(This statement was updated on October 4, 2020 to include additional information) Johnson & Johnson Posts Interim Results from Phase 1/2a Clinical Trial of its Janssen COVID-19 Vaccine Candidate

Interim analysis from the ongoing Phase 1/2a clinical trial of the Janssen COVID-19 vaccine candidate (JNJ-78436735) was posted today on the pre-print server medRxiv.The data demonstrate that a single dose of JNJ-78436735 induced a strong neutralizing antibody response in nearly all participants aged 18 years and older and was generally well-tolerated. Immune responses were similar across the age groups studied, including older adults. 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 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. 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 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.Immune Response Data Seroconversion (the development of detectable antibodies) was observed ...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Our Company Source Type: news