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Phase 3 VALOR Lyme Disease Trial: Valneva and Pfizer Announce Primary Vaccination Series Completion

Doctor injecting vaccine into patient's arm

Valneva (7.17.2024) published the article, “Phase 3 VALOR Lyme Disease Trial: Valneva and Pfizer Announce Primary Vaccination Series Completion.” Pfizer and Valneva announced that participants in their Phase 3 VALOR trial for the Lyme disease vaccine candidate VLA15 have completed the primary vaccination series which consists of three doses of the VLA15 vaccine. They will receive a booster dose approximately one year after the third dose. Precision Vaccinations (7.17.2024) discusses the potential of VLA15, a Lyme disease vaccine candidate, to become the first FDA-approved protein subunit vaccine for Lyme disease. Lyme disease, a significant vector-borne illness, has lacked an approved vaccine in the U.S. since it became a nationally notifiable condition in 1991. Over 63,000 cases were reported in 2022, mostly in the northeastern U.S.

The VALOR trial is being conducted in regions highly endemic for Lyme disease across the U.S., Canada, and Europe, and involves participants aged 5 years and older. The trial aims to assess the vaccine’s efficacy, safety, tolerability, and immunogenicity. VLA15 is a multivalent protein subunit vaccine targeting the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria responsible for Lyme disease. This vaccine, targeting the six most prevalent serotypes of the Lyme-causing bacteria Borrelia burgdorferi, is currently the most advanced in clinical development.

Participants will be monitored for Lyme disease cases until the end of the Lyme disease season in 2025. Pending positive results, Pfizer plans to submit regulatory applications to the U.S. FDA and the European Medicines Agency (EMA) in 2026. The vaccine has shown a favorable safety profile so far, with no significant safety concerns reported. The need for this vaccine is emphasized by the increasing prevalence and geographic spread of Lyme disease and lack of prevention measures.

For More Information: 

Read the Valeneva Article here.

Read the Precision Vaccinations article here.

Read more about the VLA15 Vaccine on the LDA website here.