Phase 2 Study Of VLA15, A Vaccine Candidate Against Lyme Borreliosis, In A Healthy Pediatric And Adult Study Population

Pfizer625 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

625

Conditions

Lyme Borreliosis

Interventions

VLA15BIOLOGICAL

a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate

PlaceboBIOLOGICAL

PBS (Phosphate Buffered Saline)

Eligibility

Sex: ALLMin age: 5 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (19)

New England Research Associates

Bridgeport, Connecticut, United States

Stamford Therapeutics Consortium

Stamford, Connecticut, United States

Chase Medical Research, LLC

Waterbury, Connecticut, United States

Pediatric Associates of Conn. PC

Waterbury, Connecticut, United States

Clinical Research Institute, Inc.

Minneapolis, Minnesota, United States

Foundation Pediatrics

East Orange, New Jersey, United States

Med Clinical Research Partners, LLC

Irvington, New Jersey, United States

Meridian Clinical Research LLC

Binghamton, New York, United States

Rochester Clinical Research, Inc.

Rochester, New York, United States

Richmond Behavioral Associates

Staten Island, New York, United States

...and 9 more locations

Outcomes

Primary Outcomes

Percentage of Participants With Solicited Local and Solicited Systemic Adverse Events (AEs) Within 7 Days After Vaccination 1

Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness meeting grading scale (MGS), swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever.

Time frame: From Day 1 to Day 7 after vaccination 1 at Month 0

Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2

Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness MGS, swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever.

Time frame: From Day 1 to Day 7 after vaccination 2 at Month 2

Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3

Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness MGS, swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever.

Time frame: From Day 1 to Day 7 after vaccination 3 at Month 6

Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Any Vaccination During the Main Study Phase

Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness MGS, swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever.

Time frame: From Day 1 to Day 7 after any vaccination 1, 2 or 3 at Month 0, 2 and 6, respectively

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

GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay at Day 208 was presented in this outcome measure.

Time frame: At Day 208 (Month 7)

Secondary Outcomes

Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 1 Booster Dose

Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness MGS, swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever.

Time frame: From Day 1 to Day 7 after vaccination 1 booster dose at Month 18

Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 2 Booster Dose

Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness MGS, swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever.

Time frame: From Day 1 to Day 7 after vaccination 2 booster dose at Month 30

Percentage of Participants With Solicited Local and Solicited Systemic AEs Within 7 Days After Vaccination 3 Booster Dose

Participants or their legal guardians were required to record any solicited local and systemic AEs in the electronic diary. Solicited symptoms were pre-defined symptoms which were collected via an electronic diary. Solicited local AEs included pain, tenderness, erythema/redness MGS, swelling MGS and induration/hardening MGS. Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever.

Time frame: From Day 1 to Day 7 after vaccination 3 booster dose at Month 42

Percentage of Participants With Serious Adverse Events (SAEs)

A SAE was any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was another medically important condition.

Data from ClinicalTrials.gov

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Time frame: From Day 1 of vaccination 1 up to 6 months following the last booster dose (up to Month 48)

Percentage of Participants With Adverse Events of Special Interest (AESIs)

An AESI (serious or non-serious) was one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor were appropriate.

Time frame: From Day 1 of vaccination 1 up to 6 months following the last booster dose (up to Month 48)

Percentage of Participants With Unsolicited AE

An AE was any untoward medical occurrence in a participant administered an investigational product, whether or not related to this treatment. Unsolicited AEs were defined as any solicited local or systemic AE if it had an onset date more than 6 days after vaccination or any other symptom or untoward medical event.

Time frame: Up to 28 Days after vaccination 1, 2 or 3 at Month 0, 2 and 6, respectively, and up to 28 Days after vaccination 1, 2 or 3 booster dose at Month 18, 30 and 42, respectively

Percentage of Participants With SAEs, AESIs, Solicited and Unsolicited AEs Stratified by Age Group

Percentage of participants with SAEs, AESIs, solicited and unsolicited AEs stratified by age group 5-11, 12-17 and 18-65 years were reported. SAE: any untoward medical occurrence that at any dose: resulted in death; required inpatient hospitalization or prolongation of existing hospitalization; was life-threatening; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect; was another medically important condition. AESI: scientific and medical concern specific to the sponsor's product or program. Solicited AE: predefined reactions at injection site or systemic reactions after each vaccination. Unsolicited AEs: any solicited local or systemic AE if it had an onset date more than 6 days after vaccination or any other symptom or untoward medical event.

Time frame: SAEs & AESIs: From Day 1 of vaccination up to Month 48; Solicited AEs: from Day 1 to Day 7 after vaccination 1, 2, 3, 4, 5 and 6; Unsolicited AEs: up to 28 Days after vaccination 1, 2, 3, 4, 5 and 6

GMTs for IgG Against Each OspA Serotype (ST1 to ST6) at Baseline, Days 85, 180, 365 and Month 18

GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay were evaluated.

Time frame: Baseline; Days 85, 180 and 365; Month 18

Seroconversion Rate (SCR) at Days 85, 180, 208, 365 and Month 18

Seroconversion for enzyme linked immunosorbent assay (ELISA) was defined as a change from seronegative at baseline to seropositive at a measured time point. For participants who were OspA seropositive at baseline, seroconversion was defined as a greater than or equal to (\>=) 4-fold rise in IgG antibody titer from baseline. SCR was percentage of participants with seroconversion reported for each OspA serotype specific IgG ST1 to ST6, as determined by ELISA.

Time frame: Days 85, 180, 208 and 365; Month 18

Geometric Mean of the Fold Rise (GMFR) for IgG When Compared to Baseline Against Each OspA Serotype (ST1 to ST6) at Days 85 and 208

GMFR for IgG when compared to baseline against each OspA serotype ST1 to ST6, determined by IgG binding assay at Day 85 and Day 208 were evaluated.

Time frame: Days 85 and 208

GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at Baseline, Days 85, 180, 194, 365 and Month 18

GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay stratified by age group (5-11, 12-17 and 18-65 years) were evaluated. Day 194 data was reported for adult participants only as pre-specified in protocol.

Time frame: Baseline; Days 85, 180, 194 (18 to 65 years only) and 365; Month 18

SCR Stratified by Age Group at Days 85, 180, 194, 208, 365 and Month 18

Seroconversion for ELISA was defined as a change from seronegative at baseline to seropositive at a measured time point. For participants who were OspA seropositive at baseline, seroconversion was defined as a \>=4-fold rise in IgG antibody titer from baseline. SCR was percentage of participants with seroconversion reported for each OspA serotype specific IgG ST1 to ST6, as determined by ELISA. Day 194 data was reported for adult participants only as pre-specified in protocol.

Time frame: Days 85, 180, 194 (18 to 65 years only), 208 and 365; Month 18

GMFR for IgG When Compared to Baseline Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at Days 85 and 208

GMFR for IgG when compared to baseline against each OspA serotype ST1 to ST6, stratified by age group (5-11, 12-17 and 18-65 years) determined by IgG binding assay at Day 85 and Day 208 were evaluated.

Time frame: Days 85 and 208

GMTs for IgG Against Each OspA Serotype (ST1 to ST6) at Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48

GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay were evaluated.

Time frame: Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48

SCR at Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48

Time frame: Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48

GMFR for IgG Against Each OspA Serotype (ST1 to ST6) at Months 19, 31 and 43 During the Booster Phase

GMFRs for IgG were determined by IgG binding assay for each OspA serotype (ST1-ST6) at Months 19, 31, and 43 relative to the corresponding pre-booster timepoints Months 18, 30, and 42, respectively.

Time frame: Months 19, 31 and 43

GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48

GMTs for IgG against each OspA serotype ST1 to ST6, determined by an IgG binding assay stratified by age group (5-11, 12-17 and 18-65 years) were evaluated.

Time frame: Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48

SCR Stratified by Age Group at Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48

Time frame: Months 18, 19, 23, 26, 30, 31, 39, 42, 43 and 48

GMFR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Group at Months 19, 31 and 43 During the Booster Phase

GMFRs for IgG were determined by IgG binding assay for each OspA serotype (ST1-ST6), stratified by age group (5-11, 12-17 and 18-65 years) at Months 19, 31, and 43 relative to the corresponding pre-booster timepoints Months 18, 30, and 42, respectively.

Time frame: Months 19, 31 and 43