A new classification of foods based on the extent and purpose of their processing

This paper describes a new food classification which assigns foodstuffs according to the extent and purpose of the industrial processing applied to them. Three main groups are defined: unprocessed or minimally processed foods (group 1), processed culinary and food industry ingredients (group 2), and ultra-processed food products (group 3). The use of this classification is illustrated by applying it to data collected in the Brazilian Household Budget Survey which was conducted in 2002/2003 through a probabilistic sample of 48,470 Brazilian households. The average daily food availability was 1,792 kcal/person being 42.5% from group 1 (mostly rice and beans and meat and milk), 37.5% from group 2 (mostly vegetable oils, sugar, and flours), and 20% from group 3 (mostly breads, biscuits, sweets, soft drinks, and sausages). The share of group 3 foods increased with income, and represented almost one third of all calories in higher income households. The impact of the replacement of group 1 foods and group 2 ingredients by group 3 products on the overall quality of the diet, eating patterns and health is discussed.

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Analysis of the quality of early diagnostics of cardiovascular diseases in students of educational institutions of Khabarovsk (according to the data of preventive examinations)

Dalʹnevostočnyj medicinskij žurnal ◽

10.35177/1994-5191-2020-4-13-16 ◽

2020 ◽

pp. 13-16

Keyword(s):

Blood Pressure ◽

Cardiovascular Diseases ◽

Sinus Tachycardia ◽

Blood Pressure Level ◽

Educational Institutions ◽

Conduction Disturbances ◽

Group 3 ◽

Group 2 ◽

Group 1

To identify the prevalence of early pathology of cardiovascular diseases, a survey of 400 200 girls) in the age group 15 and 17 years old was conducted as a part of routine medical of the level of blood pressure (BP) was carried out, with the calculation of the average level pressure on the basis of three separate measurements estimated by percentile tables for a registration of a standard resting ECG in 12 leads. According to the results of the survey, into 3 groups: with an increase in blood pressure above 95 ‰ (group 1 – 16 people), which recorded in males (p<0,05); Group 2 (67 people) – adolescents with a normal blood pressure level and group 3 of adolescents with a decrease in blood pressure below 5 ‰ changes in the form of rhythm and conduction disturbances were noted in almost every a predominance of sinus tachycardia in the first group. In the third group of adolescents, form of ectopic rhythm and pacemaker migration were significantly more frequently only 78 % of adolescents were referred for consultation and in-depth examination by a pediatric cardiologist.

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QOL-49. THE IMPACT OF OTOTOXICITY AND VISUAL IMPAIRMENT ON EDUCATION IN CHILDREN TREATED FOR CNS TUMOURS

Neuro-Oncology ◽

10.1093/neuonc/noaa222.704 ◽

2020 ◽

Vol 22 (Supplement_3) ◽

pp. iii440-iii440

Author(s):

Harriet Dulson ◽

Rachel McAndrew ◽

Mark Brougham

Keyword(s):

Visual Impairment ◽

Impaired Hearing ◽

Cranial Radiotherapy ◽

Radiotherapy Group ◽

Platinum Based Chemotherapy ◽

Cns Tumours ◽

Group 3 ◽

Group 2 ◽

The Impact ◽

Group 1

Abstract INTRODUCTION Children treated for CNS tumours experience a very high burden of adverse effects. Platinum-based chemotherapy and cranial radiotherapy can cause ototoxicity, which may be particularly problematic in patients who have impaired vision and cognition as a result of their tumour and associated treatment. This study assessed the prevalence of impaired hearing and vision and how this may impact upon education. METHODS 53 patients diagnosed with solid tumours in Edinburgh, UK between August 2013–2018 were included in the study. Patients were split into three groups according to treatment received: Group 1 – cisplatin-based chemotherapy and cranial radiotherapy; Group 2 - platinum-based chemotherapy, no cranial radiotherapy; Group 3 – benign brain tumours treated with surgery only. Data was collected retrospectively from patient notes. RESULTS Overall 69.5% of those treated with platinum-based chemotherapy experienced ototoxicity as assessed by Brock grading and 5.9% of patients had reduced visual acuity. Patients in Group 1 had the highest prevalence of both. 44.4% of patients in Group 1 needed increased educational support following treatment, either with extra support in the classroom or being unable to continue in mainstream school. 12.5% of Group 2 patients required such support and 31.3% in Group 3. CONCLUSIONS Children with CNS tumours frequently require support for future education but those treated with both platinum-based chemotherapy and cranial radiotherapy are at particular risk, which may be compounded by co-existent ototoxicity and visual impairment. It is essential to provide appropriate support for this patient cohort in order to maximise their educational potential.

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Surgically treated acromegaly patients have a similar quality of life whether controlled by surgery or requiring additional medical therapy (QuaLAT Study)

Pituitary ◽

10.1007/s11102-021-01153-4 ◽

2021 ◽

Author(s):

Muhammad Fahad Arshad ◽

Oluwafunto Ogunleye ◽

Richard Ross ◽

Miguel Debono

Keyword(s):

Quality Of Life ◽

Medical Treatment ◽

Physical Component Score ◽

Healthy Controls ◽

Component Score ◽

Post Surgery ◽

Group 3 ◽

Group 2 ◽

Group 1

Abstract Purpose There is no consensus on quality of life (QOL) in patients with acromegaly requiring medical treatment after surgery compared with those achieving remission by surgery alone. Methods QuaLAT is a cross-sectional study comparing QOL in surgery-only treated acromegaly patients versus those requiring medical treatment post-surgery. Patients attending clinics were identified and divided into—Group 1: patients who had surgery only and were in biochemical remission, Group 2: all patients on medical treatment post-surgery, Group 3: patients from Group 2 with biochemical control. Participants were asked to fill three questionnaires; Acromegaly Quality of Life Questionnaire (ACROQOL), 36-Item Short Form Survey (SF36), and Fatigue Severity Scale (FSS). Results There were 32 patients in Group 1 and 25 in Group 2. There was no difference in QOL scores between groups 1 and 2, as measured by ACROQOL (mean difference [MD] = − 2.5, 95% CI − 16.6 to 11.6; p = 0.72), SF36v2 [Physical component score (PCS) MD = − 4.9, 95% CI − 10.9 to 1.2; p = 0.12; mental component score MD = − 3.0, 95% CI − 10.5 to 4.4; p = 0.44], or FSS (MD = − 0.004, 95% CI − 1.14 to 1.33; p = 0.1). Comparison between groups 1 and 3 however showed that PCS (and 3 subdomains) was significantly better in group 3 (MD = − 8.3, 95% CI − 14.8 to -1.8; p = 0.01). All three QOL scores were lower when compared with healthy controls. Conclusions Medical treatment not only achieves a QOL comparable to surgery, it may also be associated with better QOL in physical subdomains. When compared with healthy controls, QOL remains worse in treated acromegaly patients compared to controls.

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Association between serum oestradiol level on the hCG administration day and neonatal birthweight after IVF-ET among 3659 singleton live births

Scientific Reports ◽

10.1038/s41598-021-85692-7 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Yu Liu ◽

Jing Li ◽

Wanyu Zhang ◽

Yihong Guo

Keyword(s):

Birth Weight ◽

Ovarian Stimulation ◽

Group 4 ◽

Group 6 ◽

Group 3 ◽

Group 5 ◽

Group 2 ◽

The Impact ◽

Ivf Et ◽

Group 1

AbstractOestradiol, an important hormone in follicular development and endometrial receptivity, is closely related to clinical outcomes of fresh in vitro fertilization-embryo transfer (IVF-ET) cycles. A supraphysiologic E2 level is inevitable during controlled ovarian hyper-stimulation (COH), and its effect on the outcome of IVF-ET is controversial. The aim of this retrospective study is to evaluate the association between elevated serum oestradiol (E2) levels on the day of human chorionic gonadotrophin (hCG) administration and neonatal birthweight after IVF-ET cycles. The data of 3659 infertile patients with fresh IVF-ET cycles were analysed retrospectively between August 2009 and February 2017 in First Hospital of Zhengzhou University. Patients were categorized by serum E2 levels on the day of hCG administration into six groups: group 1 (serum E2 levels ≤ 1000 pg/mL, n = 230), group 2 (serum E2 levels between 1001 and 2000 pg/mL, n = 524), group 3 (serum E2 levels between 2001 and 3000 pg/mL, n = 783), group 4 (serum E2 levels between 3001 and 4000 pg/mL, n = 721), group 5 (serum E2 levels between 4001 and 5000 pg/mL, n = 548 ), and group 6 (serum E2 levels > 5000 pg/mL, n = 852). Univariate linear regression was used to evaluate the independent correlation between each factor and outcome index. Multiple logistic regression was used to adjust for confounding factors. The LBW rates were as follows: 3.0% (group 1), 2.9% (group 2), 1.9% (group 3), 2.9% (group 4), 2.9% (group 5), and 2.0% (group 6) (P = 0.629), respectively. There were no statistically significant differences in the incidences of neonatal LBW among the six groups. We did not detect an association between peak serum E2 level during ovarian stimulation and neonatal birthweight after IVF-ET. The results of this retrospective cohort study showed that serum E2 peak levels during ovarian stimulation were not associated with birth weight during IVF cycles. In addition, no association was found between higher E2 levels and increased LBW risk. Our observations suggest that the hyper-oestrogenic milieu during COS does not seem to have adverse effects on the birthweight of offspring after IVF. Although this study provides some reference, the obstetric-related factors were not included due to historical reasons. The impact of the high estrogen environment during COS on the birth weight of IVF offspring still needs future research.

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THU0227 CAFFEINE INTAKE MODULATES DISEASE ACTIVITY AND CYTOKINES LEVELS IN SYSTEMIC LUPUS ERYTHEMATOSUS PATIENTS

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.2100 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 340.2-341

Author(s):

V. Orefice ◽

F. Ceccarelli ◽

C. Barbati ◽

R. Lucchetti ◽

G. Olivieri ◽

...

Keyword(s):

Disease Activity ◽

Lupus Erythematosus ◽

Caffeine Intake ◽

Caffeine Consumption ◽

Group 4 ◽

Group 3 ◽

Group 2 ◽

The Impact ◽

Group 1

Background:Systemic lupus erythematosus (SLE) is an autoimmune disease mainly affecting women of childbearing age. The interplay between genetic and environmental factors may contribute to disease pathogenesis1. At today, no robust data are available about the possible contribute of diet in SLE. Caffeine, one of the most widely consumed products in the world, seems to interact with multiple components of the immune system by acting as a non-specific phosphodiesterase inhibitor2.In vitrodose-dependent treatment with caffeine seems to down-regulate mRNA levels of key inflammation-related genes and similarly reduce levels of different pro-inflammatory cytokines3.Objectives:We evaluated the impact of caffeine consumption on SLE-related disease phenotype and activity, in terms of clinimetric assessment and cytokines levels.Methods:We performed a cross-sectional study, enrolling consecutive patients and reporting their clinical and laboratory data. Disease activity was assessed by SLE Disease Activity Index 2000 (SLEDAI-2k)4. Caffeine intake was evaluated by a 7-day food frequency questionnaire, including all the main sources of caffeine. As previously reported, patients were divided in four groups according to the daily caffeine intake: <29.1 mg/day (group 1), 29.2-153.7 mg/day (group 2), 153.8-376.5 mg/day (group 3) and >376.6 mg/day (group 4)5. At the end of questionnaire filling, blood samples were collected from each patient to assess cytokines levels. These were assessed by using a panel by Bio-Plex assays to measure the levels of IL-6, IL-10, IL-17, IL-27, IFN-γ, IFN-α and Blys.Results:We enrolled 89 SLE patients (F/M 87/2, median age 46 years, IQR 14; median disease duration 144 months, IQR 150). The median intake of caffeine was 195 mg/day (IQR 160.5). At the time of the enrollment, 8 patients (8.9%) referred a caffeine intake < 29.1 mg/day (group 1), 27 patients (30.3%) between 29.2 and 153.7 mg/day (group 2), 45 patients (51%) between 153.8 and 376.5 mg/day (group 3) and 9 patients (10.1%) >376.6 mg/day (group 4). A negative correlation between the levels of caffeine and disease activity, evaluated with SLEDAI-2K, was observed (p=0.01, r=-0.26). By comparing the four groups, a significant higher prevalence of lupus nephritis, neuropsychiatric involvement, haematological manifestations, hypocomplementemia and anti-dsDNA positivity was observed in patients with less intake of caffeine (figure 1 A-E). Furthermore, patients with less intake of caffeine showed a significant more frequent use of glucocorticoids [group 4: 22.2%,versusgroup 1 (50.0%, p=0.0001), group 2 (55.5%, p=0.0001), group 3 (40.0%, p=0.009)]. Moving on cytokines analysis, a negative correlation between daily caffeine consumption and serum level of IFNγ was found (p=0.03, r=-0.2) (figure 2A); furthermore, patients with more caffeine intake showed significant lower levels of IFNα (p=0.02, figure 2B), IL-17 (p=0.01, figure 2C) and IL-6 (p=0.003, figure 2D).Conclusion:This is the first report demonstrating the impact of caffeine on SLE disease activity status, as demonstrated by the inverse correlation between its intake and both SLEDAI-2k values and cytokines levels. Moreover, in our cohort, patients with less caffeine consumption seems to have a more severe disease phenotype, especially in terms of renal and neuropsychiatric involvement. Our results seem to suggest a possible immunoregulatory dose-dependent effect of caffeine, through the modulation of serum cytokine levels, as already suggested byin vitroanalysis.References:[1]Kaul et alNat. Rev. Dis. Prim.2016; 2. Aronsen et alEurop Joul of Pharm2014; 3. Iris et alClin Immun.2018; 4. Gladman et al J Rheumatol. 2002; 5. Mikuls et alArth Rheum2002Disclosure of Interests:Valeria Orefice: None declared, Fulvia Ceccarelli: None declared, cristiana barbati: None declared, Ramona Lucchetti: None declared, Giulio Olivieri: None declared, enrica cipriano: None declared, Francesco Natalucci: None declared, Carlo Perricone: None declared, Francesca Romana Spinelli Grant/research support from: Pfizer, Consultant of: Novartis, Gilead, Lilly, Sanofi, Celgene, Speakers bureau: Lilly, cristiano alessandri Grant/research support from: Pfizer, Guido Valesini: None declared, Fabrizio Conti Speakers bureau: BMS, Lilly, Abbvie, Pfizer, Sanofi

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Diagnosis and surgical correction of isthmocele after caesarean section

Voprosy ginekologii akušerstva i perinatologii ◽

10.20953/1726-1678-2021-3-56-62 ◽

2021 ◽

Vol 20 (3) ◽

pp. 56-62

Author(s):

N.S. Mikhaelyan ◽

◽

D.V. Bryunin ◽

I.D. Khokhlova ◽

T.A. Dzhibladze ◽

...

Keyword(s):

Caesarean Section ◽

Surgical Correction ◽

Postoperative Rehabilitation ◽

Double Row ◽

Anatomical Structures ◽

Group 3 ◽

Group 2 ◽

Uterine Scar ◽

Group 1

Objective. To compare the efficacy of different methods of surgical correction of isthmocele after caesarean section. Patients and methods. The study included 56 patients aged 29–41 years, who were divided into three groups: group 1 (n = 16) – patients who underwent surgical laparoscopy with suturing the uterine wound with single-row separate muscularmuscular sutures; group 2 (n = 23) – patients after repair of the uterus with a double-row continuous seromuscular and muscular-muscular suture performed by laparoscopy; group 3 (n = 17) consisted of patients who underwent laparotomy and suturing the uterine wound with a double-row continuous suture. Results. We developed a three-stage plastic and reconstructive surgical laparotomic and laparoscopic program in case of the uterine scar incompetence, which improved the quality of life in all patients. Pregnancy occurred 9–14 months after plastic and reconstructive surgery on the uterus and resulted in timely surgical delivery in 4 (25%) patients in group 1, in 7 (30.4%) patients in group 2 and in 3 (17.6%) patients in group 3. Two (12.5%) patients in group 1 and three (13.04%) patients in group 2 were observed during pregnancy with a period of 10–28 weeks. Conclusion. The use of laparoscopy ensured better visualization of anatomical structures (vessels, nerves, ureters, bladder), which led to a decrease in intraoperative blood loss, in the risk of damage to adjacent organs and in the development of adhesions, and to accelerated postoperative rehabilitation of patients. Key words: double-row suture, istmocele, laparoscopy, metroplasty

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Quality of Oral Anticoagulation with Vitamin K Antagonists in 'Real-World' Patients: Lessons from a Six Years Audit Study

Blood ◽

10.1182/blood-2019-129382 ◽

2019 ◽

Vol 134 (Supplement_1) ◽

pp. 1159-1159

Author(s):

Fernanda Leite ◽

Ângela Leite ◽

Sara Ferreira ◽

Jorge Coutinho

Keyword(s):

Vitamin K ◽

Therapeutic Range ◽

Patient Population ◽

Conflicts Of Interest ◽

Vitamin K Antagonists ◽

Recall Interval ◽

Group 3 ◽

Group 2 ◽

Group 1

Introduction: Among patients receiving vitamin K antagonists (VKA) therapy, maintenance of an international normalized ratio (INR) in the therapeutic range is essential for treatment efficacy and safety. This requires regular monitoring and appropriate dose adjustment. It has been reported that anticoagulation clinics should aim for a time in therapeutic range (TTR) between 70-80% to optimize benefit and minimize the risk of adverse events. Previously (in a study between September 2006 and June 2012), we have reported that patients with longer INR recall interval (4-8 weeks) showed no decrease of monitoring quality and that it would be safe to increase time between measurements. Aim: Since actual recommendations for improving TTR include shortening INR recall interval (Lip et al. 2018) we aimed to evaluate the quality of anticoagulation monitoring after having increased time between measurements beyond the 4-8 weeks recall interval. Methodology: We retrospectively analyzed 37931 appointments of 6 consecutive years (July 2012 to July 2018) corresponding to 1587 patients that are regularly followed up at an outpatient Anticoagulation Clinic of a central hospital under anticoagulation for at least 8 weeks, using TTR determined by Rosendaal method. Patients were divided according to target INR in three groups: Group 1 with target INR 2-3, including 1430 patients corresponding to 30743 appointments with mean age 69±15 years (mean±SD), majority (46.4%) with atrial fibrillation (AF); Group 2 with target INR 2.5-3.5, including 125 patients corresponding to 5439 appointments with mean age 67±12 years, majority (85.6%) with mechanical heart valves; Group 3 with target INR 3-4, including 32 patients corresponding to 1749 appointments with mean age 62±14 years, majority (62.5%) with antiphospholipid syndrome. Descriptive statistics (mean, standard deviation, minimum, maximum, chi-square), inferential statistics (t-test, A-Nova and effect sizes) tests and correlations were performed. Results: The 1587 patient population, 50.5% male, mean age of 68±17 years and 90.1% in Group 1, showed a mortality of 18%. A point-biserial correlation was run to determine the relationship between mortality and gender, age, INR group and diagnostic. Mortality was correlated with diagnosis (57.2% with AF) (rpb = -.071, n = 1587, p = .004), male gender (60%) (rpb = -.089, n = 1587, p <.001) and age (75±12) (rpb = .175, n= 1587, p<.001) but not with INR group (rpb = -.017, n = 1587, p = .499). Indeed, between groups mortality was not different [Χ2(2)=.492; p=.782; φ=.018] nor mean age [F(2, 1584)=2.588; p=.078; η2=.003], but gender distribution was unequal [Χ2(2)= 10.815; p=.004; φ=.083] with male predominating in Group 1 (51.9%) and female in Group 2 (60.8%) and 3 (65.6%). Patients in Group 1, corresponding to 90.1% of the total population, had TTR of 72%, patients in Group 2 had TTR of 69% and patients in Group 3 had TTR of 60%. Comparatively to the previous study (2006-2012), we noticed a significant decrease in patient population / appointments size (2087/ 61988) (p <.001) with a decrease of TTR in Group 1 (1927 patients) (83%) and Group 2 (120 patients) (74%) but a TTR increase in Group 3 (40 patients) (54%) (p <.001). Conclusions and Discussion: More than 90% of the population under VKA treatment showed effective TTR which may infer safety in increasing INR recall interval. The TTR decrease with a smaller population may be explained by the introduction of direct oral anticoagulants in patients with less comorbidities. The increase of TTR in patients with higher INR target suggests a better management of patients under VKA therapy that is actually the only choice for challenging patients. Disclosures No relevant conflicts of interest to declare.

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Single sitting multimodality management of hemorrhoid

International Surgery Journal ◽

10.18203/2349-2902.isj20214361 ◽

2021 ◽

Vol 8 (11) ◽

pp. 3302

Author(s):

Mahendra P. Singh

Keyword(s):

Variable Number ◽

Concomitant Treatment ◽

Stage Management ◽

Group 4 ◽

Number Of Patients ◽

Clinical Complexity ◽

Group 3 ◽

Group 2 ◽

Group 1

Background: It is usual to face clinical complexity in piles patients. They usually present with variable number of pile masses and in different grades of progression. This led to the idea of offering concomitant single stage management in our hemorrhoid patients matching to our criteria. We conducted hospital based descriptive study among the patients coming to my clinical practice falling in grade-1-3.Methods: All the patients falling in grade-1-3 and matching to our criteria were included. The study was conducted from January 2012 to December 2020. Place of study was basically at two centres: Karamdeep medical centre, Kanpur and Mayo health care, Mohali. Total number of patients were 581. Patients having grade-4 piles and with local co-morbidities were excluded from the study. Modalities of treatment used were sclerotherapy, band ligation and hemorrhoidectomy.Results: Patients managed were divided into four groups – group 1 included patients with piles in grade-1; group-2 included patients having piles in grade-1 and 2; group-3 included patients having piles in grade-1 and 3; and group-4 included patients having piles in grade-1, 2 and 3. Total 952 pile masses were treated in 581 patients. Sclerotherapy was required in 732 (77%) masses, banding in 99 (10.3%) masses and surgery in 122 (12.7%) masses.Conclusions: Concomitant treatment policy proved to be comprehensive way to tackle pile patients of grade-1-3. Mixed and matched method using surgical and non-surgical modalities in a single sitting proved to be beneficial. 86.4% cases were cured this way. Cost of the treatment was economical with lesser complications including local mutilation and better quality of life.

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Abstract 15948: Impact of Age on Safety of Radiofrequency Ablation in Patients With Atrial Fibrillation

Circulation ◽

10.1161/circ.130.suppl_2.15948 ◽

2014 ◽

Vol 130 (suppl_2) ◽

Author(s):

Janet W Elcano ◽

Hui Nam Pak

Keyword(s):

Atrial Fibrillation ◽

Phrenic Nerve Palsy ◽

Adjusted Risk ◽

Ablation Time ◽

Group 4 ◽

Major Complications ◽

Group 3 ◽

Group 2 ◽

The Impact ◽

Group 1

Background: The incidence of atrial fibrillation (AF) is increasing in the elderly population, however, there is paucity of data on the safety outcomes of this patient subgroup thus we sought to investigate on the impact of age on the safety of catheter ablation for AF. Methods and Results: We included 1,293 (male 75%) patients enrolled in Yonsei AF Ablation Cohort database in Seoul, South Korea, from March 2009 to November 2013. We divided the patients into 4 groups according to age (Group 1, aged 17-49, N=295 ; Group 2 50-59, N=421; Group 3 60-69 N=408; and Group 4 ≥ 70, N=169) and evaluated the incidence of procedure related complications. No procedure-related death occurred in this study. There was a trend of increasing incidence of procedure related complications with age noted as follows: Group 1= 3.7%; Group 2= 4.0%; Group 3=6.6%; and Group 4 7.1%, (p= 0.15). There were 28 cases (2.2%) of major complications (Group 1=1.7%, Group 2=1.9%, Group 3=2%, Group 4 4.1%), tamponade being the most common. Major complications in group 4 include: tamponade 4 cases, phrenic nerve palsy 1 case, atrioesophaeal fistula 1 and 3rd degree AV block in 1 patient. Multivariate regression analysis shows ablation time (odds ratio (OR) 1.2 confidence interval (CI)1.0-1.017, p=0.017), procedure time (OR 1.008, CI 1.0-1.15, p=0.04), decreasing eGFR (OR 1.013, CI 1.002-1.026 p=0.018), coronary artery disease (CAD) (OR 1.847, CI 1.003-3.524, p0.04) and age (OR 1.028, CI 1.003-1.055, p=0.03) were associated with increased adjusted risk of total complications. Predictors of major complications include age (OR 1.044, CI 1.003-1.086, p0.02) and ablation time (OR 1.009, CI 0.999-1.000, p=0.033). Conclusion: Our data suggest that incidence of procedural complications in RFA of AF increase with age. Ablation time and age are independent predictors of a major complication.

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Multidose Priming and Delayed Boosting Improve PfSPZ Vaccine Efficacy against Heterologous P. falciparum Controlled Human Malaria Infection

Clinical Infectious Diseases ◽

10.1093/cid/ciaa1294 ◽

2020 ◽

Cited By ~ 1

Author(s):

Kirsten E Lyke ◽

Alexandra Singer ◽

Andrea A Berry ◽

Sharina Reyes ◽

Sumana Chakravarty ◽

...

Keyword(s):

Plasmodium Falciparum ◽

Vaccine Efficacy ◽

Malaria Infection ◽

Human Malaria ◽

Group 4 ◽

Controlled Human Malaria Infection ◽

Group 3 ◽

Group 2 ◽

The Impact ◽

Group 1

Abstract Background A live-attenuated Plasmodium falciparum (Pf) sporozoite (SPZ) vaccine (PfSPZ Vaccine) has shown up to 100% protection against controlled human malaria infection (CHMI) using homologous parasites (same Pf strain as in the vaccine). Using a more stringent CHMI, with heterologous parasites (different Pf strain), we assessed the impact of higher PfSPZ doses, a novel multi-dose prime regimen, and a delayed vaccine boost upon vaccine efficacy. Methods Four groups of 15 healthy, malaria-naïve adults were immunized. Group (Grp) 1 received five doses of 4.5x10 5 PfSPZ (days 1, 3, 5, 7; week 16). Grps 2, 3 and 4 received three doses (weeks 0, 8, 16) with Gp 2 receiving 9.0×10 5/dose, Grp 3 receiving 18.0×10 5/dose, and Grp 4 receiving 27.0×10 5 for dose 1 and 9.0×10 5 for doses 2 and 3. VE was assessed by heterologous CHMI after 12 or 24 weeks. Volunteers not protected at 12 weeks were boosted prior to repeat CHMI at 24 weeks. Results At 12-week CHMI, 6/15 (40%) Group 1 (P=0.04), 3/15 (20%) Group 2 vs. 0/8 controls remained aparasitemic. At 24-week CHMI, 3/13 (23%) Group 3, 3/14 (21%) Group 4 vs. 0/8 controls remained aparasitemic (Groups 2-4, VE not significant). Post-boost, 9/14 (64%) vs. 0/8 controls remained aparasitemic (3/6 Group 1, P=0.025; 6/8 Group 2, P=0.002). Conclusions Four stacked, priming injections (multi-dose priming) showed 40% VE against heterologous CHMI, while dose escalation of PfSPZ using single dose priming was not significantly protective. Boosting unprotected subjects improved VE at 24 weeks to 64%.

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