cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.6084/m9.figshare.27930922.v1
title: Safety, tolerability, and efficacy of intranasally-administered detoxified LTh(αK) in mild-to-moderate COVID-19 patients: A randomized, double-blinded, placebo-controlled phase 2 study

description: The objective of the study was to assess the safety, tolerability, and potential efficacy of intranasally administered AD17002, a detoxified form of <i>Escherichia coli</i> heat-labile enterotoxin, in treating individuals with mild-to-moderate coronavirus disease of 2019 (COVID-19). In this randomized, double-blinded, and placebo-controlled phase 2a study, a total of 30 adults aged 20–70 years with mild-to-moderate COVID-19 were recruited from three medical centers in Taiwan in 2022–2023. The trial comprised two cohorts, and participants were randomly assigned to receive intranasal administrations of either three doses of AD17002 immunomodulator or a placebo formulation buffer. Outcome analyses were conducted on the intention-to-treat set, and the safety set that included all randomized participants exposed to the AD17002. The proportion of cycle threshold (C<i>t</i>) ≥30 and time to the recovery of key symptoms were assessed. An exploratory study was conducted to analyze the integrity of the viral genome after treatment. Administering 20 μg of AD17002 three times, either at 1-week or 1-day intervals, proved to be safe and well tolerated in subjects with mild-to-moderate COVID-19. AD17002 demonstrated a rapid and positive outcome in reducing the viral load in patients receiving the treatment. Impact of AD17002 treatment was further supported by the analysis of viral genome integrity following the treatment. The enhancement in clinical recovery by AD17002 within 5 days after symptom onset was observed but did not achieve statistical significance. According to the results, intranasal administration of AD17002 was safe, well-tolerated, and potentially effective for treating mild-to-moderate COVID-19. This study looked at a new treatment called AD17002, which is designed to boost the body’s immune response by increasing the production of special proteins called type I interferons. These proteins help the body fight infections. Previous research in animals showed that AD17002 helped clear the virus faster and reduced lung damage caused by SARS-CoV-2, the virus responsible for COVID-19. It had also been tested in humans as a nasal spray to improve flu vaccines. In this phase 2 clinical trial, AD17002 was given to people with mild-to-moderate COVID-19 caused by the viral variants. The treatment was well-tolerated, with no major side effects, and showed promising results. It helped reduce the amount of virus in the body, which was confirmed by measuring the genetic material of the virus before and after treatment. This suggests that AD17002 could be an effective way to treatCOVID-19. The study supports the idea that AD17002 might help lessen the severity of COVID-19 symptoms and reduce the spread of the virus. This is important because viral variants have become more contagious and better at evading the immune system.
DOI: 10.6084/m9.figshare.26981121
title: Human papillomavirus (HPV) vaccination in a privately funded program in Ghana: A qualitative case study

description: HPV vaccination is one of the safest and most effective interventions against HPV-related cancers. From 2013 to 2018, HPV vaccination was piloted in Ghana in preparation for a national program. Yet, at the time of this study, there was no publicly funded HPV vaccination program in Ghana. We explored an existing privately funded HPV vaccination program in Ghana to identify challenges and gaps and to gather insights to inform vaccination practice and national policy. This study used a qualitative case study research design. We conducted semi-structured interviews on experiences, barriers, and challenges in HPV vaccination at the Greater-Accra Regional Hospital between October 1 and November 26, 2023. Participants (<i>N</i> = 16) included HPV vaccinators (<i>n</i> = 8) and program/policy leaders (<i>n</i> = 8). Our thematic analysis focused on HPV vaccination processes, practice challenges, and policy interests. Four main themes emerged from our analyses. Our findings revealed many challenges faced by the HPV vaccination program. These include a lack of guiding policy/framework for the HPV vaccination program, an emphasis on sexual history, cervical screening, and HPV DNA test in determining vaccination eligibility by vaccinators, and a lack of formal provider and recipient HPV education programs. Although many vaccinators advocated for a universal HPV program, some policy/program leaders were reluctant to prioritize HPV vaccination advocacy due to their focus on acute health concerns. A vaccination program without a policy can be limited in quality and efficiency, as there will be no accountability and sustainability measures. We recommend the need to develop standardized guidelines to support evidence-based HPV vaccination practice.
DOI: 10.6084/m9.figshare.26981121.v1
title: Human papillomavirus (HPV) vaccination in a privately funded program in Ghana: A qualitative case study

description: HPV vaccination is one of the safest and most effective interventions against HPV-related cancers. From 2013 to 2018, HPV vaccination was piloted in Ghana in preparation for a national program. Yet, at the time of this study, there was no publicly funded HPV vaccination program in Ghana. We explored an existing privately funded HPV vaccination program in Ghana to identify challenges and gaps and to gather insights to inform vaccination practice and national policy. This study used a qualitative case study research design. We conducted semi-structured interviews on experiences, barriers, and challenges in HPV vaccination at the Greater-Accra Regional Hospital between October 1 and November 26, 2023. Participants (<i>N</i> = 16) included HPV vaccinators (<i>n</i> = 8) and program/policy leaders (<i>n</i> = 8). Our thematic analysis focused on HPV vaccination processes, practice challenges, and policy interests. Four main themes emerged from our analyses. Our findings revealed many challenges faced by the HPV vaccination program. These include a lack of guiding policy/framework for the HPV vaccination program, an emphasis on sexual history, cervical screening, and HPV DNA test in determining vaccination eligibility by vaccinators, and a lack of formal provider and recipient HPV education programs. Although many vaccinators advocated for a universal HPV program, some policy/program leaders were reluctant to prioritize HPV vaccination advocacy due to their focus on acute health concerns. A vaccination program without a policy can be limited in quality and efficiency, as there will be no accountability and sustainability measures. We recommend the need to develop standardized guidelines to support evidence-based HPV vaccination practice.
DOI: 10.6084/m9.figshare.27108117
title: Vaccine hesitancy educational interventions for medical students: A systematic narrative review in western countries

description: Physician recommendations can reduce vaccine hesitancy (VH) and improve uptake yet are often done poorly and can be improved by early-career training. We examined educational interventions for medical students in Western countries to explore what is being taught, identify effective elements, and review the quality of evidence. A mixed methods systematic narrative review, guided by the JBI framework, assessed the study quality using MERSQI and Cote & Turgeon frameworks. Data were extracted to analyze content and framing, with effectiveness graded using value-based judgment. Among the 33 studies with 30 unique interventions, effective studies used multiple methods grounded in educational theory to teach knowledge, skills, and attitudes. Most interventions reinforced a deficit-based approach (assuming VH stems from misinformation) which can be counterproductive. Effective interventions used hands-on, interactive methods emulating real practice, with short- and long-term follow-ups. Evidence-based approaches like motivational interviewing should frame interventions instead of the deficit model.
DOI: 10.6084/m9.figshare.27108117.v1
title: Vaccine hesitancy educational interventions for medical students: A systematic narrative review in western countries

description: Physician recommendations can reduce vaccine hesitancy (VH) and improve uptake yet are often done poorly and can be improved by early-career training. We examined educational interventions for medical students in Western countries to explore what is being taught, identify effective elements, and review the quality of evidence. A mixed methods systematic narrative review, guided by the JBI framework, assessed the study quality using MERSQI and Cote & Turgeon frameworks. Data were extracted to analyze content and framing, with effectiveness graded using value-based judgment. Among the 33 studies with 30 unique interventions, effective studies used multiple methods grounded in educational theory to teach knowledge, skills, and attitudes. Most interventions reinforced a deficit-based approach (assuming VH stems from misinformation) which can be counterproductive. Effective interventions used hands-on, interactive methods emulating real practice, with short- and long-term follow-ups. Evidence-based approaches like motivational interviewing should frame interventions instead of the deficit model.
DOI: 10.6084/m9.figshare.27967812
title: Developing and validating a culturally tailored questionnaire to assess COVID-19 vaccine hesitancy in Israel’s ultraorthodox Jewish population

description: Addressing vaccine hesitancy requires culturally adaptable tools. This study aimed to provide a better understanding of COVID-19 vaccine hesitancy in Israel’s ultraorthodox Jewish community, where vaccine hesitancy is prevalent. We developed and validated a COVID-19 vaccine hesitancy questionnaire and explored correlates of intention to receive the fourth dose of the COVID-19 vaccine in this population. A mixed-methods study employing an exploratory sequential design was conducted in May-September 2022. Building on qualitative data, a questionnaire was developed and validated in a cross-sectional study when the fourth dose was recommended to all adults. Thematic analysis identified several factors influencing COVID-19 vaccine decision-making, predominantly religious authority alongside health information sources, perceived vaccine safety, effectiveness, and trust in state authorities. In the cross-sectional study, 96/106 (90.6%) participants were vaccinated against COVID-19; 5.2%, 25.0%, 65.6%, and 4.2% received 1, 2, 3, and 4 doses, respectively. Intention to receive the fourth dose (yes/maybe) was reported by 46%. A factor analysis yielded several scales expressing perceptions regarding COVID-19, with Cronbach’s Alpha mostly between 0.689 and 0.887. Correlates of intention to receive the fourth dose were age ≥ 50 years: <i>OR = 12.45 (95% CI 1.42–108.93)</i>, male-sex: <i>4.97 (1.47–16.81)</i>, perceiving the vaccine as important/effective and safe: <i>4.11 (1.29–13.13)</i>, utilizing ultraorthodox communication channels: <i>5.86 (1.58–21.73)</i>, and the number of previously received doses: <i>3.14 (1.31–7.53)</i>. Complementary evidence emphasized the role of religious authority and information sources (ultraorthodox communication channels) and balancing perceived vaccine safety and effectiveness and disease risk in COVID-19 vaccine hesitancy in Israel’s ultraorthodox Jewish population.
DOI: 10.6084/m9.figshare.27967812.v1
title: Developing and validating a culturally tailored questionnaire to assess COVID-19 vaccine hesitancy in Israel’s ultraorthodox Jewish population

description: Addressing vaccine hesitancy requires culturally adaptable tools. This study aimed to provide a better understanding of COVID-19 vaccine hesitancy in Israel’s ultraorthodox Jewish community, where vaccine hesitancy is prevalent. We developed and validated a COVID-19 vaccine hesitancy questionnaire and explored correlates of intention to receive the fourth dose of the COVID-19 vaccine in this population. A mixed-methods study employing an exploratory sequential design was conducted in May-September 2022. Building on qualitative data, a questionnaire was developed and validated in a cross-sectional study when the fourth dose was recommended to all adults. Thematic analysis identified several factors influencing COVID-19 vaccine decision-making, predominantly religious authority alongside health information sources, perceived vaccine safety, effectiveness, and trust in state authorities. In the cross-sectional study, 96/106 (90.6%) participants were vaccinated against COVID-19; 5.2%, 25.0%, 65.6%, and 4.2% received 1, 2, 3, and 4 doses, respectively. Intention to receive the fourth dose (yes/maybe) was reported by 46%. A factor analysis yielded several scales expressing perceptions regarding COVID-19, with Cronbach’s Alpha mostly between 0.689 and 0.887. Correlates of intention to receive the fourth dose were age ≥ 50 years: <i>OR = 12.45 (95% CI 1.42–108.93)</i>, male-sex: <i>4.97 (1.47–16.81)</i>, perceiving the vaccine as important/effective and safe: <i>4.11 (1.29–13.13)</i>, utilizing ultraorthodox communication channels: <i>5.86 (1.58–21.73)</i>, and the number of previously received doses: <i>3.14 (1.31–7.53)</i>. Complementary evidence emphasized the role of religious authority and information sources (ultraorthodox communication channels) and balancing perceived vaccine safety and effectiveness and disease risk in COVID-19 vaccine hesitancy in Israel’s ultraorthodox Jewish population.
DOI: 10.6084/m9.figshare.24964657
title: Awareness regarding human papillomavirus and willingness for vaccination among college students with or without medical background in Guizhou Province

description: This cross-sectional epidemiological study aimed to investigate awareness regarding human papillomavirus (HPV) and willingness for vaccination among college students with or without medical background in Guizhou Province, China. A logistic regression model was used for univariate and multivariate analyses of cognition to determine factors influencing willingness for vaccination. In total, 2,540 questionnaires were collected, of which 2,360 were valid. The medical and nonmedical groups included 737 (31.2%) and 1,623 (68.8%) individuals, respectively. The medical group had heard of HPV and its vaccines more frequently than the nonmedical group, with the former also having greater awareness than the latter (<i>P</i> &lt; .001). Females (1,325, 56.1%) had heard of HPV and its vaccines more frequently than males (1,035, 43.9%), with the former also having greater awareness than the latter. The cost, safety, and efficacy of the HPV vaccine and lack of knowledge regarding HPV and its vaccines were the main barriers for vaccination. The overall level of knowledge regarding HPV and its vaccines was lower in the nonmedical group and males than in the medical group and females. To help promote willingness for vaccination among the nonmedical group and males, strategies that deepen their knowledge regarding the HPV vaccine are needed.
DOI: 10.6084/m9.figshare.24964657.v1
title: Awareness regarding human papillomavirus and willingness for vaccination among college students with or without medical background in Guizhou Province

description: This cross-sectional epidemiological study aimed to investigate awareness regarding human papillomavirus (HPV) and willingness for vaccination among college students with or without medical background in Guizhou Province, China. A logistic regression model was used for univariate and multivariate analyses of cognition to determine factors influencing willingness for vaccination. In total, 2,540 questionnaires were collected, of which 2,360 were valid. The medical and nonmedical groups included 737 (31.2%) and 1,623 (68.8%) individuals, respectively. The medical group had heard of HPV and its vaccines more frequently than the nonmedical group, with the former also having greater awareness than the latter (<i>P</i> &lt; .001). Females (1,325, 56.1%) had heard of HPV and its vaccines more frequently than males (1,035, 43.9%), with the former also having greater awareness than the latter. The cost, safety, and efficacy of the HPV vaccine and lack of knowledge regarding HPV and its vaccines were the main barriers for vaccination. The overall level of knowledge regarding HPV and its vaccines was lower in the nonmedical group and males than in the medical group and females. To help promote willingness for vaccination among the nonmedical group and males, strategies that deepen their knowledge regarding the HPV vaccine are needed.
DOI: 10.7910/dvn/vpwvdk
title: Replication Data for: Ranked Choice Voting, Candidate Endorsements, and Affective Polarization

description: Replication Data for: Ranked Choice Voting, Candidate Endorsements, and Affective Polarization
DOI: 10.6084/m9.figshare.25460534
title: Intranasal delivery of <i>Salmonella</i> OMVs decorated with <i>Chlamydia trachomatis</i> antigens induces specific local and systemic immune responses

description: <i>Chlamydia trachomatis</i> is an obligate intracellular pathogen responsible for the most prevalent bacterial sexually transmitted disease globally. The high prevalence of chlamydial infections underscores the urgent need for licensed and effective vaccines to prevent transmission in populations. Bacterial outer membrane vesicles (OMVs) have emerged as promising mucosal vaccine carriers due to their inherent adjuvant properties and the ability to display heterologous antigens. In this proof-of-concept study, we evaluated the immunogenicity of <i>Salmonella</i> OMVs decorated with <i>C. trachomatis</i> MOMP-derived CTH522 or HtrA antigens in mice. Following a prime-boost intranasal vaccination approach, two OMV-based <i>C. trachomatis</i> vaccines elicited significant humoral responses specific to the antigens in both systemic and vaginal compartments. Furthermore, we demonstrated strong antigen-specific IFN-γ and IL17a responses in splenocytes and cervical lymph node cells of vaccinated mice, indicating CD4<sup>+</sup> Th1 and Th17 biased immune responses. Notably, the OMV-CTH522 vaccine also induced the production of spleen-derived CD8<sup>+</sup> T cells expressing IFN-γ. In conclusion, these results highlight the potential of OMV-based <i>C. trachomatis</i> vaccines for successful use in future challenge studies and demonstrate the suitability of our modular OMV platform for intranasal vaccine applications.
DOI: 10.6084/m9.figshare.25460534.v1
title: Intranasal delivery of <i>Salmonella</i> OMVs decorated with <i>Chlamydia trachomatis</i> antigens induces specific local and systemic immune responses

description: <i>Chlamydia trachomatis</i> is an obligate intracellular pathogen responsible for the most prevalent bacterial sexually transmitted disease globally. The high prevalence of chlamydial infections underscores the urgent need for licensed and effective vaccines to prevent transmission in populations. Bacterial outer membrane vesicles (OMVs) have emerged as promising mucosal vaccine carriers due to their inherent adjuvant properties and the ability to display heterologous antigens. In this proof-of-concept study, we evaluated the immunogenicity of <i>Salmonella</i> OMVs decorated with <i>C. trachomatis</i> MOMP-derived CTH522 or HtrA antigens in mice. Following a prime-boost intranasal vaccination approach, two OMV-based <i>C. trachomatis</i> vaccines elicited significant humoral responses specific to the antigens in both systemic and vaginal compartments. Furthermore, we demonstrated strong antigen-specific IFN-γ and IL17a responses in splenocytes and cervical lymph node cells of vaccinated mice, indicating CD4<sup>+</sup> Th1 and Th17 biased immune responses. Notably, the OMV-CTH522 vaccine also induced the production of spleen-derived CD8<sup>+</sup> T cells expressing IFN-γ. In conclusion, these results highlight the potential of OMV-based <i>C. trachomatis</i> vaccines for successful use in future challenge studies and demonstrate the suitability of our modular OMV platform for intranasal vaccine applications.
DOI: 10.6084/m9.figshare.27717940
title: Safety profiles of intravesical Bacillus Calmette-Guerin in bladder cancer

description: Bladder cancer (BCa) exhibits significant sex disparities, and intravesical Bacillus Calmette-Guerin (BCG) is a widely used treatment for non-muscle invasive bladder cancer (NMIBC). A comprehensive evaluation of intravesical BCG, including the safety profile and adverse events (AEs), is essential. In particular, exploring the sex differences is crucial. We conducted a pharmacovigilance data analysis using real-world big data from the Food and Drug Administration Adverse Event Reporting System (FAERS) database. In our study, we analyzed 3,374 cases of intravesical BCG for signal mining. We detected 353 signals at the Preferred Term (PT) level and 10 signals at the System Organ Class (SOC) level when compared to the full FAERS database. When comparing between intravesical BCG and other administration routes, we identified 14 signals at the PT level and 8 signals at the SOC level. Intravesical BCG exhibited lower immune-related AEs (irAEs) risk than anti-PD-1/PD-L1 treatment, but antibiotics increased the risk. Notably, AEs associated with intravesical BCG exhibited significant sex differences. Female patients showed a higher susceptibility to developing allergic diseases such as Reiter’s syndrome and Arthralgia, while male patients were more prone to infectious diseases. Additionally, we highlighted that male patients had higher fatality rates, whereas female patients experienced higher rates of recurrence and irAEs. We have compiled an overview of AEs associated with intravesical BCG. These findings enhance understanding of safety profiles and risks, enabling informed decisions prioritizing patients.
DOI: 10.6084/m9.figshare.27717940.v1
title: Safety profiles of intravesical Bacillus Calmette-Guerin in bladder cancer

description: Bladder cancer (BCa) exhibits significant sex disparities, and intravesical Bacillus Calmette-Guerin (BCG) is a widely used treatment for non-muscle invasive bladder cancer (NMIBC). A comprehensive evaluation of intravesical BCG, including the safety profile and adverse events (AEs), is essential. In particular, exploring the sex differences is crucial. We conducted a pharmacovigilance data analysis using real-world big data from the Food and Drug Administration Adverse Event Reporting System (FAERS) database. In our study, we analyzed 3,374 cases of intravesical BCG for signal mining. We detected 353 signals at the Preferred Term (PT) level and 10 signals at the System Organ Class (SOC) level when compared to the full FAERS database. When comparing between intravesical BCG and other administration routes, we identified 14 signals at the PT level and 8 signals at the SOC level. Intravesical BCG exhibited lower immune-related AEs (irAEs) risk than anti-PD-1/PD-L1 treatment, but antibiotics increased the risk. Notably, AEs associated with intravesical BCG exhibited significant sex differences. Female patients showed a higher susceptibility to developing allergic diseases such as Reiter’s syndrome and Arthralgia, while male patients were more prone to infectious diseases. Additionally, we highlighted that male patients had higher fatality rates, whereas female patients experienced higher rates of recurrence and irAEs. We have compiled an overview of AEs associated with intravesical BCG. These findings enhance understanding of safety profiles and risks, enabling informed decisions prioritizing patients.