Lyme BorreliosisPhase 2NCT03769194

Immunogenicity and Safety Study of a Vaccine Against Lyme Borreliosis, in Healthy Adults Aged 18 to 65 Years. Randomized, Controlled, Observer-blind Phase 2 Study.

A Phase 2 study testing VLA15 in people with Lyme Borreliosis, run by Pfizer at 9 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a randomized, observer-blind, placebo controlled, multicenter Phase 2 study conducted in two study phases: a run-in phase and a main study phase. The study was investigated 3 doses of a multivalent OspA (Outer Surface Protein A) based Lyme vaccine (VLA15) in healthy adults aged 18 to 65 years of age. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Lyme Borreliosis
What is being tested?: VLA15
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 572 participants
Where: 9 sitesin 3 countries
Study dates: 17 Dec 2018to 2 Oct 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Run-in phase:
1. Subject is aged 18 to 40 years at the day of screening (Visit 0);
Main Study phase:
Subject is aged18 to 65 years at the day of screening (Visit 0);
Run-in phase and Main Study phase:
Subject is of good general health, including subjects with pharmacologically controlled chronic conditions;

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Subject has an understanding of the study and its procedures, agrees to its provisions, and gives written informed consent prior to any study-related procedures;
If subject is of childbearing potential:
Subject has a negative serum pregnancy test at screening (Visit 0);
Subject agrees to employ adequate birth control measures for the duration of the study.

Who cannot join

Subject has a chronic illness related to Lyme borreliosis (LB), an active symptomatic LB (Lyme borreliosis) as suspected or diagnosed by a physician, or received treatment for LB (Lyme borreliosis) within the last 3 months prior to Visit 0;
Subject received previous vaccination against Lyme borreliosis (LB).;
Subject had a tick bite within 4 weeks prior to Visit 1;
Subject has a medical history of or currently has a clinically relevant disease (cardiovascular, respiratory, neurologic, psychiatric conditions) which poses a risk for participation in the study, based on investigators judgement, such as individuals with poorly controlled or unstable disease, ongoing suspected or active inflammation, or poor compliance with pharmacologic treatment. Subjects with pharmacologically controlled conditions like osteoarthritis, depression, or asthma are eligible;
Subject has a medical history of or currently has a neuroinflammatory or autoimmune disease, including Guillain Barré Syndrome;
Subject has a known thrombocytopenia, bleeding disorder, or received anticoagulants in the 3 weeks prior to first vaccination or until Day 57 (Visit 3), contraindicating intramuscular vaccination as judged by the investigator;

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Subject has received an active or passive immunization within 28 days before first vaccination at Visit 1 and until Day 85; except for influenza (seasonal or pandemic) and pneumococcal vaccines which may be administered outside a 7-days interval before or after any trial vaccination;
Subject has received any other non-registered medicinal product in another clinical trial within 28 days prior to VLA15 vaccination at Visit 1 (Day 1) and throughout the entire study period or has received a registered medicinal product in another clinical trial within 28 days prior to VLA15 vaccination at Visit 1 (Day 1) and up to Day 85;
Subject has a known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired immunodeficiency, including infection with human immunodeficiency virus (HIV), status post organ transplantation or immuno-suppressive therapy within 30 days prior to Visit 1. Immuno-suppressive therapy is defined as administration of chronic (longer than 14 days) prednisone or equivalent 0.05 mg per kg/ per day. Topical and inhaled steroids are allowed;
Subject has a history of anaphylaxis or severe allergic reactions or a known hypersensitivity or allergic reactions to one of the components of the vaccine;
Subject had any malignancy in the past 5 years. If treatment for cancer was successfully completed more than 5 years ago and the malignancy is considered to be cured, the subject may be enrolled;
Subject had acute febrile infections within 10 days prior to first vaccination;
Subject is pregnant (positive serum pregnancy test at screening), has plans to become pregnant during the course of the study or is lactating at the time of enrollment. Women of childbearing potential that are unwilling or unable to employ an adequate birth control measure for the duration of the study.
Subject has donated blood or blood-derived products (plasma) within 30 days or received blood or blood-derived products (plasma) within 90 days prior to first vaccination in this study or plans to donate or use blood or blood products during the course of the study;
Subject has any condition that, in the opinion of the investigator, may compromise the subject's well-being, might interfere with evaluation of study endpoints, or would limit the subject's ability to complete the study;
Subject is committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities);
Subject is in a dependent relationship with the sponsor, an investigator or other study team member, or the study center. Dependent relationships include close relatives and household members (i.e. children, partner/spouse, siblings, parents) as well as employees of the investigator or study center personnel.

Trial locations and contacts

9 sites in 3 countries.

Country

City, postcode or hospital

9 sites in 3 countries

United States6 sites

United Medical Associates
Binghamton, New York, 13901
Regional Clinical Research, Inc.
Endwell, New York, 13706
Clinical Research Consulting, LLC
Milford, Connecticut, 06460
Rochester Clinical Research Inc.
Rochester, New York, 14609
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905
Omega Medical Research
Warwick, Rhode Island, 02886

Other trials in United States

Germany2 sites

Berliner Centrum für Reise- und Tropenmedizin (BCRT)
Berlin, 10117
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20359

Other trials in Germany

Belgium1 site

Cevac Center for vaccinology
Ghent, 9000

Other trials in Belgium

About this study

Official title: Immunogenicity and Safety Study of VLA15, A Multivalent Recombinant OspA (Outer Surface Protein A) Based Vaccine Candidate Against Lyme Borreliosis, in Healthy Adults Aged 18 to 65 Years. A Randomized, Controlled, Observer-blind Phase 2 Study.

Read the detailed description

This is a randomized, observer-blind, placebo controlled, multicenter Phase 2 study.

In the Run-in phase, a total of 120 subjects aged 18 to 40 years were randomized 1:1:1:1 to receive one of three VLA15 doses (VLA15 low dose (90 µg), VLA15 medium dose (135 µg), VLA15 high dose (180 µg)) or Placebo as intramuscular vaccinations on Days 1, 29 and 57.

Dosing was adjusted by injection volume.

In the Main Study phase, a total of 452 subjects aged 18 to 65 years were randomized 2:2:1 to receive VLA15 135 µg or VLA15 180 µg, the two dose groups were selected from the Run-in-Phase or placebo, as intramuscular vaccinations on Days 1, 29 and 57. Subjects were enrolled in two age groups (18-49 years and 50-65 years) in a ratio of approx. 2:1.

In both study phases, target was to enroll approx. 10 % or more of subjects that were baseline seropositive for Borrelia burgdorferi sensu latu (Bb s.l.).

Conditions: Lyme Borreliosis
Being tested: VLA15, Placebo
Keywords: VLA15, Lyme Borreliosis, Vaccine
Medical subject headings: Lyme Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VLA15Biological
a multivalent recombinant Outer surface protein A (OspA) based vaccine candidate
PlaceboBiological
Placebo: PBS (Phosphate Buffered Saline)

Study groups in NCT03769194
Study group	Role	What they receive
VLA15 low dose	Active comparator	VLA15 low dose with Alum. Receives: Biological: VLA15
VLA15 medium dose	Active comparator	VLA15 medium dose with Alum. Receives: Biological: VLA15
VLA15 high dose	Active comparator	VLA15 high dose with Alum. Receives: Biological: VLA15
Placebo	Placebo comparator	Not described Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype ST1 to ST6
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype ST1 to ST6, determined by ELISA at Day 85.
GMTs are calculated based on the number of subjects with non-missing results.
Measured: at Day 85 / Month 3

Secondary outcomes (19)

GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) (Outer Surface Protein A) serotype (ST1 to ST6), determined by ELISA.
GMTs are calculated based on the number of subjects with non-missing results.
Measured: up to Day 365 / Month 12
SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),
Seroconversion for ELISA is defined as:
- for subjects that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive (i.e. antibody titer of ≥40 U/mL) at a certain time point.
- for subjects that are seropositive at Visit 1 (baseline): a ≥ 4-fold rise in IgG antibody titer from Visit 1.
Percentages are based on the number of subjects with non-missing observations.
Measured: up to Day 365 / Month 12
GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
GMFR (Geometric Mean of the Fold Rise as compared to baseline) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by ELISA.
Calculations are based on number of subjects with non-missing results.
Measured: up to Day 365 / Month 12
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype (ST1 to ST6), determined by ELISA, stratified by age group - Group 18 - 49 years.
GMTs are calculated based on the number of subjects with non-missing results.
Measured: up to Day 365 / Month 12
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6), determined by ELISA, stratified by age group - Group 50 - 65 years.
GMTs are calculated based on the number of subjects with non-missing results.
Measured: up to Day 365 / Month 12
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
SCRs (Seroconversion Rate) for Seroconversion for ELISA is defined as:
- for subjects that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive (i.e. antibody titer of ≥40 U/mL) at a vertain time point.
- for subjects that are seropositive at Visit 1 (baseline): a ≥ 4-fold rise in IgG antibody titer from Visit 1.
Percentages are based on the number of subjects with non-missing observations.
Measured: up to Day 365 / Month 12
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
Seroconversion for ELISA is defined as:
- for subjects that are seronegative at Visit 1 (baseline): a change from seronegative at Visit 1 to seropositive (i.e. antibody titer of ≥40 U/mL) at a vertain time point.
- for subjects that are seropositive at Visit 1 (baseline): a ≥ 4-fold rise in IgG antibody titer from Visit 1.
Percentages are based on the number of subjects with non-missing observations.
Measured: up to Day 365 / Month 12
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6), stratified by age group - Group 18 - 49 years.
Calculations are based on number of subjects with non-missing results.
Measured: up to Day 365 / Month 12
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6), stratified by age group - Group 50 - 65 years.
Calculations are based on number of subjects with non-missing results.
Measured: up to Day 365 / Month 12
Percentage of Participants With SAEs (Serious Adverse Events)
Frequency of SAEs (Serious Adverse Events) during the entire study; frequency is being assessed in terms of percentage of participants.
Measured: up to Day 365 / Month 12
Percentage of Participants With Related SAEs (Serious Adverse Events)
Frequency of related SAEs (Serious Adverse Events) during the entire study; frequency is being assessed in terms of percentage of participants.
Measured: up to Day 365 / Month 12
Percentage of Participants With AESIs (Adverse Events of Special Interest)
Frequency of AESIs (Adverse Events of Special Interest) during the entire study; frequency is being assessed in terms of percentage of participants.
AESIs are cases of Lyme Diseases, Lyme associated Events and the onset of potentially autoimmune or neuro-inflammatory disorders.
Measured: up to Day 365 / Month 12
Percentage of Participants With Related AESIs (Adverse Events of Special Interest)
Frequency of related AESIs (Adverse Events of Special Interest) during the entire study; frequency is being assessed in terms of percentage of participants.
AESIs are cases of Lyme Diseases, Lyme associated Events and the onset of potentially autoimmune or neuro-inflammatory disorders.
Measured: up to Day 365 / Month 12
Percentage of Participants With Unsolicited AEs (Adverse Events)
Frequency of unsolicited AEs (Adverse Events) during the entire study (incl. clinically relevant laboratory parameters); frequency is being assessed in terms of percentage of participants.
Measured: up to Day 365 / Month 12
Percentage of Participants With Related Unsolicited AEs (Adverse Events)
Frequency of related unsolicited AEs (Adverse Events) during the entire study (incl. clinically relevant laboratory parameters); frequency is being assessed in terms of percentage of participants.
Measured: up to Day 365 / Month 12
Percentage of Participants With Solicited Local and Solicited Systemic AEs (Adverse Events)
Frequency of solicited local and solicited systemic AEs (Adverse Events) within 7 days after each and after any vaccination; frequency is being assessed in terms of percentage of participants.
Measured: Day 1 (day of first vaccination) through Day 7; Day 29 (day of second vaccination) through Day 35; Day 57 (day of third vaccination) through Day 63
Percentage of Participants With SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), Solicited and Unsolicited AEs (Adverse Events) - Group 18-49
Frequency of SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), solicited and unsolicited AEs (Adverse Events) during the entire study stratified by age group - Group 18-49; frequency is being assessed in terms of percentage of participants.
Measured: up to Day 365 / Month 12
Percentage of Participants With SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), Solicited and Unsolicited AEs (Adverse Events) - Group 50-65 Years
Frequency of SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), Solicited and Unsolicited AEs (Adverse Events) during the entire study stratified by age group - Group 50-65 years; frequency is being assessed in terms of percentage of participants.
Measured: up to Day 365 / Month 12
Number of Participants With AESIs (Adverse Events of Special Interest) up to Study End
Measured: up to Day 365 / Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Dec 20182 Oct 2020

First posted7 Dec 2018
Study start17 Dec 2018
Primary completion18 Dec 2019
Study completion2 Oct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Lyme BorreliosisStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 572 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03769194
Sponsor's protocol ID: VLA15-201
Status last verified: Dec 2022
First submitted: 6 Dec 2018
Last updated: 10 Jan 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Bezay N, Wagner L, Kadlecek V, Obersriebnig M, Wressnigg N, Hochreiter R, Schneider M, Dubischar K, Derhaschnig U, Klingler A, Larcher-Senn J, Eder-Lingelbach S, Bender W. Optimisation of dose level and vaccination schedule for the VLA15 Lyme borreliosis vaccine candidate among healthy adults: two randomised, observer-blind, placebo-controlled, multicentre, phase 2 studies. Lancet Infect Dis. 2024 Sep;24(9):1045-1058. doi: 10.1016/S1473-3099(24)00175-0. Epub 2024 May 31.
PubMed 38830375

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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FINtick - a Prospective Multicenter Study on Tick-borne Infections in Finland
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All Lyme Borreliosis trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety Study of VLA15, A Multivalent Recombinant OspA (Outer Surface Protein A) Based Vaccine Candidate Against Lyme Borreliosis, in Healthy Adults Aged 18 to 65 Years. A Randomized, Controlled, Observer-blind Phase 2 Study.
ClinicalTrials.gov ID: NCT03769194
Acronym / sponsor ID: VLA15-201
Conditions: Lyme Borreliosis
Keywords: VLA15, Lyme Borreliosis, Vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 572 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 17 Dec 2018 (actual)
Primary completion: 18 Dec 2019 (actual)
Study completion: 2 Oct 2020 (actual)
First posted: 7 Dec 2018 (actual)
Results: Posted 30 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This is a randomized, observer-blind, placebo controlled, multicenter Phase 2 study.

Dosing was adjusted by injection volume.

In both study phases, target was to enroll approx. 10 % or more of subjects that were baseline seropositive for Borrelia burgdorferi sensu latu (Bb s.l.).

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
VLA15 low dose	Active comparator	Biological: VLA15VLA15 low dose with Alum.
VLA15 medium dose	Active comparator	Biological: VLA15VLA15 medium dose with Alum.
VLA15 high dose	Active comparator	Biological: VLA15VLA15 high dose with Alum.
Placebo	Placebo comparator	Biological: Placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

1. Subject is aged 18 to 40 years at the day of screening (Visit 0);
Subject is aged18 to 65 years at the day of screening (Visit 0);
Subject is of good general health, including subjects with pharmacologically controlled chronic conditions;
Subject has an understanding of the study and its procedures, agrees to its provisions, and gives written informed consent prior to any study-related procedures;
If subject is of childbearing potential:

Key exclusion criteria (17 listed)

Subject has a chronic illness related to Lyme borreliosis (LB), an active symptomatic LB (Lyme borreliosis) as suspected or diagnosed by a physician, or received treatment for LB (Lyme borreliosis) within the last 3 months prior to Visit 0;
Subject received previous vaccination against Lyme borreliosis (LB).;
Subject had a tick bite within 4 weeks prior to Visit 1;
Subject has a medical history of or currently has a clinically relevant disease (cardiovascular, respiratory, neurologic, psychiatric conditions) which poses a risk for participation in the study, based on investigators judgement, such as individuals with poorly controlled or unstable disease, ongoing suspected or active inflammation, or poor compliance with pharmacologic treatment. Subjects with pharmacologically controlled conditions like osteoarthritis, depression, or asthma are eligible;
Subject has a medical history of or currently has a neuroinflammatory or autoimmune disease, including Guillain Barré Syndrome;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VLA15a multivalent recombinant Outer surface protein A (OspA) based vaccine candidate	Biological	VLA15 high dose, VLA15 low dose, VLA15 medium dose
PlaceboPlacebo: PBS (Phosphate Buffered Saline)	Biological	Placebo

Primary outcome

GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype ST1 to ST6
Time frame: at Day 85 / Month 3
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) against each OspA (Outer Surface Protein A) serotype ST1 to ST6, determined by ELISA at Day 85. GMTs are calculated based on the number of subjects with non-missing results.

19 secondary outcomes

GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
Time frame: up to Day 365 / Month 12
SCRs (Seroconversion Rate) for Each OspA (Outer Surface Protein A) Serotype Specific IgG (Immunoglobulin G) (ST1 to ST6),
Time frame: up to Day 365 / Month 12
GMFR (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6)
Time frame: up to Day 365 / Month 12
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
Time frame: up to Day 365 / Month 12
GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
Time frame: up to Day 365 / Month 12
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
Time frame: up to Day 365 / Month 12
SCRs (Seroconversion Rate) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
Time frame: up to Day 365 / Month 12
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 18 - 49 Years
Time frame: up to Day 365 / Month 12
GMFRs (Geometric Mean of the Fold Rise as Compared to Baseline) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype (ST1 to ST6) - Group 50 - 65 Years
Time frame: up to Day 365 / Month 12
Percentage of Participants With SAEs (Serious Adverse Events)
Time frame: up to Day 365 / Month 12
Percentage of Participants With Related SAEs (Serious Adverse Events)
Time frame: up to Day 365 / Month 12
Percentage of Participants With AESIs (Adverse Events of Special Interest)
Time frame: up to Day 365 / Month 12
Percentage of Participants With Related AESIs (Adverse Events of Special Interest)
Time frame: up to Day 365 / Month 12
Percentage of Participants With Unsolicited AEs (Adverse Events)
Time frame: up to Day 365 / Month 12
Percentage of Participants With Related Unsolicited AEs (Adverse Events)
Time frame: up to Day 365 / Month 12
Percentage of Participants With Solicited Local and Solicited Systemic AEs (Adverse Events)
Time frame: Day 1 (day of first vaccination) through Day 7; Day 29 (day of second vaccination) through Day 35; Day 57 (day of third vaccination) through Day 63
Percentage of Participants With SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), Solicited and Unsolicited AEs (Adverse Events) - Group 18-49
Time frame: up to Day 365 / Month 12
Percentage of Participants With SAEs (Serious Adverse Events), AESIs (Adverse Events of Special Interest), Solicited and Unsolicited AEs (Adverse Events) - Group 50-65 Years
Time frame: up to Day 365 / Month 12
Number of Participants With AESIs (Adverse Events of Special Interest) up to Study End
Time frame: up to Day 365 / Month 12

Results and safety

Results posted to the registry on 30 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VLA15 Low Dose	29	25
VLA15 Medium Dose	214	196
VLA15 High Dose	205	197
Placebo	124	115

Primary outcome: GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype ST1 to ST6

Time frame: at Day 85 / Month 3. Geometric mean (95% Confidence Interval). Unit: U/mL

Measure	VLA15 Low Dose n = 29	VLA15 Medium Dose n = 192	VLA15 High Dose n = 194	Placebo n = 121
ST1 Day 85	74.3 (46.4 to 119.0)	101.9 (87.1 to 119.4)	115.8 (98.8 to 135.7)	21.7 (20.0 to 23.6)
ST2 Day 85	180.9 (124.8 to 262.3)	279.3 (247.1 to 315.8)	303.7 (266.5 to 346.1)	21.1 (20.0 to 22.3)
ST3 Day 85	267.4 (194.8 to 367.1)	283.2 (248.2 to 323.1)	308.6 (266.8 to 356.8)	20.8 (19.8 to 21.8)
ST4 Day 85	117.0 (76.6 to 178.7)	170.9 (150.5 to 194.2)	190.7 (165.9 to 219.2)	21.8 (20.4 to 23.4)
ST5 Day 85	118.3 (78.3 to 178.9)	176.0 (154.2 to 201.0)	199.6 (172.5 to 230.9)	21.4 (20.2 to 22.6)
ST6 Day 85	115.6 (76.5 to 174.7)	183.6 (161.7 to 208.4)	208.7 (181.8 to 239.6)	21.8 (20.3 to 23.4)

Population analysed: Overall Number of Participants Analyzed Per Protocol population

19 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to Day 365. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VLA15 Low Dose	0 of 29 (0%)	26 of 29 (89.7%)	0 of 29
VLA15 Medium Dose	4 of 214 (1.9%)	203 of 214 (94.9%)	0 of 214
VLA15 High Dose	5 of 205 (2.4%)	202 of 205 (98.5%)	0 of 205
Placebo	3 of 124 (2.4%)	85 of 124 (68.5%)	0 of 124

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38830375Bezay N, Wagner L, Kadlecek V, Obersriebnig M, Wressnigg N, Hochreiter R, Schneider M, Dubischar K, Derhaschnig U, Klingler A, Larcher-Senn J, Eder-Lingelbach S, Bender W. Optimisation of dose level and vaccination schedule for the VLA15 Lyme borreliosis vaccine candidate among healthy adults: two randomised, observer-blind, placebo-controlled, multicentre, phase 2 studies. Lancet Infect Dis. 2024 Sep;24(9):1045-1058. doi: 10.1016/S1473-3099(24)00175-0. Epub 2024 May 31.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

9 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing VLA15 in people with Lyme Borreliosis, run by Pfizer at 9 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States, Germany, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

GMTs (Geometric Mean Titers) for IgG (Immunoglobulin G) Against Each OspA (Outer Surface Protein A) Serotype ST1 to ST6 (time frame: at Day 85 / Month 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03769194, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.