New Brunswick: US pharmaceutical major Johnson & Johnson's potential COVID-19 vaccine has shown development of a strong neutralizing antibody response in nearly all participants aged 18 years and older and was generally well-tolerated.
The company published an interim analysis from the ongoing Phase 1/2a clinical trial of the Janssen COVID-19 vaccine candidate (JNJ-78436735) on Friday.
" Immune responses were similar across the age groups studied, including older adults," the company said in a statement.
"The ongoing Phase 1/2a clinical trial is designed to study the safety and immunogenicity of two dose levels of the Janssen COVID-19 vaccine, and as single and two-dose schedules," the company said.
The interim analysis showed that a single dose induced a robust immune response and was generally well-tolerated.
" These data are consistent with preclinical studies, published in the scientific journal Nature, which showed that a single dose of the vaccine successfully prevented subsequent infection and provided complete protection in the lungs of nonhuman primates," read the statement.
"Based on these findings, the single dose of the Janssen COVID-19 vaccine candidate of 5x1010 virus particles (vp) has been selected for further evaluation in the Phase 3 ENSEMBLE clinical trial," the company said.
The company also plans on running a Phase 3 clinical trial of a two-dose regimen of JNJ-78436735 versus placebo later this year.
The full set of results will be published once the complete Phase 1/2a trial data are available.
" The Janssen COVID-19 vaccine candidate elicited strong antibody responses, strong T cell responses, and a Th1 response, believed to be protective against the risk of vaccine-associated enhanced respiratory disease," the company said.
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