Johnson & Johnson (J&J) has started a Phase I/IIa clinical trial of its Covid-19 vaccine candidate, Ad26.COV2.S, in healthy volunteers across the US and Belgium.
The first-in-human trial comes after the vaccine candidate showed promise in preclinical studies, where the product was able to trigger a immune response against SARS-CoV-2.
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This immune response involves the generation of neutralising antibodies that were able to prevent subsequent infection and provide complete or near-complete protection in the lungs of non-human primates (NHPs).
Beth Israel Deaconess Medical Center (BIDMC) researchers performed the pre-clinical studies in partnership with J&J unit Janssen Pharmaceutical and others.
According to the findings, out of seven vaccine prototypes assessed in the preclinical study, Ad26.COV2.S induced the highest levels of neutralising antibodies against SARS-CoV-2.
The company added that the six NHPs that received a single immunisation with its Covid-19 vaccine candidate had no detectable virus in the lower respiratory tract after exposure to the novel coronavirus.
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By GlobalDataFurthermore, only one of six NHPs had very low levels of the virus in a nasal swab at two time points.
The Phase I/IIa study will assess the safety, reactogenicity, and immunogenicity of Ad26.COV2.S in more than 1,000 healthy volunteers aged 18 to 55 years, and those aged 65 years and above.
Johnson & Johnson is also planning to conduct a Phase IIa study in the Netherlands, Spain and Germany, as well as a Phase I study in Japan.
The company’s Covid-19 clinical trial programme will also involve a Phase III study, which is expected to begin in September this year. The clinical programme is designed to assess one and two-dose regimens of the vaccine candidate in parallel studies.
Janssen Research & Development global head Mathai Mammen said: “Our pre-clinical results give us reason to be optimistic as we initiate our first-in-human clinical trial, and we are excited to enter the next stage in our research and development toward a Covid-19 vaccine.
“We know that, if successful, this vaccine can be rapidly developed, produced on a large scale and delivered around the world.”
J&J is working to boost its manufacturing capacity to potentially supply more than one billion doses of the Covid-19 vaccine candidate worldwide through 2021.
