{"title":"Risk and safety profile in checkpoint inhibitors on non-small-cel lung cancer: A systematic review.","authors":"Sara Maria Majernikova","doi":"10.1080/21645515.2024.2365771","DOIUrl":"10.1080/21645515.2024.2365771","url":null,"abstract":"<p><p>Treating non-small-cell lung cancer (NSCLC) has gained increased importance in recent years due to the high mortality rate and dismal five-year survival rate. Immune checkpoint inhibitors (ICI) are a promising approach with exceptional outcomes in NSCLC thanks to the antigenic nature of cells. Conversely, immune system over-stimulation with ICI is a double-edged sword that can lead to various negative effects ranging from mild to life-threatening. This review explores current breakthroughs in nanoparticle-based ICI and their limitations. The PubMed, Scopus and Web of Science were examined for relevant publications. Thirty-eight trials (<i>N</i> = 16,781) were included in the analyses. The mixed effects analyses on quantifying the treatment effect contributed significantly to the subgroups within studies for ICI treatment effect. Models confirmed ICI's higher impact on treatment effectivity and the decrease in respondents' mortality compared to conventional treatment regiments. ICI might be used as first-line therapy due to their proven effectiveness and safety profile.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"20 1","pages":"2365771"},"PeriodicalIF":4.1,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11212564/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141460243","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Chien-Yu Cheng, Ying-Shih Su, Chyi-Liang Chen, Mingi Chang, Shu-Wei Huang, Peng-Nien Huang, Shin-Ru Shih, Yu-Shen Hsu, Cheng-Hsun Chiu
{"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.","authors":"Chien-Yu Cheng, Ying-Shih Su, Chyi-Liang Chen, Mingi Chang, Shu-Wei Huang, Peng-Nien Huang, Shin-Ru Shih, Yu-Shen Hsu, Cheng-Hsun Chiu","doi":"10.1080/21645515.2024.2432105","DOIUrl":"10.1080/21645515.2024.2432105","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"20 1","pages":"2432105"},"PeriodicalIF":4.1,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11610553/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142751870","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Safety and immunogenicity of a SARS-CoV-2 recombinant protein subunit vaccine adjuvanted with Alum + CpG 1018 in healthy Indonesian adults: A multicenter, randomized, comparative, observer-blind, placebo-controlled phase 2 study.","authors":"Martira Maddeppungeng, Asrawati Nurdin, Yetty Movieta Nency, Rini Sekartini, Bernie Endyarni Medise, Soedjatmiko Soedjatmiko, Muh Nasrum Massi, Sidrah Darma, Andi Husni Esa Darussalam, Nur Ramadhani, Najdah Hidayah, Maisuri Tadjuddin Chalid, Sri Ramadany, Sitti Wahyuni, Irawaty Djaharuddin, Arif Santoso, Bahrul Fikri, Suriani Alimuddin, Ninny Meutia Pelupessy, Rina Masadah, Azka Zhafira Putri, Lilis Setyaningsih, Finny Fitry Yani, Fenty Anggrainy, Putri Awaliyah Deza, Nani Maharani, Endang Mahati, Rebriarina Hapsari, Nur Farhanah, Setyo Gundi Pramudo, Dimas Tri Anantyo","doi":"10.1080/21645515.2024.2429231","DOIUrl":"10.1080/21645515.2024.2429231","url":null,"abstract":"<p><p>Globally, dozens of COVID-19 vaccines are licensed under emergency or conditional authorization, but especially in low and middle-income countries, their availability varies. Indonesia decided to become independent and produce its own vaccines locally. This study investigated the safety and immunogenicity of a SARS-CoV-2 recombinant protein subunit vaccine adjuvanted with Alum + CpG 1018. This study involved 360 adults aged 18 years and above. It compared two vaccine dosages, a-12.5 µg and a 25-µg dose of receptor binding domain protein, to a placebo (1:1:1). A total of 40.6% of participants in this study experienced at least one adverse event (AE), with most being mild. There was no statistically significant difference in AEs between the groups. The microneutralization test showed the highest neutralizing antibody titer (IU/mL) in the 25 µg dose vaccine group at day 28 after the second dose (3,300 95%CI 2,215-4,914), although it was not statistically different from the 12.5 µg dose group (3,157 95%CI 2,135-4,669). Similarly, IgG antibody concentrations in the 25 µg dose vaccine group at day 28 were the highest compared to the 12.5 µg dose and placebo. According to protocol, only the formulation with the better antibody profile and comparable reactogenicity was further evaluated at months three and six. Thus, follow-up was only performed for the 25 µg dose vaccine, demonstrating antibody persistence at month six and had a favorable safety profile. These results position this SARS-CoV-2 recombinant protein subunit vaccine adjuvanted with Alum + CpG 1018 as a promising candidate to fight against COVID-19.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"20 1","pages":"2429231"},"PeriodicalIF":4.1,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11622629/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142781498","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Human vaccines and immunotherapeutics: News January 2024.","authors":"Ronald Ellis, Adam Weiss","doi":"10.1080/21645515.2024.2314870","DOIUrl":"https://doi.org/10.1080/21645515.2024.2314870","url":null,"abstract":"","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"20 1","pages":"2314870"},"PeriodicalIF":4.1,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142856334","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Human vaccines and immunotherapeutics: News May 2024.","authors":"Ronald Ellis, Adam Weiss","doi":"10.1080/21645515.2024.2367397","DOIUrl":"https://doi.org/10.1080/21645515.2024.2367397","url":null,"abstract":"","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"20 1","pages":"2367397"},"PeriodicalIF":4.1,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142856338","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Efficacy of HBV booster dose administration in Italian medical students in relation to health determinants.","authors":"Loreta Tobia, Rocco Francesco Zagà, Antonella Mattei, Claudia Cipollone, Alessia Cipriani, Adalgisa Ilaria Sedile, Leila Fabiani, Serena Bianchi","doi":"10.1080/21645515.2024.2439049","DOIUrl":"10.1080/21645515.2024.2439049","url":null,"abstract":"<p><p>We evaluated the efficacy of a booster dose of HBV in Italian medical students. We conducted a prospective observational study in students who had received a full course of anti-HBV vaccination for at least 15 y. Those with an anti-HBs titer <10 mIU/mL were offered a booster dose of the HBV vaccine and the antibody titer was reevaluated after 1 month. The participants were classified into three categories: with anti-HBs titer >100 mIU/mL, between 10 and 100 mIU/mL and <10 mIU/mL. The study population was n. 625 medical student and 355 (56.8%) with anti HBs titer <10 mIU/mL were offered a booster dose. A total of 166 of them received the booster dose and 92.77% (38 + 116/166) achieved an anti-HBs titer ≥10 mIU/mL. The post-booster anti-HBs titer response was higher, i.e. >100 mIU/mL, in subjects who had a pre-booster anti-HBs titer between 1.00 and 9.99 mIU/mL (84.38%, 81/96), compared to those with titer <1 mIU/mL (50.00%, 35/70). Subjects with a titer <1.00 mIU/mL at enrollment showed no anamnestic response (post-booster anti-HBs <10 mIU/mL, RRR 0.23, 95% CI 0.06-0.84) and to a low anamnestic response (post-booster anti-HBs 10-100 mIU/mL, RRR 0.16, 95% CI 0.07-0.38). Physical activity was linked to a better antibody response to vaccination (post-booster anti-HBs 10-100 mIU/mL: RRR 2.39, 95% CI 1.05-5.59). Immune protection following primary vaccination against HBV tends to wane over time. Booster dose induces anamnestic responses, especially in individuals who maintain titer HBsAg >1 mIU/mL and do physical activity.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"20 1","pages":"2439049"},"PeriodicalIF":4.1,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142856328","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Human vaccines and immunotherapeutics: News October 2024.","authors":"Ronald Ellis, Adam Weiss","doi":"10.1080/21645515.2024.2429976","DOIUrl":"https://doi.org/10.1080/21645515.2024.2429976","url":null,"abstract":"","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"20 1","pages":"2429976"},"PeriodicalIF":4.1,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142649319","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ruochen Bao, Hongtao Qu, Baifeng Li, Kai Cheng, Yandong Miao, Jiangtao Wang
{"title":"Knowledge mapping of immunotherapy for breast cancer: A bibliometric analysis from 2013 to 2022: A correspondence.","authors":"Ruochen Bao, Hongtao Qu, Baifeng Li, Kai Cheng, Yandong Miao, Jiangtao Wang","doi":"10.1080/21645515.2024.2352278","DOIUrl":"https://doi.org/10.1080/21645515.2024.2352278","url":null,"abstract":"","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"20 1","pages":"2352278"},"PeriodicalIF":4.8,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140960566","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Carmelo M Vicario, Massimo Mucciardi, Giulia Faraone, Chiara Lucifora, Hannah M Schade, Alessandra Falzone, Mohammad A Salehinejad, Giuseppe Craparo, Michael A Nitsche
{"title":"Individual predictors of vaccine hesitancy in the Italian post COVID-19 pandemic era.","authors":"Carmelo M Vicario, Massimo Mucciardi, Giulia Faraone, Chiara Lucifora, Hannah M Schade, Alessandra Falzone, Mohammad A Salehinejad, Giuseppe Craparo, Michael A Nitsche","doi":"10.1080/21645515.2024.2306677","DOIUrl":"10.1080/21645515.2024.2306677","url":null,"abstract":"<p><p>A wide range of survey studies have explored vaccination hesitancy/resistance during the COVID-19 pandemic and provided evidence that this can be explained by several individual variables from the ideological, clinical, and socio-affective domain. However, evidence about which individual variables predict vaccine hesitancy in the post-pandemic state of COVID-19 is meager. We administered a battery of questionnaires to a group of 120 Italian participants with high and low scores on the adult vaccine hesitancy scale (aVHS) to investigate the predictive role of ideological (i.e. political orientation), clinical (i.e. anxiety, interoceptive accuracy), and socio-affective (i.e. alexithymia, disgust sensitivity/propensity, empathy) variables on vaccine hesitancy/resistance. This study provides evidence that lower interoceptive awareness and cognitive empathy are predictors of a greater hesitancy to get vaccinated in the post-pandemic COVID-19 state.</p>","PeriodicalId":49067,"journal":{"name":"Human Vaccines & Immunotherapeutics","volume":"20 1","pages":"2306677"},"PeriodicalIF":4.1,"publicationDate":"2024-12-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10829816/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139576922","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}