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1.
Plast Reconstr Surg Glob Open ; 12(7): e5939, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38957712

RESUMO

Integration of artificial intelligence (AI), specifically with natural language processing and machine learning, holds tremendous potential to enhance both clinical practices and administrative workflows within plastic surgery. AI has been applied to various aspects of patient care in plastic surgery, including postoperative free flap monitoring, evaluating preoperative risk assessments, and analyzing clinical documentation. Previous studies have demonstrated the ability to interpret current procedural terminology codes from clinical documentation using natural language processing. Various automated medical billing companies have used AI to improve the revenue management cycle at hospitals nationwide. Additionally, AI has been piloted by insurance companies to streamline the prior authorization process. AI implementation holds potential to enhance billing practices and maximize healthcare revenue for practicing physicians.

2.
Ann Surg Open ; 5(1): e381, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38883953

RESUMO

Surgeons must be confident that the instruments they use do not pose risk of infection to patients due to bioburden or contamination. Despite this importance, surgeons are not necessarily aware of the steps required to ensure that an instrument has been properly sterilized, processed, and prepared for the next operation. At the end of an operation, instruments must be transported to the sterile processing unit. There, instruments are decontaminated before being sterilized by heat, chemical, or radiation-based methods. Following this, they are stored before being brought back into use. This review highlights the intricacies of the processing of surgical instruments at the conclusion of an operation so that they are ready for the next one.

3.
J Surg Educ ; 81(7): 929-937, 2024 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-38749815

RESUMO

OBJECTIVES: To provide an overview of the current state of physician unionization, potential factors surrounding increased unionization, and the ethical and financial issues that may arise. DESIGN: Review article. SETTING: Not applicable. PARTICIPANTS: Not applicable. RESULTS: Over the last few years, there has been a recent surge in physician unionization. Union membership among residents and fellows is also at an all-time high and continues to increase, as seven residency programs voted to unionize in 2023. The resulting threat of strikes has grown considerably over the last year as residents across 6 hospitals have threatened to strike, resulting in New York's first physician strike in over three decades. As physician practice continues to shift from private to corporate health system-based employment, more opportunities for unionization will arise. Globally, these trends have been comparable, with thousands of physicians striking across the United Kingdom, Germany, Italy, Nigeria, and New Zealand in the last year. CONCLUSION: The current state of physician unionization is of increasing significance as more physicians are presented with opportunities for unionization. Physicians perceive a lack of autonomy, and the demand to deliver high level outcomes with diminishing resources is becoming an insurmountable challenge. Additionally, physician satisfaction with their workplace has decreased with increased burnout rates. Thus, it is important to understand the current state of unionization, potential reasons for unionization among physicians and residents, and its future impact on the field of medicine.


Assuntos
Sindicatos , Humanos , Médicos , Masculino , Feminino , Satisfação no Emprego , Estados Unidos
4.
Aesthet Surg J Open Forum ; 6: ojae019, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38633727

RESUMO

Historically, demand for plastic surgery has been associated with the performance of the US economy. This study evaluates the relationship between economic performance indicators and the popularity and profitability of aesthetic surgery from 2006 to 2022, considering several recessions and the rise of social media. The data were collected from the Aesthetic Society's (AS) Aesthetic Plastic Surgery National Databank and the American Society of Plastic Surgeons' (ASPS) Plastic Surgery Statistics Report from 2006 to 2022. Procedures analyzed included the most performed cosmetic surgeries, as well as neuromodulator injections and dermal fillers. Pearson correlation tests were used to analyze the strength of association between 8 financial indicators and case volumes and expenditures for each procedure. From 2006 to 2020, ASPS data demonstrated gross domestic product (GDP) per capita year-over-year (YOY) change that was positively correlated with case volume and expenditures across 13 out of the 24 different procedure metrics (54.2%). From 2006 to 2016, AS data were positively correlated with the YOY change of theNational Association of Securities Dealers Automated Quotations (NASDAQ), Standard and Poor's 500, and Dow Jones in 12 of the 24 variables (50%). This was followed by GDP YOY change, with positive correlations to 11 variables (45.8%). YOY changes of consumer-level finances and inflation indicators were less frequently associated among both datasets.In conclusion, our study shows that aesthetic plastic surgery procedures and expenditures correlate with GDP. Although aesthetic surgery demand may be difficult to anticipate, this study elucidates several factors plastic surgeons may use as a bellwether for their practices.

5.
Aesthet Surg J Open Forum ; 6: ojae012, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-38510270

RESUMO

Plastic surgery relies heavily on clinical photography to document preoperative and postoperative changes, visualize surgical approaches, and evaluate outcomes. However, the contemporary landscape of plastic surgery photography faces challenges, including a lapse in standards due to the prevalence of smartphones, social media platforms, and security concerns related to data storage and cyberattacks. In this comprehensive review, the authors aim to provide plastic surgeons with practical guidelines for achieving standardized, high-quality clinical photography while navigating the evolving landscape of technology, security, and ethical considerations. We explore the security challenges associated with storing clinical photographs, emphasizing the legal obligations under the Health Insurance Portability and Accountability Act (HIPAA). We also discuss various storage options, including HIPAA-compliant cloud services, electronic medical records, and emerging technologies like blockchain and artificial intelligence.

6.
Aesthet Surg J ; 44(2): NP177-NP183, 2024 Jan 16.
Artigo em Inglês | MEDLINE | ID: mdl-37706359

RESUMO

The World Health Organization (WHO) estimates that over 650 million adults are obese worldwide. Recently, antidiabetic medications have rapidly become popular as weight loss medications. With the rising prevalence of obesity and the increasing demand for aesthetic procedures, it is anticipated that a growing number of patients presenting for consultation will be prescribed these medications. Therefore, it is critical for practicing plastic surgeons to understand their potential synergistic effects and safety considerations. This manuscript explores the potential benefits and considerations of antidiabetic medications in plastic surgery patients for weight loss therapy. The authors discuss the mechanisms of action, clinical efficacy, potential side effects, and relevant considerations for incorporating these medications into plastic surgery practices and medical spas.


Assuntos
Procedimentos de Cirurgia Plástica , Cirurgiões , Cirurgia Plástica , Adulto , Humanos , Procedimentos de Cirurgia Plástica/efeitos adversos , Obesidade , Redução de Peso , Hipoglicemiantes/efeitos adversos
7.
Aesthet Surg J ; 44(4): 428-435, 2024 Mar 15.
Artigo em Inglês | MEDLINE | ID: mdl-38150274

RESUMO

Private equity acquisition of independent private practices has grown dramatically in the last decade, with private equity firms increasingly investing in surgical specialties that practice in outpatient ambulatory centers. This trend has slowly started to creep into plastic surgery; therefore, understanding the concepts of private equity ownership in healthcare and its benefits and risks is critical. This article provides a fundamental economic background on private equity, describes its current state in healthcare, including trends in plastic surgery, and provides recommendations for plastic surgeons considering private equity acquisition.


Assuntos
Procedimentos de Cirurgia Plástica , Cirurgia Plástica , Humanos , Propriedade , Prática Privada
8.
J Hand Surg Glob Online ; 5(3): 375-378, 2023 May.
Artigo em Inglês | MEDLINE | ID: mdl-37323983

RESUMO

The thumb is a crucial part of the hand, and traumatic thumb amputation is a devastating injury that significantly diminishes hand function. In situations in which replantation is not possible, great toe-to-thumb transfer is a well-established option for reconstruction. Although most studies describe excellent functional outcomes and patient satisfaction, there is a paucity of literature presenting long-term follow-up to determine whether these outcomes are maintained. In this case report, we present a case of great toe-to-thumb transfer performed 40 years ago and evaluate outcomes using validated questionnaires and standardized examination maneuvers. Our results highlight sustained patient satisfaction and excellent functional outcomes decades after the initial reconstruction.

9.
J Surg Educ ; 80(6): 776-785, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-37012141

RESUMO

OBJECTIVES: Residency applicant assessment is imperfect, with little objectivity built into the process, which, unfortunately, impacts recruitment diversity. Linear rank modeling (LRM) is an algorithm that standardizes applicant assessment to model expert judgment. Over the last 5 years, we have used LRM to assist with screening and ranking integrated plastic surgery (PRS) residency applicants. This study's primary objective was to determine if LRM scores are predictive of match success and, secondarily, to compare LRM scores between gender and self-identified race categories. DESIGN: Data was collected on applicant demographics, traditional application metrics, global intuition rank, and match success. LRM scores were calculated for screened and interviewed applicants, and scores were compared by demographic groups. Univariate logistic regression was used to evaluate the association of LRM scores and traditional application metrics with match success. SETTING: University of Wisconsin, Division of Plastic and Reconstructive Surgery. Academic institution. PARTICIPANTS: Six hundred seventeen candidates who applied to a single institution over 4 application cycles (2019-2022). RESULTS: Using area under the curve modeling, LRM score was the most predictive indicator for match success. With every one-point increase in LRM score, there was an 11% and 8.3% increase in the likelihood of screened and interviewed applicant match success (p < 0.001). An algorithm was developed to estimate the probability of match success based on LRM score. No significant differences in LRM scores were appreciated for interviewed applicant gender or self-identified race groups. CONCLUSIONS: LRM score is the most predictive indicator of match success for PRS applicants and can be used to estimate an applicant's probability of successfully matching into an integrated PRS residency. Furthermore, it provides a holistic evaluation of the applicant that can streamline the application process and improve recruitment diversity. In the future, this model could be applied to assist in the match process for other specialties.


Assuntos
Internato e Residência , Procedimentos de Cirurgia Plástica , Cirurgia Plástica , Humanos , Seleção de Pessoal , Cirurgia Plástica/educação
10.
Aesthet Surg J Open Forum ; 5: ojad033, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37082332

RESUMO

Background: The financial principles of a no-cost revision policy and their implications for revision rates are not well understood. Objectives: Therefore, the primary objective of this retrospective study is to report our no-cost revision rates and, secondarily, to survey the cosmetic revision policies of other cosmetic surgery practices and detail the financial principles underpinning no-cost revisions. Methods: All aesthetic surgeries and no-cost revisions performed by the plastic surgeons, oculoplastic surgeons, and facial plastic and reconstructive surgeons at our academic outpatient cosmetic surgery center from January 1, 2016 to June 30, 2022 were identified using procedural codes. Data on the number of surgeries, number of revisions, operative minutes, and time intervals between initial and revision surgeries were collected. A survey was administered to assess the revision policies of similar cosmetic surgery practices. Results: A total of 1491 aesthetic surgeries and minimally invasive procedures were included, and 125 revision procedures were performed (8.4%). Thigh lifts (3, 13.6%), rhinoplasties or septoplasties (25, 15.8%), and otoplasties (3, 27.3%) had the highest revision rates. Three practices (15%) offered cosmetic revisions at no cost, 9 (45%) did not apply a surgeon's fee, 5 (25%) evaluated fees on a case-by-case basis, 1 (5%) offered revisions with an insurance policy, and 2 (10%) cosmetic surgery practices did not offer revisions at a reduced rate. Conclusions: Despite offering revisions at no cost, our revision rates are reasonable for an academic cosmetic surgery practice. The revision policies offered to patients on the private market are varied, but most surveyed practices offer revisions at either a reduced rate or no cost.

11.
Plast Reconstr Surg Glob Open ; 11(3): e4873, 2023 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-36910731

RESUMO

The increasing patient demand for cosmetic surgeries and minimally invasive procedures has encouraged physicians without aesthetic surgery training accredited by the American Board of Medical Specialties to provide these services. This systematic review aims to determine the rate of out-of-scope practice in medical malpractice lawsuits involving cosmetic surgery or minimally invasive procedures performed by nonplastic surgeons. Methods: Our systematic review of the Westlaw legal database from 1979 to 2022 included 64 malpractice cases. Inclusion criteria were cosmetic surgeries or minimally invasive procedures in medical malpractice lawsuits not involving board-certified plastic surgeons. Out-of-scope was defined using the procedural competencies established by the American Council for Graduate Medical Education, the Commission on Dental Accreditation, and the Council of Podiatric Medical Education. Data on legal proceedings, provider credentials and board certification, surgical interventions, and legal outcomes were collected. Results: The majority of malpractice cases involving cosmetic surgeries or minimally invasive procedures occurred when providers were practicing out of scope (N = 34; 55.7%). The verdict was ruled in favor of the plaintiff (patient) in 34.4% of cases. Out-of-scope practice occurred most in family/internal medicine, no board certification, and obstetrics/gynecology (N = 4, N = 4, and N = 3, respectively). The most common allegation was permanent injury or disfigurement (N = 21; 21.4%). Plastic surgeons provided expert testimony 44.0% of the time. Conclusion: Our review of the Westlaw legal database suggests that the majority of nonplastic surgeon cosmetic malpractice cases may occur in the setting of out-of-scope practice.

12.
Aesthet Surg J ; 43(9): 1036-1045, 2023 08 17.
Artigo em Inglês | MEDLINE | ID: mdl-36947151

RESUMO

BACKGROUND: Cosmetic surgery is a large portion of practice revenue for many plastic surgeons, and therefore understanding the economic principles of pricing is critical. Although national averages provide a starting point for price determination, they may not reflect specific economic factors. Over the last decade, publicly reported pricing for cosmetic surgery has increased in prevalence, improving price transparency for patients and surgeons alike. OBJECTIVES: This study aims to compare publicly reported prices to national cosmetic surgery averages and identify variables that have the greatest impact on price determination. METHODS: An Internet search was performed with the term "cosmetic surgery, price" for practices that publicly reported cosmetic surgery prices. Publicly reported prices were compared to national averages generated from The Aesthetic Society's Aesthetic Society Plastic Surgery National Databank Statistics. The impact of regional prices, practice type, and surgeon accreditation were analyzed for the most popular cosmetic surgery procedures. RESULTS: Sixty-six practices were identified that reported cosmetic surgery pricing information. Publicly reported prices were significantly higher for all surgical procedures except nipple procedures, excision of (excess) skin, fat grafting, fat harvest, and lip enhancement. Facility/operating room fees (n = 38) and anesthesia fees (n = 34) were the most common components included in a price, after surgeons' fees (n = 66). A significant price difference was appreciated when separating practices by region for all procedures except breast augmentation (P = .074) and liposuction (P = .088). CONCLUSIONS: Publicly reported prices provide greater insight than national averages into specific pricing factors and strategies that can be employed when setting surgical prices.


Assuntos
Lipectomia , Mamoplastia , Procedimentos de Cirurgia Plástica , Cirurgia Plástica , Humanos , Custos e Análise de Custo
13.
Aesthet Surg J Open Forum ; 5: ojad008, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36844458

RESUMO

Medical malpractice lawsuits can be a source of emotional, physical, and financial distress for both providers and patients. A thorough understanding of the medical malpractice process's history and current landscape will help providers navigate malpractice challenges. Given the impact and prevalence of medical malpractice, in this paper, the authors sought to dissect the intricate anatomy of a medical malpractice lawsuit. This includes a comprehensive and detailed report of tort reform, the criteria of a medical malpractice suit, and a description of the court proceedings. In addition, the authors also performed an extensive review of the medicolegal literature and have provided recommendations for healthcare providers to avoid these lawsuits in their practice.

15.
Plast Reconstr Surg ; 151(2): 443-449, 2023 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-36696334

RESUMO

SUMMARY: The Emergency Medical Treatment and Labor Act (EMTALA) was enacted by Congress in 1986 to protect uninsured patients against economic discrimination. Although this law has been established for several decades, recent passage of the No Surprises Act may invoke new implications for the health care system under EMTALA. Therefore, it is worthwhile to review EMTALA's applications to the practice of plastic surgery and review EMTALA in the context of the recently passed No Surprises Act. First, providers are mandated by EMTALA to administer a medical screening examination to any patient presenting for emergent care. Second, providers must administer medical stabilization if the medical screening examination reveals an emergent condition. If the hospital lacks specialized capabilities to provide stabilizing care, they are required to transfer the patient to a facility that can provide care. Although EMTALA's provisions protect patients and provide them with leverage to obtain emergency care, the act has been associated with out-of-network, or "surprise," medical bills for the insured population and, ultimately, may be detrimental to plastic surgeons in emergency settings. The concerns related to EMTALA within plastic surgery involve the overburdening of surgeons at tertiary care centers because of uncompensated care and high rates of interfacility transfers. In addition, the recent passage of the No Surprises Act to end out-of-network emergency bills may further impact care provided by plastic surgeons in emergency settings under EMTALA's mandate. Potential methods to address these concerns include increasing on-call reimbursement rates and implementation of emergency department telemedicine services.


Assuntos
Serviço Hospitalar de Emergência , Telemedicina , Humanos , Estados Unidos , Tratamento de Emergência , Transferência de Pacientes , Pessoas sem Cobertura de Seguro de Saúde
16.
Plast Reconstr Surg Glob Open ; 10(7): e4406, 2022 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-35813108

RESUMO

Background: Out-of-network, or "surprise" bills, have grown common in recent years and have raised substantial concern for patients. Congress recently enacted the No Surprises Act, effective on January 1, 2022, ending the majority of out-of-network bills for privately insured patients. The aim of this review is to briefly summarize the history of surprise billing, describe the regulations of the No Surprises Act, and examine the impact this legislation will have on the field of plastic surgery. Methods: A PubMed and Google Scholar literature search was conducted on out-of-network billing, or surprise bills, and the No Surprises Act. Media outlets, governmental agencies, and local and national medical organizations were additionally queried for surprise billing and the No Surprises Act. Results: Under the No Surprises Act, privately insured patients are protected from surprise medical bills in emergency and nonemergency settings, and uninsured or self-pay patients must be provided a good faith estimate of service fees before receiving nonemergent care. Plastic surgeons may consent patients to receive out-of-network bills if consent is obtained at least 72 hours before rendering a nonemergency service. Despite these patient protections, this act may influence plastic surgeons' reimbursement rates and incentivize surgeons to alter their network status. Conclusions: The No Surprises Act provides significant protections for patients. However, it may have adverse effects for plastic surgeons. Plastic surgeons will only get paid in-network fees while providing care to patients unless consent is properly obtained in a nonemergent setting.

17.
Plast Reconstr Surg Glob Open ; 10(4): e4282, 2022 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-35494881

RESUMO

Background: Postsurgical pyoderma gangrenosum is a rare condition characterized by ulcerative lesion development at surgical sites. It is frequently misdiagnosed as infection and mismanaged with surgical debridement, which only worsens the condition. Achieving the correct diagnosis is crucial to delivering the appropriate medical therapy. This article presents four clinical cases of postsurgical pyoderma gangrenosum in breast surgery patients, and proposes a work-up schematic to aid in its diagnosis based on literature review and author experience. Methods: Four patients who developed postsurgical pyoderma gangrenosum following breast surgery were identified by chart review at our institution. Results: The cases include two breast reduction patients, an abdominally based breast reconstruction patient, and a breast augmentation patient. The time to diagnosis and treatment varied greatly between the patients, with diagnosis achieved as early as 13 days postoperatively to as late as one year postoperatively. Two of the four patients were initially mismanaged with surgical debridement, and all patients were treated with at least one course of antibiotics for a misdiagnosis of surgical site infection before they were correctly diagnosed. Conclusions: Postsurgical pyoderma gangrenosum is a rare, ulcerative condition that is difficult to diagnose and often mismanaged with surgical debridement. Diagnosis requires a high clinical suspicion and should be considered in patients with ulcerative lesions resistant to antibiotic therapy, in patients who have bilateral lesions with NAC sparring, and in those with systemic inflammatory conditions. Diagnosis is usually delayed, so it is imperative that surgeons keep this diagnosis in mind when treating breast patients with postsurgical wounds.

18.
Aesthetic Plast Surg ; 45(6): 3005-3018, 2021 12.
Artigo em Inglês | MEDLINE | ID: mdl-34231016

RESUMO

PURPOSE: Plastic surgery procedures, including minimally invasive cosmetic procedures, continue to grow in popularity. Although dermatologic complications following plastic surgery procedures are rare, the authors have encountered several of these complications in their practice, including herpes simplex virus (HSV-1) and varicella zoster virus (VZV) infections, pyoderma gangrenosum (PG), contact dermatitis, and suture hypersensitivity. These cases prompted a systematic literature review of dermatologic complications following plastic surgery procedures. METHODS: The authors conducted a systematic review of PubMed, MEDLINE, EMBASE, Scopus, Web of Science, and the Cochrane Library to identify relevant articles published from 1975 to 2021. Articles were independently reviewed by the authors to determine whether studies met inclusion criteria. RESULTS: The majority of articles that met inclusion criteria represented level V evidence. The most robust evidence in the literature was for PG, for which there were 63 total studies. Pyoderma gangrenosum was most frequently reported following breast surgery (85.1%), while HSV-1 infections were frequently seen following minimally invasive procedures (84.6%). VZV reactivation was reported after a range of interventions, including pedicled flap surgeries and laser treatments. Other complications, such as suture hypersensitivity, were less frequently reported in the literature, usually as isolated case reports. CONCLUSIONS: Dermatologic complications represent a rare but serious concern following plastic surgery procedures. While most dermatologic complications resolve with appropriate treatment, sequelae of these conditions can be devastating to the patient's overall outcome. Plastic surgeons performing procedures at a high risk of these complications should recognize the diagnostic criteria to facilitate appropriate treatment. LEVEL OF EVIDENCE III: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors   www.springer.com/00266 .


Assuntos
Procedimentos de Cirurgia Plástica , Cirurgia Plástica , Bibliometria , Humanos , Mastectomia , Procedimentos de Cirurgia Plástica/efeitos adversos , Retalhos Cirúrgicos
19.
Plast Reconstr Surg ; 147(3): 538-544, 2021 03 01.
Artigo em Inglês | MEDLINE | ID: mdl-33587559

RESUMO

BACKGROUND: Consistently selecting successful, productive applicants from an annual candidate pool is the goal of all resident selection practices. Efforts to routinely identify high-quality applicants involve scrutiny of multiple factors and formulation of an ordinal rank list. Linear modeling offers a quantified approach to applicant selection that is strongly supported by decades of psychological research. METHODS: For the 2019 residency application process, the University of Wisconsin Plastic Surgery Residency Program used linear modeling in their evaluation and ranking process. A linear model was developed using United States Medical Licensing Examination Step 1 and Step 2 scores, letters of recommendation, publications, and extracurricular activities as inputs. RESULTS: The applicant's total score was calculated from a maximum total score of 100. The mean and median scores were 49 and 48, respectively, and applicants were ranked according to total score. A separate rank list was maintained using our program's standard methodology for applicant ranking, which involves global intuitive scoring during the interview process. The Spearman rank correlation coefficient between the two lists was 0.532, and differences between the rank lists were used as a fulcrum for discussion before making the final rank list. CONCLUSIONS: This article presents the first known instance of the use of linear modeling to improve consistency, increase fairness, and decrease bias in the plastic surgery residency selection process. Transparent sharing of methodology may be useful to other programs seeking to optimize their own ranking methodology. Furthermore, it indicates to applicants that they are being evaluated based on fair, quantifiable criteria.


Assuntos
Internato e Residência/normas , Modelos Lineares , Seleção de Pessoal/métodos , Critérios de Admissão Escolar , Cirurgia Plástica/educação , Viés , Humanos , Internato e Residência/ética , Seleção de Pessoal/ética , Seleção de Pessoal/normas , Wisconsin
20.
Lancet Infect Dis ; 21(5): 637-646, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-33485468

RESUMO

BACKGROUND: To mitigate the effects of COVID-19, a vaccine is urgently needed. BBV152 is a whole-virion inactivated SARS-CoV-2 vaccine formulated with a toll-like receptor 7/8 agonist molecule adsorbed to alum (Algel-IMDG) or alum (Algel). METHODS: We did a double-blind, multicentre, randomised, controlled phase 1 trial to assess the safety and immunogenicity of BBV152 at 11 hospitals across India. Healthy adults aged 18-55 years who were deemed healthy by the investigator were eligible. Individuals with positive SARS-CoV-2 nucleic acid and/or serology tests were excluded. Participants were randomly assigned to receive either one of three vaccine formulations (3 µg with Algel-IMDG, 6 µg with Algel-IMDG, or 6 µg with Algel) or an Algel only control vaccine group. Block randomisation was done with a web response platform. Participants and investigators were masked to treatment group allocation. Two intramuscular doses of vaccines were administered on day 0 (the day of randomisation) and day 14. Primary outcomes were solicited local and systemic reactogenicity events at 2 h and 7 days after vaccination and throughout the full study duration, including serious adverse events. Secondary outcome was seroconversion (at least four-fold increase from baseline) based on wild-type virus neutralisation. Cell-mediated responses were evaluated by intracellular staining and ELISpot. The trial is registered at ClinicalTrials.gov (NCT04471519). FINDINGS: Between July 13 and 30, 2020, 827 participants were screened, of whom 375 were enrolled. Among the enrolled participants, 100 each were randomly assigned to the three vaccine groups, and 75 were randomly assigned to the control group (Algel only). After both doses, solicited local and systemic adverse reactions were reported by 17 (17%; 95% CI 10·5-26·1) participants in the 3 µg with Algel-IMDG group, 21 (21%; 13·8-30·5) in the 6 µg with Algel-IMDG group, 14 (14%; 8·1-22·7) in the 6 µg with Algel group, and ten (10%; 6·9-23·6) in the Algel-only group. The most common solicited adverse events were injection site pain (17 [5%] of 375 participants), headache (13 [3%]), fatigue (11 [3%]), fever (nine [2%]), and nausea or vomiting (seven [2%]). All solicited adverse events were mild (43 [69%] of 62) or moderate (19 [31%]) and were more frequent after the first dose. One serious adverse event of viral pneumonitis was reported in the 6 µg with Algel group, unrelated to the vaccine. Seroconversion rates (%) were 87·9, 91·9, and 82·8 in the 3 µg with Algel-IMDG, 6 µg with Algel-IMDG, and 6 µg with Algel groups, respectively. CD4+ and CD8+ T-cell responses were detected in a subset of 16 participants from both Algel-IMDG groups. INTERPRETATION: BBV152 led to tolerable safety outcomes and enhanced immune responses. Both Algel-IMDG formulations were selected for phase 2 immunogenicity trials. Further efficacy trials are warranted. FUNDING: Bharat Biotech International.


Assuntos
Vacinas contra COVID-19/imunologia , COVID-19/prevenção & controle , SARS-CoV-2/imunologia , Adolescente , Adulto , Anticorpos Neutralizantes/sangue , Anticorpos Antivirais/sangue , Vacinas contra COVID-19/efeitos adversos , Método Duplo-Cego , Feminino , Humanos , Imunoglobulina G/sangue , Masculino , Pessoa de Meia-Idade , Receptor 7 Toll-Like/agonistas , Receptor 8 Toll-Like/agonistas , Vacinação , Vacinas de Produtos Inativados/imunologia , Adulto Jovem
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