Phase 2
N=625
Phase 2 Study Of VLA15, A Vaccine Candidate Against Lyme Borreliosis, In A Healthy Pediatric And Adult Study Population
Lyme Borreliosis
Bottom Line
View on ClinicalTrials.gov: NCT04801420 ↗Enrolled (actual)
625
Serious AEs
1.0%
Results posted
Jun 2023
Primary outcome: Primary: Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 — 63.0; 59.3; 12.5; 60.4 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- VLA15 (Biological); Placebo (Biological)
- Age
- Pediatric, Adult, Older Adult · 5+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1 |
63.0; 59.3; 12.5; 60.4; 44.5; 81.6 | — |
| PRIMARY Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 |
56.8; 7.9; 8.4; 32.1; 24.3; 81.4 | — |
| PRIMARY Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 |
57.3; 62.4; 5.6; 59.5; 41.7; 74.3 | — |
| PRIMARY Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase |
80.5; 77.0; 16.8; 77.0; 57.0; 92.6 | — |
| PRIMARY Geometric Mean Titers (GMTs) for Immunoglobulin G (IgG) Against Each Outer Surface Protein A (OspA) Serotype (ST1 to ST6) at Day 208 During the Main Study Phase |
333.2; 197.3; 23.8; 656.0; 460.3; 21.9 | — |
| SECONDARY Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Booster Dose |
— | — |
| SECONDARY Percentage of Participants With Serious Adverse Events (SAEs) |
0.0; 1.1; 1.9; 0.7; 1.1 | — |
| SECONDARY Percentage of Participants With Adverse Events of Special Interest (AESIs) |
0.0; 0.5; 0.0; 1.2; 0.8 | — |
| SECONDARY Percentage of Participants With Unsolicited Adverse Events |
16.8; 25.1; 24.5; 20.9; 22.1 | — |
| SECONDARY Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group |
0.0; 1.1; 1.9; 0.5; 0.9; 0.0 | — |
| SECONDARY GMTs for IgG Against Each OspA Serotype (ST1 to ST6) at Baseline, Day 85, Day 180 and Day 194 During the Main Study Phase |
— | — |
| SECONDARY Seroconversion Rate for Each OspA Serotype (ST1 to ST6) Specific IgG at Day 85, 180, 194 and 208 |
— | — |
| SECONDARY Geometric Mean of the Fold Rise (GMFR) for IgG Against Each OspA Serotype (ST1 to ST6) at Day 85 and Day 208 During the Main Study Phase |
— | — |
| SECONDARY GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at Baseline, Day 85, Day 180, Day 194 and Day 208 During the Main Study Phase |
— | — |
| SECONDARY Seroconversion Rate for Each OspA Serotype (ST1 to ST6) Specific IgG at Day 85, 180, 194 and 208 Stratified by Age Group During the Main Study Phase |
— | — |
| SECONDARY Geometric Mean of the Fold Rise (GMFR) for IgG Against Each OspA Serotype (ST1 to ST6) at Day 85, Day 180, Day 194 and Day 208 Stratified by Age Group During the Main Study Phase |
— | — |
| SECONDARY GMTs for IgG Against Each OspA Serotype (ST1 to ST6) During the Booster Phase |
— | — |
| SECONDARY SCR for Each OspA Serotype (ST1 to ST6) IgG During the Booster Phase |
— | — |
| SECONDARY GMFR for IgG Against Each OspA Serotype (ST1 to ST6) at Month 19 During the Booster Phase |
— | — |
| SECONDARY GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Cohort During the Booster Phase |
— | — |
| SECONDARY SCR for Each OspA Serotype (ST1 to ST6) IgG Stratified by Age Cohort During the Booster Phase |
— | — |
| SECONDARY GMFR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Cohort During the Booster Phase |
— | — |
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 50 months per subject.
Eligibility 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 5 months after each booster vaccination (Booster 1 until Month 23, Booster 2 until Month 35 and Booster 3 until Month 47)
- 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 with the sponsor/investigator
Data sourced from ClinicalTrials.gov (NCT04801420). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.