Pfizer, Valneva Initiate Phase 3 Study for Investigational Lyme Disease Vaccine Candidate

Approximately 6000 participants aged 5 years and older at 50 sites in different countries are set to received 3 doses of VLA 15 µg or the saline placebo, followed by a booster.

Pfizer and Valneva announced the initiation of a phase 3 clinical study, Vaccine Against Lyme for Outdoor Recreationists (VALOR), which is intended to investigate the efficacy, safety, and immunogenicity of the investigational Lyme disease vaccine candidate, VLA15.1

“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,” Annaliesa Anderson, PhD, senior vice president and head of Vaccine Research & Development at Pfizer, said in a statement. “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."1

The study is a placebo-controlled, randomized trial that is set to enroll approximately 6000 individuals aged 5 years and older. The study will be conducted at up to 50 sites located where Lyme disease is highly endemic, including in Finland, Germany, the Netherlands, Poland, Sweden, and the United States.1

Individuals in the study will receive 3 doses of VLA15 180 µg or the saline placebo as a primary vaccination series, followed by 1 booster dose of either the vaccine or the placebo. Individuals will be randomized on a 1-to-1 basis.1

Data from the phase 2 studies continue to show strong immunogenicity in adults and children with acceptable safety and tolerability in both study populations.1

“We are extremely pleased to reach this important milestone in the development of VLA15. Lyme disease continues to spread, representing a high unmet medical need that impacts the lives of many in the Northern Hemisphere,” Juan Carlos Jaramillo, MD, chief medical officer of Valneva, said in the statement.1

Pfizer could submit a biologic license application to the FDA and a marketing authorization application to the European Medicines Agency in 2025, after the completion of the phase 3 study.1

VLA15 is the only Lyme disease vaccine candidate in clinical development, according to a Pfizer statement.

It is an investigational multivalent protein subunit vaccine that uses an established mechanism that targets the outer surface protein A of Borrelia burgdorferi, the bacteria that cause Lyme disease.1

The CDC states that recent estimates suggest that there are approximately 476,000 new cases of Lyme disease each year in the United States, according to the CDC.2

References

1. Pfizer and Valneva initiate phase 3 study of Lyme disease vaccine candidate VLA15. News release. Pfizer. August 8, 2022. Accessed August 9, 2022. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-valneva-initiate-phase-3-study-lyme-disease

2. Lyme disease. CDC. Updated April 29, 2021. Accessed August 9, 2022. https://www.cdc.gov/lyme/datasurveillance/index.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Flyme%2Fstats%2Findex.html