By Julie Steenhuysen
CHICAGO, July 30 (Reuters) – Johnson & & Johnson on Thursday started U.S. human safety trials for its COVID-19 vaccine after launching details of a study in monkeys that revealed its best-performing vaccine prospect used strong security in a single dosage.
When exposed to the virus, six out of six animals who got the candidate vaccine were entirely protected from lung disease and five out of six were secured from infection as measured by the existence of virus in nasal swabs, according to the study released in the journal Nature.
” This gives us confidence that we can check a single-shot vaccine in this epidemic and learn whether it has a protective result in humans,” Dr. Paul Stoffels, J&Js primary clinical officer, informed Reuters in a telephone interview.
The U.S. government is backing J&Js vaccine effort with $456 million in funding as part of a spending spree targeted at speeding production of a vaccine to end the pandemic, which has contaminated millions and eliminated more than 660,000 individuals.
Stoffels said prior tests of this kind of vaccine in other illness found that a 2nd shot considerably increases defense. However in a pandemic a single-shot vaccine has a considerable benefit, sidestepping a great deal of the logistical concerns associated with getting people to come back for their second dose.
The business prepares to take up the question of one or 2 dosages in its stage 1 trial, which started today in the United States.
Depending upon those outcomes, J&J prepares to start massive, phase 3 testing with a single-shot program in the 2nd half of September. Around the exact same time, the company will start a parallel phase 3 research study testing a two-shot program of the vaccine, Stoffels said.
J&Js vaccine uses a typical cold infection referred to as adnovirus type 26 or Ad26 to shuttle coronavirus proteins into cells in the body, triggering the body to mount an immune defense versus the infection.
In the monkey study, scientists from J&J and Harvards Beth Israel Deaconess Medical Center studied seven various prospective vaccines in 32 animals and compared the results to 20 control animals who got placebo shots.
Six weeks later on, all of the animals were exposed to the SARS-CoV-2 infection. All 20 animals that received the placebo developed high levels of virus in their lungs and nasal swabs.
In the best-performing prospect, which J&J selected for human screening, none of the animals had infection in their lungs and just one showed low levels of infection in nasal swabs. Lab tests revealed they all had established antibodies capapable of reducing the effects of the infection after a single shot.
” This study reveals that even simply a single immunization with the Ad26 vaccine leads to neutralizing antibody reactions and robust security of monkeys against COVID-19,” said Dr. Dan Barouch, a vaccine scientist at Beth Isreal Deaconness who led the research in partnership with J&J.
( Reporting by Julie Steenhuysen; modifying by Richard Pullin).