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A Study to Learn About Different Dosing Schedules of a Lyme Disease Vaccine in Healthy Adults
A Study to Learn About Different Dosing Schedules of a Lyme Disease Vaccine in Healthy Adults

NCT07226882

Active Not RecruitingPhase 3

Sponsor: Pfizer

Conditions: Lyme Borreliosis

Interventions: VLA15, Placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 44 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* Pregnant or breastfeeding participants.
* 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.
* Any prior Lyme disease vaccination, or recent or concurrent participation in a separate interventional study.
* Staff or direct family of the study site staff and Sponsor.
Locations (6)
  • Warren Township, New Jersey, United States
  • Cortland, New York, United States
  • Horseheads, New York, United States
  • Pittsburgh, Pennsylvania, United States
  • Scranton, Pennsylvania, United States
  • Uniontown, Pennsylvania, United States