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October 4, 2021

Janssen’s RSV vaccine meets all endpoints in Phase IIb trial in adults

The investigational vaccine demonstrated 70% efficacy against any symptomatic RSV-linked ARI and 80% efficacy against LRTD.

The Janssen Pharmaceutical Companies of Johnson & Johnson has reported that its experimental vaccine candidate for respiratory syncytial virus (RSV) met all endpoints in the Phase IIb CYPRESS clinical trial in adult subjects aged 65 and above.

The vaccine showed an 80% efficacy against RSV-caused lower respiratory tract disease (LRTD) in elderly patients in the trial.

The randomised, placebo-controlled, double-blind Phase IIb trial recruited a total of 5,782 subjects at 40 centres in the US.

These subjects were categorised into a 1:1 ratio before the onset of RSV season and given the vaccine or placebo.

Immunogenicity and safety evaluations were carried out in a subset of nearly 200 and 695 subjects, respectively.

A questionnaire or a clinician’s assessment helped to gather symptoms related to the disease.

The first incidence of RSV-caused LRTD was the primary goal while the secondary efficacy goal was the first manifestation of acute respiratory infection (ARI) linked to RSV.

Data also showed that the trial met primary and secondary goals, with the vaccine showing 70% efficacy against any symptomatic ARI linked to RSV.

In elderly subjects, the vaccine induced strong humoral and cellular immune responses, with those in the immunogenicity subset demonstrating a considerable improvement in RSV neutralising antibodies following 14 days of inoculation.

The vaccine was found to be well-tolerated in all subjects.

Janssen Research and Development Vaccines global therapeutic area head Penny Heaton said: “The findings from our CYPRESS study are very encouraging as we seek to deliver a long-awaited preventive vaccine to stave off the severe complications associated with RSV in adults.

“As older adults are at high risk of developing serious, a potentially life-threatening illness from RSV, there is an urgent need for a vaccine to prevent the significant morbidity and mortality caused by the virus.”

A common and extremely contagious respiratory virus, RSV causes bronchitis, bronchiolitis and pneumonia.

Last month, Janssen commenced the Phase III EVERGREEN trial of the vaccine in adult subjects aged 60 and above.

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