrestricted use has raised concern about its continued effectiveness. This study evaluates the efficacy and safety of miltefosine for the treatment of VL after a decade of use in India. Methods. An open-label, noncomparative study was performed in which 567 patients received oral miltefosine (50 mg for patients weighing <25 kg, 100 mg in divided doses for those weighing =25 kg, and 2.5 mg per kg for those aged <12 years, daily for 28 days) in a directly observed manner. Patients were followed up for 6 months to see the response to therapy. Results. At the end of treatment the initial cure rate was 97.5% (intention to treat), and 6 months after the end of treatment the final cure rate was 90.3%. The overall death rate was 0.9% (5 of 567), and 2 deaths were related to drug toxicity. Gastrointestinal intolerance was frequent (64.5%). The drug was interrupted in 9 patients (1.5%) because of drug-associated adverse events. Conclusions. As compared to the phase III trial that led to registration of the drug a decade ago, there is a substantial increase in the failure rate of oral miltefosine for treatment of VL in India. © The Author 2012.
Intracranial aspergilloma in an immunocompetent geriatric patient: A diagnostic dilemma
(John Wiley and Sons Inc, 2024) Gaurav Sharma; Amit Kumar; Anup Singh
[No abstract available]
Iron Isomaltoside-Induced Anaphylaxis
(Lippincott Williams and Wilkins, 2022) Upinder Kaur; Amit Singh; Indrajeet S. Gambhir; Shubham Kashyap; Anup Singh; Sankha S. Chakrabarti
[No abstract available]
Musculoskeletal Ultrasonography in Detecting Disease Activity in Patients of Juvenile Idiopathic Arthritis: A Cross-Sectional Study
(Wolters Kluwer Medknow Publications, 2019) Sharad Dev; Ashish Verma; Anup Singh
Background: Musculoskeletal ultrasonography (MSUS) is a powerful tool to detect subclinical disease in juvenile idiopathic arthritis (JIA). The study was done to compare the results of clinical examination and ultrasonography (US) in identifying disease activity in joints of patients of JIA. Methods: Patients of JIA attending rheumatology clinic of a tertiary care referral center in northern India over a span of 1 year from June 2015 to June 2016 were enrolled in the study. The diagnosis of JIA was established using International League of Associations for Rheumatology 2001 criteria. Clinically determination of synovitis was compared to MSUS parameters of active disease such as synovial hypertrophy, effusion, and increased vascularity in large joints only (bilateral knee, ankle, wrist, and elbow). Results: A total of 108 patients were enrolled in a study period and 864 joints were examined. Synovitis was detected in 305 joints by clinical examination. However, US demonstrated synovitis in 502 joints (additional 209 joints). Twenty patients who were initially thought to be oligoarticular by clinical examination were later classified to polyarticular subtype on the basis of MSUS findings. A significant correlation between erosions and rheumatoid factor and anti-cyclic citrullinated peptide values was found. Conclusion: Our study found that MSUS has a definite role in assessing the disease activity in JIA patients and this modality may be considered as an adjunct in this context, as well as considered for future inclusion in classification criteria for JIA. © 2019 Indian Journal of Rheumatology.
Of cross-immunity, herd immunity and country-specific plans: Experiences from COVID-19 in India
(International Society on Aging and Disease, 2020) Sankha Shubhra Chakrabarti; Upinder Kaur; Anup Singh; Suddhachitta Chakrabarti; Manigreeva Krishnatreya; Bimal Kumar Agrawal; Amit Mittal; Amit Singh; Rahul Khanna; Indrajeet Singh Gambhir; Kunlin Jin; Sasanka Chakrabarti
India has witnessed a high number of COVID-19 cases, but mortality has been quite low, and most cases have been asymptomatic or mild. In early April, we had hypothesized a low COVID-19 mortality in India, based on the concept of cross-immunity. The presence of cross-immunity is presumed to lead to a milder course of disease and allow the time necessary for the development of adaptive immunity by the body to eliminate the virus. Evidence supporting our hypothesis has started showing up. Multiple studies have shown the generation of different T cell subsets and B cells responding to epitopes of viral proteins, especially of the spike protein, as a part of adaptive immunity against SARS-CoV-2. Cross-reactive T-cells have been demonstrated in patients who have been previously exposed to endemic coronaviruses. The interplay of cross-immunity and herd immunity is apparent in the COVID-19 scenario in India from the presence of a large number of asymptomatic or mild cases, a low infection-fatality ratio and a generally flat curve of percentage positivity of cases with respect to total testing, both in periods of strict lock-down and step-wise unlocking. It seems that cross-immunity resulted in faster generation of herd immunity. Although the initial restrictive measures such as lockdown prevented the rapid spread of the outbreak, further extension of such measures and overly expensive ones such as enhanced testing in India will result in a huge burden on the health economics as well as the society. Hence, we propose a restructuring of the health services and approach to COVID-19. The restructured health services should move away from indiscriminate testing, isolation and quarantine, and instead, the emphasis should be on improving facilities for testing and management of only critical COVID cases and the replacement of complete lockdowns by the selective isolation and quarantine of susceptible persons such as the aged and those with co-morbidities. In the process of describing India-specific plans, we emphasize why the development of country-specific plans for tackling epidemics is important, instead of adopting a “one policy fits all” approach. Copyright: © 2020 Chakrabarti SS. et al.
Paraparesis in coarctation of aorta: Diagnosis in disguise
(Chinese Medical Association, 2015) Anup Singh; Annesh Bhattacharya; Nilesh Kumar
[No abstract available]
Persistent Health Issues, Adverse Events, and Effectiveness of Vaccines during the Second Wave of COVID-19: A Cohort Study from a Tertiary Hospital in North India
(MDPI, 2022) Upinder Kaur; Sapna Bala; Aditi Joshi; Noti Taruni Srija Reddy; Chetan Japur; Mayank Chauhan; Nikitha Pedapanga; Shubham Kumar; Anurup Mukherjee; Vaibhav Mishra; Dolly Talda; Rohit Singh; Rohit Kumar Gupta; Ashish Kumar Yadav; Poonam Jyoti Rana; Jyoti Srivastava; Shobha Bhat K; Anup Singh; G. Naveen Kumar P.; Manoj Pandey; Kishor Patwardhan; Sangeeta Kansal; Sankha Shubhra Chakrabarti
Background There is paucity of real-world data on COVID-19 vaccine effectiveness from cohort designs. Variable vaccine performance has been observed in test-negative case-control designs. There is also scarce real-world data of health issues in individuals receiving vaccines after prior COVID-19, and of adverse events of significant concern (AESCs) in the vaccinated. Methods: A cohort study was conducted from July 2021 to December 2021 in a tertiary hospital of North India. The primary outcome was vaccine effectiveness against COVID-19 during the second wave in India. Secondary outcomes were AESCs, and persistent health issues in those receiving COVID-19 vaccines. Regression analyses were performed to determine risk factors of COVID-19 outcomes and persistent health issues. Results: Of the 2760 health care workers included, 2544 had received COVID-19 vaccines, with COVISHIELD (rChAdOx1-nCoV-19 vaccine) received by 2476 (97.3%) and COVAXIN (inactivated SARS-CoV-2 vaccine) by 64 (2.5%). A total of 2691 HCWs were included in the vaccine effectiveness analysis, and 973 COVID-19 events were reported during the period of analysis. Maximum effectiveness of two doses of vaccine in preventing COVID-19 occurrence was 17% across three different strategies of analysis adopted for robustness of data. One-dose recipients were at 1.27-times increased risk of COVID-19. Prior SARS-CoV-2 infection was a strong independent protective factor against COVID-19 (aOR 0.66). Full vaccination reduced moderate–severe COVID-19 by 57%. Those with lung disease were at 2.54-times increased risk of moderate–severe COVID-19, independent of vaccination status. AESCs were observed in 33/2544 (1.3%) vaccinees, including one case each of myocarditis and severe hypersensitivity. Individuals with hypothyroidism were at 5-times higher risk and those receiving a vaccine after recovery from COVID-19 were at 3-times higher risk of persistent health issues. Conclusions: COVID-19 vaccination reduced COVID-19 severity but offered marginal protection against occurrence. The possible relationship of asthma and hypothyroidism with COVID-19 outcomes necessitates focused research. With independent protection of SARS-CoV-2 infection, and high-risk of persistent health issues in individuals receiving vaccine after recovery from SARS-CoV-2 infection, the recommendation of vaccinating those with prior SARS-CoV-2 infection needs reconsideration. © 2022 by the authors.
Predictive markers of failure of first line anti retroviral treatment in HIV patients in India
(2013) Anup Singh; Amit Agarwal; Jaya Chakravarty; Sarita kumari; Madhukar Rai; Shyam Sundar
Background: In India where Anti-retroviral therapy (ART) is not guided by regular viral load assessment and genotyping resistance testing, there is need to find markers that can predict failure to ART. This study was done to find predictive markers of failure of first line ART in treatment-naive HIV patients in the National treatment programme running in India. Methods: A retrospective case control study was done at ART centre, Department of Medicine, S. S. Hospital, Banaras Hindu University, Varanasi and Uttar Pradesh. Cases were patients who failed first line ART and started on second line ART from December 2008 to January 2011.Patients well tolerating on first line ART since five years (2005) was taken as controls. Various factors were analysed in both groups and comparison was done to find their level of significance. Results: Seventy eight (78) patients who failed first line ART (cases) and 202 patients in control group were analysed. Mean Baseline CD4 count of cases (103.92 ± 87.27) were significantly lower than control group (206.93 ± 169.91) [p<0.0001]. Failure group had significantly higher mean age (38.10 ± 7.89 yrs) as compared to control (35.35 ± 7.58) [p<0.008]. Peak CD4 count in failure group [236.19 ± 165.88; median=197; IQR=159.8 (126.7.296.5)] was significantly lower than control group [676.70 ± 276.20; median =690.5; IQR=368(466,834)] {p<0.001}. The median time to reach peak CD4 count was significantly less in failure group [median=18 months; IQR=21(7.5, 28.5)] as compared to control group [median=58months; IQR=18(36, 54)] {p<0.001}. Patients who were in the failure group had a higher proportion of patients with a negative change in weight (73.1%) and higher number of patients with history of tuberculosis (59%). Conclusions: Monitoring of time to achieve peak CD4 count and level of peak CD4 count achieved were found to be the novel factors besides other inexpensive markers, which can predict the failure of first line ART. © 2013 Singh A, et al.