Clinical trial NCT04801420: Phase 2 Study Of VLA15, A Vaccine Candidate Against Lyme Borreliosis, In A Healthy Pediatric And Adult Study Population
Official title: SAFETY AND IMMUNOGENICITY STUDY OF VLA15, A MULTIVALENT RECOMBINANT OSPA BASED VACCINE CANDIDATE AGAINST LYME BORRELIOSIS: A RANDOMIZED, CONTROLLED, OBSERVER-BLIND PHASE 2 STUDY IN A HEALTHY PEDIATRIC AND ADULT STUDY POPULATION
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Lyme Borreliosis
Keywords: VLA15
Lyme Borreliosis
Vaccine
Lyme disease
Borrelia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Valneva Austria GmbH
First posted: 2021-03-17
Enrollment: 625
Sex: ALL
Minimum age (years): 5
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 50 months per subject.

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 all eligible subjects will receive booster injections with VLA15 or placebo at Month 18, 30 and 42.

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

Primary outcomes:
measure: Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1
timeFrame: From Day 1 to Day 7 after vaccination 1 at Month 0
measure: Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2
timeFrame: From Day 1 to Day 7 after vaccination 2 at Month 2
measure: Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3
timeFrame: From Day 1 to Day 7 after vaccination 3 at Month 6
measure: Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase
timeFrame: From Day 1 to Day 7 after vaccination 1, 2 or 3 at Month 0, 2 and 6 respectively
measure: 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
timeFrame: Day 208 (Month 7)
Secondary outcomes:
measure: Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Booster Dose
timeFrame: Within 7 days after booster dose
measure: Percentage of Participants With Serious Adverse Events (SAEs)
timeFrame: From Day 1 of vaccination up to Day 208 (Month 7)
measure: Percentage of Participants With Adverse Events of Special Interest (AESIs)
timeFrame: From Day 1 of vaccination up to Day 208 (Month 7)
measure: Percentage of Participants With Unsolicited Adverse Events
timeFrame: From Day 1 to Day 28 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively
measure: Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group
timeFrame: SAEs, AESIs: From Day 1 of vaccination (vac) up to Day 208 (Month 7), Solicited AEs: From Day 1 to Day 7 after vac 1, 2 and 3 at Month 0, 2 and 6, respectively; Unsolicited AEs: From Day 1 to Day 28 after vac 1, 2 and 3 at Month 0, 2 and 6, respectively
measure: GMTs for IgG Against Each OspA Serotype (ST1 to ST6) at Baseline, Day 85, Day 180 and Day 194 During the Main Study Phase
timeFrame: Baseline, Day 85, Day 180 and Day 194
measure: Seroconversion Rate for Each OspA Serotype (ST1 to ST6) Specific IgG at Day 85, 180, 194 and 208
timeFrame: Day 85, Day 180, Day 194 and Day 208
measure: 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
timeFrame: Baseline, Day 85 and 208
measure: 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
timeFrame: Baseline, Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208
measure: 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
timeFrame: Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208
measure: 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
timeFrame: Baseline, Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208
measure: GMTs for IgG Against Each OspA Serotype (ST1 to ST6) During the Booster Phase
timeFrame: Up to Month 48
measure: SCR for Each OspA Serotype (ST1 to ST6) IgG During the Booster Phase
timeFrame: Up to Month 48
measure: GMFR for IgG Against Each OspA Serotype (ST1 to ST6) at Month 19 During the Booster Phase
timeFrame: Month 19
measure: GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Cohort During the Booster Phase
timeFrame: Up to Month 48
measure: SCR for Each OspA Serotype (ST1 to ST6) IgG Stratified by Age Cohort During the Booster Phase
timeFrame: Up to Month 48
measure: GMFR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Cohort During the Booster Phase
timeFrame: Up to Month 48
Other outcomes:
Locations:
city: Bridgeport
country: United States
facility: New England Research Associates
state: Connecticut
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium
state: Connecticut
city: Waterbury
country: United States
facility: Chase Medical Research, LLC
state: Connecticut
city: Waterbury
country: United States
facility: Pediatric Associates of Conn. PC
state: Connecticut
city: Marlborough
country: United States
facility: Quest Diagnostics
state: Massachusetts
city: Minneapolis
country: United States
facility: Clinical Research Institute, Inc.
state: Minnesota
city: East Orange
country: United States
facility: Foundation Pediatrics
state: New Jersey
city: Irvington
country: United States
facility: Med Clinical Research Partners, LLC
state: New Jersey
city: Binghamton
country: United States
facility: Meridian Clinical Research LLC
state: New York
city: Bronx
country: United States
facility: Advantage Clinical Trials
state: New York
city: Pearl River
country: United States
facility: Pfizer Vaccine Research and Development
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Cleveland
country: United States
facility: Velocity Clinical Research, Inc.
state: Ohio
city: Erie
country: United States
facility: Allegheny Health and Wellness Pavilion
state: Pennsylvania
city: Erie
country: United States
facility: Liberty Family Practice
state: Pennsylvania
city: Fort Washington
country: United States
facility: Lockman & Lubell Pediatric Associates
state: Pennsylvania
city: Providence
country: United States
facility: Hasbro Children's Hospital
state: Rhode Island
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Warwick
country: United States
facility: Velocity Clinical Research Providence
state: Rhode Island
city: Berlin
country: Germany
facility: Synevo Studien Service Labor GmbH c/o Institut für Medizinische Diagnostik
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: