Single Injection COVID-19 Vaccine Firmly Protects Non-Human Primates Against SARS-CoV-2

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The results lay the foundation for the clinical development program.

The development of a safe and effective vaccine will likely be necessary to end the COVID-19[feminine[feminine pandemic. A group of scientists, led by Beth Israel Deaconess Medical Center (BIDMC) immunologist Dan H. Barouch, MD, PhD, are now reporting that a lead COVID-19 vaccine candidate developed at BIDMC in collaboration with Johnson & Johnson has raised neutralizing antibodies and is securely protected non-human primates (NHPs) against SRAS-CoV-2, the virus that causes COVID-19. This study builds on the team’s previous results and is published in the journal Nature.

Dan H. Barouch, MD, PhD, director of the BIDMC Virology and Vaccine Research Center.
Crédit: Beth Israel Deaconess Medical Center

“This vaccine has led to robust protection against SARS-CoV-2 in rhesus macaques and is currently being evaluated in humans,” said Barouch, director of the BIDMC Center for Virology and Vaccine Research.

The vaccine uses a common cold virus, called adenovirus serotype 26 (Ad26), to deliver the SARS-CoV-2 spike protein into host cells, where it stimulates the body to increase immune responses against the coronavirus. Barouch has been working on developing a COVID-19 vaccine since January, when Chinese scientists released the SARS-CoV-2 genome. Barouch’s group, in collaboration with Johnson & Johnson, have developed a series of candidate vaccines designed to express different variants of the SARS-CoV-2 spike protein, which is the primary target of neutralizing antibodies.

Barouch and his colleagues conducted a study of 52 NHPs, immunizing 32 adult rhesus macaques with a single dose of one of seven different versions of the Ad26 vaccine, and giving 20 animals sham vaccines as placebo controls. All vaccinated animals developed neutralizing antibodies after immunization. Six weeks after immunization, all animals were exposed to SARS-CoV-2. All 20 animals that received the sham vaccine were infected and had elevated levels of the virus in their lungs and nasal swabs. Of the six animals that received the optimal vaccine candidate, Ad26.COV2.S, none showed virus in their lungs, and only one animal showed low levels of virus in nasal swabs.

Additionally, neutralizing antibody responses were correlated with protection, suggesting that this biomarker will be useful in the clinical development of COVID-19 vaccines for use in humans.

“Our data show that a single immunization with Ad26.COV2.S strongly protects rhesus macaques against the challenge of SARS-CoV-2,” said Barouch, also professor of medicine at William Bosworth Castle at Harvard Medical School, member du Ragon. MGH Institute, WITHand Harvard, and co-leader of the Massachusetts Consortium on Pathogen Readiness Vaccine Working Group. “A single injection vaccination has practical and logistical advantages over a two-dose regimen for global deployment and pandemic control, but a two-dose vaccine will likely be more immunogenic, so both regimens are underway. evaluation in clinical trials. We look forward to the results of clinical trials that will determine the safety and immunogenicity, and ultimately the efficacy, of the Ad26.COV2.S vaccine in humans. ”

Researchers at Beth Israel Deaconess Medical Center (BIDMC) and other institutions have launched a first phase 1/2 human clinical trial of the Ad26.COV2.S vaccine in healthy volunteers. Kathryn E. Stephenson, MD, MPH, is the principal investigator of the trial at BIDMC, which is funded by Janssen Vaccines & Prevention, BV, a pharmaceutical research arm of Johnson & Johnson.

Pending the results of clinical trials, the Ad26.COV2.S vaccine is in the process of starting a phase 3 efficacy trial with 30,000 participants in September.

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Reference: “Single-injection Ad26 vaccine protects against SARS-CoV-2 in rhesus macaques” by Noe B. Mercado, Roland Zahn, Frank Wegmann, Carolin Loos, Abishek Chandrashekar, Jingyou Yu, Jinyan Liu, Lauren Peter, Katherine McMahan, Lisa H. Postanoski, Xuan He, David R. Martinez, Lucy Rutten, Rinke Bos, Danielle van Manen, Jort Vellinga, Jerome Custers, Johannes P. Langedijk, Ted Kwaks, Mark JG Bakkers, David Zuijdgeest, Sietske K. Rosendahl Huber, Caroline Atyeo, Stephanie Fischinger, John S. Burke, Jared Feldman, Blake M. Hauser, Timothy M. Caradonna, Esther A. Bondzie, Gabriel Dagotto, Makda S. Gebre, Emily Hoffman, Catherine Jacob-Dolan, Marinela Kirilova, Zhenfeng Li, Zijin Lin, Shant H. Mahrokhian, Lori F. Maxfield, Felix Nampanya, Ramya Nityanandam, Joseph P. Nkolola, Shivani Patel, John D. Ventura, Kaylee Verrington, Huahua Wan, Laurent Pessaint, Alex Van Ry, Kelvin Blade , Amanda Strasbaugh, Mehtap Cabus, Renita Brown, Anthony Cook, Serge Zouantchangadou, Elyse Teow, Ha nne Andersen, M ark G. Lewis, Yongfei Cai, Bing Chen, Aaron G. Schmidt, R. Keith Reeves, Ralph S. Baric, Douglas A. Lauffenburger, Galit Alter, Paul Stoffels, Mathai Mammen, Johan Van Hoof, Hanneke Schuitemaker and Dan H. Barouch, July 30, 2020, Nature.
DOI: 10.1038 / s41586-020-2607-z

Co-authors were Noe D. Mercado, Abishek Chandrashekar, Jingyou Yu, Jinyan Liu, Lauren Peter, Katherine McMahan, Lisa H. Tostanoski, Esther A. Bondzie, Gabriel Dagotto, Makda S. Gebre, Xuan He, Emily Hoffman, Catherine Jacob -Dolan, Marinela Kiriloya, Zhenfen Li, Zijin Lin, Shant H. Mahrokhian, Lori F. Maxfield, Felix Nampanya, Ramya Mityanandam, Joseph P. Nkolola, Shivanai Patel, John D. Ventura, Kaylee Verrignton and Huahua Wan of BIDMC; Lucy Rutten, Rinke Bos, Danielle van Manan, Jort Vellinga, Jerome Custers, Johannes P. Langedijk, Ted Kwaks, Paul Stoffels, Mathai Mammen, Johan Van Hoof and Hanneke Schuitemaker of Janssen Vaccines & Prevention BV; Carolin Loos, Caroline Atyeo, Stephanie Fischinger, John S. Burke, Jared Feldman, Blake M. Hauser, Timothy M. Caradonna, Aaron G. Schmidt and Galit Alter of the Ragon Institute of MGH, MIT and Harvard; Douglas A. Lauffenburger of the Massachusetts Institute of Technology; David Martinez and Ralph S. Baric of the University of North Carolina at Chapel Hill; Laurent Pessaint, Alex Van Ry, Kelvin Blade, Amanda Strasbaugh, Mehtap Cabus, Renita Brown, Anthony Cook, Serge Zouantchangadou, Elyse Teow, Hanne Anderson and Mark G. Lewis of Bioqual; and Yongfei Cai and Bing Chen from the Children’s Hospital.

The authors declare an absence of competing financial interests. Barouch, Zahn, Wegman, Rutten, Bos, Manan, Vellinga, Custers, Langedijk, Kwaks and Schuitemaker are the co-inventors of related vaccine patents. Zahn, Wegman, Rutten, Bos, Manan, Vellinga, Custers, Langedijk, Kwaks, Stoeffels, Mammen, Van Hoof and Schuitemaker are employees of Janssen Vaccines & Prevention BV and hold shares in Johnson & Johnson.

This project was funded in part by the Advanced Biomedical Research and Development Authority of the Ministry of Health and Social Services (BARDA) under contract HHS0100201700018C. We also thank Janssen Vaccines & Prevention BV, the Ragon Institute of MGH, MIT and Harvard, Mark and Lisa Schwartz Foundation, the Massachusetts Consortium on Pathogen Readiness (MassCPR) and the National Institutes of Health (OD024917, AI129797, AI124377, AI128751, AI126603 to DHB; AI007151 and AI152296 to DRM; AI146779 to AGS; 272201700036I-0-759301900131-1, AI100625, AI110700, AI132178, AI149644, AI108197 to RSB). We also recognize the award from the Burroughs Wellcome Fund Postgraduate Enrichment Program at DRM



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