Login

Lost your password?
Don't have an account? Sign Up

J&Js COVID-19 vaccine generates positive pre-c

J&J

An experimental vaccine candidate currently being developed by Johnson and Johnson has proved promising in early, pre-clinical studies.

The vaccine, Ad26.COV2.S, induced a robust immune response in monkeys, demonstrated by high levels of neutralising antibodies. According to J&J, this immune response successfully prevented subsequent infection and provided complete or near-complete protection from the SARS-CoV-2 virus, which causes COVID-19.

In the studies, J&J’s researchers initially immunised the animals with a number of vaccine candidates – out of seven vaccine prototypes tested in the study, scientists found that Ad26.COV2.S elicited the highest levels of neutralising antibodies to SARS-CoV-2.

All six animals that received a single immunisation with the lead vaccine candidate showed no detectable virus in their lower respiratory tract after exposure to SARS-CoV-2, and only one showed very low levels of the virus in a nasal swab at two time points.

Based on the promising results from the animal study, J&J has started a phase 1/2a human clinical trial of the vaccine trial in the US and Belgium. This clinical trial programme will evaluate both one- and two-dose regimens of Ad26.COV2.S in over 1,000 health adults aged 18 to 55 years, as well as adults aged 65 and over.

If all goes to plan in the first-in-human clinical trials, J&J hopes to begin a pivotal phase 3 trial of the single vaccine dose versus placebo in September, as well as a parallel phase 3 study of a two-dose regimen versus placebo.

The company added that it will emphasise representation of populations that have been the most impacted by the pandemic in the phase 3 trial programme. In the US, this would include significant representation of participants over 65 years of age and certain minority ethnic groups.

J&J and the US government’s Biomedical Advanced Research and Development Authority (BARDA) have collectively committed $1bn to the vaccine project, which will be spent on R&D and clinical testing of the vaccine.

“We are excited to see these pre-clinical data because they show our SARS-CoV-2 vaccine candidate generated a strong antibody response and provided protection with a single dose,” said Paul Stoffels, vice chairman of the executive committee and chief scientific officer, J&J.

“The findings give us confidence as we progress our vaccine development and upscale manufacturing in parallel, having initiated a phase 1/2a trial in July with the intention to move into a phase 3 trial in September,” he added.

<!–

var disqus_shortname = ‘pmlive’;
var disqus_identifier = ‘1346045’;
var disqus_title = ‘J&amp;J’s COVID-19 vaccine generates positive pre-clinical results’;
var disqus_url = ‘https://www.pmlive.com/pharma_news/j_and_js_covid-19_vaccine_generates_positive_pre-clinical_results_1346045’;

(function() {
var dsq = document.createElement(‘script’); dsq.type = ‘text/javascript’; dsq.async = true;
dsq.src = ‘https://’ + disqus_shortname + ‘.disqus.com/embed.js’;
(document.getElementsByTagName(‘head’)[0] || document.getElementsByTagName(‘body’)[0]).appendChild(dsq);
})();

Please enable JavaScript to view the comments.
–>

Author:

Leave a Comment

Your email address will not be published. Required fields are marked *

*
*