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5. Safety, tolerability, and immunogenicity of an adult pneumococcal conjugate vaccine, V116 (STRIDE-3): a randomised, double-blind, active comparator controlled, international phase 3 trial

Author

Abdel-Malek, Michael, Adelglass, Jeffrey, Alpizar, Sady Armad, Anderson, Duane, Andrews, Charles P., Askling, Helena Hervius, Baker, Jeffrey B., Baron, Mira, Barranco-Santana, Elizabeth A., Beckes, John, Bergthold, James H., Bosson, Peter, Buntinx, Erik, Bush, Larry Marc, Butuk, David J., Cartagena Ayala, Edgardo F., Choi, Hee Jung, Choi, Jung Hyun, Choi, Won Suk, Choi, Young Hwa, Clark, James R., Cornely, Oliver A., Cox, Steve E., Daboul, Nizar, De La Cruz, Luis Ignacio, De Silva, Pamela, Degen, Olaf, Ebuh, Valentine, Elzi, Stanton R., Fiel, Thomas, Fitzgibbons, William Patrick, Fraser, Neil J., Freeman, George Hartley, Galloway, Christopher, Garcia-Huidobro, Diego, Garza, Juan Carlos, George, Anil, Griffin, Carl Patrick, Guduri, Sridhar, Guner, Hatice Rahmet, Gunner, Elizabeth, Hanabergh, Enrique, Harper, Charles Harold, Harris, Kathleen, Hemmersmeier, John Matthew, Hill, John M., Huang, Ching-Tai, Huang, Kuo-Chin, Huberty, Chad Roger, Image, Bejamin James, Jandl, Margret, Johnston, William Henry, Jr., Kamerbeek, Jackie Marie, Karabay, Oguz, Ko, Jae-Hoon, Koksal, Iftihar, Kwon, Ki Tae, Leah, Amber, Lee, Dong-Gun, Lee, Jacob, Lenzmeier, Thomas C., Loh, Denissa, Lupercio, Rafael, Luts, Andes Erik, Lutz, Thomas, Martinez, Jose, Mayer, Renae, Miller, Vicki, Morales-Ramirez, Javier O., Munoz, Manuel, Navarro, Jesus Ovidio, Odekirk, Larry Lee, Odia, Patrick, Odio, Alberto J., O'Sullivan, Matthew, Patel, Minesh Arun, Pelayo, Enrique, Perez Cortes, Carlos, Pervaiz, Syed, Probst, Jared, Quinn, Dean Richard, Rigonan, Kathryn R., Rosario-Matos, Nicolas, Rosen, Jeffrey Bruce, Sannesten, Andrej, Schaefer, Axel, Schellberg, Sven, Sharma, Manjoo, Sher, Lawrence D., Shi, Hyejin, Shockey, Gerald R., Singh, Raj, Sjoberg, Folke, Smith, Brian, Smith, Christohper A., Smith, Deon, Smith, Susan Elizabeth, Song, Joon Young, Staben, Jonathan, Steil, Kenneth, Su, Chien-Tien, Ünal, Serhat, Wie, Seong-Heong, Wijewardane, Priyantha, Williams, Michael John, Wolf, Thomas A., Yang, Yi-Ching, Yeom, Joon Sup, Platt, Heather L, Bruno, Christopher, Barranco-Santana, Elizabeth A, Grijalva, Carlos G, Orenstein, Walter A, Morgan, Leslie, Fernsler, Doreen, Xu, Weifeng, Waleed, Muhammad, Li, Jianing, and Buchwald, Ulrike K

Published
2024
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10. Immunogenicity and safety of SARS-CoV-2 recombinant protein nanoparticle vaccine GBP510 adjuvanted with AS03: interim results of a randomised, active-controlled, observer-blinded, phase 3 trial

Author

Philippot, Agathe, Solmi, Francesca, Ceregido, Maria Angeles, Shim, Byoung-Shik, Seo, Sang Hwan, D'Souza, Simone, Thaisrivichai, Patchara, Carlos, Josefina, Alberto, Edison, Nitayaphan, Sorachai, Ratanasuwan, Winai, Mootsikapun, Piroon, Chaiwarith, Romanee, Chan Quang, Luong, Karpenko, Olena, Yurkiv, Tatiana, Kutovyi, Vitalii, Bartko, Angela, Gyrina, Olga, Barna, Olga, Pugach, Mykhailo, Thurlow, Claire, Carson, Simon, Smith, Susan, Williams, Mike, Hemi Senior, Tiwini, Humphrey, Tim, Sheahan, Davitt, Park, Hokeun, Lee, Yoon Yeong, Kang, Seung Gu, Song, Joon Young, Choi, Won Suk, Heo, Jung Yeon, Kim, Eun Jin, Lee, Jin Soo, Jung, Dong Sik, Kim, Shin-Woo, Park, Kyung-Hwa, Eom, Joong Sik, Jeong, Su Jin, Lee, Jacob, Kwon, Ki Tae, Choi, Hee Jung, Sohn, Jang Wook, Kim, Young Keun, Yoo, Byung Wook, Jang, In-Jin, Capeding, Maria Z., Roman, François, Breuer, Thomas, Wysocki, Piotr, Carter, Lauren, Sahastrabuddhe, Sushant, Song, Manki, D'Cor, Naveena, Kim, Hun, Ryu, Ji Hwa, Lee, Su Jeen, Park, Yong Wook, and Cheong, Hee Jin

Published
2023
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13. Safety and immunogenicity of the bi-cistronic GLS-5310 COVID-19 DNA vaccine delivered with the GeneDerm suction device

Author

Kim, Woo Joo, Roberts, Christine C., Song, Joon Young, Yoon, Jin Gu, Seong, Hye, Hyun, Hak-Jun, Lee, Hyojin, Gil, Areum, Oh, Yeeun, Park, Ji-eun, Jeon, Bohyun, Lee, Ji-Eun, Choi, Sang Kyu, Yoon, Sun Kyung, Lee, Sunhee, Kim, Byoungguk, Kane, Deborah, Spruill, Susan, Kudchodkar, Sagar B., Muthumani, Kar, Park, Young K., Kwon, Ijoo, Jeong, Moonsup, and Maslow, Joel N.

Published
2023
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14. Safety and immunogenicity of a SARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) adjuvanted with AS03: A randomised, placebo-controlled, observer-blinded phase 1/2 trial

Author

Song, Joon Young, Choi, Won Suk, Heo, Jung Yeon, Lee, Jin Soo, Jung, Dong Sik, Kim, Shin-Woo, Park, Kyung-Hwa, Eom, Joong Sik, Jeong, Su Jin, Lee, Jacob, Kwon, Ki Tae, Choi, Hee Jung, Sohn, Jang Wook, Kim, Young Keun, Noh, Ji Yun, Kim, Woo Joo, Roman, François, Ceregido, Maria Angeles, Solmi, Francesca, Philippot, Agathe, Walls, Alexandra C., Carter, Lauren, Veesler, David, King, Neil P., Kim, Hun, Ryu, Ji Hwa, Lee, Su Jeen, Park, Yong Wook, Park, Ho Keun, and Cheong, Hee Jin

Published
2022
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16. Changes in the incidence of invasive disease due to Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria meningitidis during the COVID-19 pandemic in 26 countries and territories in the Invasive Respiratory Infection Surveillance Initiative: a prospective analysis of surveillance data

Author

Brueggemann, Angela B, Jansen van Rensburg, Melissa J, Shaw, David, McCarthy, Noel D, Jolley, Keith A, Maiden, Martin C J, van der Linden, Mark P G, Amin-Chowdhury, Zahin, Bennett, Désirée E, Borrow, Ray, Brandileone, Maria-Cristina C, Broughton, Karen, Campbell, Ruth, Cao, Bin, Casanova, Carlo, Choi, Eun Hwa, Chu, Yiu Wai, Clark, Stephen A, Claus, Heike, Coelho, Juliana, Corcoran, Mary, Cottrell, Simon, Cunney, Robert J, Dalby, Tine, Davies, Heather, de Gouveia, Linda, Deghmane, Ala-Eddine, Demczuk, Walter, Desmet, Stefanie, Drew, Richard J, du Plessis, Mignon, Erlendsdottir, Helga, Fry, Norman K, Fuursted, Kurt, Gray, Steve J, Henriques-Normark, Birgitta, Hale, Thomas, Hilty, Markus, Hoffmann, Steen, Humphreys, Hilary, Ip, Margaret, Jacobsson, Susanne, Johnston, Jillian, Kozakova, Jana, Kristinsson, Karl G, Krizova, Pavla, Kuch, Alicja, Ladhani, Shamez N, Lâm, Thiên-Trí, Lebedova, Vera, Lindholm, Laura, Litt, David J, Martin, Irene, Martiny, Delphine, Mattheus, Wesley, McElligott, Martha, Meehan, Mary, Meiring, Susan, Mölling, Paula, Morfeldt, Eva, Morgan, Julie, Mulhall, Robert M, Muñoz-Almagro, Carmen, Murdoch, David R, Murphy, Joy, Musilek, Martin, Mzabi, Alexandre, Perez-Argüello, Amaresh, Perrin, Monique, Perry, Malorie, Redin, Alba, Roberts, Richard, Roberts, Maria, Rokney, Assaf, Ron, Merav, Scott, Kevin J, Sheppard, Carmen L, Siira, Lotta, Skoczyńska, Anna, Sloan, Monica, Slotved, Hans-Christian, Smith, Andrew J, Song, Joon Young, Taha, Muhamed-Kheir, Toropainen, Maija, Tsang, Dominic, Vainio, Anni, van Sorge, Nina M, Varon, Emmanuelle, Vlach, Jiri, Vogel, Ulrich, Vohrnova, Sandra, von Gottberg, Anne, Zanella, Rosemeire C, and Zhou, Fei

Published
2021
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21. The Impact of Leadership Roles and Internships on Undergraduate Business Major Field Test (MFT) Scores

Author

Ward, Chris, Yates, Dan, and Song, Joon Young

Abstract

It is often the goal or mission of higher education to prepare graduates for leadership roles in organizations and the community. Even if we are to assume that leadership skills can be developed, determining the appropriate ways to teach and measure leadership is often debated. Our study used quantitative data from the ETS Business Major Field Test (MFT) as an external measure and compared those results to specific items on a survey to determine if students who had leadership roles on campus or internships also scored higher on the ETS MFT test.

Published
2014

22. Blending Research and Teamwork to Enhance Undergraduate Education: Results from National Survey of Student Engagement and Business ETS Major Field Test

Author

Ward, Chris, Yates, Dan, and Song, Joon Young

Abstract

This study is a continuation of previous work by the authors. Most of the NSSE (National Survey of Student Engagement) scales are positively related to higher Business ETS MFT (Major Field Test) scores. The NSSE scales are Active and Collaborative Learning, Enriching Educational Experiences and Integration of Diversity into Coursework. In particular, the NSSE scale of Integration of Diversity into Coursework appears to be significant. Students seem to earn higher scores on the ETS MFT when diversity is integrated into courses. Two of the scales, however, are negatively related to GPA: Level of Academic Challenge and Integration of Diversity into Coursework. The items we added to the survey included a leadership position held on campus and, a NSSE item, the number of courses that expect students to put together ideas or concepts from different courses when completing assignments or during class discussions, were both significant. The positive partial correlation indicated a 0.223 and 0.181 (at the 5% significance level), respectively, for these two items. Other items of interest will be discussed in the paper.

Published
2012

23. Examining the Relationship between the National Survey of Student Engagement and the ETS Business Major Field Test

Author

Ward, Chris, Yates, Dan, and Song, Joon Young

Abstract

In this study, the authors examined the relationship between the various NSSE (National Survey of Student Engagement) survey items or classifications and the ETS Major Field Test (MFT) in Business. The sample consisted of 87 business students at a small liberal arts college. Many of the survey items were linked positively to the ETS Major Field Test. The results suggest that MFT is a better measurement than GPA for NSSE. As a noteworthy finding from the analysis, we need to mention that MFT is a better measurement of student engagement described in the NSSE rather than GPA. Therefore, it seems that the MFT is a valid external measurement of student engagement. In particular, the MFT shows a relative strength in assessing "Integration of Diversity into Coursework."

Published
2010

26. Development and Validation of an Enzyme-Linked Immunosorbent Assay-Based Protocol for Evaluation of Respiratory Syncytial Virus Vaccines.

Author

Nham, Eliel, Jang, A-Yeung, Ji, Hyun Jung, Ahn, Ki Bum, Bae, Joon-Yong, Park, Man-Seong, Yoon, Jin Gu, Seong, Hye, Noh, Ji Yun, Cheong, Hee Jin, Kim, Woo Joo, Seo, Ho Seong, and Song, Joon Young

Subjects
RESPIRATORY syncytial virus, VIRAL vaccines, RESPIRATORY syncytial virus infection vaccines, ENZYME-linked immunosorbent assay, GENETIC recombination, IMMUNOGLOBULIN G, ALKALINE phosphatase
Abstract

Recently, respiratory syncytial virus (RSV) vaccines based on the prefusion F (pre-F) antigen were approved in the United States. We aimed to develop an enzyme-linked immunosorbent assay (ELISA)-based protocol for the practical and large-scale evaluation of RSV vaccines. Two modified pre-F proteins (DS-Cav1 and SC-TM) were produced by genetic recombination and replication using an adenoviral vector. The protocol was established by optimizing the concentrations of the coating antigen (pre-F proteins), secondary antibodies, and blocking buffer. To validate the protocol, we examined its accuracy, precision, and specificity using serum samples from 150 participants across various age groups and the standard serum provided by the National Institute of Health. In the linear correlation analysis, coating concentrations of 5 and 2.5 μg/mL of DS-Cav1 and SC-TM showed high coefficients of determination (r > 0.90), respectively. Concentrations of secondary antibodies (alkaline phosphatase-conjugated anti-human immunoglobulin G, diluted 1:2000) and blocking reagents (5% skim milk/PBS-T) were optimized to minimize non-specific reactions. High accuracy was observed for DS-Cav1 (r = 0.90) and SC-TM (r = 0.86). Further, both antigens showed high precision (coefficient of variation < 15%). Inhibition ELISA revealed cross-reactivity of antibodies against DS-Cav1 and SC-TM, but not with the attachment (G) protein. [ABSTRACT FROM AUTHOR]

Published
2024
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31. COVID-19 Vaccination Strategies in the Endemic Period: Lessons from Influenza.

Author

Nham, Eliel, Noh, Ji Yun, Park, Ok, Choi, Won Suk, Song, Joon Young, Cheong, Hee Jin, and Kim, Woo Joo

Subjects
COVID-19 vaccines, COVID-19, INFLUENZA, ZOONOSES, VACCINE effectiveness
Abstract

Coronavirus disease 2019 (COVID-19) is a highly contagious zoonotic respiratory disease with many similarities to influenza. Effective vaccines are available for both; however, rapid viral evolution and waning immunity make them virtually impossible to eradicate with vaccines. Thus, the practical goal of vaccination is to reduce the incidence of serious illnesses and death. Three years after the introduction of COVID-19 vaccines, the optimal vaccination strategy in the endemic period remains elusive, and health authorities worldwide have begun to adopt various approaches. Herein, we propose a COVID-19 vaccination strategy based on the data available until early 2024 and discuss aspects that require further clarification for better decision making. Drawing from comparisons between COVID-19 and influenza vaccination strategies, our proposed COVID-19 vaccination strategy prioritizes high-risk groups, emphasizes seasonal administration aligned with influenza vaccination campaigns, and advocates the co-administration with influenza vaccines to increase coverage. [ABSTRACT FROM AUTHOR]

Published
2024
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32. Age-Stratified Seroprevalence of Respiratory Syncytial Virus: Analysis Using Prefusion F and G Protein Antibodies.

Author

Nham, Eliel, Jang, A-Yeung, Hyun, Hakjun, Yoon, Jin Gu, Noh, Ji Yun, Cheong, Hee Jin, Kim, Woo Joo, Ahn, Ki Bum, Ji, Hyun Jung, Seo, Ho Seong, Bae, Joon-Yong, Park, Man-Seong, and Song, Joon Young

Subjects
RESPIRATORY syncytial virus, G proteins, RESPIRATORY syncytial virus infections, RESPIRATORY syncytial virus infection vaccines, SEROPREVALENCE
Abstract

This is a cross-sectional serosurveillance study for RSV. Between June and September of 2021, a total of 150 sera were collected from 30 individuals in each age group (<5, 5–18, 19–49, 50–64, and ≥65 years). Seroprevalence was estimated using enzyme-linked immunosorbent assays targeting two stabilized prefusion F (preF; DS-Cav1 and SC-TM) and G proteins. The overall seroprevalence was low in young children and older adults, despite them having a higher risk of severe RSV infection. There was a remarkable difference in age-stratified seroprevalence rates between anti-preF and anti-G protein antibodies. Given the high disease burden and low seroprevalence in both infants and old adults, RSV vaccination would be crucial for pregnant women and people aged over 60 years. [ABSTRACT FROM AUTHOR]

Published
2024
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40. Omicron BA.2 breakthrough infection elicits CD8+ T cell responses recognizing the spike of later Omicron subvariants.

Author

Kim, Sang-Hoon, Kim, Jihye, Jung, Sungmin, Noh, Ji Yun, Kim, Jinnam, Park, Heedo, Song, Young Goo, Peck, Kyong Ran, Park, Su-Hyung, Park, Man-Seong, Ko, Jae-Hoon, Song, Joon Young, Choi, Jun Yong, Jung, Min Kyung, and Shin, Eui-Cheol

Subjects
BREAKTHROUGH infections, T cells, SARS-CoV-2 Omicron variant, COVID-19 vaccines, IMMUNOLOGIC memory
Abstract

Here, we examine peripheral blood memory T cell responses against the SARS-CoV-2 BA.4/BA.5 variant spike among vaccinated individuals with or without Omicron breakthrough infections. We provide evidence supporting a lack of original antigenic sin in CD8+ T cell responses targeting the spike. We show that BNT162b2-induced memory T cells respond to the BA.4/BA.5 spike. Among individuals with BA.1/BA.2 breakthrough infections, IFN-γ–producing CD8+ T cell responses against the BA.4/BA.5 spike increased. In a subgroup with BA.2 breakthrough infections, IFN-γ–producing CD8+ T cell responses against the BA.2-mutated spike region increased and correlated directly with responses against the BA.4/BA.5 spike, indicating that BA.2 spike–specific CD8+ T cells elicited by BA.2 breakthrough infection cross-react with the BA.4/BA.5 spike. We identified CD8+ T cell epitope peptides that are present in the spike of BA.2 and BA.4/BA.5 but not the original spike. These peptides are fully conserved in the spike of now-dominant XBB lineages. Our study shows that breakthrough infection by early Omicron subvariants elicits CD8+ T cell responses that recognize epitopes within the spike of newly emerging subvariants. Editor's summary: Recent studies have suggested that memory T cells play a critical role in protecting individuals immunized with SARS-CoV-2 vaccines against variants. Kim et al. tracked memory T cell responses in a cohort of vaccinated individuals in Korea who experienced breakthrough Omicron subvariant infection. They confirmed that BNT162b2 vaccination induced memory CD4+ and CD8+ T cells specific to BA.4/BA.5 spike, even if these individuals had a prior SARS-CoV-2 infection. Breakthrough infection with early Omicron subvariants (BA.1/BA.2) induced an increase in cross-reactive CD8+ T cell responses specific to BA.4/BA.5 spike. They identified peptides in the BA.2 spike that were fully conserved in BA.4/BA.5 and later subvariants but absent in original spike. Together, these findings provide further evidence that breakthrough infection can induce cross-reactive memory T cell responses that contribute to protection against newly emerging SARS-CoV-2 subvariants. —Christiana Fogg [ABSTRACT FROM AUTHOR]

Published
2024
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42. Effectiveness of Antiviral Therapy on Long COVID: A Systematic Review and Meta-Analysis.

Author

Choi, Yu Jung, Seo, Yu Bin, Seo, Jun-Won, Lee, Jacob, Nham, Eliel, Seong, Hye, Yoon, Jin Gu, Noh, Ji Yun, Cheong, Hee Jin, Kim, Woo Joo, Kim, Eun Jung, and Song, Joon Young

Subjects
POST-acute COVID-19 syndrome, MEDICAL databases, COVID-19 treatment, DRUG efficacy, SCIENCE databases
Abstract

Antiviral treatment reduces the severity and mortality of SARS-CoV-2 infection; however, its effectiveness against long COVID-19 is unclear. This study aimed to evaluate the effectiveness of antiviral drugs in preventing long COVID and related hospitalizations/deaths. Scientific and medical databases were searched from 1 January 2020 to 30 June 2023. We included observational cohort studies comparing individuals receiving early antiviral therapy for COVID-19 and those receiving supportive treatment. A fixed-effects model was used to merge the effects reported in two or more studies. The risk of post-acute sequelae of COVID-19 (PASC) was combined as an odds ratio (OR). Six studies were selected, including a total of 3,352,235 participants. The occurrence of PASC was 27.5% lower in patients who received antiviral drugs during the early stages of SARS-CoV-2 infection (OR = 0.725; 95% confidence interval [CI] = 0.409–0.747) than in the supportive treatment group. Moreover, the risk of PASC-associated hospitalization and mortality was 29.7% lower in patients receiving early antiviral therapy than in the supportive treatment group (OR = 0.721; 95% CI = 0.697–0.794). Early antiviral therapy was associated with a reduced risk of PASC and related hospitalization or death. Thus, early antiviral therapy is recommended for at-risk individuals. [ABSTRACT FROM AUTHOR]

Published
2023
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48. Herpes Zoster Reactivation After mRNA and Adenovirus-Vectored Coronavirus Disease 2019 Vaccination: Analysis of National Health Insurance Database.

Author

Yoon, Jin Gu, Kim, Young-Eun, Choi, Min Joo, Choi, Won Suk, Seo, Yu Bin, Jung, Jaehun, Hyun, Hak-Jun, Seong, Hye, Nham, Eliel, Noh, Ji Yun, Song, Joon Young, Kim, Woo Joo, Kim, Dong Wook, and Cheong, Hee Jin

Subjects
COVID-19, HERPES zoster, NATIONAL health insurance, ADENOVIRUS diseases, VACCINATION, DATABASES, PROPENSITY score matching
Abstract

Background Our study aimed to determine the risk of herpes zoster reactivation and coronavirus disease 2019 (COVID-19) vaccination (mRNA vaccine [BNT162b2] and adenovirus-vectored vaccine [ChAdOx1 nCoV-19]). Methods This retrospective study analyzed herpes zoster cases diagnosed between 26 February 2021 and 30 June 2021 and registered in the National Health Insurance Service database. A matched case-control study with a 1:3 matching ratio and a propensity score matching (PSM) study with a 1:1 ratio of vaccinated and unvaccinated individuals were performed. Results In the matched case control analysis, BNT162b2 was associated with an increased risk of herpes zoster reactivation (first dose adjusted odds ratio [aOR], 1.11; 95% confidence interval [CI], 1.06–1.15; second dose aOR, 1.17; 95% CI, 1.12–1.23). PSM analysis revealed a statistically significant increase in risk within 18 days following any vaccination (adjusted hazard ratio [aHR], 1.09; 95% CI, 1.02–1.16). BNT162b2 was associated with an increased risk at 18 days postvaccination (aHR, 1.65; 95% CI, 1.35–2.02) and second dose (aHR, 1.10; 95% CI, 1.02–1.19). However, the risk did not increase in both analyses of ChAdOx1 vaccination. Conclusions mRNA COVID-19 vaccination possibly increases the risk of herpes zoster reactivation, and thus close follow-up for herpes zoster reactivation is required. [ABSTRACT FROM AUTHOR]

Published
2023
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