Study Assessing the Safety, Immunogenicity and Dose Response of VLA15, A New Vaccine Candidate Against Lyme Borreliosis
2 other identifiers
interventional
179
2 countries
5
Brief Summary
Observer-blind, partially randomized, multi-center dose escalation Phase I study in healthy adults below 40 years of age. 180 subjects will be enrolled in 6 treatment groups (different doses; different formulation: with/without adjuvant); vaccinations will be given I.M.(intramuscular) into the deltoid region on Days 0, 28 and 56. Study participants will be followed up until one year after first vaccination. Booster Extension: Subjects in the 48µg and 90µg Treatment groups who received a complete Primary immunization schedule will be included into a Booster Extension 13 months after the first immunization.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2017
Typical duration for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2016
CompletedFirst Posted
Study publicly available on registry
January 4, 2017
CompletedStudy Start
First participant enrolled
January 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 28, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 16, 2019
CompletedApril 5, 2023
March 1, 2023
8 months
December 21, 2016
March 31, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (8)
Rate of SAEs to Day 84
up to Day 84 (Month 3) after first vaccination
Rate of related SAEs to Day 84
up to Day 84 (Month 3) after first vaccination
Rate of any solicited or unsolicited Grade 3 or Grade 4 events up to Day 84
up to Day 84 (Month 3) after first vaccination
Rate of any solicited or related unsolicited Grade 3 or Grade 4 events up to Day 84
up to Day 84 (Month 3) after first vaccination
Rate of solicited local AEs within 7 days after each and after any vaccination up to Day 84
up to Day 84 (Month 3) after first vaccination
Rate of solicited systemic AEs within 7 days after each and after any vaccination up to Day 84
up to Day 84 (Month 3) after first vaccination
Rate of unsolicited AEs to Day 84, including clinically significant laboratory parameter changes
up to Day 84 (Month 3) after first vaccination
Rate of related unsolicited AEs to Day 84, including clinically significant laboratory parameter changes
up to Day 84 (Month 3) after first vaccination
Secondary Outcomes (10)
Rate of SAEs during the entire study period
up to Day 365 (Month 12)
Rate of related SAEs during the entire study period
up to Day 365 (Month 12)
Rate of any solicited or unsolicited Grade 3 or Grade 4 AEs during the entire study period
up to Day 365 (Month 12)
Rate of any solicited or related unsolicited Grade 3 or Grade 4 AEs during the entire study period
up to Day 365 (Month 12)
Rate of unsolicited AEs during the entire study period
up to Day 365 (Month 12)
- +5 more secondary outcomes
Study Arms (6)
VLA15 12 µg with Alum
ACTIVE COMPARATORVLA15 12 µg (microgram) with Alum has an injection volume of 100 µl (microliter). The amount of Alum per injection is 0.05 mg (milligram).
VLA15 12 µg w/o Alum
ACTIVE COMPARATORVLA15 12 µg (microgram) without (w/o) Alum (aluminum hydroxide) has an injection volume of 100 µl (microliter).
VLA15 48 µg with Alum
ACTIVE COMPARATORVLA15 48 µg (microgram) with Alum (aluminum hydroxide) has an injection volume of 400 µl (microliter). The amount of Alum per injection is 0.2 mg (milligram).
VLA15 48 µg w/o Alum
ACTIVE COMPARATORVLA15 48 µg (microgram) without (w/o) Alum (aluminum hydroxide) has an injection volume of 400 µl (microliter).
VLA15 90 µg with Alum
ACTIVE COMPARATORVLA15 90 µg (microgram) with Alum (aluminum hydroxide) has an injection volume of 750 µl (microliter). The amount of Alum per injection is 0.375 mg (milligram).
VLA15 90 µg w/o Alum
ACTIVE COMPARATORVLA15 90 µg (microgram) without (w/o) Alum (aluminum hydroxide) has an injection volume of 750 µl (microliter).
Interventions
I.M. vaccination with a multivalent outer surface protein A (OspA) based vaccine candidate on days 0, 28 and 56; three different doses
I.M. vaccination with a multivalent outer surface protein A (OspA) based vaccine candidate on days 0, 28 and 56; three different doses
Eligibility Criteria
You may qualify if:
- Healthy adults ≥18 to \<40 years of age (for US healthy adults ≥ 19 years to \<40 years) at the time of screening. Health status is assessed by investigator at time of screening based on medical history, physical examination, and laboratory parameters.
- Written informed consent obtained from the subject prior to any study related procedures.
- BMI ≥18.5 and \<30 at Visit 0 (Screening Visit).
- Men or women; women require a negative pregnancy test at screening. Women with childbearing potential must agree to use an adequate contraception during the entire study.
- Booster Extension:
- Completed Primary immunization schedule (three vaccinations)
- Randomization into 48µg or 90µg group with or without Alum
- Written informed consent for Booster Extension obtained from the subject prior to any study related procedures.
- Enrolled at study site in Belgium
- Men or women; women require a negative pregnancy test before booster vaccination. Women of childbearing potential must agree to use an adequate contraception during the entire study.
You may not qualify if:
- Pathological findings in any of the investigations (i.e. medical history, physical examination) as deemed clinically relevant by the investigator or any abnormal laboratory parameter of hematology, clinical chemistry, coagulation, RF (Rheumatoid Factor) or ACPA (Anti-citrullinated protein antibodies) at the Screening Visit.
- Medical history of severe cardiovascular, respiratory (including asthma), metabolic, neurological, hepatic, rheumatic, hematological, gastrointestinal, renal disorders.
- Medical history of or current musculoskeletal disorders as deemed clinically relevant by the investigator, arthritis or chronic musculoskeletal pain.
- Previous vaccination against Lyme borreliosis with any (investigational) vaccine.
- Use of any other investigational or non-registered medicinal product within 30 days prior to VLA15 vaccination at Visit 1 (Day 0) and throughout the entire study period.
- Chronic illness related to Lyme borreliosis (LB), a history of or active symptomatic LB as suspected or diagnosed by a physician. Subjects with a positive serology test result for Borrelia burgdorferi sensu lato (s.l.) antibodies at screening are excluded.
- Tick bite within 3 weeks prior to screening, or tick bite during vaccination period (i.e. Day 0 to Day 56).
- Known active infection with Babesia microti (babesiosis) or Anaplasma phagocytophilum (ehrlichiosis).
- Active or passive immunization four weeks before first vaccination at Visit 1 and up to Day 84 (i.e. 4 weeks after the last VLA15 immunization). Afterwards, vaccinations should be avoided, except for influenza (seasonal or pandemic) vaccines which may be administered after Day 84 (i.e. 4 weeks after the last VLA15 immunization). Subjects susceptible to require a vaccine during the study period (e.g. due to planned travel) should be excluded at screening.
- Known congenital, hereditary or acquired immunodeficiency, including infection with human immunodeficiency virus (HIV), status post organ transplantation or immuno-suppressive therapy within 30 days prior to Day 0 and up to Day 84. Immuno-suppressive therapy is defined as administration of chronic (longer than 14 days) prednisone or equivalent ≥ 0.05 mg/kg/day. Topical and inhaled steroids are allowed.
- Planned intake of NSAID (Nonsteroidal anti-inflammatory drug) within three days prior and within seven days after any VLA15 vaccination.
- History of severe hypersensitivity reactions and anaphylaxis.
- History of allergic bronchial asthma and severe allergic rhinoconjunctivitis.
- Known hypersensitivity or allergic reactions to one of the components of the vaccine.
- History of autoimmune disease, including Type I Diabetes mellitus. Subjects with vitiligo or thyroid disease taking thyroid hormone replacement are not excluded.
- +40 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Valneva Austria GmbHcollaborator
Study Sites (5)
eStudy Site
La Mesa, California, 91942, United States
eStudySite
La Mesa, California, 91942, United States
Celerion Inc.
Lincoln, Nebraska, 68502, United States
Celerion, Inc
Lincoln, Nebraska, 68502, United States
University Hospital Ghent
Ghent, 9000, Belgium
Related Publications (1)
Bezay N, Hochreiter R, Kadlecek V, Wressnigg N, Larcher-Senn J, Klingler A, Dubischar K, Eder-Lingelbach S, Leroux-Roels I, Leroux-Roels G, Bender W. Safety and immunogenicity of a novel multivalent OspA-based vaccine candidate against Lyme borreliosis: a randomised, phase 1 study in healthy adults. Lancet Infect Dis. 2023 Oct;23(10):1186-1196. doi: 10.1016/S1473-3099(23)00210-4. Epub 2023 Jul 4.
PMID: 37419129DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
- PRINCIPAL INVESTIGATOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2016
First Posted
January 4, 2017
Study Start
January 31, 2017
Primary Completion
September 28, 2017
Study Completion
January 16, 2019
Last Updated
April 5, 2023
Record last verified: 2023-03