Article
Immunology
Michael K. McCracken, Caitlin H. Kuklis, Chandrika B. Kannadka, David A. Barvir, Mark A. Sanborn, Adam T. Waickman, Hayden C. Siegfried, Kaitlin A. Victor, Kristin L. Hatch, Rafael De la Barrera, Shannon D. Walls, Wiriya Rutvisuttinunt, Jeffrey R. Currier, Heather Friberg, Richard G. Jarman, Gregory D. Gromowski
Summary: In a study on rhesus macaques, priming with purified inactivated vaccines followed by administration of a tetravalent live attenuated vaccine led to higher peak viremias and in vitro ADE activity. Additionally, the primed groups displayed more balanced and higher neutralizing antibody seroconversion and titers post live attenuated vaccine administration compared to the control group.
Article
Multidisciplinary Sciences
Pragya D. Yadav, Raches Ella, Sanjay Kumar, Dilip R. Patil, Sreelekshmy Mohandas, Anita M. Shete, Krishna M. Vadrevu, Gaurav Bhati, Gajanan Sapkal, Himanshu Kaushal, Savita Patil, Rajlaxmi Jain, Gururaj Deshpande, Nivedita Gupta, Kshitij Agarwal, Mangesh Gokhale, Basavaraj Mathapati, Siddhanath Metkari, Chandrashekhar Mote, Dimpal Nyayanit, Deepak Y. Patil, B. S. Sai Prasad, Annasaheb Suryawanshi, Manoj Kadam, Abhimanyu Kumar, Sachin Daigude, Sanjay Gopale, Triparna Majumdar, Deepak Mali, Prasad Sarkale, Shreekant Baradkar, Pranita Gawande, Yash Joshi, Sidharam Fulari, Hitesh Dighe, Sharda Sharma, Rashmi Gunjikar, Abhinendra Kumar, Kaumudi Kalele, Vellimedu K. Srinivas, Raman R. Gangakhedkar, Krishna M. Ella, Priya Abraham, Samiran Panda, Balram Bhargava
Summary: This study demonstrates the protective efficacy and immunogenicity of the inactivated SARS-CoV-2 vaccine BBV152 in rhesus macaques, indicating that the vaccine candidate is in clinical development.
NATURE COMMUNICATIONS
(2021)
Article
Cell Biology
Xuan He, Malika Aid, Abishek Chandrashekar, Jingyou Yu, Katherine McMahan, Frank Wegmann, Catherine Jacob-Dolan, Jenny S. Maron, Caroline Atyeo, Huahua Wan, Daniel Sellers, Jinyan Liu, Michelle Lifton, Sarah Gardner, Esther A. Bondzie, Julia Barrett, Kunza Ahmad, Tochi Anioke, Jake Yalley-Ogunro, Jeanne Muench, Adrienne Goode, Hanne Andersen, Mark G. Lewis, Galit Alter, Hanneke Schuitemaker, Roland Zahn, Dan H. Barouch
Summary: This study found that single-shot Ad26.COV2.S immunization in rhesus macaques resulted in durable immune responses, including binding and neutralizing antibodies, memory B cells, and long-lasting plasma cells. Boosting with Ad26.COV2.S or Ad26.COV2.S.351 significantly increased the humoral and cellular immune responses, which were highly cross-reactive against multiple SARS-CoV-2 variants. The modified Ad26.COV2.S.351 vaccine showed slightly higher immune responses against specific variants.
SCIENCE TRANSLATIONAL MEDICINE
(2022)
Article
Immunology
Arundhathi Venkatasubramaniam, Grant Liao, Eunice Cho, Rajan P. Adhikari, Tom Kort, Frederick W. Holtsberg, Karen E. Elsass, Dean J. Kobs, Thomas L. Rudge, Keith D. Kauffman, Nickiana E. Lora, Daniel L. Barber, M. Javad Aman, Hatice Karauzum
Summary: The 4-component staphylococcal vaccine targeting secreted toxins shows good safety and immunogenicity in non-human primates, generating both humoral and cellular immune responses. Targeting secreted toxins could be a potential next-generation approach for staphylococcal vaccines in humans.
FRONTIERS IN IMMUNOLOGY
(2021)
Article
Microbiology
Rafael A. Larocca, Peter Abbink, John D. Ventura, Abishek Chandrashekar, Noe Mercado, Zhenfeng Li, Erica Borducchi, Rafael A. de la Barrera, Kenneth H. Eckels, Kayvon Modjarrad, Michael P. Busch, Nelson L. Michael, Dan H. Barouch
Summary: The study shows that baseline immunity induced by DENV vaccination does not significantly enhance ZIKV infection or impair the protective efficacy of ZIKV vaccines.
Article
Microbiology
Margherita Rosati, Mahesh Agarwal, Xintao Hu, Santhi Devasundaram, Dimitris Stellas, Bhabadeb Chowdhury, Jenifer Bear, Robert Burns, Duncan Donohue, Laurent Pessaint, Hanne Andersen, Mark G. Lewis, Evangelos Terpos, Meletios Athanasios Dimopoulos, Alexander Wlodawer, James I. Mullins, David J. Venzon, George N. Pavlakis, Barbara K. Felber
Summary: Both DNA and mRNA vaccines have shown promise in animal models, with DNA vaccines demonstrating protective efficacy and immunogenicity against SARS-CoV-2 in rhesus macaques. DNA vaccine regimens can induce potent antibody and T cell responses, with the co-immunization of protein showing superior effectiveness.
Article
Immunology
Petra Mooij, Juan Garcia-Arriaza, Patricia Perez, Adrian Lazaro-Frias, Babs E. Verstrepen, Kinga P. Boszormenyi, Daniella Mortier, Zahra Fagrouch, Gwendoline Kiemenyi-Kayere, Henk Niphuis, Roja Fidel Acar, Lisette Meijer, Marieke A. Stammes, Ivanela Kondova, Ernst J. Verschoor, Corine H. GeurtsvanKessel, Erwin de Bruin, Reina S. Sikkema, Joanna Luczkowiak, Rafael Delgado, Dolores Montenegro, Eugenia Puentes, Esteban Rodriguez, Willy M. J. M. Bogers, Gerrit Koopman, Mariano Esteban
Summary: This study demonstrates that a modified vaccinia virus Ankara (MVA) vector expressing a full-length SARS-CoV-2 spike (S) protein (MVA-S) vaccine has good safety and high immunogenicity in rhesus macaques. Vaccination with MVA-S can induce neutralizing antibodies against SARS-CoV-2 and its variants, reduce viral loads, and alleviate lung pathology caused by the disease. The findings support the potential use of MVA-S as a vaccine for SARS-CoV-2 in clinical trials.
FRONTIERS IN IMMUNOLOGY
(2022)
Article
Immunology
Shengxue Luo, Panli Zhang, Bochao Liu, Chan Yang, Chaolan Liang, Qi Wang, Ling Zhang, Xi Tang, Jinfeng Li, Shuiping Hou, Jinfeng Zeng, Yongshui Fu, Jean-Pierre Allain, Tingting Li, Yuming Zhang, Chengyao Li
Summary: Novel adenovirus vectored COVID-19 vaccine candidates Sad23L-nCoV-S and Ad49L-nCoV-S were constructed and evaluated for immunogenicity in mice and rhesus macaques. Prime-boost regimen induced high levels of antibodies and T-cell responses, demonstrating strong immunity. The findings support the potential for clinical trials of the vaccines.
EMERGING MICROBES & INFECTIONS
(2021)
Article
Immunology
Ginger Young, Melissa Zahralban-Steele, Hansi J. Dean
Summary: This study evaluated the immunogenicity and efficacy of Takeda's purified inactivated Zika vaccine (PIZV) candidate in macaques previously vaccinated with several commercially available heterologous flavivirus vaccines. Heterologous flavivirus vaccination did not induce Zika virus neutralizing antibodies and did not affect neutralizing antibody titers after one dose of PIZV. After a second PIZV dose, previous vaccination with flavivirus vaccines had a variable impact on Zika virus neutralizing antibody titers. However, all macaques were protected against viremia after Zika virus challenge 8-12 months post-PIZV vaccination. Therefore, vaccine-induced immunity against heterologous flavivirus vaccines does not affect PIZV efficacy in macaques.
Article
Cell Biology
Marco Mandolesi, Daniel J. Sheward, Leo Hanke, Junjie Ma, Pradeepa Pushparaj, Laura Perez Vidakovics, Changil Kim, Monika Adori, Klara Lenart, Karin Lore, Xaquin Castro Dopico, Jonathan M. Coquet, Gerald M. McInerney, Gunilla B. Karlsson Hedestam, Ben Murrell
Summary: The study demonstrates that protein immunization with adjuvanted SARS-CoV-2 spike trimers can induce potent neutralizing antibody responses in mice and rhesus macaques, with exceptionally high titers lasting at least 4 months.
CELL REPORTS MEDICINE
(2021)
Article
Immunology
Puthupparampil V. Scaria, Charles Anderson, Olga Muratova, Nada Alani, Hung V. Trinh, Steven T. Nadakal, Irfan Zaidi, Lynn Lambert, Zoltan Beck, Emma K. Barnafo, Kelly M. Rausch, Chris Rowe, Beth Chen, Gary R. Matyas, Mangala Rao, Carl R. Alving, David L. Narum, Patrick E. Duffy
Summary: Studies showed that using ALFQ liposomal adjuvant can enhance the immunogenicity of malaria transmission-blocking vaccine candidates Pfs25-EPA and Pfs230D1-EPA in Rhesus macaques. Both conjugates generated strong antibody responses and functional activity after two vaccinations, although the activity declined.
Article
Virology
Jingyou Yu, Natalie D. Collins, Noe B. Mercado, Katherine McMahan, Abishek Chandrashekar, Jinyan Liu, Tochi Anioke, Aiquan Chang, Victoria M. Giffin, David L. Hope, Daniel Sellers, Felix Nampanya, Sarah Gardner, Julia Barrett, Huahua Wan, Jason Velasco, Elyse Teow, Anthony Cook, Alex Van Ry, Laurent Pessaint, Hanne Andersen, Mark G. Lewis, Christian Hofer, Donald S. Burke, Erica K. Barkei, Hannah A. D. King, Caroline Subra, Diane Bolton, Kayvon Modjarrad, Nelson L. Michael, Dan H. Barouch
Summary: This study examined the immunogenicity and protective efficacy of an oral live vaccine against SARS-CoV-2 in rhesus macaques. The results showed that the oral vaccine provided partial protection against respiratory SARS-CoV-2 challenge, but further optimization of the vaccine formulation and administration route is needed.
JOURNAL OF VIROLOGY
(2022)
Article
Immunology
Ruoheng Yang, Qingwei Liu, Wei Pang, Fei Gao, Huabin Liang, Wei Zhang, Yalong Lin, Min Li, Zhihua Liu, George F. Gao, Linqi Zhang, Hui Xiao, Yongtang Zheng, Zhong Huang, Xia Jin
Summary: The study showed that the Zika virus E80 is more suitable as a vaccine candidate compared to EDIII, as E80 induced stronger and longer-lasting antibody responses. The quantity, quality, and durability of virion-binding neutralizing antibodies are correlated with protection.
Article
Infectious Diseases
Lo Vang, Christopher S. Morello, Jason Mendy, Danielle Thompson, Darly Manayani, Ben Guenther, Justin Julander, Daniel Sanford, Amit Jain, Amish Patel, Paul Shabram, Jonathan Smith, Jeff Alexander
Summary: A Zika virus-like particle (VLP) vaccine was developed using genetically engineered VLPs, which induced protective neutralizing antibodies in both mice and nonhuman primates, supporting further evaluation in human clinical trials.
PLOS NEGLECTED TROPICAL DISEASES
(2021)
Article
Virology
Pragya D. Yadav, Sanjay Kumar, Kshitij Agarwal, Mukul Jain, Dilip R. Patil, Kapil Maithal, Basavaraj Mathapati, Suresh Giri, Sreelekshmy Mohandas, Anita Shete, Gajanan Sapkal, Deepak Y. Patil, Ayan Dey, Harish Chandra, Gururaj Deshpande, Nivedita Gupta, Priya Abraham, Himanshu Kaushal, Rima R. Sahay, Anuradha Tripathy, Dimpal Nyayanit, Rajlaxmi Jain, Abhimanyu Kumar, Prasad Sarkale, Shreekant Baradkar, Chozhavel Rajanathan, Hari Prasad Raju, Satish Patel, Niraj Shah, Pankaj Dwivedi, Dharmendra Singh
Summary: The development of a needle-free injection system (NFIS) has addressed concerns about injection site pain, bloodborne pathogen transmission, and mass immunization. This study evaluated the efficacy of NFIS and needle injection system (NIS) for delivering the DNA vaccine candidate ZyCoV-D in rhesus macaques against SARS-CoV-2 infection. The results showed that the 2 mg dose delivered by NFIS induced significant IgG and neutralizing antibody titers, with further increases after virus challenge. NFIS also stimulated increased lymphocyte proliferation and cytokine response. This study demonstrated the efficiency of NFIS in delivering the 2 mg ZyCoV-D vaccine candidate.
JOURNAL OF MEDICAL VIROLOGY
(2023)
Article
Biotechnology & Applied Microbiology
M. Dong, C. Fisher, G. Anez, M. Rios, H. L. Nakhasi, J. P. Hobson, M. Beanan, D. Hockman, E. Grigorenko, R. Duncan
JOURNAL OF APPLIED MICROBIOLOGY
(2016)
Article
Infectious Diseases
German Anez, Daniel A. R. Heisey, Caren Chancey, Rafaelle C. G. Fares, Luz M. Espina, Katia P. R. Souza, Andrea Teixeira-Carvalho, David E. Krysztof, Gregory A. Foster, Susan L. Stramer, Maria Rios
PLOS NEGLECTED TROPICAL DISEASES
(2016)
Article
Pathology
Elena Grigorenko, Carolyn Fisher, Sunali Patel, Valerie Winkelman, Phillip Williamson, Caren Chancey, German Anez, Maria Rios, Victoria Majam, Sanjai Kumar, Robert Duncan
JOURNAL OF MOLECULAR DIAGNOSTICS
(2017)
Article
Hematology
German Anez, Evgeniya Volkova, Zhen Jiang, Daniel A. R. Heisey, Caren Chancey, Rafaelle C. G. Fares, Maria Rios
Article
Public, Environmental & Occupational Health
Eduardo J. M. Nascimento, Matthew I. Bonaparte, Ping Luo, Timothy S. Vincent, Branda Hu, James K. George, German Anez, Fernando Noriega, Lingyi Zheng, James W. Huleatt
AMERICAN JOURNAL OF TROPICAL MEDICINE AND HYGIENE
(2019)
Article
Multidisciplinary Sciences
Rafaelle Fares-Gusmao, Bruno Coelho Rocha, Emilia Sippert, Marion C. Lanteri, German Anez, Maria Rios
SCIENTIFIC REPORTS
(2019)
Article
Biotechnology & Applied Microbiology
German Anez, James Hedrick, Michael W. Simon, Shane Christensen, Robert Jeanfreaue, Eddy Yau, Judy Pan, Emilia Jordanov, Mandeep S. Dhingra
HUMAN VACCINES & IMMUNOTHERAPEUTICS
(2020)
Article
Multidisciplinary Sciences
Youyi Fong, Yunda Huang, David Benkeser, Lindsay N. Carpp, German Anez, Wayne Woo, Alice McGarry, Lisa M. Dunkle, Iksung Cho, Christopher R. Houchens, Karen Martins, Lakshmi Jayashankar, Flora Castellino, Christos J. Petropoulos, Andrew Leith, Deanne Haugaard, Bill Webb, Yiwen Lu, Chenchen Yu, Bhavesh Borate, Lars W. P. van der Laan, Nima S. Hejazi, April K. Randhawa, Michele P. Andrasik, James G. Kublin, Julia Hutter, Maryam Keshtkar-Jahromi, Tatiana H. Beresnev, Lawrence Corey, Kathleen M. Neuzil, Dean Follmann, Julie A. Ake, Cynthia L. Gay, Karen L. Kotloff, Richard A. Koup, Ruben O. Donis, Peter B. Gilbert
Summary: In the PREVENT-19 phase 3 trial, the NVX-CoV2373 vaccine's effectiveness against COVID-19 was assessed using markers such as spike IgG, RBD IgG, and nAb ID50. The study found that higher concentrations of these markers were associated with lower COVID-19 risk and higher vaccine efficacy. The results suggest that these markers could be used across different vaccine platforms to guide decision-making on vaccine approval and usage.
NATURE COMMUNICATIONS
(2023)
Article
Immunology
Eddie Underwood, Lisa M. Dunkle, Shabir A. Madhi, Cynthia L. Gay, Paul T. Heath, Karen L. Kotloff, Katherine Smith, Gordon Chau, Shirley Galbiati, Alice McGarry, Wayne Woo, Iksung Cho, Katia Alves, German Anez, Chijioke Bennett, Vivek Shinde, Louis Fries, Raburn M. Mallory, Gregory M. Glenn, Seth Toback
Summary: NVX-CoV2373 is a recombinant protein vaccine composed of SARS-CoV-2 spike trimer nanoparticles formulated with Matrix-M adjuvant. It has shown favorable safety and immunogenicity profiles, providing protection against severe and symptomatic disease caused by SARS-CoV-2, including variants. Additionally, its adjuvanted protein platform offers solutions to vaccine hesitancy and global vaccine equity.
EXPERT REVIEW OF VACCINES
(2023)
Article
Pediatrics
Betzana Zambrano, James Peterson, Carmen Deseda, Katie Julien, Craig A. Spiegel, Clifford Seyler, Michael Simon, Robert Hoki, Marc Anderson, Brad Brabec, German Anez, Jiayuan Shi, Judy Pan, Audrey Hagenbach, Dalia Von Barbier, Kucku Varghese, Emilia Jordanov, Mandeep Singh Dhingra
Summary: The immunogenicity and safety of a booster dose of tetanus toxoid-conjugate quadrivalent meningococcal vaccine (MenACYW-TT), alone or co-administered with MenB vaccine, were assessed in healthy 13-25-year olds. The MenACYW-TT booster induced a robust immune response against all serogroups and was well tolerated.
PEDIATRIC RESEARCH
(2023)
Article
Immunology
Anthony M. Marchese, Xiang Zhou, John Kinol, Eddie Underwood, Wayne Woo, Alice McGarry, Hadi Beyhaghi, German Anez, Seth Toback, Lisa M. Dunkle
Summary: The PREVENT-19 trial showed that the Novavax adjuvanted, recombinant spike protein COVID-19 vaccine (NVX-CoV2373) had a vaccine efficacy (VE) of 90% in preventing symptomatic COVID-19. The study also revealed a post hoc VE of 100% against hospitalization for COVID-19 among both the per-protocol efficacy population and an expanded efficacy population. These additional findings provide important public health information about the attributes of NVX-CoV2373.
Correction
Multidisciplinary Sciences
Youyi Fong, Yunda Huang, David Benkeser, Lindsay N. Carpp, German Anez, Wayne Woo, Alice McGarry, Lisa M. Dunkle, Iksung Cho, Christopher R. Houchens, Karen Martins, Lakshmi Jayashankar, Flora Castellino, Christos J. Petropoulos, Andrew Leith, Deanne Haugaard, Bill Webb, Yiwen Lu, Chenchen Yu, Bhavesh Borate, Lars W. P. van der Laan, Nima S. Hejazi, April K. Randhawa, Michele P. Andrasik, James G. Kublin, Julia Hutter, Maryam Keshtkar-Jahromi, Tatiana H. Beresnev, Lawrence Corey, Kathleen M. Neuzil, Dean Follmann, Julie A. Ake, Cynthia L. Gay, Karen L. Kotloff, Richard A. Koup, Ruben O. Donis, Peter B. Gilbert
NATURE COMMUNICATIONS
(2023)
Article
Medicine, General & Internal
German Anez, Lisa M. Dunkle, Cynthia L. Gay, Karen L. Kotloff, Jeffrey M. Adelglass, Brandon Essink, James D. Campbell, Shane Cloney-Clark, Mingzhu Zhu, Joyce S. Plested, Pavitra Roychoudhury, Alexander L. Greninger, Nita Patel, Alice McGarry, Wayne Woo, Iksung Cho, Gregory M. Glenn, Filip Dubovsky
Summary: This study evaluated the safety, immunogenicity, and efficacy of the NVX-CoV2373 vaccine in adolescents aged 12 to 17 years. The results showed that the vaccine elicited neutralizing antibody responses in adolescents and effectively prevented COVID-19, including the Delta variant. Adverse reactions were mostly mild to moderate and transient. The study concluded that NVX-CoV2373 is safe, immunogenic, and efficacious in adolescents.
Article
Medicine, General & Internal
Anne-Marie Rick, Matthew B. Laurens, Ying Huang, Chenchen Yu, Thomas C. S. Martin, Carina A. Rodriguez, Christina A. Rostad, Rebone M. Maboa, Lindsey R. Baden, Hana M. El Sahly, Beatriz Grinsztejn, Glenda E. Gray, Cynthia L. Gay, Peter B. Gilbert, Holly E. Janes, James G. Kublin, Yunda Huang, Brett Leav, Ian Hirsch, Frank Struyf, Lisa M. Dunkle, Kathleen M. Neuzil, Lawrence Corey, Paul A. Goepfert, Stephen R. Walsh, Dean Follmann, Karen L. Kotloff
Summary: This study found that previous infection, hybrid immunity, and vaccination all provide substantial protection against symptomatic and severe COVID-19 during the early Delta period. Hybrid immunity, which combines previous infection with vaccination, is more effective than vaccination alone. Vaccination, previous infection, and hybrid immunity all offer near-complete protection against severe disease.
Article
Medicine, General & Internal
Deborah A. Theodore, Angela R. Branche, Lily Zhang, Daniel S. Graciaa, Madhu Choudhary, Timothy J. Hatlen, Raadhiya Osman, Tara M. Babu, Samuel T. Robinson, Peter B. Gilbert, Dean Follmann, Holly Janes, James G. Kublin, Lindsey R. Baden, Paul Goepfert, Glenda E. Gray, Beatriz Grinsztejn, Karen L. Kotloff, Cynthia L. Gay, Brett Leav, Jacqueline Miller, Ian Hirsch, Jerald Sadoff, Lisa M. Dunkle, Kathleen M. Neuzil, Lawrence Corey, Ann R. Falsey, Hana M. El Sahly, Magdalena E. Sobieszczyk, Yunda Huang
Summary: This study identified risk factors associated with COVID-19, severe COVID-19, and SARS-CoV-2 infection through the analysis of data from four COVID-19 vaccine trials. The results showed that workplace exposure and living condition risk were associated with increased rates of COVID-19, while age ≥65 years and Black or African American race were associated with decreased rates of COVID-19. Factors such as race, diabetes, and comorbidities were associated with increased rates of severe COVID-19.