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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:
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.
This is a Phase 3, randomized, parallel-group, placebo-controlled, double-blinded (third-party unblinded) study to evaluate the safety, tolerability, and immunogenicity of different vaccination schedules of the 6-valent OspA-based Lyme disease (LD) vaccine, VLA15, in healthy participants 18 through 44 years of age.
Participants will be randomized in a 1:1:1:1 ratio to 1 of the 4 parallel study groups. Each participant will receive 4 doses of VLA15 and 1 dose of placebo (saline) at different time points. This study will use an external data monitoring committee (EDMC). The EDMC is independent of the Pfizer study team and includes only external members. The EDMC charter describes the role of the EDMC in more detail.
Approximately 200 participants will be enrolled in the study.
Healthy individuals 18 through 44 years of age who are willing to comply with all study procedures and provide signed informed consent will be enrolled. Pregnant or breastfeeding individuals and fertile individuals who are unwilling or unable to use effective contraceptive methods as outlined in this protocol will not be enrolled. Individuals who have contraindication to vaccination, conditions or treatments that can inhibit the ability to mount an immune response to a vaccine, or other conditions that may increase the risk of study participation will be excluded from this study. Individuals who have previously received a licensed or investigational vaccine for LD will also be excluded from this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Participants will receive 4 doses of VLA15 and 1 dose of placebo injection at different visits. Placebo will be given at Visit 3. Injections will be given as intramuscular shots. |
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| Group 2 | Experimental | Participants will receive 4 doses of VLA15 and 1 dose of placebo injection at different visits. Placebo will be given at Visit 5. Injections will be given as intramuscular shots. |
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| Group 3 | Experimental | Participants will receive 4 doses of VLA15 and 1 dose of placebo injection at different visits. Placebo will be given at Visit 7. Injections will be given as intramuscular shots. |
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| Group 4 | Experimental | Participants will receive 4 doses of VLA15 and 1 dose of placebo injection at different visits. Placebo will be given at Visit 9. Injections will be given as intramuscular shots. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VLA15 | Biological | Participants will receive IM injection of 6-valent OspA-based Lyme disease vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Concentration (GMC) of Anti-Outer Surface Protein A (OspA) Immunoglobulin G (IgG) | At 1 month after the fourth VLA15 dose | |
| Geometric Mean Fold Rise (GMFR) of Anti-Outer Surface Protein A (OspA) Immunoglobulin G (IgG) Concentrations | Before the first dose to 1 month after the fourth VLA15 dose | |
| Sero-Response Rate Based on Anti-Outer Surface Protein A (OspA) Immunoglobulin G (IgG) Concentrations. | Before the first dose to 1 month after the fourth VLA15 dose | |
| Percentage of Participants With Local Reactions For Each Group | Within 7 days after each vaccination | |
| Percentage of Participants With Systemic Events For Each Group | Within 7 days after each vaccination | |
| Percentage of Participants With Adverse Events (AEs) For Each Group | Within 1 month after each vaccination | |
| Percentage of Participants With Serious Adverse Events (SAEs) For Each Group | From the time the participant provides informed consent up to approximately 6 months after the last vaccination | |
| Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) For Each Group | From the time the participant provides informed consent up to approximately 6 months after the last vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Concentration (GMC) of Anti-Outer Surface Protein A (OspA) Immunoglobulin G (IgG) | At 1 month after the third VLA15 dose | |
| Geometric Mean Fold Rise (GMFR) of Anti-Outer Surface Protein A (OspA) Immunoglobulin G (IgG) Concentrations | Before the first dose to 1 month after the third VLA15 dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IMA Clinical Research Warren | Warren Township | New Jersey | 07059 | United States | ||
| Smith Allergy and Asthma Specialists |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Term |
|---|---|
| D008193 | Lyme Disease |
| D020852 | Lyme Neuroborreliosis |
| ID | Term |
|---|---|
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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Third-party unblinded
| Placebo | Biological | Saline |
|
| Sero-Response Rate Based on Anti-Outer Surface Protein A (OspA) Immunoglobulin G (IgG) Concentrations. | Before the first dose to 1 month after the third VLA15 dose |
| Cortland |
| New York |
| 13045 |
| United States |
| Smith Allergy & Asthma Specialists | Horseheads | New York | 14845 | United States |
| Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18) | Pittsburgh | Pennsylvania | 15236 | United States |
| Northeast Clinical Trials Group | Scranton | Pennsylvania | 18510 | United States |
| Preferred Primary Care Physicians | Uniontown | Pennsylvania | 15401 | United States |
| D001899 | Borrelia Infections |
| D013145 | Spirochaetales Infections |
| D017282 | Tick-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D020806 | Central Nervous System Bacterial Infections |
| D002494 | Central Nervous System Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |