Valneva new Lyme vaccine in early trials

Scientists are stepping up efforts in the battle against Lyme disease. A new Lyme vaccine is undergoing its first phase of trials, which involves three stages of approval before the vaccine can be sold to the public. There is currently no clinically approved Lyme disease vaccine for humans available on the market.

The Lyme vaccine works by stimulating the human immune system to produce antibodies that attack the disease-causing bacteria inside the tick, preventing it from entering its host. Lyme disease is a debilitating, inflammatory disease, that can make people develop a rash, and feel fatigued, and later, suffer from neurological and cardiac disorders.

Valneva, the French drug manufacturer developing the vaccine, announced in early June that its first human trial of the vaccine is proving to be up to 96 percent effective with no significant side effects. The U.S. Food and Drug Administration granted the companys vaccine, known as VLA15, a fast track designation in July of 2017.

Its exciting news, Dr. Peter Krause, of the Yale School of Medicine and Public Health, told The Block Island Times in a phone interview. Krause has been researching the effects of Lyme disease and babesiosis on Block Island since the early 90s. This vaccine could be very helpful for people living in Lyme areas like Block Island.

Krause said that due to the lengthy process of approving drugs like this one, it could take a few years before its available for sale on the market. Valneva is reporting that the vaccine would be sold at an affordable price, although the cost of the drug is not yet known.

Krause said the stages involved with clinical trials focus on safety and how the drug works. During the first stage the drug is tested on about 100 people; the second stage involves about 1,000 people; and the third and final stage incorporates a large sample of people.

Krause told The Times that he was involved with clinical trials for the first Lyme disease vaccine that was introduced by Smith Kline Beecham called LYMErix. Those trials, he said, were carried out in a few different locales, including on Block Island around 1991 or 1992. People on Block Island helped develop that vaccine, said Krause. Some participants received the vaccine, while others got a placebo.

Krause said that while the LYMErix vaccine was effective, the manufacturer pulled it off the market because it did not have government support, and the market was limited to certain locales. He said the vaccine also required multiple doses and a booster shot.

They found it did work, said Krause. (Valneva) is using the same idea with its drug (VLA15). Theyve taken the same protein (lipoprotein OspA) and increased it with the addition of six different sub-types. Krause said LYMErix could have been made more effective if the company continued manufacturing the drug. The original vaccine was an effective vaccine, but for financial reasons the company couldnt justify continuing with it.

Krause noted that his research of late has been focused more on babesiosis than Lyme disease, and looking at whats happened on Block Island over a period of time. He is planning on visiting the island in the fall to discuss his research, and speak with people about vector-borne disease. I havent done that in a number of years.

Krause, and Columbia University Professor Dr. Maria Diuk-Wasser, have been conducting a joint research effort on Block Island, including the annual free Lyme testing at the Block Island Medical Center. Dr. Diuk-Wasser has been piloting field research on the island for the past six years, and identified that the Lone Star Tick was now also inhabiting the island.

The researchers held free Lyme disease and babesiosis testing at the Block Island Medical Center on Memorial Day. Krause said that 100 people participated in the testing, and blood samples will be tested at the Yale University lab. He said that anyone who participated in the testing can contact him at: (203) 785-3223.

Diuk-Wasser is seeking participants for her Block Island field research via the Tick App (thetickapp.org). In July, we will visit houses to conduct tick collections and a quick one-time survey as well. People can sign up for a house visit by completing a form on our website and going to the Block Island tab, she said. At the end of the season well conduct another Lyme disease testing to match peoples activity patterns with their infection status.

We are interested in understanding better which behaviors affect exposure to ticks and how that determines human infection, said Diuk-Wasser. And this also has to do with peoples knowledge and perceptions about the disease ticks can transmit. Thus, its our intention to match the data from the Lyme disease testing and tick data with peoples knowledge, preventing practices and activities that might increase or decrease their risk.

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