Jakub K. Simon
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View article: Squalamine and claramine A1 disperse Pseudomonas aeruginosa biofilm
Squalamine and claramine A1 disperse Pseudomonas aeruginosa biofilm Open
View article: Durability of Immunogenicity and Protection of rVSV∆G-ZEBOV-GP Vaccine in a Nonhuman Primate EBOV Challenge Model
Durability of Immunogenicity and Protection of rVSV∆G-ZEBOV-GP Vaccine in a Nonhuman Primate EBOV Challenge Model Open
The rVSVΔG-ZEBOV-GP vaccine demonstrated efficacy in preventing Ebola virus (EBOV) disease in a ring vaccination clinical trial conducted during the 2014–2016 West Africa outbreak and is licensed by regulatory agencies, including the US FD…
View article: rVSVΔG-ZEBOV-GP Vaccine Is Highly Immunogenic and Efficacious Across a Wide Dose Range in a Nonhuman Primate EBOV Challenge Model
rVSVΔG-ZEBOV-GP Vaccine Is Highly Immunogenic and Efficacious Across a Wide Dose Range in a Nonhuman Primate EBOV Challenge Model Open
The recombinant vesicular stomatitis virus-Zaire Ebolavirus envelope glycoprotein vaccine (rVSVΔG-ZEBOV-GP) was highly effective against Ebola virus disease in a ring vaccination trial conducted during the 2014–2016 outbreak in Guinea and …
View article: A phase 2, randomized, blinded, dose-finding, controlled clinical trial to evaluate the safety, tolerability, and immunogenicity of a 24-valent pneumococcal conjugate vaccine (VAX-24) in healthy adults 65 years and older
A phase 2, randomized, blinded, dose-finding, controlled clinical trial to evaluate the safety, tolerability, and immunogenicity of a 24-valent pneumococcal conjugate vaccine (VAX-24) in healthy adults 65 years and older Open
Despite current polysaccharide and conjugate vaccine use, pneumococcal diseases remain prevalent in older adults. VAX-24 is a 24-valent pneumococcal conjugate vaccine (PCV) containing eCRM, a proprietary carrier protein with non-native ami…
View article: Immunogenicity and Vaccine Shedding After 1 or 2 Doses of rVSVΔG-ZEBOV-GP Ebola Vaccine (ERVEBO®): Results From a Phase 2, Randomized, Placebo-controlled Trial in Children and Adults
Immunogenicity and Vaccine Shedding After 1 or 2 Doses of rVSVΔG-ZEBOV-GP Ebola Vaccine (ERVEBO®): Results From a Phase 2, Randomized, Placebo-controlled Trial in Children and Adults Open
Background The rVSVΔG-ZEBOV-GP vaccine (ERVEBO®) is a single-dose, live-attenuated, recombinant vesicular stomatitis virus vaccine indicated for the prevention of Ebola virus disease (EVD) caused by Zaire ebolavirus in individuals 12 month…
View article: Antibodies against the Ebola virus soluble glycoprotein are associated with long-term vaccine-mediated protection of non-human primates
Antibodies against the Ebola virus soluble glycoprotein are associated with long-term vaccine-mediated protection of non-human primates Open
The 2013 Ebola epidemic in Central and West Africa heralded the emergence of wide-spread, highly pathogenic viruses. The successful recombinant vector vaccine against Ebola (rVSVΔG-ZEBOV-GP) will limit future outbreaks, but identifying mec…
View article: Randomized Trial of Vaccines for Zaire Ebola Virus Disease
Randomized Trial of Vaccines for Zaire Ebola Virus Disease Open
No safety concerns were identified in this trial. With all three vaccine regimens, immune responses were seen from day 14 through month 12. (Funded by the National Institutes of Health and others; PREVAC ClinicalTrials.gov number, NCT02876…
View article: Safety and immunogenicity of intramuscular, single-dose V590 (rVSV-SARS-CoV-2 Vaccine) in healthy adults: Results from a phase 1 randomised, double-blind, placebo-controlled, dose-ranging trial
Safety and immunogenicity of intramuscular, single-dose V590 (rVSV-SARS-CoV-2 Vaccine) in healthy adults: Results from a phase 1 randomised, double-blind, placebo-controlled, dose-ranging trial Open
The study was funded by Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
View article: Association Between State Hepatitis A Vaccination Requirements and Hepatitis A Vaccination Rates
Association Between State Hepatitis A Vaccination Requirements and Hepatitis A Vaccination Rates Open
Using National Immunization Survey Child and Teen (2008-2017), we associated state vaccination requirements with hepatitis A (Hep A) vaccination rates in children and adolescents. States with school entry or both childcare and school entry…
View article: Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in adults living with HIV
Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in adults living with HIV Open
Objectives: To evaluate safety and immunogenicity of V114 [15-valent pneumococcal conjugate vaccine (PCV) containing serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F], followed by 23-valent pneumococcal polysaccha…
View article: Baseline Asymptomatic Malaria Infection and Immunogenicity of Recombinant Vesicular Stomatitis Virus–Zaire Ebola Virus Envelope Glycoprotein
Baseline Asymptomatic Malaria Infection and Immunogenicity of Recombinant Vesicular Stomatitis Virus–Zaire Ebola Virus Envelope Glycoprotein Open
Background The effect of malaria infection on the immunogenicity of the recombinant vesicular stomatitis virus–Zaire Ebola virus envelope glycoprotein (GP) vaccine (rVSVΔG-ZEBOV-GP) (ERVEBO) is unknown. Methods The Sierra Leone Trial to In…
View article: Using the power law model to predict the long-term persistence and duration of detectable hepatitis A antibody after receipt of hepatitis A vaccine (VAQTA™)
Using the power law model to predict the long-term persistence and duration of detectable hepatitis A antibody after receipt of hepatitis A vaccine (VAQTA™) Open
VAQTA™ (Hepatitis A Vaccine, inactivated [HAVi]; Merck & Co., Inc., Kenilworth, NJ, USA) is currently licensed for prevention of disease caused by hepatitis A virus in persons ≥12 months of age. This report summarizes statistical models de…
View article: Effects of Gamma Irradiation of Human Serum Samples from rVSVΔG-ZEBOV-GP (V920) Ebola Virus Vaccine Recipients on Plaque-Reduction Neutralization Assays
Effects of Gamma Irradiation of Human Serum Samples from rVSVΔG-ZEBOV-GP (V920) Ebola Virus Vaccine Recipients on Plaque-Reduction Neutralization Assays Open
Gamma irradiation (GI) is included in the CDC guidance on inactivation procedures to render a group of select agents and toxins nonviable. The Ebola virus falls within this group because it potentially poses a severe threat to public healt…
View article: Development of Pandemic Vaccines: ERVEBO Case Study
Development of Pandemic Vaccines: ERVEBO Case Study Open
Preventative vaccines are considered one of the most cost-effective and efficient means to contain outbreaks and prevent pandemics. However, the requirements to gain licensure and manufacture a vaccine for human use are complex, costly, an…
View article: Estimation of the correlates of protection of the rVSVΔG-ZEBOV-GP Zaire ebolavirus vaccine: a post-hoc analysis of data from phase 2/3 clinical trials
Estimation of the correlates of protection of the rVSVΔG-ZEBOV-GP Zaire ebolavirus vaccine: a post-hoc analysis of data from phase 2/3 clinical trials Open
Merck Sharp & Dohme, Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness and Response, US Department of Health and Human Services.
View article: 28. Immunogenicity of rVSVΔG-ZEBOV-GP Ebola Vaccine (ERVEBO™) in Participants by Age, Sex, and Baseline GP-ELISA Titer: A Post Hoc Analysis of Three Phase 2/3 Trials
28. Immunogenicity of rVSVΔG-ZEBOV-GP Ebola Vaccine (ERVEBO™) in Participants by Age, Sex, and Baseline GP-ELISA Titer: A Post Hoc Analysis of Three Phase 2/3 Trials Open
Background The recent Ebola virus disease (EVD) outbreak in the Democratic Republic of the Congo highlights the sustained threat of EVD morbidity and mortality where healthcare and vaccine delivery are challenging. ERVEBO®, a live recombin…
View article: 161. impact of State Childcare and School Hepatitis a Vaccination Requirements on Coverage of Hepatitis a Vaccines in the United States
161. impact of State Childcare and School Hepatitis a Vaccination Requirements on Coverage of Hepatitis a Vaccines in the United States Open
Background Widespread Hepatitis A (Hep A) outbreaks in the United States (US) have raised the importance of vaccination. Vaccination requirements for childcare and school entry could be an effective strategy to ensure compliance to recomme…
View article: Extended effect of short-course azithromycin for the treatment of diarrhoea in children on antimicrobial resistance in nasopharyngeal and intestinal bacteria: Study Protocol for the antimicrobial resistance sub-study of the multicountry AntiBiotics for Children with Diarrhea (ABCD) trial
Extended effect of short-course azithromycin for the treatment of diarrhoea in children on antimicrobial resistance in nasopharyngeal and intestinal bacteria: Study Protocol for the antimicrobial resistance sub-study of the multicountry AntiBiotics for Children with Diarrhea (ABCD) trial Open
Introduction Antimicrobial resistance (AMR) is a major public health challenge worldwide, threatening the important gains that have been made in reducing mortality due to infectious diseases. Despite current World Health Organization guide…
View article: Immune responses to O-specific polysaccharide (OSP) in North American adults infected with Vibrio cholerae O1 Inaba
Immune responses to O-specific polysaccharide (OSP) in North American adults infected with Vibrio cholerae O1 Inaba Open
ClinicalTrials.gov NCT01895855.
View article: Effect of Gamma Irradiation on the Antibody Response Measured in Human Serum from Subjects Vaccinated with Recombinant Vesicular Stomatitis Virus–Zaire Ebola Virus Envelope Glycoprotein Vaccine
Effect of Gamma Irradiation on the Antibody Response Measured in Human Serum from Subjects Vaccinated with Recombinant Vesicular Stomatitis Virus–Zaire Ebola Virus Envelope Glycoprotein Vaccine Open
rVSVΔG-ZEBOV-GP vaccine is a live recombinant (r) vesicular stomatitis virus (VSV), where the VSV G protein is replaced with the Zaire Ebola virus (ZEBOV) glycoprotein (GP). For vaccine immunogenicity testing, clinical trial sera collected…
View article: Immunogenicity, Lot Consistency, and Extended Safety of rVSVΔG-ZEBOV-GP Vaccine: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study in Healthy Adults
Immunogenicity, Lot Consistency, and Extended Safety of rVSVΔG-ZEBOV-GP Vaccine: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study in Healthy Adults Open
Background This double-blind study assessed immunogenicity, lot consistency, and safety of recombinant vesicular stomatitis virus-Zaire Ebola virus envelope glycoprotein vaccine (rVSVΔG-ZEBOV-GP). Methods Healthy adults (N = 1197) were ran…
View article: Age-related immunogenicity and reactogenicity of live oral cholera vaccine CVD 103-HgR in a randomized, controlled clinical trial
Age-related immunogenicity and reactogenicity of live oral cholera vaccine CVD 103-HgR in a randomized, controlled clinical trial Open
Aging is accompanied by a decline in immune function which can lead to decreased responses to vaccines. Attenuated recombinant Vibrio cholerae O1 vaccine strain CVD 103-HgR elicits a rapid serum vibriocidal antibody (SVA) response and prot…
View article: rVSVΔG-ZEBOV-GP (also designated V920) recombinant vesicular stomatitis virus pseudotyped with Ebola Zaire Glycoprotein: Standardized template with key considerations for a risk/benefit assessment
rVSVΔG-ZEBOV-GP (also designated V920) recombinant vesicular stomatitis virus pseudotyped with Ebola Zaire Glycoprotein: Standardized template with key considerations for a risk/benefit assessment Open
View article: Correction: A clinically parameterized mathematical model of Shigella immunity to inform vaccine design
Correction: A clinically parameterized mathematical model of Shigella immunity to inform vaccine design Open
[This corrects the article DOI: 10.1371/journal.pone.0189571.].
View article: Lipopolysaccharide-specific memory B cell responses to an attenuated live cholera vaccine are associated with protection against Vibrio cholerae infection
Lipopolysaccharide-specific memory B cell responses to an attenuated live cholera vaccine are associated with protection against Vibrio cholerae infection Open
NCT01895855.
View article: Anti-O-specific polysaccharide (OSP) immune responses following vaccination with oral cholera vaccine CVD 103-HgR correlate with protection against cholera after infection with wild-type Vibrio cholerae O1 El Tor Inaba in North American volunteers
Anti-O-specific polysaccharide (OSP) immune responses following vaccination with oral cholera vaccine CVD 103-HgR correlate with protection against cholera after infection with wild-type Vibrio cholerae O1 El Tor Inaba in North American volunteers Open
ClinicalTrials.gov NCT01895855.
View article: Safety and immunogenicity of single-dose live oral cholera vaccine strain CVD 103-HgR in healthy adults age 18–45
Safety and immunogenicity of single-dose live oral cholera vaccine strain CVD 103-HgR in healthy adults age 18–45 Open
Clinicaltrials.gov NCT02094586.
View article: A clinically parameterized mathematical model of Shigella immunity to inform vaccine design
A clinically parameterized mathematical model of Shigella immunity to inform vaccine design Open
We refine and clinically parameterize a mathematical model of the humoral immune response against Shigella, a diarrheal bacteria that infects 80-165 million people and kills an estimated 600,000 people worldwide each year. Using Latin hype…
View article: Randomized, Placebo-Controlled, Double-Blind Phase 2 Trial Comparing the Reactogenicity and Immunogenicity of a Single Standard Dose to Those of a High Dose of CVD 103-HgR Live Attenuated Oral Cholera Vaccine, with Shanchol Inactivated Oral Vaccine as an Open-Label Immunologic Comparator
Randomized, Placebo-Controlled, Double-Blind Phase 2 Trial Comparing the Reactogenicity and Immunogenicity of a Single Standard Dose to Those of a High Dose of CVD 103-HgR Live Attenuated Oral Cholera Vaccine, with Shanchol Inactivated Oral Vaccine as an Open-Label Immunologic Comparator Open
Reactive immunization with a single-dose cholera vaccine that could rapidly (within days) protect immunologically naive individuals during virgin soil epidemics, when cholera reaches immunologically naive populations that have not experien…
View article: Identification of immune correlates of protection in Shigella infection by application of machine learning
Identification of immune correlates of protection in Shigella infection by application of machine learning Open