A Study to Learn About Different Dosing Schedules of a Lyme Disease Vaccine in Healthy Adults
A legfontosabb adatok
- Hol
- Cortland, Horseheads, Pittsburgh, Scranton, Uniontown és Warren Township (Egyesült Államok)Mind a 6 helyszín megnézése
- Fázis
- 3. fázis
Helyszínek itt: Egyesült Államok
- Smith Allergy and Asthma SpecialistsCortland, Egyesült ÁllamokNo longer taking part
- Smith Allergy & Asthma SpecialistsHorseheads, Egyesült ÁllamokNo longer taking part
- Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)Pittsburgh, Egyesült ÁllamokNo longer taking part
- Northeast Clinical Trials GroupScranton, Egyesült ÁllamokNo longer taking part
- Preferred Primary Care PhysiciansUniontown, Egyesült ÁllamokNo longer taking part
- IMA Clinical Research WarrenWarren Township, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- Pfizer
- Azonosító
- NCT07226882
- A regiszteradat frissítve
- 2026. május 6.
- Eredeti leírás
The purpose of this study is to learn about the safety and effects of the Lyme disease vaccine (called VLA15) when given at different time points.A teljes eredeti leírásKevesebb
A PHASE 3, PLACEBO-CONTROLLED, DOUBLE-BLINDED, RANDOMIZED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF DIFFERENT VACCINATION SCHEDULES OF 6-VALENT OSPA-BASED LYME DISEASE VACCINE, VLA15, IN HEALTHY ADULT PARTICIPANTS
The purpose of this study is to learn about the safety and effects of the Lyme disease vaccine (called VLA15) when given at different time points.
This study is seeking participants who:
* are generally healthy and between 18 and 44 years of age, * have never had a vaccine for Lyme disease before, * are not currently taking, or haven't recently taken, medicines like chemotherapy, blood products, or blood thinners, and * are not pregnant or breastfeeding and do not plan to become pregnant while receiving the study vaccine.
All participants in this study will receive a total of 5 doses through a shot in the upper arm. Four doses will be the study vaccine (VLA15), and 1 dose will be saltwater.
The study will compare the experiences of people receiving the study vaccine at different time points. This will help see if the study vaccine is safe and will help understand its effect on the body.
Participants will take part in this study for about 2 years. During this time, the participants will have 11 planned visits - 8 will be at the study clinic and 3 will be done over the phone. The clinic visits may include having a health check, giving a small amount of blood (about 20 mL or 4 teaspoons), and getting the study vaccine or saltwater as a shot.
Bevonási feltételek: Participants who are healthy as determined by medical history and clinical judgment; Participants willing and able to comply with all scheduled visits, IP receipt, and other procedures throughout the study; Able to provide Informed Consent.
Kizáró feltételek: Any prior Lyme disease vaccination, or recent or concurrent participation in a separate interventional study; Allergies or contraindications to vaccines or their components; Health issues including: blood clotting deficiencies, immunodeficiencies, bone marrow disorder, or uncontrolled psychiatric conditions; Receipt of therapies to treat malignancies, blood/plasma products and immunoglobulins, systemic corticosteroids and immunosuppressants, or anticoagulant therapy in recent medical history; Pregnant or breastfeeding participants; Staff or direct family of the study site staff and Sponsor.