UK taking part in two-shot Johnson & Johnson vaccine trial

LEXINGTON, Ky. (WTVQ) – Fresh off completing its role in the trial of the single-dose Johnson & Johnson COVID vaccine, the University of Kentucky HealthCare is now joining the ongoing tests of a two-doze vaccine.

Johnson & Johnson announced the trial of a two dose version last October after the single-dose tests already was under way around the world.

UK Healthcare is expected to discuss the two-dose test during apress conference Tuesday.

In addition to the single-dose regimen study, the Janssen Pharmaceutical Companies of Johnson & Johnson has now initiated the two-dose regimen trial, which is a complementary, planned, pivotal, large-scale, multi-country Phase 3 trial that will study the safety and efficacy of a two-dose regimen of the investigational Janssen vaccine candidate  in up to 30,000 participants worldwide.

While a potentially safe and effective single-dose preventive COVID-19 vaccine would have significant benefits, particularly in a pandemic setting, Janssen’s COVID-19 vaccine program has been designed to be extremely thorough and driven by science, the company said.

It’s the reason the company is investigating multiple doses and dosing regimens to evaluate their long-term efficacy,  it said in October.

The company recently filed for approval for emergency use of the one-dose vaccine and that approval could come in early March.

The other two primary vaccines already approved in the U.S. — Moderna and Pfizer — require two doses.

The interim analysis showed that a single dose of the COVID-19 vaccine candidate induced a robust immune response and was generally well-tolerated, the company said in results released two weeks ago.

UK Healthcare, Baptist Lexington and Norton in Louisville took part in the one-dose study, as well, working with almost 90 local volunteers.

The Phase 3 ENSEMBLE 2 study (NCT04614948) is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of a two-dose vaccine regimen versus placebo in adults 18 years old and older with and without comorbidities associated with an increased risk for severe COVID-19.

The study will assess efficacy of the investigational vaccine after both the first and second dose to evaluate protection against the virus and potential incremental benefits for duration of protection with a second dose.

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