The research results laid the foundation for the clinical development plan.
May need to develop a safe and effective vaccine to end Coronavirus disease Pandemic. A team of scientists led by Dr. Dan H. Barouch, an immunologist at Beth Israel Deaconess Medical Center (BIDMC), now reports that the leading candidate COVID-19 vaccine developed by BIDMC in collaboration with Johnson & Johnson has improved neutralizing antibodies and gained potency Protection of non-human primates (NHPs) against SARS-CoV-2, It is the virus that causes COVID-19. This research is based on the team’s previous results and published in the journal nature.
Barouch, director of the BIDMC Virology and Vaccine Research Center, said: “This vaccine can lead to strong protection against SARS-CoV-2 in rhesus monkeys and is currently being evaluated in humans.”
The vaccine uses a common cold virus (called adenovirus serotype 26 (Ad26)) to deliver the SARS-CoV-2 spike protein to host cells, thereby stimulating the body to increase the immune response to the coronavirus. Since Chinese scientists released the SARS-CoV-2 genome in January this year, Barouch has been working on developing a COVID-19 vaccine. Barouch’s team worked with Johnson & Johnson to develop a series of candidate vaccines designed to express different variants of the SARS-CoV-2 spike protein, which is the main target of neutralizing antibodies.
Barouch and colleagues conducted a study in 52 NHPs, using one of seven different versions of Ad26-based vaccines to immunize 32 adult rhesus monkeys with a single dose, and gave 20 animal sham vaccines as placebo controls . After immunization, all vaccinated animals produced neutralizing antibodies. Six weeks after immunization, all animals were exposed to SARS-CoV-2. All 20 animals that received the fake vaccine were infected and showed high levels of virus in their lungs and nasal swabs. Of the six animals that received the best candidate vaccine Ad26.COV2.S, none showed virus in the lungs, and only one animal showed low levels of virus in nasal swabs.
Moreover, the neutralizing antibody response is associated with protection, indicating that this biomarker will be useful in the clinical development of a COVID-19 vaccine for humans.
Barush said: “Our data shows that a single immunization with Ad26.COV2.S can effectively protect rhesus monkeys against SARS-CoV-2 attacks.” MGH Institute, versus, Harvard University, and the leader of the Vaccine Working Group of the Mass. “For global deployment and pandemic control, a single immunization has practical and logistical advantages over the two-injection regimen, but the two-injection vaccine may have higher immunogenicity, so both regimens are being evaluated in clinical trials. Looking forward to determining the safety and immunogenicity of the Ad26.COV2.S vaccine in humans, and finally determining the results of clinical trials for its efficacy.”
Researchers at Beth Israel Deaconess Medical Center (BIDMC) and other institutions have launched a phase 1/2 clinical trial of the Ad26.COV2.S vaccine in healthy volunteers. Kathryn E. Stephenson (Kathryn E. Stephenson) of MPH, MD, is the principal investigator of BIDMC. The research was funded by the Johnson & Johnson Pharmaceutical Research Institute BJ Johnson Vaccine and Prevention Foundation.
Before waiting for the clinical trial results, the Ad26.COV2.S vaccine is expected to start a phase 3 efficacy trial in 30,000 participants in September.
Reference: References provided by Noe B. Mercado, Roland Zahn, Frank Wegmann, Carolin Loos, Abishek Chandrashekar, Yu Jingyou, Jinyan Liu, Lauren Peter, Katherine McMahan, Lisa and others: “A single Ad26 vaccine can prevent SARS in macaques -CoV-2” H. Tostanoski, 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, Li Zhenfeng, Lin 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, Hanne Andersen, M York Lewis, Cai Yongfei, Chen Bing, Aaron Schmidt, R. Keith Reeves, Ralph S. Baric, Douglas A. Laufenberg, Galit Alter, Paul Stoffels, Mattei Mamen, John Fan Hoff, Hannek Schutmek and Dan H. Baruch, July 30, 2020, nature.
DOI: 10.1038 / s41586-020-2607-z
Co-authors include Noe D. Mercado, Abishek Chandrashekar, Yu Jingyou, 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, Lizhenfen, Linjin Lin, Shant H. Mahrokhian, Lori F. Maxfield, Felix Nampanya, Ramya Mityanandam, Joseph P. Nkolola, Shivanai Patel, John D. Ventura, Kaylee Verrignton, and Huahua Wan; Lucy Rutten, Rinke , 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; MGH, Carolin of MIT and Harvard Ragon Institute Loos, Caroline Atyeo, Stephanie Fischinger, John S. Burke, Jared Feldman, Blake M. Hauser, Timothy M. Caradonna, Aaron G. Schmidt and Galit Alter Douglas A. Lauffenburger of Massachusetts Institute of Technology; University of North Carolina at Chapel Hill David Martinez and Ralph S. Baric; 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 Mark G. Lewis of the Children’s Hospital Cai Yong Fei and Chen Bing.
The author declares that there are no competing economic 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 of Johnson & Johnson.
This project is partly funded by the Biomedical Advanced Research and Development Agency (BARDA) of the Ministry of Health and Human Services, and the contract is HHS0100201700018C. We also thank Janssen Vaccines and Prevention BV, MGH, MIT’s Ragon Institute and Harvard, Mark and Lisa Schwartz Foundation, Massachusetts Alliance for Pathogen Preparedness (MassCPR) and National Institutes of Health (OD024917) , AI129797, AI124377, AI128751, AI126603 of D128; AI007151 and AI152296 of DRM; AI146779 of AGS; 272201700036I-0-759301900131-1, AI100625, AI110700, AI132178, AI149644, AI108197 to RSB). We also thank DRM for awarding Burroughs Wellcome Foundation Postdoctoral Enrichment Program Award