Lyme Borreliosis, Nervous SystemPhase 1NCT03010228

Study Assessing the Safety, Immunogenicity and Dose Response of VLA15, A New Vaccine Candidate Against Lyme Borreliosis

A Phase 1 study testing VLA15 with Alum and VLA15 without Alum in people with Lyme Borreliosis, Nervous System, run by Pfizer at 5 sites in 2 countries.

Completed

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

Official record

Search all trials

Trial summary

Observer-blind, partially randomized, multi-center dose escalation Phase I study in healthy adults below 40 years of age. 180 subjects will be enrolled in 6 treatment groups (different doses; different formulation: with/without adjuvant); vaccinations will be given I.M.(intramuscular) into the deltoid region on Days… Read more about this study

Who is it for?: Ages 18 to 39 yearsHealthy volunteers can take part
Conditions the study is for: Lyme Borreliosis, Nervous System
What is being tested?: VLA15 with Alum and VLA15 without Alum
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 179 participants
Where: 5 sitesin 2 countries
Study dates: 31 Jan 2017to 16 Jan 2019
Phase: Phase 1
Are there results?: None posted in the registry

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 39 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adults ≥18 to <40 years of age (for US healthy adults ≥ 19 years to <40 years) at the time of screening. Health status is assessed by investigator at time of screening based on medical history, physical examination, and laboratory parameters.
Written informed consent obtained from the subject prior to any study related procedures.
BMI ≥18.5 and <30 at Visit 0 (Screening Visit).
Men or women; women require a negative pregnancy test at screening. Women with childbearing potential must agree to use an adequate contraception during the entire study.
Booster Extension:
Completed Primary immunization schedule (three vaccinations)

Show all 10Show fewer

Randomization into 48µg or 90µg group with or without Alum
Written informed consent for Booster Extension obtained from the subject prior to any study related procedures.
Enrolled at study site in Belgium
Men or women; women require a negative pregnancy test before booster vaccination. Women of childbearing potential must agree to use an adequate contraception during the entire study.

Who cannot join

Pathological findings in any of the investigations (i.e. medical history, physical examination) as deemed clinically relevant by the investigator or any abnormal laboratory parameter of hematology, clinical chemistry, coagulation, RF (Rheumatoid Factor) or ACPA (Anti-citrullinated protein antibodies) at the Screening Visit.
Medical history of severe cardiovascular, respiratory (including asthma), metabolic, neurological, hepatic, rheumatic, hematological, gastrointestinal, renal disorders.
Medical history of or current musculoskeletal disorders as deemed clinically relevant by the investigator, arthritis or chronic musculoskeletal pain.
Previous vaccination against Lyme borreliosis with any (investigational) vaccine.
Use of any other investigational or non-registered medicinal product within 30 days prior to VLA15 vaccination at Visit 1 (Day 0) and throughout the entire study period.
Chronic illness related to Lyme borreliosis (LB), a history of or active symptomatic LB as suspected or diagnosed by a physician. Subjects with a positive serology test result for Borrelia burgdorferi sensu lato (s.l.) antibodies at screening are excluded.

Show all 55Show fewer

Tick bite within 3 weeks prior to screening, or tick bite during vaccination period (i.e. Day 0 to Day 56).
Known active infection with Babesia microti (babesiosis) or Anaplasma phagocytophilum (ehrlichiosis).
Active or passive immunization four weeks before first vaccination at Visit 1 and up to Day 84 (i.e. 4 weeks after the last VLA15 immunization). Afterwards, vaccinations should be avoided, except for influenza (seasonal or pandemic) vaccines which may be administered after Day 84 (i.e. 4 weeks after the last VLA15 immunization). Subjects susceptible to require a vaccine during the study period (e.g. due to planned travel) should be excluded at screening.
Known congenital, hereditary or acquired immunodeficiency, including infection with human immunodeficiency virus (HIV), status post organ transplantation or immuno-suppressive therapy within 30 days prior to Day 0 and up to Day 84. Immuno-suppressive therapy is defined as administration of chronic (longer than 14 days) prednisone or equivalent ≥ 0.05 mg/kg/day. Topical and inhaled steroids are allowed.
Planned intake of NSAID (Nonsteroidal anti-inflammatory drug) within three days prior and within seven days after any VLA15 vaccination.
History of severe hypersensitivity reactions and anaphylaxis.
History of allergic bronchial asthma and severe allergic rhinoconjunctivitis.
Known hypersensitivity or allergic reactions to one of the components of the vaccine.
History of autoimmune disease, including Type I Diabetes mellitus. Subjects with vitiligo or thyroid disease taking thyroid hormone replacement are not excluded.
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.
Acute febrile infections within 4 weeks prior to first vaccination and body temperature >37.8 C (oral) prior to each vaccination.
Known or suspected alcohol abuse, alcohol dependence, i.e. an average of more than approximately 60 g alcohol (approximately 1 liter of beer or 0.5 liter of wine) per day] or illicit drug use within the last year;
Inability or unwillingness to avoid more than the usual intake of alcohol (i.e. not more than 60 g alcohol (approximately 1 liter of beer or 0.5 liter of wine) per day) during the 48 hours after vaccination.
Pregnancy (positive pregnancy test), lactation or inadequate contraception in women with childbearing potential
Inability or unwillingness to provide informed consent or not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
Donation of blood or blood-derived products (e.g. plasma) within 4 weeks prior to Visit 0 (Screening Visit) and during the entire study.
Receipt of blood or blood-derived products in the past 3 months prior to Visit 0 (Screening Visit) or anticipation of such products during the entire study.
Mental disorder as deemed clinically relevant by the investigator.
History of Guillain-Barré-Syndrome (GBS).
Any condition which might interfere with study objectives or that would limit the subject's ability to complete the study in the opinion of the investigator.
Persons who are committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities).
Persons who are in a dependent relationship with the sponsor, an investigator or other study team members, 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.
Booster Extension:
Individual stopping rule was met during the Initial Study.
Subject has a known thrombocytopenia, bleeding disorder, or receipt of anticoagulants in the 3 weeks prior to booster vaccination contraindicating I.M. vaccination as judged by the investigator.
Pathological findings in the symptom driven physical examination as deemed clinically relevant by the investigator or any clinically significant abnormal laboratory parameter of hematology, clinical chemistry based on investigator judgement at Visit 8. Subjects with a positive test result for RF and ACPA at Visit 8 are excluded.
Use of any other investigational or non-registered medicinal product within 30 days prior to VLA15 booster vaccination at Visit 9 and throughout the entire Booster Extension period.
Tick bite within 3 weeks prior to booster vaccination (i.e. Visit 9).
Known active infection with Babesia microti (babesiosis) or Anaplasma phagocytophilum (ehrlichiosis).
Active or passive immunization four weeks before and within 7 days after booster vaccination at Visit 9.
Known congenital, hereditary or acquired immunodeficiency, including infection with human immunodeficiency virus (HIV), status post organ transplantation or immuno-suppressive therapy within 30 days prior to booster vaccination and up to 28 days after. Immuno-suppressive therapy is defined as administration of chronic (longer than 14 days) prednisone or equivalent ≥ 0.05 mg/kg/day. Topical and inhaled steroids are allowed.
Developed any of the following conditions since enrolment into Initial Study:
Chronic illness related to Lyme borreliosis (LB), a history of or active symptomatic LB as suspected or diagnosed by a physician.
Severe cardiovascular, respiratory (including asthma), metabolic, neurological, hepatic, rheumatic, hematological, gastrointestinal, renal disorders.
Musculoskeletal disorders as deemed clinically relevant by the investigator, arthritis or chronic musculoskeletal pain.
Severe hypersensitivity reactions and anaphylaxis.
Allergic bronchial asthma and severe allergic rhinoconjunctivitis.
Hypersensitivity or allergic reactions to one of the components of the vaccine.
Autoimmune disease, including Type I Diabetes mellitus. Subjects with vitiligo or thyroid disease taking thyroid hormone replacement are not excluded.
Mental disorder as deemed clinically relevant by the investigator.
Guillain-Barré-Syndrome (GBS)
Malignancy
Known or suspected alcohol abuse alcohol dependence, i.e. an average of more than approximately 60 g alcohol (approximately 1 liter of beer or 0.5 liter of wine per day) or illicit drug use within the last year.
Inability or unwillingness to avoid more than the usual intake of alcohol (i.e. not more than 60 g alcohol (approximately 1 liter of beer or 0.5 liter of wine) per day) during the 48 hours after vaccination.
Pregnancy (positive pregnancy test), lactation or inadequate contraception in women of childbearing potential.
Inability or unwillingness to provide informed consent or not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
Any condition which might interfere with study objectives or that would limit the subject's ability to complete the study in the opinion of the investigator.
Persons who are committed to an institution (by virtue of an order issued either by the judicial or the administrative authorities).
Persons who are in a dependent relationship with the sponsor, an investigator or other study team members, 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

5 sites in 2 countries.

Country

City, postcode or hospital

5 sites in 2 countries

United States4 sites

eStudy Site
La Mesa, California, 91942
eStudySite
La Mesa, California, 91942
Celerion Inc.
Lincoln, Nebraska, 68502
Celerion, Inc
Lincoln, Nebraska, 68502

Other trials in United States

Belgium1 site

University Hospital Ghent
Ghent, 9000

Other trials in Belgium

About this study

Official title: Study Assessing the Safety, Immunogenicity and Dose Response of VLA15, A New Multivalent Recombinant OspA Vaccine Candidate Against Lyme Borreliosis, In Healthy Adults Aged Below 40 Years

Observer-blind, partially randomized, multi-center dose escalation Phase I study in healthy adults below 40 years of age.

180 subjects will be enrolled in 6 treatment groups (different doses; different formulation: with/without adjuvant); vaccinations will be given I.M.(intramuscular) into the deltoid region on Days 0, 28 and 56. Study participants will be followed up until one year after first vaccination.

Booster Extension:

Subjects in the 48µg and 90µg Treatment groups who received a complete Primary immunization schedule will be included into a Booster Extension 13 months after the first immunization.

Read the detailed description

This is an observer-blind, partially randomized, multi-center dose escalation Phase I study which aims to assess the safety, immunogenicity and dose response of VLA15 in healthy adults aged below 40 years.

Overall 180 subjects will be enrolled in 6 treatment groups: VLA15 12µg with and w/o (without) Alum, VLA15 48µg with and w/o Alum, VLA15 90µg with and w/o Alum.

For the first 24 subjects, the study will be open-label and subjects will not be randomized but included into a staggered dose escalation scheme for safety precaution. Thereafter, the study will be conducted observer-blind in respect to the investigators and site staff involved in clinical evaluation of subjects, subjects will be blinded as well. Remaining 156 subjects will be randomized into the 6 treatment groups. I.M. vaccinations are administered on Days 0, 28 and 56 into deltoid region of the non-dominant arm.

The study will investigate the safety and tolerability as well as immunogenicity of VLA15. The primary objective addresses safety and tolerability of the vaccine up to three months after enrollment, i.e. 84 days after first vaccination. The study includes 1 screening visit and 8 outpatient visits from day 0 through day 365. In addition, safety phone calls will be performed.

Booster Extension:

Subjects in the 48µg and 90µg dose Groups at the Belgian site, who received a complete primary immunization schedule (three vaccinations), will be included into a Booster Extension to investigate the safety and immunogenicity of a booster dose of VLA15 administered 13 months after the first immunization. An extension analysis on safety and immunogenicity will be performed after the last subject has completed the last study visit at Month 19. Additionally a M14 interim analysis on immunogenicity data will be performed, when all subjects completed Month 14.

For inclusion in the Booster Extension of this study only subjects are eligible, who were enrolled in Belgium, completed the primary immunization schedule (three vaccinations) and were randomized into 48µg or 90µg dose groups with or without alum. Subjects included in the staggered dose escalation phase will not be asked to participate in the Booster Extension for operational reasons.

Conditions: Lyme Borreliosis, Nervous System
Being tested: VLA15 with Alum, VLA15 without Alum
Keywords: VLA15, Lyme Borreliosis, Multivalent Recombinant OspA Vaccine
Medical subject headings: Lyme Neuroborreliosis, Lyme Disease

What participants receive

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

VLA15 with AlumBiological
I.M. vaccination with a multivalent outer surface protein A (OspA) based vaccine candidate on days 0, 28 and 56; three different doses
VLA15 without AlumBiological
I.M. vaccination with a multivalent outer surface protein A (OspA) based vaccine candidate on days 0, 28 and 56; three different doses

Study groups in NCT03010228
Study group	Role	What they receive
VLA15 12 µg with Alum	Active comparator	VLA15 12 µg (microgram) with Alum has an injection volume of 100 µl (microliter). The amount of Alum per injection is 0.05 mg (milligram). Receives: Biological: VLA15 with Alum
VLA15 12 µg w/o Alum	Active comparator	VLA15 12 µg (microgram) without (w/o) Alum (aluminum hydroxide) has an injection volume of 100 µl (microliter). Receives: Biological: VLA15 without Alum
VLA15 48 µg with Alum	Active comparator	VLA15 48 µg (microgram) with Alum (aluminum hydroxide) has an injection volume of 400 µl (microliter). The amount of Alum per injection is 0.2 mg (milligram). Receives: Biological: VLA15 with Alum
VLA15 48 µg w/o Alum	Active comparator	VLA15 48 µg (microgram) without (w/o) Alum (aluminum hydroxide) has an injection volume of 400 µl (microliter). Receives: Biological: VLA15 without Alum
VLA15 90 µg with Alum	Active comparator	VLA15 90 µg (microgram) with Alum (aluminum hydroxide) has an injection volume of 750 µl (microliter). The amount of Alum per injection is 0.375 mg (milligram). Receives: Biological: VLA15 with Alum
VLA15 90 µg w/o Alum	Active comparator	VLA15 90 µg (microgram) without (w/o) Alum (aluminum hydroxide) has an injection volume of 750 µl (microliter). Receives: Biological: VLA15 without Alum

What is being measured

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

Rate of SAEs to Day 84
Measured: up to Day 84 (Month 3) after first vaccination
Rate of related SAEs to Day 84
Measured: up to Day 84 (Month 3) after first vaccination
Rate of any solicited or unsolicited Grade 3 or Grade 4 events up to Day 84
Measured: up to Day 84 (Month 3) after first vaccination
Rate of any solicited or related unsolicited Grade 3 or Grade 4 events up to Day 84
Measured: up to Day 84 (Month 3) after first vaccination
Rate of solicited local AEs within 7 days after each and after any vaccination up to Day 84
Measured: up to Day 84 (Month 3) after first vaccination
Rate of solicited systemic AEs within 7 days after each and after any vaccination up to Day 84
Measured: up to Day 84 (Month 3) after first vaccination
Rate of unsolicited AEs to Day 84, including clinically significant laboratory parameter changes
Measured: up to Day 84 (Month 3) after first vaccination
Rate of related unsolicited AEs to Day 84, including clinically significant laboratory parameter changes
Measured: up to Day 84 (Month 3) after first vaccination

Secondary outcomes (10)

Rate of SAEs during the entire study period
Measured: up to Day 365 (Month 12)
Rate of related SAEs during the entire study period
Measured: up to Day 365 (Month 12)
Rate of any solicited or unsolicited Grade 3 or Grade 4 AEs during the entire study period
Measured: up to Day 365 (Month 12)
Rate of any solicited or related unsolicited Grade 3 or Grade 4 AEs during the entire study period
Measured: up to Day 365 (Month 12)
Rate of unsolicited AEs during the entire study period
Measured: up to Day 365 (Month 12)
Rate of related unsolicited AEs during the entire study period
Measured: up to Day 365 (Month 12)
Changes in laboratory parameters and rate of subjects with abnormal laboratory parameter
Measured: up to Day 365 (Month 12)
GMTs (Geometric Mean Titre) for IgG against each OspA serotype ST1 to ST6, determined by ELISA
Measured: Day 0, 28, 56, 84, 180, 236 and 365
SCRs (Seroconversion Rate, defined based on fold increase of each OspA serotype specific IgG (ST1 to ST6) as compared to baseline)
Measured: Day 28, 56, 84, 180, 236 and 365
GMFR (Geometric Mean of the fold rise as compared to baseline) for IgG against each OspA serotype ST1 to ST6, determined by ELISA
Measured: Day 28, 56, 84, 180, 236 and 365

Timeline

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

31 Jan 201716 Jan 2019

First posted4 Jan 2017 (estimated)
Study start31 Jan 2017
Primary completion28 Sep 2017
Study completion16 Jan 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Lyme Borreliosis, Nervous SystemStudies 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 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 179 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03010228
Sponsor's protocol ID: VLA15-101
Other IDs: C4601005
Status last verified: Mar 2023
First submitted: 21 Dec 2016
Last updated: 5 Apr 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Bezay N, Hochreiter R, Kadlecek V, Wressnigg N, Larcher-Senn J, Klingler A, Dubischar K, Eder-Lingelbach S, Leroux-Roels I, Leroux-Roels G, Bender W. Safety and immunogenicity of a novel multivalent OspA-based vaccine candidate against Lyme borreliosis: a randomised, phase 1 study in healthy adults. Lancet Infect Dis. 2023 Oct;23(10):1186-1196. doi: 10.1016/S1473-3099(23)00210-4. Epub 2023 Jul 4.
PubMed 37419129

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?

See locations

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain
Post-treatment Lyme Disease Syndrome, Chronic Pain
RecruitingObservational study
FINtick - a Prospective Multicenter Study on Tick-borne Infections in Finland
Tick Borne Encephalitis (TBE), Lyme Borreliosis
Recruiting
Effectiveness of an Intervention Combining Adapted Physical Activity and Therapeutic Education in Patients With Chronic Symptoms Attributed to Lyme Borreliosis.
Lyme Borreliosis, Physical Activity
Not yet recruitingObservational study
The Precision Mito- Mito Map COMPASS Study
Mitochondrial Diseases, Myalgic Encephalomyelitis Chronic Fatigue Syndrome

All Lyme Borreliosis, Nervous System trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study Assessing the Safety, Immunogenicity and Dose Response of VLA15, A New Multivalent Recombinant OspA Vaccine Candidate Against Lyme Borreliosis, In Healthy Adults Aged Below 40 Years
ClinicalTrials.gov ID: NCT03010228
Acronym / sponsor ID: VLA15-101
Conditions: Lyme Borreliosis, Nervous System
Keywords: VLA15, Lyme Borreliosis, Multivalent Recombinant OspA Vaccine
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 179 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Collaborators: Valneva Austria GmbH
Study start: 31 Jan 2017 (actual)
Primary completion: 28 Sep 2017 (actual)
Study completion: 16 Jan 2019 (actual)
First posted: 4 Jan 2017 (estimated)
Results: Not posted in the source record

Clinical summary

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

Observer-blind, partially randomized, multi-center dose escalation Phase I study in healthy adults below 40 years of age.

Booster Extension:

Subjects in the 48µg and 90µg Treatment groups who received a complete Primary immunization schedule will be included into a Booster Extension 13 months after the first immunization.

Detailed description

Overall 180 subjects will be enrolled in 6 treatment groups: VLA15 12µg with and w/o (without) Alum, VLA15 48µg with and w/o Alum, VLA15 90µg with and w/o Alum.

Booster Extension:

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
VLA15 12 µg with Alum	Active comparator	Biological: VLA15 with AlumVLA15 12 µg (microgram) with Alum has an injection volume of 100 µl (microliter). The amount of Alum per injection is 0.05 mg (milligram).
VLA15 12 µg w/o Alum	Active comparator	Biological: VLA15 without AlumVLA15 12 µg (microgram) without (w/o) Alum (aluminum hydroxide) has an injection volume of 100 µl (microliter).
VLA15 48 µg with Alum	Active comparator	Biological: VLA15 with AlumVLA15 48 µg (microgram) with Alum (aluminum hydroxide) has an injection volume of 400 µl (microliter). The amount of Alum per injection is 0.2 mg (milligram).
VLA15 48 µg w/o Alum	Active comparator	Biological: VLA15 without AlumVLA15 48 µg (microgram) without (w/o) Alum (aluminum hydroxide) has an injection volume of 400 µl (microliter).
VLA15 90 µg with Alum	Active comparator	Biological: VLA15 with AlumVLA15 90 µg (microgram) with Alum (aluminum hydroxide) has an injection volume of 750 µl (microliter). The amount of Alum per injection is 0.375 mg (milligram).
VLA15 90 µg w/o Alum	Active comparator	Biological: VLA15 without AlumVLA15 90 µg (microgram) without (w/o) Alum (aluminum hydroxide) has an injection volume of 750 µl (microliter).

Who may qualify

Ages: 18 to 39 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Healthy adults ≥18 to <40 years of age (for US healthy adults ≥ 19 years to <40 years) at the time of screening. Health status is assessed by investigator at time of screening based on medical history, physical examination, and laboratory parameters.
Written informed consent obtained from the subject prior to any study related procedures.
BMI ≥18.5 and <30 at Visit 0 (Screening Visit).
Men or women; women require a negative pregnancy test at screening. Women with childbearing potential must agree to use an adequate contraception during the entire study.
Completed Primary immunization schedule (three vaccinations)

Key exclusion criteria (55 listed)

Pathological findings in any of the investigations (i.e. medical history, physical examination) as deemed clinically relevant by the investigator or any abnormal laboratory parameter of hematology, clinical chemistry, coagulation, RF (Rheumatoid Factor) or ACPA (Anti-citrullinated protein antibodies) at the Screening Visit.
Medical history of severe cardiovascular, respiratory (including asthma), metabolic, neurological, hepatic, rheumatic, hematological, gastrointestinal, renal disorders.
Medical history of or current musculoskeletal disorders as deemed clinically relevant by the investigator, arthritis or chronic musculoskeletal pain.
Previous vaccination against Lyme borreliosis with any (investigational) vaccine.
Use of any other investigational or non-registered medicinal product within 30 days prior to VLA15 vaccination at Visit 1 (Day 0) and throughout the entire study period.

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
VLA15 with AlumI.M. vaccination with a multivalent outer surface protein A (OspA) based vaccine candidate on days 0, 28 and 56; three different doses	Biological	VLA15 12 µg with Alum, VLA15 48 µg with Alum, VLA15 90 µg with Alum
VLA15 without AlumI.M. vaccination with a multivalent outer surface protein A (OspA) based vaccine candidate on days 0, 28 and 56; three different doses	Biological	VLA15 12 µg w/o Alum, VLA15 48 µg w/o Alum, VLA15 90 µg w/o Alum

Primary outcome

Rate of SAEs to Day 84
Time frame: up to Day 84 (Month 3) after first vaccination
Rate of related SAEs to Day 84
Time frame: up to Day 84 (Month 3) after first vaccination
Rate of any solicited or unsolicited Grade 3 or Grade 4 events up to Day 84
Time frame: up to Day 84 (Month 3) after first vaccination
Rate of any solicited or related unsolicited Grade 3 or Grade 4 events up to Day 84
Time frame: up to Day 84 (Month 3) after first vaccination
Rate of solicited local AEs within 7 days after each and after any vaccination up to Day 84
Time frame: up to Day 84 (Month 3) after first vaccination
Rate of solicited systemic AEs within 7 days after each and after any vaccination up to Day 84
Time frame: up to Day 84 (Month 3) after first vaccination
Rate of unsolicited AEs to Day 84, including clinically significant laboratory parameter changes
Time frame: up to Day 84 (Month 3) after first vaccination
Rate of related unsolicited AEs to Day 84, including clinically significant laboratory parameter changes
Time frame: up to Day 84 (Month 3) after first vaccination

10 secondary outcomes

Rate of SAEs during the entire study period
Time frame: up to Day 365 (Month 12)
Rate of related SAEs during the entire study period
Time frame: up to Day 365 (Month 12)
Rate of any solicited or unsolicited Grade 3 or Grade 4 AEs during the entire study period
Time frame: up to Day 365 (Month 12)
Rate of any solicited or related unsolicited Grade 3 or Grade 4 AEs during the entire study period
Time frame: up to Day 365 (Month 12)
Rate of unsolicited AEs during the entire study period
Time frame: up to Day 365 (Month 12)
Rate of related unsolicited AEs during the entire study period
Time frame: up to Day 365 (Month 12)
Changes in laboratory parameters and rate of subjects with abnormal laboratory parameter
Time frame: up to Day 365 (Month 12)
GMTs (Geometric Mean Titre) for IgG against each OspA serotype ST1 to ST6, determined by ELISA
Time frame: Day 0, 28, 56, 84, 180, 236 and 365
SCRs (Seroconversion Rate, defined based on fold increase of each OspA serotype specific IgG (ST1 to ST6) as compared to baseline)
Time frame: Day 28, 56, 84, 180, 236 and 365
GMFR (Geometric Mean of the fold rise as compared to baseline) for IgG against each OspA serotype ST1 to ST6, determined by ELISA
Time frame: Day 28, 56, 84, 180, 236 and 365

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
Derived from this study: PubMed 37419129Bezay N, Hochreiter R, Kadlecek V, Wressnigg N, Larcher-Senn J, Klingler A, Dubischar K, Eder-Lingelbach S, Leroux-Roels I, Leroux-Roels G, Bender W. Safety and immunogenicity of a novel multivalent OspA-based vaccine candidate against Lyme borreliosis: a randomised, phase 1 study in healthy adults. Lancet Infect Dis. 2023 Oct;23(10):1186-1196. doi: 10.1016/S1473-3099(23)00210-4. Epub 2023 Jul 4.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Lyme Borreliosis, Nervous System

RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain
Post-treatment Lyme Disease Syndrome, Chronic Pain
RecruitingObservational study
FINtick - a Prospective Multicenter Study on Tick-borne Infections in Finland
Tick Borne Encephalitis (TBE), Lyme Borreliosis
Recruiting
Effectiveness of an Intervention Combining Adapted Physical Activity and Therapeutic Education in Patients With Chronic Symptoms Attributed to Lyme Borreliosis.
Lyme Borreliosis, Physical Activity
Not yet recruitingObservational study
The Precision Mito- Mito Map COMPASS Study
Mitochondrial Diseases, Myalgic Encephalomyelitis Chronic Fatigue Syndrome

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

Pfizer CT.gov Call Center principal investigator

Pfizer

5 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VLA15 with Alum and VLA15 without Alum in people with Lyme Borreliosis, Nervous System, run by Pfizer at 5 sites in 2 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 55 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 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Rate of SAEs to Day 84 (time frame: up to Day 84 (Month 3) after first vaccination). The study lists 8 primary outcomes in all. 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 NCT03010228, 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 5 Apr 2023.