Phase 2 Study Of VLA15, A Vaccine Candidate Against Lyme Borreliosis, In A Healthy Peadiatric And Adult Study Population
Study Details
Study Description
Brief Summary
VLA15-221 is a Phase 2 study, which will be conducted in two parts: Main Study Phase (Part A) and Booster Phase (Part B). The study will compare the safety and immunogenicity of two different primary immunization schedules applying three (Month 0-2-6) or two (Month 0-6) vaccinations. Within the study, 600 healthy subjects aged 5-65 years will be included. Subjects with a history of Lyme borreliosis (previous infection with Borrelia) as well as Borrelia naïve subjects will be enrolled. Study duration per subject will be a maximum of 19 months in Part A and additional 37 months for subjects enrolled in the Part B.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
VLA15-221 is a randomized, observer-blind, placebo controlled, multicenter Phase 2 study, which is set up in two parts: Main Study Phase (Part A) and Booster Phase (Part B). In Part A 600 subjects aged 5-65 years will be enrolled 1:1:1 into three groups: Group 1 will be vaccinated with VLA15 at Month 0-2-6, Group 2 will be vaccinated with VLA15 at Month 0-6 and with placebo at Month 2 and Group 3 will be vaccinated with placebo at Month 0-2-6. In Part B a subset of subjects will receive a booster injection with VLA15 or placebo at Month 18.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part A+B - Group 1 Part A: VLA15 at Month 0, 2 and 6 - Part B: VLA15 or placebo depending on schedule selection |
Biological: VLA15
a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate
Biological: Placebo
PBS (Phosphate Buffered Saline)
|
| Experimental: Part A+B - Group 2 Part A: VLA15 at Month 0 and 6, placebo at Month 2 - Part B: VLA15 or placebo depending on schedule selection |
Biological: VLA15
a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate
Biological: Placebo
PBS (Phosphate Buffered Saline)
|
| Placebo Comparator: Part A+B - Group 3 Placebo |
Biological: Placebo
PBS (Phosphate Buffered Saline)
|
Outcome Measures
Primary Outcome Measures
- Frequency of solicited local and solicited systemic AEs (Adverse Events) [7 Days]
Frequency of solicited local and solicited systemic AEs (Adverse Events) within 7 days after each and any vaccination of the primary vaccination series (Part A)
- GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype [Day 208/Month 7]
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype ST1 to ST6, determined by an IgG (Immunoglobulin G) binding assay at Day 208/Month 7 (Part A).
Secondary Outcome Measures
- Frequency of solicited local and solicited systemic AEs (Adverse Events) [7 Days]
Frequency of solicited local and solicited systemic AEs (Adverse Events) within 7 days after booster dose administration (Part B)
- Frequency of SAEs (Serious Adverse Events) [until Month 54]
Frequency of SAEs (Serious Adverse Events) during the entire study
- Frequency of AESIs (Adverse Events of Special Interest) [until Month 54]
Frequency of AESIs (Adverse Events of Special Interest) during the entire study.
- Frequency of unsolicited AEs (Adverse Events) after each vaccination [28 Days]
Frequency of unsolicited AEs (Adverse Events) within 28 days after each vaccination
- Frequency of SAEs (Serious Adverse Events), AESIs(Adverse Events of Special Interest), unsolicited and solicited AEs stratified by age cohort [until Month 54]
Frequency of SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), unsolicited and solicited AEs (Adverse Events) stratified by age cohort
- GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (Part A) [until Month 18]
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by an IgG (Immunoglobulin G) binding assay, at baseline (screening visit) and at Day 85, 180, 194, 365 and Month 18 (Part A)
- SCRs (Seroconversion Rates) for each OspA (Outer Surface Protein A) serotype specific IgG (Immunoglobulin G) (Part A) [until Month 18]
SCRs (Seroconversion Rates) for each OspA (Outer Surface Protein A) serotype specific IgG (Immunoglobulin G) (ST1 to ST6), determined by an IgG (Immunoglobulin G) binding assay, at Day 85, 180, 194, 208, 365 and Month 18 (Part A)
- GMFRs (Geometric Mean of the Fold Rises) for IgG against each OspA (Outer Surface Protein A) serotype (Part A) [until Day 208]
GMFRs (Geometric Mean of the Fold Rises) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by an IgG (Immunoglobulin G) binding assay, at Day 85 and 208 (Part A)
- GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype stratified by age cohort (Part A) [until Month 19]
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by an IgG (Immunoglobulin G) binging assay, at specified time-points, stratified by age cohort. (Part A)
- SCRs (Seroconversion Rates) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype stratified by age cohort (Part A) [until Month 19]
SCRs (Seroconversion Rates) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by an IgG (Immunoglobulin G) binging assay, at specified time-points, stratified by age cohort. (Part A)
- GMFRs (Geometric Mean Fold Rises) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype stratified by age cohort (Part A) [until Month 19]
GMFRs (Geometric Mean Fold Rises) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by an IgG (Immunoglobulin G) binging assay, at specified time-points, stratified by age cohort. (Part A)
- GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (Part B) [until Month 54]
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by an IgG (Immunoglobulin G) binding assay, at Month 18, 19, 23, 26, 30, 36, 42, 48 and 54 (Part B)
- SCRs (Seroconversion Rates) for each OspA (Outer Surface Protein A) serotype specific IgG (Immunoglobulin G) (Part B) [until Month 54]
SCRs (Seroconversion Rates) for each OspA (Outer Surface Protein A) serotype specific IgG (ST1 to ST6), determined by an IgG (Immunoglobulin G) binding assay, at Month 18, 19, 23, 26, 30, 36, 42, 48 and 54 (Part B)
- GMFRs (Geometric Mean of the Fold Rises) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (Part B) [Month 19]
GMFRs (Geometric Mean of the Fold Rises) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by an IgG (Immunoglobulin G) binding assay, at Month 19 (Part B)
- GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype stratified by age cohort (Part B) [until Month 54]
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by an IgG (Immunoglobulin G) binding assay, at specified time-points, stratified by age cohort. (Part B)
- SCRs (Seroconversion Rates) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype stratified by age cohort (Part B) [until Month 54]
SCRs (Seroconversion Rates) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by an IgG (Immunoglobulin G) binding assay, at specified time-points, stratified by age cohort. (Part B)
- GMFRs (Geometric Mean Fold Rises) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype stratified by age cohort (Part B) [until Month 54]
GMFRs (Geometric Mean Fold Rises) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by an IgG (Immunoglobulin G) binding assay, at specified time-points, stratified by age cohort. (Part B)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Subject is aged 5 to 65 years at the day of screening (Visit 0)
-
Subject is of good general health
-
Parent(s)/legal representative(s) and subject understand the study and its procedures, agree to its provisions
-
for subjects aged 18-65 years: written informed consent prior to any study related procedures
-
for subjects aged 5-17 years: written informed consent by the subject's legal representative(s), according to local requirements, and written informed assent of the subject, if applicable, prior to any study related procedures.
-
If subject is of childbearing potential: Subject has a negative serum pregnancy test at screening (Visit 0) and agrees to employ adequate birth control measures according to following timelines:
-
Main Study Phase: duration of entire study
-
Booster Phase: until Month 23 (i.e. 5 months after booster dose)
-
Subject is willing and able to comply with scheduled visits, treatment plan, and other study procedures
-
Subject is available for the duration of the study and can be contacted by telephone during study participation
Exclusion Criteria:
-
Subject has a chronic illness related to Lyme borreliosis (LB), an active symptomatic LB, or received treatment for LB within the last 3 months prior to Day 1;
-
Subject received previous vaccination against LB;
-
Subject had a tick bite within 4 weeks prior to Day 1;
-
Subject has a medical history of or currently has a clinically relevant disease;
-
Subject has a medical history of or currently has a neuro-inflammatory or autoimmune disease;
-
Subject has a known thrombocytopenia, bleeding disorder, or received anticoagulants in the 3 weeks prior to Day 1;
-
Subject has received an active or passive immunization within 4 weeks prior to Day 1;
-
Subject has received any other registered or non-registered medicinal product in another clinical trial within 4 weeks prior to vaccination at Day 1;
-
Subject has a known or suspected defect of the immune system or received immuno-suppressive therapy within 4 weeks prior to Day 1;
-
Subject has a history of anaphylaxis of unknown cause or severe allergic reactions of unknown cause or has a known hypersensitivity or allergic reactions to one of the components of the vaccine;
-
Subject had any malignancy in the past 5 years;
-
Subject is pregnant, has plans to become pregnant during the course of the study or is lactating at the time of enrollment;
-
Subject has donated or plans to donate blood or blood-derived products 4 weeks prior to Day 1;
-
Subject has any condition that may compromise its well-being, might interfere with evaluation of study endpoints, or would limit the subject's ability to complete the study;
-
Subject is in a dependent relationship;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stamford Therapeutics Consortium | Stamford | Connecticut | United States | 06905 |
| 2 | Chase Medical Research, LLC | Waterbury | Connecticut | United States | 06708 |
| 3 | Clinical Research Institute, Inc. | Minneapolis | Minnesota | United States | 55402 |
| 4 | Med Clinical Research Partners, LLC/ Foundation Pediatrics | Irvington | New Jersey | United States | 07111 |
| 5 | Meridian Clinical Research, LLC | Binghamton | New York | United States | 13901 |
| 6 | Advantage Clinical Trials | Bronx | New York | United States | 10468 |
| 7 | Rochester Clinical Research, Inc. | Rochester | New York | United States | 14609 |
| 8 | Richmond Behavioral Associates | Staten Island | New York | United States | 10312 |
| 9 | Velocity Clinical Research - Cleveland | Cleveland | Ohio | United States | 44122 |
| 10 | Square-1 Clinical Research, Inc. - AHN Health and Wellness Pavilion | Erie | Pennsylvania | United States | 16506 |
| 11 | Sqare-1 Clinical Research - Liberty Family Practice | Erie | Pennsylvania | United States | 16508 |
| 12 | Lockman & Lubell Pediatric Associates | Fort Washington | Pennsylvania | United States | 19034 |
| 13 | The Miriam Hospital - Lifespan Clinical Research Center | Providence | Rhode Island | United States | 02906 |
| 14 | Velocity Clinical Research - Providence | Warwick | Rhode Island | United States | 02886 |
Sponsors and Collaborators
- Valneva Austria GmbH
- Pfizer
Investigators
- Study Chair: Valneva Clinical Development, Valneva Austria GmbH
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VLA15-221