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19 pages, 2063 KiB

Open AccessArticle

Safety and Immunogenicity of the Convacell^® Recombinant N Protein COVID-19 Vaccine

by Sevastyan Rabdano, Ellina Ruzanova, Denis Makarov, Anastasiya Vertyachikh, Valeriya Teplykh, German Rudakov, Iuliia Pletyukhina, Nikita Saveliev, Konstantin Zakharov, Diana Alpenidze, Vasiliy Vasilyuk, Sergei Arakelov and Veronika Skvortsova

Vaccines 2024, 12(1), 100; https://doi.org/10.3390/vaccines12010100 - 19 Jan 2024

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Abstract

We have developed Convacell^®—a COVID-19 vaccine based on the recombinant nucleocapsid (N) protein of SARS-CoV-2. This paper details Convacell’s^® combined phase I/II and IIb randomized, double-blind, interventional clinical trials. The primary endpoints were the frequency of adverse effects (AEs) and [...] Read more.

We have developed Convacell^®—a COVID-19 vaccine based on the recombinant nucleocapsid (N) protein of SARS-CoV-2. This paper details Convacell’s^® combined phase I/II and IIb randomized, double-blind, interventional clinical trials. The primary endpoints were the frequency of adverse effects (AEs) and the titers of specific anti-N IgGs induced by the vaccination; secondary endpoints included the nature of the immune response. Convacell^® demonstrated high safety in phase I with no severe AEs detected, 100% seroconversion by day 42 and high and sustained for 350 days anti-N IgG levels in phase II. Convacell^® also demonstrated a fused cellular and humoral immune response. Phase IIb results showed significant post-vaccination increases in circulating anti-N IgG and N protein-specific IFNγ⁺-producing PBMC quantities among 438 volunteers. Convacell^® showed same level of immunological efficacy for single and double dose vaccination regimens, including for elderly patients. The clinical studies indicate that Convacell^® is safe and highly immunogenic. Full article

(This article belongs to the Special Issue Vaccines for COVID-19)

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18 pages, 1437 KiB

Open AccessFeature PaperArticle

COVID-19 Vaccination in Pregnancy: Pilot Study for Maternal and Neonatal MicroRNA Profiles

by Wei-Chun Chen, Shu-Yu Hu, Ching-Fen Shen, Mei-Hsiu Cheng, Jun-Jie Hong, Ching-Ju Shen and Chao-Min Cheng

Vaccines 2023, 11(12), 1814; https://doi.org/10.3390/vaccines11121814 - 04 Dec 2023

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Abstract

This pilot study explores alterations in miRNA profiles among pregnant women and their neonates upon receiving different doses of COVID-19 vaccines. Blood samples, including maternal blood (MB) and neonatal cord blood (CB), collected from five pregnant women were scrutinized using the miRNA PanelChip [...] Read more.

This pilot study explores alterations in miRNA profiles among pregnant women and their neonates upon receiving different doses of COVID-19 vaccines. Blood samples, including maternal blood (MB) and neonatal cord blood (CB), collected from five pregnant women were scrutinized using the miRNA PanelChip Analysis System, identifying nine distinct miRNAs, including miR-451a and miR-1972, which exhibited significant downregulation with two vaccine doses in both MB and CB. When compared with women vaccinated with four doses, miR-486-5p, miR-451a, and miR-1972 in the two-dose group also showed notable downregulation. Evaluating recipients of three and four doses, miR-423-5p and miR-1972 expression were significantly reduced in both MB and CB. Further comparative analysis highlighted a decline in miR-223-3p expression with increasing vaccine doses, while miR15a-5p, miR-16-5p, and miR-423-5p showed an upward trend. Notably, miR-451a, miR-1972, and miR-423-5p levels varied across doses and were associated with pathways such as “PI3K-Akt”, “neurotrophin signaling”, and “cortisol synthesis”, suggesting the profound influence of vaccination on diverse molecular mechanisms. Our research has uncovered that escalating vaccine dosages impact miRNA profiles, which may be associated with the immunological response mechanisms in both the mother and fetus, thus indicating a substantial impact of vaccination on various molecular processes. Full article

(This article belongs to the Special Issue Vaccines for COVID-19)

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15 pages, 2270 KiB

Open AccessArticle

Safety, Tolerability, and Immunogenicity of Booster Dose with MVC-COV1901 or MVC-COV1901-Beta SARS-CoV-2 Vaccine in Adults: A Phase I, Prospective, Randomized, Open-Labeled Study

by Chia En Lien, Ming-Che Liu, Ning-Chi Wang, Luke Tzu-Chi Liu, Chung-Chin Wu, Wei-Hsuan Tang, Wei-Cheng Lian, Kuan-Ying A. Huang and Charles Chen

Vaccines 2023, 11(12), 1798; https://doi.org/10.3390/vaccines11121798 - 01 Dec 2023

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Abstract

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines based on variant strains have been in use as booster doses to update immunity against circulating variants. Here we present the results of a phase one prospective, randomized, and open-labeled trial to study the safety [...] Read more.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines based on variant strains have been in use as booster doses to update immunity against circulating variants. Here we present the results of a phase one prospective, randomized, and open-labeled trial to study the safety and immunogenicity of a booster dose consisting of a subunit vaccine based on the stabilized prefusion SARS-CoV-2 spike protein, MVC-COV1901, or its Beta version, MVC-COV1901-Beta. Participants aged ≥18 and <55 years who received two or three prior doses of MVC-COV1901 vaccines were enrolled and were to receive a booster dose of either 15 mcg of MVC-COV1901, 15 mcg, or 25 mcg of MVC-COV1901-Beta in a 1:1:1 ratio. Adverse reactions after either MVC-COV1901 or MVC-COV1901-Beta booster doses after two or three doses of MVC-COV1901 were comparable and mostly mild and transient. At four weeks after the booster dose, participants with two prior doses of MVC-COV1901 had higher levels of neutralizing antibodies against ancestral SARS-CoV-2, Beta, and Omicron variants than participants with three prior doses of MVC-COV1901, regardless of the type of booster used. MVC-COV1901 and MVC-COV1901-Beta can both be effectively used as booster doses against SARS-CoV-2, including the BA.4/BA.5 Omicron variants. Full article

(This article belongs to the Special Issue Vaccines for COVID-19)

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11 pages, 275 KiB

Open AccessArticle

Effectiveness of the Booster Dose in Protecting against COVID-19, Colombia 2022

by Jubby Marcela Gálvez, Ángela María Pinzón-Rondón, Henry Mauricio Chaparro-Solano, Hanna Valentina Tovar-Romero, Juliana Ramírez-Prieto, Sergio Andrés Ortigoza-Espitia and Ángela María Ruiz-Sternberg

Vaccines 2023, 11(9), 1461; https://doi.org/10.3390/vaccines11091461 - 07 Sep 2023

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Abstract

Vaccination has proven to be one of the most effective strategies against the COVID-19 pandemic. Several studies have evaluated and confirmed its effectiveness in different populations, particularly in reducing severe outcomes such as hospitalization and death. Some studies have investigated the effectiveness of [...] Read more.

Vaccination has proven to be one of the most effective strategies against the COVID-19 pandemic. Several studies have evaluated and confirmed its effectiveness in different populations, particularly in reducing severe outcomes such as hospitalization and death. Some studies have investigated the effectiveness of vaccination against the infection, identifying the need for booster doses. This study aimed to explore the effectiveness of the vaccination schedule on the probability of infection in a sample of Colombian patients during the fourth wave of the COVID-19 pandemic, which was associated with the emergence and predominance of the Omicron variant. A cross-sectional study was conducted on individuals who underwent RT-PCR testing for COVID-19 detection in a dedicated laboratory in Bogotá, Colombia, between 30 December 2021 and 7 February 2022. A total of 1468 subjects was included in the study, of whom 36.6% (n = 538) had a positive PCR test for COVID-19. The comparison between fully vaccinated individuals with a booster dose and those without the booster dose revealed a 28% reduction in the odds of infection (OR = 0.719 CI 0.531–0.971). Age (OR = 1.009 CI 1.001–1.018) and low economic status (OR = 1.812 CI 1.416–2.319) were associated with an increased risk of infection. These findings suggest the need for a booster vaccination in the general population to improve the prevention rates of SARS-CoV-2 infection and mitigate severe outcomes. Full article

(This article belongs to the Special Issue Vaccines for COVID-19)

13 pages, 256 KiB

Open AccessArticle

A Qualitative Study on Barriers to COVID-19 Vaccine Uptake among Community Members in Tanzania

by Melina Bernard Mgongo, Rachel N. Manongi, Innocent B. Mboya, James S. Ngocho, Caroline Amour, Monica Mtei, Julieth S. Bilakwate, Ahmed Yusuph Nyaki, Johnston M. George, Beatrice J. Leyaro, Amina Farah, James T. Kengia, Florian Tinuga, Abdalla H. Bakari, Fatimata B. Kirakoya, Awet Araya, Ntuli A. Kapologwe and Sia E. Msuya

Vaccines 2023, 11(8), 1366; https://doi.org/10.3390/vaccines11081366 - 15 Aug 2023

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Abstract

The use of vaccines is one of the key tools in reversing the COVID-19 pandemic; however, various reports reported the low uptake of the vaccines. This study explored the barriers to the COVID-19 vaccine uptake among community members in Tanzania. A qualitative explorative [...] Read more.

The use of vaccines is one of the key tools in reversing the COVID-19 pandemic; however, various reports reported the low uptake of the vaccines. This study explored the barriers to the COVID-19 vaccine uptake among community members in Tanzania. A qualitative explorative study was conducted in December 2021 and April 2022 in eight regions of Tanzania. Focus group discussions (FGDs) and in-depth interviews (IDIs) were the methods of data collection. A total of 48 FGDs and 32 IDIs were conducted. Participants were aware of the COVID-19 disease and vaccines. The barriers to the COVID-19 vaccine non-uptake included receiving contradicting statements from top government leaders, vaccine preceded the education, myths towards vaccines, the presence of different types of vaccines, the process of getting the vaccine, the influence of social media and random people from the community, and vaccine conflicting religious beliefs. Despite being aware of the vaccine, the uptake of the COVID-19 vaccine is still low. Interventions that focus on increasing community knowledge about COVID-19 vaccines and addressing myths about the vaccines are needed. Full article

(This article belongs to the Special Issue Vaccines for COVID-19)

13 pages, 1251 KiB

Open AccessArticle

Cardiac Function Evaluation after SARS-CoV-2 mRNA Vaccination in Children and Adolescents: A Prospective Speckle-Tracking Echocardiography Study

by Jolanda Sabatino, Costanza Di Chiara, Daria Lauretta, Jennifer Fumanelli, Greta Luana D’Ascoli, Daniele Donà, Sandra Cozzani, Andrea Oletto, Carlo Giaquinto and Giovanni Di Salvo

Vaccines 2023, 11(8), 1348; https://doi.org/10.3390/vaccines11081348 - 09 Aug 2023

Cited by 2 | Viewed by 1547

Abstract

Background: Possible cardiac impairment after SARS-CoV-2 mRNA vaccination is a common driver of parental vaccine hesitancy. We performed a comprehensive echocardiographic evaluation of biventricular function in vaccinated children with or without previous COVID-19 compared to healthy controls. Methods: We conducted a single-center, prospective, [...] Read more.

Background: Possible cardiac impairment after SARS-CoV-2 mRNA vaccination is a common driver of parental vaccine hesitancy. We performed a comprehensive echocardiographic evaluation of biventricular function in vaccinated children with or without previous COVID-19 compared to healthy controls. Methods: We conducted a single-center, prospective, case–control study enrolling children and adolescents aged 5–18 years attending the pediatric clinic of the University Hospital of Padua from April to June 2022. Three months after receiving the primary mRNA vaccination or booster dose, the patients underwent a cardiac assessment, including standard echocardiography and speckle-tracking echocardiography (STE). A pre-pandemic historical cohort of age- and gender-matched healthy children were used as a control. Results: A total of 39 post-VACCINE cases (24, 61% female), mean age 12.6 ± 2.6 years (range 8–17), were enrolled in the study. Ninety percent (N = 35) of patients were previously healthy. No differences in left ventricular diameters, left ventricular ejection fraction (LVEF), and tricuspid annular plane systolic excursion (TAPSE) were observed between cases and controls. Global longitudinal strain (GLS) was in the normal range in all individuals, with no differences between post-VACCINE cases and controls (−21.7 ± 2.3% vs. 21.2 ± 1.8%; p = 0.338). However, GLS was found to be slightly but significantly reduced in post-VACCINE children with a previous COVID-19 compared to naïve-vaccinated individuals (post-VACCINE+COVID-19: −19.9 ± 1.1% vs. post-VACCINE-only: −22.0 ± 2.3%; p = 0.002). Conclusions: We did not observe an impairment in GLS or in other indices of LV structure or function after mRNA COVID-19 vaccination. Full article

(This article belongs to the Special Issue Vaccines for COVID-19)

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15 pages, 926 KiB

Open AccessArticle

Symptom-Specific Hospital Contacts in 12–18-Year-Olds Vaccinated against COVID-19: A Danish Register-Based Cohort Study

by Selina Kikkenborg Berg, Helle Wallach-Kildemoes, Line Ryberg Rasmussen, Ulrikka Nygaard, Nina Marie Birk, Henning Bundgaard, Annette Kjær Ersbøll, Lau Caspar Thygesen, Susanne Dam Nielsen and Anne Vinggaard Christensen

Vaccines 2023, 11(6), 1049; https://doi.org/10.3390/vaccines11061049 - 31 May 2023

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Abstract

In this register-based real-life cohort study, changes in symptom-specific hospital contacts among 12–18-year-olds following two doses of the BNT162b2 COVID-19 vaccine compared to unvaccinated peers were investigated. Using national register data, vaccinated and unvaccinated adolescents were sex and age-matched each week during the [...] Read more.

In this register-based real-life cohort study, changes in symptom-specific hospital contacts among 12–18-year-olds following two doses of the BNT162b2 COVID-19 vaccine compared to unvaccinated peers were investigated. Using national register data, vaccinated and unvaccinated adolescents were sex and age-matched each week during the inclusion period from May to September 2021. Symptom-specific hospital contacts covering ICD-10 R diagnoses were assessed before first the vaccine dose and after the second vaccine dose. Taking previous rates of symptom-specific hospital contacts into account, differences between vaccinated and unvaccinated adolescents were found. For some hospital contacts, higher rates were seen among the vaccinated, and for others, higher rates were seen among the unvaccinated. Unspecific cognition symptoms may be important to monitor in vaccinated girls, and likewise for throat and chest pain in vaccinated boys within the first months post-vaccination. In perspective, symptom-specific hospital contacts after vaccination against COVID-19 must be assessed by taking the risk of infection and symptoms following COVID-19 infection into account. Full article

(This article belongs to the Special Issue Vaccines for COVID-19)

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14 pages, 2834 KiB

Open AccessArticle

Comparison of Adverse Effects of Two SARS-CoV-2 Vaccines Administered in Workers of the University of Padova

by Paola Mason, Rosario Rizzuto, Luca Iannelli, Flavio Baccaglini, Valerio Rizzolo, Andrea Baraldo, Barbara Melloni, Francesca Maffione, Camilla Pezzoli, Maria Laura Chiozza, Giampietro Rupolo, Marco Biasioli, Filippo Liviero, Maria Luisa Scapellato, Andrea Trevisan, Stefano Merigliano, Alberto Scuttari, Angelo Moretto and Bruno Scarpa

Vaccines 2023, 11(5), 951; https://doi.org/10.3390/vaccines11050951 - 05 May 2023

Cited by 2 | Viewed by 1477

Abstract

Introduction: In Italy, on December 2020, workers in the education sector were identified as a priority population to be vaccinated against COVID-19. The first authorised vaccines were the Pfizer-BioNTech mRNA (BNT162b2) and the Oxford-AstraZeneca adenovirus vectored (ChAdOx1 nCoV-19) vaccines. Aim: To [...] Read more.

Introduction: In Italy, on December 2020, workers in the education sector were identified as a priority population to be vaccinated against COVID-19. The first authorised vaccines were the Pfizer-BioNTech mRNA (BNT162b2) and the Oxford-AstraZeneca adenovirus vectored (ChAdOx1 nCoV-19) vaccines. Aim: To investigate the adverse effects of two SARS-CoV-2 vaccines in a real-life preventive setting at the University of Padova. Methods: Vaccination was offered to 10116 people. Vaccinated workers were asked to voluntarily report symptoms via online questionnaires sent to them 3 weeks after the first and the second shot. Results: 7482 subjects adhered to the vaccination campaign and 6681 subjects were vaccinated with ChAdOx1 nCoV-19 vaccine and 137 (fragile subjects) with the BNT162b2 vaccine. The response rate for both questionnaires was high (i.e., >75%). After the first shot, the ChAdOx1 nCoV-19 vaccine caused more fatigue (p < 0.001), headache (p < 0.001), myalgia (p < 0.001), tingles (p = 0.046), fever (p < 0.001), chills (p < 0.001), and insomnia (p = 0.016) than the BNT162b2 vaccine. After the second dose of the BNT162b2 vaccine, more myalgia (p = 0.033), tingles (p = 0.022), and shivers (p < 0.001) than the ChAdOx1 nCoV-19 vaccine were elicited. The side effects were nearly always transient. Severe adverse effects were rare and mostly reported after the first dose of the ChAdOx1 nCoV-19 vaccine. They were dyspnoea (2.3%), blurred vision (2.1%), urticaria (1.3%), and angioedema (0.4%). Conclusions: The adverse effects of both vaccines were transient and, overall, mild in severity. Full article

(This article belongs to the Special Issue Vaccines for COVID-19)

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14 pages, 2175 KiB

Open AccessArticle

Longitudinal Changes in IgG-Type SARS-CoV-2 Antibody Titers after COVID-19 Vaccination and a Prominent Increase in Antibody Titers When Infected after Vaccination

by Hiroshi Kusunoki, Michiko Ohkusa, Rie Iida, Ayumi Saito, Mikio Kawahara, Kazumi Ekawa, Nozomi Kato, Keita Yamasaki, Masaharu Motone and Hideo Shimizu

Vaccines 2023, 11(4), 860; https://doi.org/10.3390/vaccines11040860 - 17 Apr 2023

Cited by 3 | Viewed by 1682

Abstract

Objective: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody titers level and duration of elevated levels are considered important indicators for confirming the efficacy of coronavirus disease 2019 (COVID-19) vaccines. The objective of this study was to demonstrate the changes in antibody titers [...] Read more.

Objective: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibody titers level and duration of elevated levels are considered important indicators for confirming the efficacy of coronavirus disease 2019 (COVID-19) vaccines. The objective of this study was to demonstrate the changes in antibody titers after the second and third doses of the COVID-19 vaccine, and to determine the antibody titers in cases of spontaneous infection with SARS-CoV-2 after vaccination. Materials and Methods: From June 2021 to February 2023, IgG-type SARS-CoV-2 antibody titers were measured in 127 participants, including 74 outpatients and 53 members of staff, at the Osaka Dental University Hospital (64 males and 63 females, mean age 52.3 ± 19.0 years). Results: Consistent with previous reports, the SARS-CoV-2 antibody titer decreased with time, not only after the second dose but also after the third dose of the vaccine if there was no spontaneous COVID-19 infection. We also confirmed that the third booster vaccination was effective in increasing the antibody titer. A total of 21 cases of natural infections were observed after administering two or more doses of the vaccine. Thirteen of these patients had post-infection antibody titers exceeding 40,000 AU/mL, and some cases continued to maintain antibody titers in the tens of thousands of AU/mL even after more than 6 months had passed since infection. Conclusions: The rise in and duration of antibody titers against SARS-CoV-2 are considered important indicators for confirming the efficacy of novel COVID-19 vaccines. A longitudinal follow-up of antibody titers after vaccination in larger studies is warranted. Full article

(This article belongs to the Special Issue Vaccines for COVID-19)

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9 pages, 1172 KiB

Open AccessBrief Report

Immunogenicity of Co-Administered Omicron BA.4/BA.5 Bivalent COVID-19 and Quadrivalent Seasonal Influenza Vaccines in Israel during the 2022–2023 Winter Season

by Stephen Moss, Menucha Jurkowicz, Ital Nemet, Nofar Atari, Limor Kliker, Bayan Abd-Elkader, Tal Gonen, Emily Toth Martin, Yaniv Lustig, Gili Regev-Yochay and Michal Mandelboim

Vaccines 2023, 11(10), 1624; https://doi.org/10.3390/vaccines11101624 - 22 Oct 2023

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Abstract

Vaccination against COVID-19 and influenza provides the best defense against morbidity and mortality. Administering both vaccines concurrently may increase vaccination rates and reduce the burden on the healthcare system. This study evaluated the immunogenicity of healthcare workers in Israel who were co-administered with [...] Read more.

Vaccination against COVID-19 and influenza provides the best defense against morbidity and mortality. Administering both vaccines concurrently may increase vaccination rates and reduce the burden on the healthcare system. This study evaluated the immunogenicity of healthcare workers in Israel who were co-administered with the Omicron BA.4/BA.5 bivalent COVID-19 vaccine and the 2022–2023 quadrivalent influenza vaccine. SARS-CoV-2 neutralizing antibody titers were measured via microneutralization while influenza antibody titers were measured via hemagglutination inhibition. No immunogenic interference was observed by either vaccine when co-administered. Antibody titers against SARS-CoV-2 variants increased significantly in the cohort receiving the COVID-19 vaccine alone and in combination with the influenza vaccine. Antibody titers against the A/H1N1 influenza strain increased significantly in the cohort receiving the influenza vaccine alone and in combination with the COVID-19 vaccine. Antibody titers against B/Victoria increased significantly in the cohort that received both vaccines. This study has important public health implications for the 2023–2024 winter season, and supports co-administration of both vaccines as a viable immunization strategy. Full article

(This article belongs to the Special Issue Vaccines for COVID-19)

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9 pages, 624 KiB

Open AccessBrief Report

High Levels of Anti-SARS-CoV-2 Receptor-Binding Domain (RBD) Antibodies One Year Post Booster Vaccinations among Hospital Workers in Indonesia: Was the Second Booster Needed?

by Amila Hanifan Muslimah, Marita Restie Tiara, Hofiya Djauhari, Muhammad Hafizh Dewantara, Evan Susandi, Agnes Rengga Indrati, Bachti Alisjahbana, Arto Yuwono Soeroto and Rudi Wisaksana

Vaccines 2023, 11(8), 1300; https://doi.org/10.3390/vaccines11081300 - 30 Jul 2023

Cited by 2 | Viewed by 1175

Abstract

In August 2022, Indonesia prioritized healthcare workers to receive the second booster dose. We conducted a sequential serosurvey to understand the dynamics of the antibody titers. The first serosurvey, which was conducted in June 2021, 1–6 months after Sinovac vaccination, showed a median [...] Read more.

In August 2022, Indonesia prioritized healthcare workers to receive the second booster dose. We conducted a sequential serosurvey to understand the dynamics of the antibody titers. The first serosurvey, which was conducted in June 2021, 1–6 months after Sinovac vaccination, showed a median antibody level of 41.4 BAU/mL (interquartile range (IQR): 10–629.4 BAU/mL). The second serosurvey was conducted one month (August 2021) after the first Moderna booster vaccine and showed a median level of 4000 BAU/mL (IQR: 3081–4000 BAU/mL). The last serosurvey was conducted a year (August 2022) after the booster and showed a median level of 4000 BAU/mL (IQR: 4000–4000 BAU/mL). In this last survey, only 39 (11.9%) of healthcare workers had antibody levels below the maximum level of 4000 BAU/mL. Thus, one year after the first booster dose, we did not observe the waning of antibody levels. The average increase was perhaps because of natural infection. Based on these considerations, we believe that a second booster dose was not necessary for this category of subjects at that time. Because vaccine supply is often limited, priority could be given to the general population or other high-risk patient groups with low antibody titers based on serological tests. Full article

(This article belongs to the Special Issue Vaccines for COVID-19)

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