cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.6084/m9.figshare.26892093
title: Vaccines against mpox: MVA-BN and LC16m8

description: Global outbreaks involving mpox clade IIb began in mid-2022. Today, clade IIb and clade I outbreaks continue. Reliable mpox vaccines can prevent serious mpox disease and death. Globally, two vaccines hold mpox indications, regardless of mpox viral clade: MVA-BN (Bavarian Nordic) and LC16m8 (KM Biologics). This review summarizes the human and pivotal animal data establishing safety and efficacy for MVA-BN and LC16m8, including real-world evidence gathered during mpox outbreaks from 2022 through 2024. Some regulatory decisions for MVA-BN and LC16m8 followed pathways based on surrogate outcomes, including lethal-challenge studies in nonhuman primates, among other atypical aspects. Nonetheless, MVA-BN and LC16m8 hold unencumbered registration in multiple countries. Effectiveness of MVA-BN as primary preventive vaccination (PPV) in humans against clade IIb mpox is clear from real-world studies; effectiveness of LC16m8 against clade IIb is likely from surrogate endpoints. Effectiveness of MVA-BN and LC16m8 as PPV against more-lethal clade I is likely, based on animal-challenge studies with multiple orthopoxvirus species and other studies. Both vaccines have solid safety records. MVA-BN’s replication incompetence favors adoption, whereas LC16m8 has more pediatric data. Additional real-world evidence, in additional geographic settings and special populations (e.g. pregnancy, immune suppression, atopic dermatitis), is needed. Mpox outbreaks spread
globally in 2022, hospitalizing many people. Many recent mpox cases in Africa
occur in children. Two vaccines, known as MVA-BN and LC16m8, can help prevent mpox. MVA-BN protects
animals from lethal doses of mpox and similar viruses. During outbreaks, MVA-BN
lowered the chance of mpox disease by 62% to 85%. In people already exposed to mpox,
MVA-BN reduced disease risk by 20%. MVA-BN may help reduce how serious mpox
cases are, even if this vaccine does not block infection fully. MVA-BN cannot
grow inside the body, making it very safe, even in children. Side effects
include pain, redness, swelling, and itching. Some people feel muscle pain, headache,
fatigue, nausea, or chills after vaccination. Several million people have
received MVA-BN so far, including thousands of people living with HIV. LC16m8 protects
animals from lethal doses of mpox and similar viruses. There are not much data about
LC16m8 used during mpox outbreaks. LC16m8 contains a weakened virus. Side
effects include fever, fatigue, redness, swollen lymph nodes, and itching.
Vaccine virus can spread to other parts of the body. Over 90,000 people have
received LC16m8 so far. No significant safety signals were found after these
doses, including 50,000 children. People who are immunosuppressed, have certain
skin diseases, or are pregnant should not be given LC16m8. Health officials recommend mpox vaccine for people at risk, including
children.
DOI: 10.6084/m9.figshare.26892093.v1
title: Vaccines against mpox: MVA-BN and LC16m8

description: Global outbreaks involving mpox clade IIb began in mid-2022. Today, clade IIb and clade I outbreaks continue. Reliable mpox vaccines can prevent serious mpox disease and death. Globally, two vaccines hold mpox indications, regardless of mpox viral clade: MVA-BN (Bavarian Nordic) and LC16m8 (KM Biologics). This review summarizes the human and pivotal animal data establishing safety and efficacy for MVA-BN and LC16m8, including real-world evidence gathered during mpox outbreaks from 2022 through 2024. Some regulatory decisions for MVA-BN and LC16m8 followed pathways based on surrogate outcomes, including lethal-challenge studies in nonhuman primates, among other atypical aspects. Nonetheless, MVA-BN and LC16m8 hold unencumbered registration in multiple countries. Effectiveness of MVA-BN as primary preventive vaccination (PPV) in humans against clade IIb mpox is clear from real-world studies; effectiveness of LC16m8 against clade IIb is likely from surrogate endpoints. Effectiveness of MVA-BN and LC16m8 as PPV against more-lethal clade I is likely, based on animal-challenge studies with multiple orthopoxvirus species and other studies. Both vaccines have solid safety records. MVA-BN’s replication incompetence favors adoption, whereas LC16m8 has more pediatric data. Additional real-world evidence, in additional geographic settings and special populations (e.g. pregnancy, immune suppression, atopic dermatitis), is needed. Mpox outbreaks spread
globally in 2022, hospitalizing many people. Many recent mpox cases in Africa
occur in children. Two vaccines, known as MVA-BN and LC16m8, can help prevent mpox. MVA-BN protects
animals from lethal doses of mpox and similar viruses. During outbreaks, MVA-BN
lowered the chance of mpox disease by 62% to 85%. In people already exposed to mpox,
MVA-BN reduced disease risk by 20%. MVA-BN may help reduce how serious mpox
cases are, even if this vaccine does not block infection fully. MVA-BN cannot
grow inside the body, making it very safe, even in children. Side effects
include pain, redness, swelling, and itching. Some people feel muscle pain, headache,
fatigue, nausea, or chills after vaccination. Several million people have
received MVA-BN so far, including thousands of people living with HIV. LC16m8 protects
animals from lethal doses of mpox and similar viruses. There are not much data about
LC16m8 used during mpox outbreaks. LC16m8 contains a weakened virus. Side
effects include fever, fatigue, redness, swollen lymph nodes, and itching.
Vaccine virus can spread to other parts of the body. Over 90,000 people have
received LC16m8 so far. No significant safety signals were found after these
doses, including 50,000 children. People who are immunosuppressed, have certain
skin diseases, or are pregnant should not be given LC16m8. Health officials recommend mpox vaccine for people at risk, including
children.
DOI: 10.3535/qqn-emf-16l
title: Lepidoptera Linnaeus, 1758

description: Digital Specimen for the physical specimen hosted at Naturalis Biodiversity Center.
DOI: 10.3535/4lr-96a-j8q
title: Lepidoptera Linnaeus, 1758

description: Digital Specimen for the physical specimen hosted at Naturalis Biodiversity Center.
DOI: 10.3535/ml8-rv1-bbr
title: Lepidoptera Linnaeus, 1758

description: Digital Specimen for the physical specimen hosted at Naturalis Biodiversity Center.
DOI: 10.6084/m9.figshare.25427736
title: Waning intra-season vaccine effectiveness against influenza A(H3N2) underlines the need for more durable protection

description: The question of whether influenza vaccine effectiveness (VE) wanes over the winter season is still open and some contradictory findings have been reported. This study investigated the possible decline in protection provided by the available influenza vaccines. An individual-level pooled analysis of six test-negative case-control studies conducted in Italy between the 2018/2019 and 2022/2023 seasons was performed. Multivariable logistic regression analyses were performed to estimate weekly change in the odds of testing positive for influenza 14 days after vaccination. Of 6490 patients included, 1633 tested positive for influenza. Each week that had elapsed since vaccination was associated with an increase in the odds of testing positive for any influenza (4.9%; 95% CI: 2.0–8.0%) and for A(H3N2) (6.5%; 95% CI: 2.9–10.3%). This decline in VE was, however, significant only in children and older adults. A similar increase in the odds of testing positive was seen when the dataset was restricted to vaccinees only. Conversely, VE waning was less evident for A(H1N1)pdm09 or B strains. Significant waning of VE, especially against influenza A(H3N2), may be one of the factors associated with suboptimal end-of-season VE. Next-generation vaccines should provide more durable protection against A(H3N2).
DOI: 10.6084/m9.figshare.25427736.v1
title: Waning intra-season vaccine effectiveness against influenza A(H3N2) underlines the need for more durable protection

description: The question of whether influenza vaccine effectiveness (VE) wanes over the winter season is still open and some contradictory findings have been reported. This study investigated the possible decline in protection provided by the available influenza vaccines. An individual-level pooled analysis of six test-negative case-control studies conducted in Italy between the 2018/2019 and 2022/2023 seasons was performed. Multivariable logistic regression analyses were performed to estimate weekly change in the odds of testing positive for influenza 14 days after vaccination. Of 6490 patients included, 1633 tested positive for influenza. Each week that had elapsed since vaccination was associated with an increase in the odds of testing positive for any influenza (4.9%; 95% CI: 2.0–8.0%) and for A(H3N2) (6.5%; 95% CI: 2.9–10.3%). This decline in VE was, however, significant only in children and older adults. A similar increase in the odds of testing positive was seen when the dataset was restricted to vaccinees only. Conversely, VE waning was less evident for A(H1N1)pdm09 or B strains. Significant waning of VE, especially against influenza A(H3N2), may be one of the factors associated with suboptimal end-of-season VE. Next-generation vaccines should provide more durable protection against A(H3N2).
DOI: 10.3535/s1g-vgf-yeg
title: Animalia

description: Digital Specimen for the physical specimen hosted at Naturalis Biodiversity Center.
DOI: 10.6084/m9.figshare.26661330
title: National trends in patterns of under-vaccination in early childhood: National Immunization Survey-Child, United States, 2011–2021

description: The study's objective was to examine national trends in patterns of under-vaccination in the United States. The National Immunization Survey-Child (NIS-Child) is an annual cross-sectional survey that collects provider-verified vaccination records from a large national probability sample of children. Records from the 2011–2021 NIS-Child were used to assess receipt of the combined 7-vaccine series by age 24 months. Based on prior work, patterns indicative of hesitancy included zero vaccines, not starting ≥1 series, and consistent vaccine-limiting. Patterns indicative of practical issues included starting all series but missing doses. Up-to-date (UTD) was defined as receiving all doses in the combined 7-vaccine series. The study population comprised 127,257 children. Over the observation period, patterns indicative of hesitancy significantly decreased (p-trend &lt; 0.0001), patterns indicative of practical issues significantly decreased (p-trend &lt; 0.0001), and UTD significantly increased (p-trend &lt; 0.0001). In 2021, the weighted percentage in each category was as follows: probable hesitancy 6.3% (95% confidence interval [CI] 5.4%, 7.2%), probable practical issues 26.0% (95% CI 24.4%, 27.6%), and UTD 67.7% (95% CI 66.0%, 69.4%). Over an 11-year period, vaccination coverage in the United States for the combined 7-vaccine series has improved, with patterns suggestive of practical issues or hesitancy declining.
DOI: 10.6084/m9.figshare.26661330.v1
title: National trends in patterns of under-vaccination in early childhood: National Immunization Survey-Child, United States, 2011–2021

description: The study's objective was to examine national trends in patterns of under-vaccination in the United States. The National Immunization Survey-Child (NIS-Child) is an annual cross-sectional survey that collects provider-verified vaccination records from a large national probability sample of children. Records from the 2011–2021 NIS-Child were used to assess receipt of the combined 7-vaccine series by age 24 months. Based on prior work, patterns indicative of hesitancy included zero vaccines, not starting ≥1 series, and consistent vaccine-limiting. Patterns indicative of practical issues included starting all series but missing doses. Up-to-date (UTD) was defined as receiving all doses in the combined 7-vaccine series. The study population comprised 127,257 children. Over the observation period, patterns indicative of hesitancy significantly decreased (p-trend &lt; 0.0001), patterns indicative of practical issues significantly decreased (p-trend &lt; 0.0001), and UTD significantly increased (p-trend &lt; 0.0001). In 2021, the weighted percentage in each category was as follows: probable hesitancy 6.3% (95% confidence interval [CI] 5.4%, 7.2%), probable practical issues 26.0% (95% CI 24.4%, 27.6%), and UTD 67.7% (95% CI 66.0%, 69.4%). Over an 11-year period, vaccination coverage in the United States for the combined 7-vaccine series has improved, with patterns suggestive of practical issues or hesitancy declining.
DOI: 10.3535/79k-d6x-lnl
title: Lepidoptera Linnaeus, 1758

description: Digital Specimen for the physical specimen hosted at Naturalis Biodiversity Center.
DOI: 10.3535/exk-rgb-gqm
title: Delias pheres Jordan, 1912

description: Digital Specimen for the physical specimen hosted at Naturalis Biodiversity Center.
DOI: 10.3535/cd9-9px-rff
title: Lepidoptera Linnaeus, 1758

description: Digital Specimen for the physical specimen hosted at Naturalis Biodiversity Center.
DOI: 10.6084/m9.figshare.24805724
title: Predicted serotype-specific effectiveness of pneumococcal conjugate vaccines V114 and PCV20 against invasive pneumococcal disease in children

description: Next-generation, higher-valency pneumococcal conjugate vaccines (PCVs), 15-valent PCV V114 and 20-valent PCV (PCV20), have been assessed by comparing their immune responses across serotypes shared with the 13-valent PCV (PCV13). Without efficacy or real-world vaccine effectiveness (VE) it becomes important to relate IgG titers to VE to aid in the interpretation of the immune response elicited by V114 and PCV20. We estimated the protective antibody concentrations for each serotype in 7-valent PCV (PCV7) and PCV13 which were then used to predict the serotype-specific VE for each PCV7 and PCV13 non PCV7 serotype present in V114 and PCV20. The predicted effectiveness of V114 was comparable to PCV7 and PCV13 for 11 of the 13 shared serotypes (1, 4, 5, 6B, 7F, 9 V, 14, 18C, 19A, 19F, and 23F), with improved effectiveness against serotype 3 and decreased effectiveness against serotype 6A. PCV20 had predicted effectiveness comparable to PCV7 and PCV13 for 7 of the 13 shared serotypes (5, 6A, 7F, 9 V, 18C, 19F, and 23F), with decreased effectiveness against the remaining serotypes (1, 3, 4, 6B, 14, and 19A). Prediction of serotype-specific VE values suggests that V114 retains greater effectiveness than PCV20 toward most serotypes present in PCV7 and PCV13. Pediatric pneumococcal conjugate vaccines (PCVs) first became available in 2000, when the seven-valent PCV (PCV7) was approved. Since then, PCV7 has been replaced by higher-valency vaccines, including the ten-valent (PCV10) and thirteen-valent (PCV13) vaccines and, more recently, fifteen- and twenty-valent vaccines (V114 and PCV20, respectively). The increase in valency provides broader serotype coverage against invasive pneumococcal disease (IPD) in children. However, IPD due to serotypes contained in PCV7 and PCV13 continue to be observed. In the current study, we used a previously published method to estimate the vaccine effectiveness of V114 and PCV20 in a US and Puerto Rican pediatric population that is recommended to receive a 3 + 1 dosing schedule.
DOI: 10.6084/m9.figshare.24805724.v1
title: Predicted serotype-specific effectiveness of pneumococcal conjugate vaccines V114 and PCV20 against invasive pneumococcal disease in children

description: Next-generation, higher-valency pneumococcal conjugate vaccines (PCVs), 15-valent PCV V114 and 20-valent PCV (PCV20), have been assessed by comparing their immune responses across serotypes shared with the 13-valent PCV (PCV13). Without efficacy or real-world vaccine effectiveness (VE) it becomes important to relate IgG titers to VE to aid in the interpretation of the immune response elicited by V114 and PCV20. We estimated the protective antibody concentrations for each serotype in 7-valent PCV (PCV7) and PCV13 which were then used to predict the serotype-specific VE for each PCV7 and PCV13 non PCV7 serotype present in V114 and PCV20. The predicted effectiveness of V114 was comparable to PCV7 and PCV13 for 11 of the 13 shared serotypes (1, 4, 5, 6B, 7F, 9 V, 14, 18C, 19A, 19F, and 23F), with improved effectiveness against serotype 3 and decreased effectiveness against serotype 6A. PCV20 had predicted effectiveness comparable to PCV7 and PCV13 for 7 of the 13 shared serotypes (5, 6A, 7F, 9 V, 18C, 19F, and 23F), with decreased effectiveness against the remaining serotypes (1, 3, 4, 6B, 14, and 19A). Prediction of serotype-specific VE values suggests that V114 retains greater effectiveness than PCV20 toward most serotypes present in PCV7 and PCV13. Pediatric pneumococcal conjugate vaccines (PCVs) first became available in 2000, when the seven-valent PCV (PCV7) was approved. Since then, PCV7 has been replaced by higher-valency vaccines, including the ten-valent (PCV10) and thirteen-valent (PCV13) vaccines and, more recently, fifteen- and twenty-valent vaccines (V114 and PCV20, respectively). The increase in valency provides broader serotype coverage against invasive pneumococcal disease (IPD) in children. However, IPD due to serotypes contained in PCV7 and PCV13 continue to be observed. In the current study, we used a previously published method to estimate the vaccine effectiveness of V114 and PCV20 in a US and Puerto Rican pediatric population that is recommended to receive a 3 + 1 dosing schedule.
DOI: 10.3535/c3h-1aa-fx9
title: Lepidoptera Linnaeus, 1758

description: Digital Specimen for the physical specimen hosted at Naturalis Biodiversity Center.
DOI: 10.6084/m9.figshare.25766161
title: Accelerate vaccine development using seamless phase 2/3 trial designs

description: Traditional vaccine development, often a lengthy and costly process of three separated phases. However, the swift development of COVID-19 vaccines highlighted the critical importance of accelerating the approval of vaccines. This article showcases a seamless phase 2/3 trial design to expedite the development process, particularly for multi-valent vaccines. This study utilizes simulation to compare the performance of seamless phase 2/3 design with that of conventional trial design, specifically by re-envisioning a 9-valent HPV vaccine trial. Across three cases, several key performance metrics are evaluated: overall power, type I error rate, average sample size, trial duration, the percentage of early stop, and the accuracy of dose selection. On average, when the experimental vaccine was assumed to be effective, the seamless design that performed interim analyses based solely on efficacy saved 555.73 subjects, shortened trials by 10.29 months, and increased power by 3.70%. When the experimental vaccine was less effective than control, it saved an average of 887.73 subjects while maintaining the type I error rate below 0.025. The seamless design proves to be a compelling strategy for vaccine development, given its versatility in early stopping, re-estimating sample sizes, and shortening trial durations.
DOI: 10.6084/m9.figshare.25766161.v1
title: Accelerate vaccine development using seamless phase 2/3 trial designs

description: Traditional vaccine development, often a lengthy and costly process of three separated phases. However, the swift development of COVID-19 vaccines highlighted the critical importance of accelerating the approval of vaccines. This article showcases a seamless phase 2/3 trial design to expedite the development process, particularly for multi-valent vaccines. This study utilizes simulation to compare the performance of seamless phase 2/3 design with that of conventional trial design, specifically by re-envisioning a 9-valent HPV vaccine trial. Across three cases, several key performance metrics are evaluated: overall power, type I error rate, average sample size, trial duration, the percentage of early stop, and the accuracy of dose selection. On average, when the experimental vaccine was assumed to be effective, the seamless design that performed interim analyses based solely on efficacy saved 555.73 subjects, shortened trials by 10.29 months, and increased power by 3.70%. When the experimental vaccine was less effective than control, it saved an average of 887.73 subjects while maintaining the type I error rate below 0.025. The seamless design proves to be a compelling strategy for vaccine development, given its versatility in early stopping, re-estimating sample sizes, and shortening trial durations.
DOI: 10.15468/dl.bev74m
title: Occurrence Download

description: A dataset containing 264 species occurrences available in GBIF matching the query:
{
 "TaxonKey" : [
 "is Cnidoscolus pubescens Pohl"
 ]
}

 The dataset includes 264 records from 47 constituent datasets; see https://api.gbif.org/v1/occurrence/download/0101850-250525065834625/datasets/export for details.
 
Data from some individual datasets included in this download may be licensed under less restrictive terms.
DOI: 10.3535/dwe-e3v-tcy
title: Lepidoptera Linnaeus, 1758

description: Digital Specimen for the physical specimen hosted at Naturalis Biodiversity Center.
DOI: 10.3535/h6y-798-dq5
title: Lepidoptera Linnaeus, 1758

description: Digital Specimen for the physical specimen hosted at Naturalis Biodiversity Center.
DOI: 10.6084/m9.figshare.27645970
title: Immunogenicity and safety of two-dose or three-dose regimens of inactivated COVID-19 vaccines in patients with pulmonary tuberculosis: a randomised clinical trial

description: To assess the immunogenicity and safety of two-dose regimen of inactivated COVID-19 vaccines in patients with pulmonary tuberculosis (PTB) and explored the potential benefits of additional dose. In total, 182 PTB patients were randomly (1:1) assigned to the standard-dose group to receive three standard doses of inactivated COVID-19 vaccines, or the double-dose boosting group to receive two standard doses plus a double dose, with a 28-day interval. Forty healthy controls were assigned to receive two doses of inactivated COVID-19 vaccines 28 days apart. The primary endpoint was neutralizing antibodies 28 days after the second vaccination. Two doses of inactivated COVID-19 vaccines induced comparable neutralizing antibodies in PTB patients and the healthy controls, with GMTs against ancestral SARS-CoV-2 of 36.8 vs 31.4 (<i>p</i> = 0.4618) and seroconversion rates of 83.9% vs 87.5% (<i>p</i> = 0.6965). In the PTB patients, a third dose at day 56 led to a modest increase in neutralizing antibodies compared to the second dose, with a GMT fold increase of 1.3–1.8. Most adverse reactions were mild pain at the injection site. Inactivated COVID-19 vaccine was safe and immunogenic in PTB patients, and two-dose immunization could induce moderate level of humoral responses similar to the healthy adults. www.clinicaltrials.gov identifier: NCT05148949.