Infectious Disease

Valneva is investigating vaccine candidates for Lyme illness in youngsters

December 28, 2020

1 min read

Source / information

Disclosure:
Jansen and Jaramillo do not report any relevant financial information.

ADD SUBJECT TO EMAIL ALARMS

Receive an email when new articles are published

Please enter your email address to receive an email when new articles are published . “data-action =” subscribe “> subscribe

We could not process your request. Please try again later. If you continue to have this problem, please contact customerservice@slackinc.com.

Back to Healio

Valneva this month announced plans to begin investigating its Lyme vaccine candidate VLA15 in children from the first quarter of 2021.

It is the first time the vaccine, which is jointly developed and marketed with Pfizer, has been studied in a pediatric population.

The study will enroll participants ages 5 to 65 and compare a reduced immunization schedule of two doses in 6 months to a 6 month regimen of three doses.

“This will be an important study that we expect to demonstrate, on a simplified schedule, that the vaccine can be used in populations at risk of the devastating effects of Lyme disease,” said Pfizer, Senior Vice President President and Head of Vaccine Research Development Kathrin Jansen, PhD, said in a press release.

The study – named VLA15-221 – will complement two ongoing Phase 2 studies, VLA15-201 and VLA15-202, which have already reported positive data, Valneva said.

Data from the VLA15-221 study is expected in the second quarter of 2022. The study is also looking at the administration of a booster dose given 1 year after the 6 month dose.

Valneva said all three phase 2 studies are expected to support a phase 3 central efficacy study that will encompass all main target populations for the Lyme disease vaccine candidate from 2022.

“We believe that early involvement of the pediatric population could support the Phase 3 trial to include all key audiences for our future Lyme vaccine candidate and potentially support successful market entry and recommendations,” said Valneva, Chief Medical Officer Juan Carlos Jaramillo, MD, said in a press release. “We are pleased that Pfizer and Valneva have decided to accelerate this development step while preparing for a possible start in Phase 3, which is expected in 2022.”

Valneva said the first dose given in the new study will trigger a $ 10 million payout from Pfizer.

Since LYMERix was discontinued by GlaxoSmithKline in 2002, there has been no approved vaccine for Lyme disease in the United States.

ADD SUBJECT TO EMAIL ALARMS

Receive an email when new articles are published

Please enter your email address to receive an email when new articles are published . “data-action =” subscribe “> subscribe

We could not process your request. Please try again later. If you continue to have this problem, please contact customerservice@slackinc.com.

Back to Healio

Related Articles