Pfizer and Velneva announced the beginning of a Phase 3 clinical trial of their Lyme disease vaccine candidate VLA15.
According to the press release by Pfizer, the randomized, placebo-controlled study is planned to enroll approximately 6,000 participants 5 years of age and older.
The study is being conducted at up to 50 sites located in areas where Lyme disease is highly endemic, including Finland, Germany, the Netherlands, Poland, Sweden, and the United States.
Participants will receive three doses of VLA15 180 µg or saline placebo as a primary vaccination series, followed by one booster dose of VLA15 or saline placebo (1:1 ratio).
"With increasing global rates of Lyme disease, providing a new option for people to help protect themselves from the disease is more important than ever," said Annaliesa Anderson, Ph.D., Senior Vice President and Head of Vaccine Research & Development at Pfizer.
"We hope that the data generated from the Phase 3 study will further support the positive evidence for VLA15 to date, and we are looking forward to collaborating with the research sites across the U.S. and Europe on this important trial."
The US Food and Drug Administration approved the LYMErix vaccine against Lyme disease in 1998. However, some people reported that they developed arthritis after receiving a jab. Even though the FDA investigation did not find the strong links between the vaccine and arthritis, the sales of LYMErix dropped and the manufacturer pulled the vaccine out of the market in 2002.
Lyme disease is caused by the bacterium Borrelia burgdorferi and, rarely, Borrelia mayonii, according to the Centers for Disease Control and Prevention (CDC). It is transmitted to humans through the bite of infected blacklegged ticks.
The tick must stay attached for 36 to 48 hours to transfer the infection to someone. However, people are often unaware they've been bitten because the immature ticks, called nymphs, are extremely difficult to notice. The adult ticks are more visible; therefore, they are usually removed before transmitting the disease.
Typical symptoms of Lyme disease include fever, headache, fatigue, and a skin rash called erythema migrans (EM).
The EM resembles a red oval and occurs in approximately 70 to 80 percent of infected persons. The rash begins at the site of a tick bite after 3 to 30 days. It expands gradually over several days reaching up to 12 inches or more. The EM is rarely itchy or painful.
Infection can spread to joints, the heart, and the nervous system if left untreated.
Around 476,000 cases of Lyme disease are diagnosed and treated annually in the United States.
2. CDC. Lyme Disease.
4. National Library of Medicine. Comparison of Lyme Disease in the United States and Europe.