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Completed

NCT Number: NCT04801420

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

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.

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Key information

Conditions

Lyme Borreliosis Bacterial Infections Bacterial Infections and Mycoses Borrelia Infections Gram-Negative Bacterial Infections Infections Lyme Disease Spirochaetales Infections Tick-Borne Diseases Vector Borne Diseases

Age range

5 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

New England Research Associates, Bridgeport, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VLA15

Biological

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

Placebo

Biological

PBS (Phosphate Buffered Saline)

Primary outcomes

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

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

    Participants or their legal guardians were required to record any solicited local and systemic adverse events 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), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method.

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

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

    Participants or their legal guardians were required to record any solicited local and systemic adverse events 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), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method.

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

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

    Participants or their legal guardians were required to record any solicited local and systemic adverse events 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), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method.

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

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

    Participants or their legal guardians were required to record any solicited local and systemic adverse events 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), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever. Two-sided 95% confidence intervals were calculated according to Altman method.

  5. 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

    Time frame: Day 208 (Month 7)

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

Secondary outcomes

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

    Time frame: Within 7 days after booster dose

    Participants or their legal guardians were required to record any solicited local and systemic adverse events in the electronic diary. Solicited local AEs included pain, tenderness, erythema (redness), swelling and induration (hardening). Solicited systemic AEs included headache, muscle pain, joint pain, nausea, vomiting, fatigue and fever.

  2. Percentage of Participants With Serious Adverse Events (SAEs)

    Time frame: From Day 1 of vaccination up to Day 208 (Month 7)

    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. Two-sided 95% confidence intervals were calculated according to Altman method.

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

    Time frame: From Day 1 of vaccination up to Day 208 (Month 7)

    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. Two-sided 95% confidence intervals were calculated according to Altman method.

  4. Percentage of Participants With Unsolicited Adverse Events

    Time frame: From Day 1 to Day 28 after vaccination 1, 2 and 3 at Month 0, 2 and 6, respectively

    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. Two-sided 95% confidence intervals were calculated according to Altman method.

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

    Time frame: 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

    Percentage of participants with SAEs, AESIs, solicited and unsolicited AEs stratified by age group 18 to 65, 12 to 17 and 5 to 11 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. Unsolicited AEs were collected only up to 28 days after any vaccination. Two-sided 95% confidence intervals were calculated according to Altman method.

  6. GMTs for IgG Against Each OspA Serotype (ST1 to ST6) at Baseline, Day 85, Day 180 and Day 194 During the Main Study Phase

    Time frame: Baseline, Day 85, Day 180 and Day 194

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

  7. Seroconversion Rate for Each OspA Serotype (ST1 to ST6) Specific IgG at Day 85, 180, 194 and 208

    Time frame: Day 85, Day 180, Day 194 and Day 208

    Seroconversion Rate (SCR) for each OspA serotype specific IgG ST1 to ST6, determined by enzyme linked immunosorbent assay (ELISA). Seroconversion for ELISA was defined as: 1) For participants who were seronegative at screening: percentage of participants with a change from seronegative at screening to seropositive (i.e. antibody titer of >=40 Units per milliliter [U/mL]) at a certain time point. 2) For participants who were seropositive at screening: percentage of participants with a >= 4-fold rise in OspA IgG antibody titer from screening.

  8. 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

    Time frame: Baseline, Day 85 and 208

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

  9. 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

    Time frame: Baseline, Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208

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

  10. 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

    Time frame: Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208

    SCR for each OspA serotype specific IgG ST1 to ST6, determined by ELISA stratified by age group (18 to 65, 12 to 17 and 5 to 11 years). Seroconversion for ELISA was defined as: 1) For participants who were seronegative at screening: percentage of participants with a change from seronegative at screening to seropositive (i.e. antibody titer of >=40 Units per milliliter [U/mL]) at a certain time point. 2) For participants who were seropositive at screening: percentage of participants with a >= 4-fold rise in OspA IgG antibody titer from screening.

  11. 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

    Time frame: Baseline, Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208

    GMFR as compared to baseline for IgG against each OspA serotype ST1 to ST6, stratified by age group (18 to 65, 12 to 17 and 5 to 11 years) determined by IgG binding assay at Day 85, Day 180, Day 194 (18 to 65 years only) and Day 208.

  12. GMTs for IgG Against Each OspA Serotype (ST1 to ST6) During the Booster Phase

    Time frame: Up to Month 48

  13. SCR for Each OspA Serotype (ST1 to ST6) IgG During the Booster Phase

    Time frame: Up to Month 48

    Seroconversion for ELISA was defined as: 1) For participants who were seronegative at screening: a change from seronegative at screening to seropositive (i.e. antibody titer of >=40 U/mL) at a certain time point. 2) For participants who were seropositive at screening: a >= 4-fold rise in OspA IgG antibody titer from screening.

  14. GMFR for IgG Against Each OspA Serotype (ST1 to ST6) at Month 19 During the Booster Phase

    Time frame: Month 19

  15. GMTs for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Cohort During the Booster Phase

    Time frame: Up to Month 48

  16. SCR for Each OspA Serotype (ST1 to ST6) IgG Stratified by Age Cohort During the Booster Phase

    Time frame: Up to Month 48

    Seroconversion for ELISA was defined as: 1) For participants who were seronegative at screening: a change from seronegative at screening to seropositive (i.e. antibody titer of >=40 U/mL) at a certain time point. 2) For participants who were seropositive at screening: a >= 4-fold rise in OspA IgG antibody titer from screening.

  17. GMFR for IgG Against Each OspA Serotype (ST1 to ST6) Stratified by Age Cohort During the Booster Phase

    Time frame: Up to Month 48

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Valneva Austria GmbH

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2025
First posted
Mar 17, 2021
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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