Posted on 09/08/2021 9:51:31 AM PDT by Red Badger
An international collaboration led by Luk H. Vandenberghe, Ph.D., in the Department of Ophthalmology at Mass Eye and Ear, a member of Mass General Brigham, reported that a novel, gene-based COVID-19 vaccine leveraging a unique adeno-associated viral vector (AAV) platform was highly effective at eliciting neutralizing antibody responses and cellular immunity from a single dose. The vaccine provided nonhuman primates near-complete protection against a live SARS-CoV-2 viral challenge led by immunology researcher, Roger Le Grand, Ph.D., of the French Alternative Energies and Atomic Energy Commission (CEA).
With support from Novartis Gene Therapies, the AAVCOVID vaccine was shown to be producible with efficient, scalable, and industry-established manufacturing processes. The investigators further demonstrated that the vaccine product is stable at room-temperature storage conditions for up to one month, facilitating potential future distribution of the vaccine.
The new research, published September 8 in Cell Host & Microbe, represents the first peer-reviewed study to demonstrate AAVCOVID vaccine's preclinical effectiveness and the maintenance of immunity at peak levels for at least 11 months from a single-dose immunization. The study authors hope these findings support a move towards clinical trials with a goal of global distribution in parts of the world that are currently underserved by vaccination.
"Our findings, bolstered by long-term durability and protection data, show the AAV vaccine platform may address some of the ongoing elements of the health crisis and should warrant further study in clinical trials," said AAVCOVID principal investigator Luk H. Vandenberghe, Ph.D., director of the Grousbeck Gene Therapy Center at Mass Eye and Ear and Associate Professor of Ophthalmology at Harvard Medical School. "More durable and accessible vaccine options are of paramount need as the pandemic persists globally. We further believe our data validate this novel platform for consideration of other health threats for which vaccines are pursued."
Durable immune response and vaccine potency observed
In the new study, two AAVCOVID vaccine candidates with different SARS-CoV2 virus spike-based antigens were analyzed in a battery of experiments to measure effectiveness, duration of response, potency and stability. The candidates were derived from genetic data collected on the Wuhan strain of the SARS-CoV-2 virus. One vaccine candidate, AC1, was found to be superior in its ability to produce sustained immune responses in mouse and nonhuman primate models.
Early studies in mice revealed a single injection of the AC1 AAVCOVID candidate induced significant neutralizing antibody and T-cell levels, with antibody levels persisting for more than six months.
Next, to gain a better sense of how the vaccine might work in people, the AC1 AAVCOVID candidate was studied in a nonhuman primate model. The AC1 vaccine led to antibody levels that peaked at week 11 and remained at peak for at least 11 months. The antibodies were detected in lung tissues, which may suggest mitigating some of the pulmonary effects of COVID-19 infection. The vaccine also induced long-term functional memory T-cell responses.
No adverse effects were observed in either animal model.
Further testing established the feasibility of large-scale manufacturing of the vaccine in already available industry processes through Novartis Gene Therapies. The researchers also tested cold-chain storage requirements, or the need to keep the vaccines at specific low temperatures to retain potency. They analyzed the vaccine's potencies when stored at -112⁰F (-80⁰C), 39⁰F (4⁰C) or 77⁰F (25⁰C) to approximate freezing, refrigerated and room temperatures, respectively. The vaccine was shown to be stable after one month at room temperature, with stability at colder temperatures exceeding three months.
Immune protection supported by challenge study
Led by Dr. Le Grand, SARS-CoV-2 viral challenge studies were conducted with the AC1 vaccine candidate in nonhuman primates at the Infectious Disease Models and Innovative Therapies (IDMIT) department at CEA in Fontenay-aux-Roses, France. Compared to unvaccinated animals that showed COVID-19 infection in the nose, trachea and lung, the animals that received an AC1 immunization nine weeks prior to the challenge all demonstrated near-complete protection against COVID-19 infection. In particular, the upper airways were highly protected from COVID-19, as no major lung damage was seen in immunized animals, while two controls showed lesions caused by the virus.
"The remarkable efficacy induced in the nonhuman primate model after a single injection of the AAVCOVID vaccine does represent an important step in the development of a COVID-19 vaccine. Many possibilities are offered by the platform for antigen engineering. Rapid production scalability and easy distribution make AAV vaccines of particular interest for new pathogen threats readiness," explained Roger Le Grand, Ph.D., executive director of IDMIT.
The different variants of COVID-19, including the Delta variant, were also neutralized by serum from the AC1 candidate in vaccinated animals. Consistent to other Wuhan-based vaccines currently in market, variants are neutralized to a lesser amount as compared to the ancestral strain.
AAV-based platform may address persisting global challenges in pandemic response
AAVCOVID is a vaccine strategy that employs an AAV vector—a well-studied class of viral vectors used in approved gene therapies—to deliver genetic sequences for antigens of the SARS-CoV-2 virus spike protein to elicit a sustained immune response. The vaccine employs a specific AAV designed by Dr. Vandenberghe called rh32.33, which offers favorable inflammatory properties needed for vaccines and lacks pre-existing immunity in humans. This vaccine is the first COVID-19 vaccine developed on the AAV technology. While other viral vector vaccines exist, it is highly distinct from adenoviral vaccines, several of which are currently approved worldwide for COVID-19.
"It is exciting to see the progress in developing this AAV vaccine platform against SARS Co-V-2, and the potential it holds for future vaccine development against other pathogens," said Joan W. Miller, MD, Chief of Ophthalmology at Mass Eye and Ear, Mass General Hospital, and Brigham and Women's Hospital, and Chair of Ophthalmology and David Glendenning Cogan Professor of Ophthalmology at Harvard Medical School. "This is a wonderful example of successful international collaborative research, which is especially critical when addressing a global pandemic like COVID-19."
The new study showed that an AAVCOVID vaccine can address some of the biological and logistical hurdles that have persisted since the pandemic began, and more than six months since vaccines became approved for use.
There remains a critical need for additional vaccination strategies, as rollouts of approved vaccines have been uneven worldwide, especially in low- and middle-income countries. Most COVID-19 vaccines require two injections, and the need for a booster may become a reality, as the duration of effectiveness has been reported to wane over time. A single-dose vaccine that offers one-year-immunity can not only offer a solution that is more desirable for adherence, but also decrease billions of dollars in global healthcare costs associated with the production of multiple-dose and booster vaccines.
An AAV-based vaccine can also leverage existing manufacturing facilities used to produce and distribute AAV-based gene therapies.
Cold storage also remains a challenge in many parts of the world, and AAVCOVID's ability to retain potency and stability for up to one month at room temperature could address some of these challenges.
"We believe an AAVCOVID vaccine has the potential to provide a more accessible option for people across the globe, especially to those with limited access to medical care," said first study author Nerea Zabaleta Lasarte, Ph.D., a postdoctoral research fellow at the Grousbeck Gene Therapy Center at Mass Eye and Ear. "The AAV-based platform provides a new approach to vaccines never used before, and outside-the-box strategies that can get more inoculations to a greater number of people regardless of where they live remain profoundly needed."
Future study of vaccine platform and new delivery methods
The peer-reviewed findings build on preprint results published earlier this year that showed efficacy and potency at three-month tests, and the team plans to continue to collect data on the duration of response from a single-dose injection.
The team will also explore additional delivery options for the vaccine, including for needleless vaccine delivery. The temperature stability of AAVCOVID observed in the study could lend itself to easier-to-distribute formulations of the vaccine, such as in liquid drops or pills that can be shipped to far reaches of the globe commercially.
AAVCOVID researchers hope their findings can compel additional study in clinical trials.
Explore further
COVID-19: An innovative candidate vaccine shows efficacy in preclinical models
More information: Nerea Zabaleta et al, An AAV-based, room-temperature-stable, single-dose COVID-19 vaccine provides durable immunogenicity and protection in non-human primates, Cell Host & Microbe (2021). DOI: 10.1016/j.chom.2021.08.002
Journal information: Cell Host & Microbe
Provided by Massachusetts Eye and Ear
gene-based COVID-19 vaccine
It’s another notavax. Still not taking it without a few years of observation.
Still a spike protein vax?
Don’t believe a single word that ever comes out of the completely utterly evil and depraved vaccine industry they are liars liars frauds deceivers and minions of Satan himself
Here is the 100+ year sorted demented depraved history of the vaccine industry
Excerpt
“The most dangerous man to any government is the man who is able to think things out… without regard to the prevailing superstitions and taboos. Almost inevitably he comes to the conclusion that the government he lives under is dishonest, insane, intolerable.”
– H L Mencken
“No country and no people can be free and ignorant at the same time.”
– Thomas Jefferson
“The only safe vaccine is the one that is never used.”
– James Shannon
Former National Institutes of Health (NIH) Director
“I haven’t got a flu shot and I don’t intend to.”
– George W. Bush 2004 Presidential Candidate
“Vaccinations only prove that you can inject someone
with highly acidic toxic poisonous chemicals and that person
hopefully surviving the debilitating side effects, such as multiple
sclerosis, lesions on the brain, paralysis, breakdown of the red
and white blood cells, ulcerations of the liver, lung, kidney, pancreas,
stomach and bowels, seizures and death. Vaccinations provide
zero immunity. True immunity that leads to health and fitness
can only be achieved by making healthy lifestyle and dietary choices.”
– Dr. Robert O. Young
The pH Miracle Living Center
http://www.phmiracleliving.com
The following is a history of virology, bacteriology, mycology and vaccination that has lead to many of the out-breaks and/or epidemics from the Spanish Flu Epidemic to Polio to HIV/AIDS to the Gulf War Syndrome and now to our latest epidemics of prostate and breast cancer, diabetes, obesity and the rise of autism in children.
Dr. Young has stated that the use of vaccinations, antibiotics and anti-fungals will only poison the body leading to the one sickness and one disease – latent tissue acidosis and then death.
All vaccinations, antibiotics and anti-fungals are the acids of morbid fermentation of plant, animal and human matter and when ingested or injected can only prove that you can poison the body and hopefully live through it.
The day will soon come when scientists will proclaim that the use of vaccinations, antibiotics and anti-fungals are harmful to the human body and should not be used under ANY circumstances.
In the words of Thomas Edison, ‘The Doctor of the Future will give no medicine, but will involve the patient in the proper use of food, fresh air, and exercise.’
The future that Thomas Edison speaks is here and now! Read on to understand and to see the course we have been walking for the last several centuries and how things must change before it is to late.
———————————————————————————————-
I’m fully aware of the politicization, fear mongering, desire for control, etc etc etc, surrounding everything about covid and these shots. Putting that aside for a moment..
In the past, hasn’t all this work taken years for these companies and researchers to come up with these treatments? From some other comments I’ve read, between initial development and testing, all sorts of trials, etc, it’s looking to me that it should take at least 5 years or more before anything is put in a box or a vial.
Am I missing something? Are folks that conditioned to believe all of this? They didn’t develop the flu vaccines that many take in a few months, right?
Yup, sounds promising but much work needs to be done..
No more pig-in-a-poke (pun intended)
Spike protein! Get your spike protein here.
Not no but fvk no ever
Just talked with an employee at the VA where I’m volunteering.
She was surprised that I wasn’t going to get the jab.
I explained that I had a bone marrow transplant and I couldn’t find any Information either way that said the government shot was safe or not so I was waiting.
She was stunned when I explained that the shot was experimental so she and others were the “human trials” that all previous vaccines went through before releasing it to the public.
She just realized that the government had used her as a guinea pig!
Since you arent getting the shot...some medical professionals are using Xclear.
No idea if it really works but I am going to use it before I go to physical therapy
https://www.yahoo.com/now/xlear-submits-covid-19-pre-141500289.html
Will it make you Round-Up ready?
Uh-huh.
No. It shouldn’t take 5 years to put it in a box or vial. Experimental therapies should be available with informed consent.
The thing that has my hackles up is that there are people trying to make the notavax compulsory - take it or lose your job, can’t go to school, or go to jail. It sets all my alarm bells ringing, the more so as we discover that the notavax is nearly useless and that ‘they’ want the vic, er, recipients to take additional ‘boosters.’ I am forced to conclude that there is something to the notavax that has nothing to do with COVID-19.
Except I’d rather take a vaccine developed in 6 months in 2021 than take one that took 5 to 10 years in 1950.(and I did take several in 1955, when starting public school)
Thanks!
I will investigate.
It has been extraordinarily obvious to me for >20 years that our media lies to us by omission routinely. And by commission as well, really any way they can, they will. That this isn’t routinely assumed is sad, especially on the topic of a Big Pharma jab when so much of the media is funded by Big Pharma.
Apparently the Best and Brightest don’t work at the VA.
You don’t like Big Pharma working your immune system on the subscription model? What is wrong with you!?
Do I really need the /s?
She’s in housekeeping. A sweet lady but is likely educated by the mainstream media.
Ha!
I would love to learn of a panacea - take this genetic therapy and you’ll be resistant or immune to everything.
But I’d still wait at least five years to see what the side effects were...
Disclaimer: Opinions posted on Free Republic are those of the individual posters and do not necessarily represent the opinion of Free Republic or its management. All materials posted herein are protected by copyright law and the exemption for fair use of copyrighted works.