Vaccine Info

VLA15 Lyme Disease Vaccine

VLA-15 Lyme Disease Vaccine Description

VLA15 is a multivalent Lyme Disease vaccine candidate targeting the outer surface protein A (OspA) of Borrelia. It is designed for prophylactic, active immunization against Lyme disease aiming for protection against the majority of human pathogenic Borrelia species.

The VLA15 Lyme disease vaccine is designed to confer protection by raising antibodies that prevent Borrelia from migrating from ticks to humans after a bite. The safety profile is expected to be similar to other vaccines using the same technology that has been approved for active immunization in adults and children.

The medical need for a Lyme disease vaccine is steadily increasing as the disease footprint continues to widens in the USA and in Europe.

The VLA15 vaccine is currently the only active vaccine program in clinical development against Lyme disease. The program was granted Fast Track designation by the U.S. FDA in July 2017.

On April 30, 2020, Valneva and Pfizer announced they will work closely together throughout the development of VLA15. Pfizer will lead to late-stage development and have sole control of the commercialization of the vaccine.

On June 8, 2020, Valneva announced that the antitrust-related condition precedent for its collaboration agreement with Pfizer had been met.

On July 22, 2020, the Phase 2 study VLA15-201 announced it met its endpoints. Compared to Phase 1, the higher doses used in this trial elicited higher antibody responses across all serotypes. And, encouraging immunogenicity profile confirmed, including older adults.

Valneva announced various results and forecasts on August 4, 2020, highlighting the first Phase 2 study, conducted in the EU and US, the endpoint readout was immunogenicity at Day 85 (one month after finalization of primary immunization).

Valneva SE is a specialty vaccine company providing prevention against diseases with major unmet medical needs.

VLA15 Lyme Disease Vaccine Indication

Lyme disease is a systemic infection caused by Borrelia bacteria transmitted to humans by infected Ixodes ticks. It is considered the most common vector-borne illness in the Northern Hemisphere. 

The target population includes individuals at risk above 2 years of age living in endemic areas, people planning to travel to endemic areas to pursue outdoor activities and people at risk who have a history of Lyme disease (an infection with Borrelia does not confer protective immunity against all pathogenic Borrelia species).

Lyme Disease Diagnostic Tests

The U.S. CDC currently recommends a 2-step testing process for Lyme disease. Both steps are required and can be done using the same blood sample.

VLA15 Lyme Disease Vaccine Dosage

Valneva has been conducting two Phase 2 studies in parallel in more than 800 people. In the first study VLA15-201 a short vaccination schedule has been tested (0-1-2 month) in 572 subjects while in the second study, VLA15-202, a longer vaccination schedule (0-2-6 months) has been tested in 246 subjects. In both studies, people received 2-dose levels (either 135µg or 180µg) of VLA15 in 3 injections or placebo.

Valneva expects to report initial results for the second Phase 2 study, VLA15-202, within a few months. 

VLA15 Lyme Disease Vaccine News

October 20, 2020 - Valneva SE announced positive initial results for its second Phase 2 study (VLA15-202) of Lyme disease vaccine candidate VLA15, which investigated a vaccination schedule of Month 0-2-6 based on matching doses.VLA15 was generally safe across all doses and age groups tested. 

August 12, 2020 - A national survey was jointly created with Hollins University, Duke University, Clemson University, and the University of Rhode Island the goal to determine if coronavirus restrictions have affected the time that people or their pets spend outdoors and if this change is associated with an increased risk of exposure to ticks.

August 4, 2020 - Valneva Reports H1 Results Marked by Major Corporate Achievements.

July 31, 2020 - Health officials in the United Kingdom have reported the first locally transmitted babesiosis case. In addition, Public Health England saw the second ever UK-acquired case of tick-borne encephalitis.

July 22, 2020 - Valneva SE announced positive initial results for its first Phase 2 study (VLA15-201) of Lyme disease vaccine candidate VLA15, which was found immunogenic across all dose groups tested. Compared to Phase 1, the higher doses used in this trial elicited higher antibody responses across all serotypes. Seroconversion rates (SCR) in the highest dose ranged from 81.5% (ST1) to 95.8% (ST2).

June 8, 2020 – Valneva SE announced that the antitrust-related condition precedent for its Lyme vaccine collaboration agreement with Pfizer has been met. As a result, the Agreement is now effective and Valneva will receive a $130 million upfront payment. Valneva and Pfizer announced their collaboration at the end of April 2020 to develop and commercialize Valneva’s Lyme disease vaccine candidate VLA15, which is currently in Phase 2 clinical studies.

May 25, 2020 - Clinicians should be aware of the risk of Lyme carditis in patients presenting with atrioventricular (AV) block, especially those with a history of outdoor exposure in Lyme endemic areas, even if they do not endorse tick exposure or history of erythema migrans.

May 7, 2020 - Valneva Reports Q1 Results and Updates 2020 Guidance Following Major Lyme Partnering Deal.

April 30, 2020 – Valneva SE and Pfizer announced a collaboration to develop and commercialize Valneva’s Lyme disease vaccine candidate VLA15, which is currently in Phase 2 clinical studies. VLA15 is the only active Lyme disease vaccine program in clinical development today and covers six serotypes that are prevalent in North America and Europe.

March 24, 2020 - Valneva SE said it 'continues to closely follow the study monitoring/visits/blood draws within the COVID-19 framework and sees the Phase 2 progress as relatively unaffected. All testing activities relating to the data analysis are proceeding as planned to provide the first Phase 2 data mid-2020. The Company also re-affirms its commitment to complete the partnering process for late-stage development and commercialization in the next few months.

September 30, 2019 - Valneva SE announced that it has completed patient recruitment of the Phase 2 studies for its Lyme disease vaccine candidate, VLA15. Valneva SE said in a press release published on September 30, 2019, comprising immunogenicity and safety data from these studies are expected in mid-2020, will support the dose and vaccination schedule to be used in Phase 3 clinical studies.

July 1, 2019: A second Phase 2 clinical trial for the development of Lyme disease vaccine candidate VLA15 has been announced. Following the Run-In phase for Valneva’s first Phase 2 study VLA15-201, the 2 dosage levels (135µg and 180µg) have been selected for further development based on Data and Safety Monitoring Board clearance. 

June 12, 2019 - An independent Data Safety Monitoring Board has cleared 2 dosage levels to be used for clinical development.

September 1, 2017 - Brave New Worlds: The Expanding Universe of Lyme Disease.

Lyme Disease Clinical Trials

Clinical Trial NCT03970733: Alternative Schedule Study For VLA15, a Vaccine Candidate Against Lyme Borreliosis (Active) - Last Update Posted: April 13, 2020

  • The objectives for this Phase 2 VLA15-202 clinical study are to determine the optimal dosage level and vaccination schedule for use in Phase 3 pivotal field efficacy studies, based on immunogenicity and safety data. 
  • A total of 250 subjects will be randomized 2:2:1 into three treatment groups to receive either VLA15 with Alum (two different dose levels) or Placebo.
  • The study duration per subject will be a maximum of 19 months. Overall study Duration is estimated to be 21 months.

Clinical Trial NCT03769194: A Phase 2 Randomized, Controlled, Observer-blind Study to Determine the Immunogenicity and Safety of a Vaccine Against Lyme Borreliosis, in Healthy Adults Aged 18 to 65 Years.  (Active) - Last Update Posted: April 9, 2020

  • This ongoing Phase 2 study (VLA15-201) involves 120 subjects and testing of three dosage levels of VLA15, or placebo.
  • Enrolment of subjects for the run-in phase has been completed.
  • Based upon a final review of the run-in safety data by a Data Safety Monitoring Board (DSMB), the two highest safe doses will be taken further into the main study phase.

Clinical Trial NCT03010228:  A Phase 1 Study Assessing the Safety, Immunogenicity, and Dose-Response of VLA15, A New Vaccine Candidate Against Lyme Borreliosis (Completed)

This is an observer-blind, partially randomized, multi-center dose-escalation Phase I study which aims to assess the safety, immunogenicity, and dose-response of VLA15 in healthy adults aged below 40 years.

  • Overall 180 subjects will be enrolled in 6 treatment groups: VLA15 12µg with and w/o (without) Alum, VLA15 48µg with and w/o Alum, VLA15 90µg with and w/o Alum.
  • For the first 24 subjects, the study will be open-label and subjects will not be randomized but included in a staggered dose escalation scheme for safety precaution. Thereafter, the study will be conducted observer-blind in respect to the investigators and site staff involved in the clinical evaluation of subjects, subjects will be blinded as well.
  • The remaining 156 subjects will be randomized into the 6 treatment groups. I.M. vaccinations are administered on Days 0, 28 and 56 into the deltoid region of the non-dominant arm.
  • The study will investigate the safety and tolerability as well as the immunogenicity of VLA15.
  • The primary objective addresses the safety and tolerability of the vaccine up to three months after enrollment, i.e. 84 days after the first vaccination. The study includes 1 screening visit and 8 outpatient visits from day 0 through day 365. In addition, safety phone calls will be performed.

Booster Extension:

  • Subjects in the 48µg and 90µg dose Groups at the Belgian site, who received a complete primary immunization schedule (three vaccinations), will be included in a Booster Extension to investigate the safety and immunogenicity of a booster dose of VLA15 administered 13 months after the first immunization.
  • An extension analysis on safety and immunogenicity will be performed after the last subject has completed the last study visit at Month 19.
  • Additionally, an M14 interim analysis on immunogenicity data will be performed, when all subjects completed Month 14.
  • For inclusion in the Booster Extension of this study only subjects are eligible, who were enrolled in Belgium, completed the primary immunization schedule (three vaccinations) and were randomized into 48µg or 90µg dose groups with or without alum. Subjects included in the staggered dose-escalation phase will not be asked to participate in the Booster Extension for operational reasons.
10/20/2020 - 12:56