Lyme disease caused by Borrelia species Lyme disease and tick fever
Conditions
Interventions
Intervention Name: PF-07307405 (VLA15) (Vaccine) // Normal Saline (Placebo)
Unit dose strength: 0,5mL
Route of Administration: Intramuscular injection
IMP
Sourcing: Provided centrally by the sponsor
P
Sponsors
Pfizer
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1.Male or female participants >= 5 years of age at enrolment (younger population only recruited in countries that have received full regulatory approval). Type of Participant and Disease Characteristics: 2.Participants who reside in areas with endemic Lyme disease and who lead lifestyles that put them at increased risk for Lyme disease. 3.Participants or participants' parent(s)/legal guardian(s), who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures (younger population only recruited in countries that have received full regulatory approval). 4.Healthy male and female participants at enrollment 5.Capable of giving signed informed consent, and assent (as appropriate).
Exclusion criteria
Exclusion criteria: 1. Pregnant female participants. Participants unwilling or unable to use effective methods of contraception as outlined in this protocol from the signing of the informed consent through 28 days after completion of the primary vaccination series and from the booster dose through 28 days after the booster vaccination. Medical Conditions: 2. Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components. 3. Any diagnosis of Lyme disease within the past 3 months. 4. Any history of Lyme carditis, neuroborreliosis, arthritis, or other disseminated Lyme disease regardless of when diagnosed. 5. Known tick bite within the past 4 weeks. 6. Newly developed or unstable underlying conditions that may interfere with the assessment of Lyme disease, including but not limited to chronic arthralgia/arthritis, second/third-degree AV heart block, chronic pain syndromes, and chronic skin conditions that reduce the ability to detect cutaneous manifestations of Lyme disease. 7. Underlying clotting deficiency (eg, bleeding disorder, thrombocytopenia) that may increase the risk of excessive bleeding following required study procedures. 8. Congenital or acquired immunodeficiency or treatments that would inhibit the ability to mount an immune response to a vaccine. 9. Any unstable autoimmune condition with a manifestation (eg, arthritic and neurologic) that may interfere with the assessment of Lyme disease (Potential participants with well-controlled, stable autoimmune conditions under the care of a rheumatologist are eligible). 10. Underlying bone marrow disorder such as myelodysplasia, myeloma, or myeloproliferative disorder, treated within the past year, or any history of bone marrow transplant. 11. Malignancy that required treatment with chemotherapy (including the use of adjunctive and hormonal therapy), immunotherapy, radiation therapy, or antineoplastic target therapies within the past 24 months. 12. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. Prior/Concomitant Therapy: 13. Receipt of a previous vaccination for Lyme disease. 14. Treatment for Lyme disease in the 3 months prior to study intervention administration. 15. Chronic systemic doxycycline or minocycline or other tetracycline class drug use for acne or any other chronic suppressive antibiotics used to treat other conditions. 16. Receipt of blood/plasma products or immunoglobulins within 6 months before study intervention administration through conclusion of the study. 17. Receipt of systemic corticosteroids (>=20 mg/day of prednisone or equivalent) for >=14 days within 28 days before study intervention administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted. 18. Receipt of chronic systemic treatment with other known immunosuppressant medications, or radiotherapy, within 6 months before study intervention administration. 19. Receipt of anticoagulant therapy within 1 month before study intervention administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy: Clinically- and laboratory-confirmed Lyme disease caused by B burgdorferi sensu lato (as determined by the AC). VE, defined as the relative risk reduction of the clinically- and laboratory-confirmed Lyme disease cases in the VLA15 group compared to the placebo group, from 28 days after receiving the booster dose through the end of the Lyme disease season following the booster dose (end of October), and in compliance with the key protocol criteria (evaluable efficacy population). Primary Safety: * Local reactions (pain at the injection site, redness, and swelling). * Systemic events (fever, headache, fatigue, muscle pain, and joint pain). * AEs. * NDCMCs. * SAEs. Primary Immunogenicity (Lot-Consistency Subset): Anti-OspA quantitative immunological assay titer. In participants receiving all primary series and booster dose of 3 different lots of vaccine in compliance with the key predefined criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Efficacy: * Clinically- and laboratory-confirmed Lyme disease caused by B burgdorferi sensu lato (as determined by the AC). VE, defined as the relative risk reduction of the clinically- and laboratory-confirmed Lyme disease cases in the VLA15 group compared to the placebo group, from 28 days after receiving the booster dose through the end of the Lyme disease season following the booster dose (end of October), and in compliance with the key protocol criteria among participants enrolled from NA sites (evaluable efficacy population). *Clinically- and laboratory-confirmed Lyme disease caused by B burgdorferi sensu lato (as determined by the AC). VE, defined as the relative risk reduction of the clinically- and laboratory-confirmed Lyme disease cases in the VLA15 group compared to the placebo group, from 28 days after completing the primary series through the end of the Lyme disease season following the primary series (end of October), and in compliance with the key protocol criteria (evaluable efficacy population). | — |
Countries
Netherlands
Outcome results
None listed