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Article ; Online: Evaluation of Anatomic Features and Assessment Tools to Determine Treatment of Ankyloglossia.

Unkel, John H / Martin, Cornelius / Berry, Elizabeth J / Patel, Shital N / Reinhartz, Dennis / Reinhartz, Judy

Journal of dentistry for children (Chicago, Ill.)

2021 Volume 88, Issue 3, Page(s) 150–155

Abstract: Purpose: ...

Abstract	Purpose:
MeSH term(s)	Ankyloglossia/surgery ; Breast Feeding ; Child ; Female ; Humans ; Infant ; Lingual Frenum/surgery ; Pediatric Dentistry ; Tongue/surgery
Language	English
Publishing date	2021-12-23
Publishing country	United States
Document type	Journal Article
ZDB-ID	390120-8
ISSN	1935-5068 ; 1551-8949 ; 0022-0353
ISSN (online)	1935-5068
ISSN	1551-8949 ; 0022-0353
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Article ; Online: Comparison of different QT correction methods for nonclinical safety assessment in ketamine-anesthetized Indian rhesus monkeys (

Bhatt, Laxit K / Shah, Chitrang R / Patel, Rajesh J / Patel, Shital D / Patel, Sudhir R / Patel, Vipul A / Patel, Jitendra H / Dwivedi, Pankaj / Shah, Niraj A / Sundar, Rajesh S / Jain, Mukul R

Toxicology mechanisms and methods

2023 Volume 33, Issue 6, Page(s) 490–501

Abstract: Rhesus monkeys are a non-rodent species employed in the preclinical safety evaluation of pharmaceuticals and biologics. These nonhuman primate species have been increasingly used in biomedical research because of the similarity in their ionic mechanisms ... ...

Abstract	Rhesus monkeys are a non-rodent species employed in the preclinical safety evaluation of pharmaceuticals and biologics. These nonhuman primate species have been increasingly used in biomedical research because of the similarity in their ionic mechanisms of repolarization with humans. Heart rate and QT interval are two primary endpoints in determining the pro-arrhythmic risk of drugs. As heart rate and QT interval have an inverse relationship, any change in heart rate causes a subsequent change in QT interval. This warrants for calculation of a corrected QT interval. This study aimed to identify an appropriate formula that best corrected QT for change in heart rate. We employed seven formulas based on source-species type, clinical relevance, and requirements of various international regulatory guidelines. Data showed that corrected QT interval values varied drastically for different correction formulas. Equations were compared on their slope values based on QTc versus RR plots. The rank order of the slope for different formulas was (closest to farthest from zero) QTcNAK, QTcHAS, QTcBZT, QTcFRD, QTcVDW, QTcHDG, and QTcFRM. QTcNAK emerged to be the best correcting formula in this study. It showed the least correlation with the RR interval (
MeSH term(s)	Animals ; Humans ; Electrocardiography ; Macaca mulatta ; Ketamine/toxicity ; Heart Rate ; Pharmaceutical Preparations ; Long QT Syndrome/chemically induced
Chemical Substances	Ketamine (690G0D6V8H) ; Pharmaceutical Preparations
Language	English
Publishing date	2023-03-15
Publishing country	England
Document type	Journal Article
ZDB-ID	2081252-8
ISSN	1537-6524 ; 1537-6516 ; 1051-7235
ISSN (online)	1537-6524
ISSN	1537-6516 ; 1051-7235
DOI	10.1080/15376516.2023.2187730
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Article ; Online: A Retrospective Comparison of Electrocardiographic Parameters in Ketamine and Tiletamine-Zolazepam Anesthetized Indian Rhesus Monkeys (

Bhatt, Laxit K / Shah, Chitrang R / Patel, Shital D / Patel, Sudhir R / Patel, Vipul A / Patel, Rajesh J / Joshi, Nikita M / Shah, Niraj A / Patel, Jitendra H / Dwivedi, Pankaj / Sundar, Rajesh / Jain, Mukul R

International journal of toxicology

2023 Volume 43, Issue 2, Page(s) 184–195

Abstract: Electrocardiographic evaluation is performed in rhesus monkeys to establish the cardiovascular safety of candidate molecules before progressing to clinical trials. These animals are usually immobilized chemically by ketamine (KTM) and tiletamine- ... ...

Abstract	Electrocardiographic evaluation is performed in rhesus monkeys to establish the cardiovascular safety of candidate molecules before progressing to clinical trials. These animals are usually immobilized chemically by ketamine (KTM) and tiletamine-zolazepam (TZ) to obtain a steady-state heart rate and to ensure adequate human safety. The present study aimed to evaluate the effect of these anesthetic regimens on different electrocardiographic parameters. Statistically significant lower HR and higher P-wave duration, RR, QRS, and QT intervals were observed in the KTM-anesthetized group in comparison to TZ-anesthetized animals. No significant changes were noticed in the PR interval and p-wave amplitude. Sex-based significance amongst these parameters was observed in male and female animals of TZ- and KTM-anesthetized groups. Regression analysis of four QTc formulas in TZ-anesthetized rhesus monkeys revealed that QTcNAK (Nakayama) better corrected the QT interval than QTcHAS (Hassimoto), QTcBZT (Bazett), and QTcFRD (Fridericia) formulas. QTcNAK exhibited the least correlation with the RR interval (slope closest to zero and r = .01) and displayed no statistical significance between male and female animals. These data will prove useful in the selection of anesthetic regimens for chemical restraint of rhesus monkeys in nonclinical safety evaluation studies.
MeSH term(s)	Animals ; Humans ; Male ; Female ; Ketamine/toxicity ; Tiletamine/toxicity ; Macaca mulatta ; Zolazepam/toxicity ; Retrospective Studies ; Anesthetics/toxicity ; Heart Rate
Chemical Substances	Ketamine (690G0D6V8H) ; Tiletamine (2YFC543249) ; Zolazepam (G1R474U58U) ; Anesthetics
Language	English
Publishing date	2023-12-18
Publishing country	United States
Document type	Journal Article
ZDB-ID	1379845-5
ISSN	1092-874X ; 1091-5818
ISSN (online)	1092-874X
ISSN	1091-5818
DOI	10.1177/10915818231221276
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Article ; Online: Monitoring Water Spread and Aquatic Vegetation using Spectral Indices in Nalsarovar, Gujarat State-India

Kirtan R. Chauhan / Jinal J. Patel / Shital H. Shukla / Manik H. Kalubarme

International Journal of Environment and Geoinformatics, Vol 8, Iss 1, Pp 49-

2021 Volume 56

Abstract: Nalsarovar Bird Sanctuary, a natural freshwater lake (a relict sea) that is the largest natural wetland in the Thar Desert Bio-geographic Province and represents a dynamic environment with salinity and depth varying depending on rainfall. For maintaining ...

Abstract	Nalsarovar Bird Sanctuary, a natural freshwater lake (a relict sea) that is the largest natural wetland in the Thar Desert Bio-geographic Province and represents a dynamic environment with salinity and depth varying depending on rainfall. For maintaining ecological balance in coastal and inland environments, wetlands play an important role and the changes in wetland environment can be monitored using satellite remote sensing technique. The present study was carried out using Landsat-7 TM (Feb-2002), Landsat-5 TM (Feb- 2009) and Sentinel-2 multi-spectral data (Feb-2018) covering Nalsarovar area in Ahmedabad district. The study area of Nalsarovar with 10km buffer was extracted from the satellite digital data. Various spectral indices like Normalized difference Vegetation Index (NDVI), Normalized difference Water Index (NDWI) and Normalized difference Turbidity Index (NDTI) were generated for better identification and delineation of water body and aquatic vegetation in the Nalsarovar. The composite images of these indices were also generated to map and monitor changes in water spread and aquatic vegetation in the Nalsarovar. The water spread and aquatic vegetation in the Nalsarovar along with the land use classes were mapped using False Colour Composite (FCC) images of differed years. The result indicates that the water spread in Nalsarovar has changed from 2002, 2009 and 2018 depending on the monsoon pattern during these years. During drought year of 2002 total precipitation was very less resulting drastic reduction in the water spread in Nalsarovar. The aquatic vegetation has changed from 146.81 ha during 2002 to 510.93 ha during 2018. The land use change indicates that agriculture land, built-up, water body & wetland has increased and barren land, salt affected area has decreased. The aquatic vegetation in Nalsarovar was clearly visible on composite images generated using NDVI, NDWI and NDTI of different years. This study gives clear idea for land use change detection and water spread monitoring using two ...
Keywords	nalsarovar ; change detection ; ndvi ; ndwi ; ndti ; Environmental sciences ; GE1-350
Subject code	333
Language	English
Publishing date	2021-03-01T00:00:00Z
Publisher	IJEGEO
Document type	Article ; Online
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Article ; Online: Sources of clinical information used in HIV care and treatment: Are providers' choices related to their demographic and practice characteristics?

Mgbere, Osaro / Khuwaja, Salma / Vigil, Karen J / Patel, Shital M / Wang, Jason / Essien, Ekere James

Health informatics journal

2018 Volume 25, Issue 4, Page(s) 1572–1587

Abstract: HIV medical care providers need a wide range of evidence-based clinical information resources to manage their patients' health. We determined whether providers' choice of information sources for HIV care and treatment are associated with their ... ...

Abstract	HIV medical care providers need a wide range of evidence-based clinical information resources to manage their patients' health. We determined whether providers' choice of information sources for HIV care and treatment are associated with their demographic and medical practice characteristics. Data used for this study were obtained from a probability sample of HIV medical care providers in 13 outpatient HIV facilities in Houston/Harris County, Texas, surveyed between June and September 2009. The mean number of information sources used by HIV medical care providers for HIV care and treatment was 5.83 (95% confidence interval: 4.90-6.75). Antiretroviral therapy guidelines (95.6%), medical journals and textbooks (82.6%), and Internet sources (69.5%) were ranked first, second, and third as sources of clinical information. At least one of the providers' demographic or medical practice characteristics was significantly (
MeSH term(s)	Adult ; Attitude of Health Personnel ; Demography/statistics & numerical data ; Female ; HIV Infections/therapy ; Health Personnel/psychology ; Health Personnel/standards ; Health Personnel/statistics & numerical data ; Humans ; Information Services/standards ; Information Services/statistics & numerical data ; Male ; Middle Aged ; Surveys and Questionnaires ; Texas
Language	English
Publishing date	2018-08-07
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2213115-2
ISSN	1741-2811 ; 1460-4582
ISSN (online)	1741-2811
ISSN	1460-4582
DOI	10.1177/1460458218788906
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Article ; Online: Tibial Spine Fractures in the Child and Adolescent Athlete: A Systematic Review and Meta-analysis.

The American journal of sports medicine

2023 Volume 52, Issue 5, Page(s) 1357–1366

Abstract: Background: Tibial spine fractures (TSFs) are uncommon injuries that may result in substantial morbidity in children. A variety of open and arthroscopic techniques are used to treat these fractures, but no single standardized operative method has been ... ...

Abstract	Background: Tibial spine fractures (TSFs) are uncommon injuries that may result in substantial morbidity in children. A variety of open and arthroscopic techniques are used to treat these fractures, but no single standardized operative method has been identified. Purpose: To systematically review the literature on pediatric TSFs to determine the current treatment approaches, outcomes, and complications. Study design: Meta-analysis; Level of evidence, 4. Methods: A systematic review of the literature was performed in accordance with the PRISMA (Preferred Reporting Items for Systematic Review and Meta-Analyses) guidelines using PubMed, Embase, and Cochrane databases. Studies evaluating treatment and outcomes of patients <18 years old were included. Patient demographic characteristics, fracture characteristics, treatments, and outcomes were abstracted. Descriptive statistics were used to summarize categorical and quantitative variables, and a meta-analytic technique was used to compare observational studies with sufficient data. Results: A total of 47 studies were included, totaling 1922 TSFs in patients (66.4% male) with a mean age of 12 years (range, 3-18 years). The operative approach was open reduction and internal fixation in 291 cases and arthroscopic reduction and internal fixation in 1236 cases; screw fixation was used in 411 cases and suture fixation, in 586 cases. A total of 13 nonunions were reported, occurring most frequently in Meyers and McKeever type III fractures (n = 6) and in fractures that were treated nonoperatively (n = 10). Arthrofibrosis rates were reported in 33 studies (n = 1700), and arthrofibrosis was present in 190 patients (11.2%). Range of motion loss occurred significantly more frequently in patients with type III and IV fractures ( Conclusion: Despite variation in TSF treatment, good overall outcomes have been reported with low complication rates in both open and arthroscopic treatment and with both screw and suture fixation. Arthrofibrosis remains a concern after surgical treatment for TSF, but no significant difference in incidence was found between the analysis groups. Larger studies are necessary to compare outcomes and form a consensus on how to treat and manage patients with TSFs.
MeSH term(s)	Humans ; Male ; Adolescent ; Child ; Female ; Arthroscopy/methods ; Suture Techniques ; Knee Joint/surgery ; Tibia/surgery ; Tibial Fractures/etiology ; Tibial Fractures/surgery ; Anterior Cruciate Ligament Injuries/surgery ; Fracture Fixation, Internal/methods ; Knee Fractures ; Treatment Outcome
Language	English
Publishing date	2023-06-16
Publishing country	United States
Document type	Meta-Analysis ; Systematic Review ; Journal Article
ZDB-ID	197482-8
ISSN	1552-3365 ; 0363-5465
ISSN (online)	1552-3365
ISSN	0363-5465
DOI	10.1177/03635465231175674
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Article: COVID-19 Infection in Reproductive Age Group Females: Experience of a Tertiary Care Urban Teaching Hospital.

Mehta, Ami V / Patel, Rina V / Shah, Parul T / Deliwala, Kruti J / Mehta, Shital T / Vyas, Rupa C / Shah, Akshay C / Khambhojia, Janak / Gupta, Aishwarya / Saiyed, Fiza

Journal of obstetrics and gynaecology of India

2021 Volume 71, Issue Suppl 1, Page(s) 42–46

Abstract: ... This is a retrospective study done at Sardar Vallabhbhai Patel Institute of Medical Science and Research ...

Abstract	Background: The objective of this study was to find out the effect, course of disease and management of the COVID-19 infection in pregnant women and compare it with non-pregnant population. Method: This is a retrospective study done at Sardar Vallabhbhai Patel Institute of Medical Science and Research (SVPIMSR), Smt. NHL MMC, Ahmedabad, from April 1, 2020, to September 30, 2020 Result: A total of 709 women (Group A-205, Group B-504) were included in the study, In group A 90% of patients were asymptomatic, while in group B 48% asymptomatic patients. Group A had 5.9% and group B had 13.1% patients having comorbidities. In group A, smaller number of patients had raised inflammatory markers as compared to group B. Only 4% patients of group A showed significant changes on chest X-ray as compared to 16% in group B. Only 2.9% patients of group A required intensive care unit admission as compared to 10.31% patients of group B. Mean hospital stay of group A was 10.6 days, and that of group B was 12.1 days. Conclusion: In pregnancy, due to the physiological alterations in cardiovascular, respiratory and immune system, the pregnant women are vulnerable to infections. Although pregnancy is immunocompromised state, the severity of Coivd-19 disease is milder as compared to non-pregnant COVID-19-positive patients.
Language	English
Publishing date	2021-08-14
Publishing country	India
Document type	Journal Article
ZDB-ID	410688-x
ISSN	0971-9202 ; 0022-3190
ISSN	0971-9202 ; 0022-3190
DOI	10.1007/s13224-021-01519-5
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Article ; Online: Vitamin D status and outcomes for hospitalised older patients with COVID-19.

Baktash, Vadir / Hosack, Tom / Patel, Nishil / Shah, Shital / Kandiah, Pirabakaran / Van den Abbeele, Koenraad / Mandal, Amit K J / Missouris, Constantinos G

Postgraduate medical journal

2020 Volume 97, Issue 1149, Page(s) 442–447

Abstract: Purpose: Older adults are more likely to be vitamin D deficient. The aim of the study was to determine whether these patients have worse outcomes with COVID-19.: Methods: We conducted a prospective cohort study between 1 March and 30 April 2020 to ... ...

Abstract	Purpose: Older adults are more likely to be vitamin D deficient. The aim of the study was to determine whether these patients have worse outcomes with COVID-19. Methods: We conducted a prospective cohort study between 1 March and 30 April 2020 to assess the importance of vitamin D deficiency in older patients with COVID-19. The cohort consisted of patients aged ≥65 years presenting with symptoms consistent with COVID-19 (n=105). All patients were tested for serum 25-hydroxyvitamin D (25(OH)D) levels during acute illness. Diagnosis of COVID-19 was confirmed via viral reverse transcriptase PCR swab or supporting radiological evidence. COVID-19-positive arm (n=70) was sub-divided into vitamin D-deficient (≤30 nmol/L) (n=39) and -replete groups (n=35). Subgroups were assessed for disease severity using biochemical, radiological and clinical markers. Primary outcome was in-hospital mortality. Secondary outcomes were laboratory features of cytokine storm, thoracic imaging changes and requirement of non-invasive ventilation (NIV). Results: COVID-19-positive arm demonstrated lower median serum 25(OH)D level of 27 nmol/L (IQR=20-47 nmol/L) compared with COVID-19-negative arm, with median level of 52 nmol/L (IQR=31.5-71.5 nmol/L) (p value=0.0008). Among patients with vitamin D deficiency, there was higher peak D-dimer level (1914.00 μgFEU/L vs 1268.00 μgFEU/L) (p=0.034) and higher incidence of NIV support and high dependency unit admission (30.77% vs 9.68%) (p=0.042). No increased mortality was observed between groups. Conclusion: Older adults with vitamin D deficiency and COVID-19 may demonstrate worse morbidity outcomes. Vitamin D status may be a useful prognosticator.
MeSH term(s)	Aged ; Biomarkers/blood ; COVID-19/blood ; COVID-19/mortality ; COVID-19/physiopathology ; COVID-19/therapy ; Female ; Fibrin Fibrinogen Degradation Products/analysis ; Geriatric Assessment/methods ; Hospital Mortality ; Hospitalization/statistics & numerical data ; Humans ; Male ; Outcome Assessment, Health Care ; Pneumonia, Viral/diagnostic imaging ; Pneumonia, Viral/etiology ; Predictive Value of Tests ; Radiography, Thoracic/statistics & numerical data ; SARS-CoV-2/isolation & purification ; Severity of Illness Index ; United Kingdom/epidemiology ; Vitamin D/analogs & derivatives ; Vitamin D/blood ; Vitamin D Deficiency/blood ; Vitamin D Deficiency/epidemiology ; Vitamin D Deficiency/therapy
Chemical Substances	Biomarkers ; Fibrin Fibrinogen Degradation Products ; fibrin fragment D ; Vitamin D (1406-16-2) ; 25-hydroxyvitamin D (A288AR3C9H)
Keywords	covid19
Language	English
Publishing date	2020-08-27
Publishing country	England
Document type	Journal Article
ZDB-ID	80325-x
ISSN	1469-0756 ; 0032-5473
ISSN (online)	1469-0756
ISSN	0032-5473
DOI	10.1136/postgradmedj-2020-138712
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Article ; Online: A randomized, controlled Phase 1b trial of the Sm-TSP-2 Vaccine for intestinal schistosomiasis in healthy Brazilian adults living in an endemic area.

David J Diemert / Rodrigo Correa-Oliveira / Carlo Geraldo Fraga / Frederico Talles / Marcella Rezende Silva / Shital M Patel / Shirley Galbiati / Jessie K Kennedy / Jordan S Lundeen / Maria Flavia Gazzinelli / Guangzhao Li / Lara Hoeweler / Gregory A Deye / Maria Elena Bottazzi / Peter J Hotez / Hana M El Sahly / Wendy A Keitel / Jeffrey Bethony / Robert L Atmar

PLoS Neglected Tropical Diseases, Vol 17, Iss 3, p e

2023 Volume 0011236

Abstract: Background Recombinant Schistosoma mansoni Tetraspanin-2 formulated on Alhydrogel (Sm-TSP-2/Alhydrogel) is being developed to prevent intestinal and hepatic disease caused by S. mansoni. The tegumentary Sm-TSP-2 antigen was selected based on its unique ... ...

Abstract	Background Recombinant Schistosoma mansoni Tetraspanin-2 formulated on Alhydrogel (Sm-TSP-2/Alhydrogel) is being developed to prevent intestinal and hepatic disease caused by S. mansoni. The tegumentary Sm-TSP-2 antigen was selected based on its unique recognition by cytophilic antibodies in putatively immune individuals living in areas of ongoing S. mansoni transmission in Brazil, and preclinical studies in which vaccination with Sm-TSP-2 protected mice following infection challenge. Methods A randomized, observer-blind, controlled, Phase 1b clinical trial was conducted in 60 healthy adults living in a region of Brazil with ongoing S. mansoni transmission. In each cohort of 20 participants, 16 were randomized to receive one of two formulations of Sm-TSP-2 vaccine (adjuvanted with Alhydrogel only, or with Alhydrogel plus the Toll-like receptor-4 agonist, AP 10-701), and 4 to receive Euvax B hepatitis B vaccine. Successively higher doses of antigen (10 μg, 30 μg, and 100 μg) were administered in a dose-escalation fashion, with progression to the next dose cohort being dependent upon evaluation of 7-day safety data after all participants in the preceding cohort had received their first dose of vaccine. Each participant received 3 intramuscular injections of study product at intervals of 2 months and was followed for 12 months after the third vaccination. IgG and IgG subclass antibody responses to Sm-TSP-2 were measured by qualified indirect ELISAs at pre- and post-vaccination time points through the final study visit. Results Sm-TSP-2/Alhydrogel administered with or without AP 10-701 was well-tolerated in this population. The most common solicited adverse events were mild injection site tenderness and pain, and mild headache. No vaccine-related serious adverse events or adverse events of special interest were observed. Groups administered Sm-TSP-2/Alhydrogel with AP 10-701 had higher post-vaccination levels of antigen-specific IgG antibody. A significant dose-response relationship was seen in those administered ...
Keywords	Arctic medicine. Tropical medicine ; RC955-962 ; Public aspects of medicine ; RA1-1270
Subject code	610
Language	English
Publishing date	2023-03-01T00:00:00Z
Publisher	Public Library of Science (PLoS)
Document type	Article ; Online
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Article ; Online: A randomized, controlled Phase 1b trial of the Sm-TSP-2 Vaccine for intestinal schistosomiasis in healthy Brazilian adults living in an endemic area.

Diemert, David J / Correa-Oliveira, Rodrigo / Fraga, Carlo Geraldo / Talles, Frederico / Silva, Marcella Rezende / Patel, Shital M / Galbiati, Shirley / Kennedy, Jessie K / Lundeen, Jordan S / Gazzinelli, Maria Flavia / Li, Guangzhao / Hoeweler, Lara / Deye, Gregory A / Bottazzi, Maria Elena / Hotez, Peter J / El Sahly, Hana M / Keitel, Wendy A / Bethony, Jeffrey / Atmar, Robert L

PLoS neglected tropical diseases

2023 Volume 17, Issue 3, Page(s) e0011236

Abstract: Background: Recombinant Schistosoma mansoni Tetraspanin-2 formulated on Alhydrogel (Sm-TSP-2/Alhydrogel) is being developed to prevent intestinal and hepatic disease caused by S. mansoni. The tegumentary Sm-TSP-2 antigen was selected based on its unique ...

Abstract	Background: Recombinant Schistosoma mansoni Tetraspanin-2 formulated on Alhydrogel (Sm-TSP-2/Alhydrogel) is being developed to prevent intestinal and hepatic disease caused by S. mansoni. The tegumentary Sm-TSP-2 antigen was selected based on its unique recognition by cytophilic antibodies in putatively immune individuals living in areas of ongoing S. mansoni transmission in Brazil, and preclinical studies in which vaccination with Sm-TSP-2 protected mice following infection challenge. Methods: A randomized, observer-blind, controlled, Phase 1b clinical trial was conducted in 60 healthy adults living in a region of Brazil with ongoing S. mansoni transmission. In each cohort of 20 participants, 16 were randomized to receive one of two formulations of Sm-TSP-2 vaccine (adjuvanted with Alhydrogel only, or with Alhydrogel plus the Toll-like receptor-4 agonist, AP 10-701), and 4 to receive Euvax B hepatitis B vaccine. Successively higher doses of antigen (10 μg, 30 μg, and 100 μg) were administered in a dose-escalation fashion, with progression to the next dose cohort being dependent upon evaluation of 7-day safety data after all participants in the preceding cohort had received their first dose of vaccine. Each participant received 3 intramuscular injections of study product at intervals of 2 months and was followed for 12 months after the third vaccination. IgG and IgG subclass antibody responses to Sm-TSP-2 were measured by qualified indirect ELISAs at pre- and post-vaccination time points through the final study visit. Results: Sm-TSP-2/Alhydrogel administered with or without AP 10-701 was well-tolerated in this population. The most common solicited adverse events were mild injection site tenderness and pain, and mild headache. No vaccine-related serious adverse events or adverse events of special interest were observed. Groups administered Sm-TSP-2/Alhydrogel with AP 10-701 had higher post-vaccination levels of antigen-specific IgG antibody. A significant dose-response relationship was seen in those administered Sm-TSP-2/Alhydrogel with AP 10-701. Peak anti-Sm-TSP-2 IgG levels were observed approximately 2 weeks following the third dose, regardless of Sm-TSP-2 formulation. IgG levels fell to low levels by Day 478 in all groups except the 100 μg with AP 10-701 group, in which 57% of subjects (4 of 7) still had IgG levels that were ≥4-fold higher than baseline. IgG subclass levels mirrored those of total IgG, with IgG1 being the predominant subclass response. Conclusions: Vaccination of adults with Sm-TSP-2/Alhydrogel in an area of ongoing S. mansoni transmission was safe, minimally reactogenic, and elicited significant IgG and IgG subclass responses against the vaccine antigen. These promising results have led to initiation of a Phase 2 clinical trial of this vaccine in an endemic region of Uganda. Trial registration: NCT03110757.
MeSH term(s)	Animals ; Humans ; Mice ; Adjuvants, Immunologic ; Aluminum Hydroxide ; Brazil ; Immunoglobulin G ; Schistosoma mansoni ; Schistosomiasis mansoni ; Protozoan Vaccines
Chemical Substances	Adjuvants, Immunologic ; Aluminum Hydroxide (5QB0T2IUN0) ; Immunoglobulin G ; lactonic deoxybenzoin glucoside (37636-71-8) ; Protozoan Vaccines
Language	English
Publishing date	2023-03-30
Publishing country	United States
Document type	Randomized Controlled Trial ; Clinical Trial, Phase I ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2429704-5
ISSN	1935-2735 ; 1935-2735
ISSN (online)	1935-2735
ISSN	1935-2735
DOI	10.1371/journal.pntd.0011236
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In stock of ZB MED Cologne/Königswinter

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In stock of ZB MED Cologne/Königswinter

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In stock of ZB MED Cologne/Königswinter

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In stock of ZB MED Cologne/Königswinter

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Full text online

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Inter-library loan at ZB MED

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Order via subito