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Phase 1/2a results for J&J’s COVID-19 vaccine show early promise

Vaccine produced neutralising antibodies in 98% of participants

Results from a phase 1/2a study of Johnson & Johnson’s (J&J) potential COVID-19 vaccine candidate have come back positive, as the company’s launches a large-scale phase 3 trial across three continents.

According to interim results published on the pre-print server medRxiv on Friday, a single dose of J&J’s JNJ-78436735/Ad26.COV2.S vaccine produced a strong immune response against the novel coronavirus, SARS-CoV-2, which causes COVID-19.

The pre-print results have not been certified by peer review, but given the speed at which drugmakers like J&J are developing their COVID-19 vaccines, there is less time to follow traditional protocol with regards to publishing trial data.

Researchers from J&J’s pharmaceutical division Janssen said, from data available at the interim analysis, 98% of participants had neutralising antibodies 29 days after vaccination. The levels of neutralising antibodies in the vaccine treatment group were in the same range as people who have recovered from COVID-19 infections.

In addition, 99% of participants had developed detectable antibodies, while the candidate also elicited strong antibody responses, strong T-cell responses and a Th1 response. The Th1 response is believed to protect against the risk of vaccine-associated enhanced respiratory disease.

High levels of neutralising antibodies are an important indicator of efficacy in early clinical trials, as they defend cells from pathogens, including SARS-CoV-2.

Although the results are promising and have led to a 60,000-participant phase 3 trial, only a small number of immune response results for people over the age of 65 were available at the time of the interim analysis.

In addition, J&J reported that similar immunogenicity was observed across both dose levels, although it added that it has selected the lower dose for further clinical evaluation.

The 1,000-person phase 1/2a trial was supported by the US government’s Biomedical Advanced Research and Development Authority (BARDA), which has collectively committed $1bn to the vaccine project.

In July, J&J’s shot induced a robust immune response in early animal studies, demonstrated by high levels of neutralising antibodies. None of the six animals that received a single immunisation with J&J’s vaccine showed any 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.

Article by
Lucy Parsons

28th September 2020

From: Research

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