Immunogenicity and Safety Study of a Vaccine Against Lyme... | NCT03769194

NCT03769194

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
VLA15 low dose	Active Comparator	VLA15 low dose with Alum.	Biological: VLA15
VLA15 medium dose	Active Comparator	VLA15 medium dose with Alum.	Biological: VLA15
VLA15 high dose	Active Comparator	VLA15 high dose with Alum.	Biological: VLA15
Placebo	Placebo Comparator		Biological: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VLA15	Biological	a multivalent recombinant Outer surface protein A (OspA) based vaccine candidate	VLA15 high dose VLA15 low dose VLA15 medium dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	at Day 85 / Month 3

Secondary Outcomes

Measure	Description	Time Frame
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.	up to Day 365 / Month 12

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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;
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:
1. Subject has a negative serum pregnancy test at screening (Visit 0);
2. Subject agrees to employ adequate birth control measures for the duration of the study.

Exclusion Criteria:

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;
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.

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Research Consulting, LLC		Milford	Connecticut	06460	United States
Stamford Therapeutics Consortium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38830375	Derived	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.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	VLA15 Low Dose	VLA15 low dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
FG001	VLA15 Medium Dose	VLA15 medium dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jun 13, 2019	May 5, 2021

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	VLA15 Low Dose	VLA15 low dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
BG001	VLA15 Medium Dose	VLA15 medium dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
BG002	VLA15 High Dose	VLA15 high dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
BG003	Placebo	Placebo: Placebo: PBS (Phosphate Buffered Saline)
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00029.2± 6.13 BG00141.7± 13.26 BG00241.6± 12.56 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00016 BG001117 BG002

Race/Ethnicity, Customized

Number

number of participants

Title

Denominators

Categories

American Indian or Alaska Native

Title	Measurements
	BG0000 BG0011 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Overall Number of Participants Analyzed Per Protocol population

Posted

Geometric Mean

95% Confidence Interval

U/mL

at Day 85 / Month 3

ID	Title	Description
OG000	VLA15 Low Dose	VLA15 low dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG001	VLA15 Medium Dose	VLA15 medium dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG002	VLA15 High Dose	VLA15 high dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG003	Placebo	Placebo: Placebo: PBS (Phosphate Buffered Saline)

Units	Counts
Participants	OG00029 OG001192 OG002194 OG003

Title

Denominators

Categories

ST1 Day 85

Title	Measurements
	OG00074.3(46.4 to 119.0) OG001101.9(87.1 to 119.4) OG002115.8(98.8 to 135.7) OG003

Secondary

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.

Posted

Geometric Mean

95% Confidence Interval

U/mL

up to Day 365 / Month 12

ID	Title	Description
OG000	VLA15 Low Dose	VLA15 low dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG001	VLA15 Medium Dose	VLA15 medium dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG002	VLA15 High Dose	VLA15 high dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG003	Placebo	Placebo: Placebo: PBS (Phosphate Buffered Saline)

Secondary

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.

Posted

Number

95% Confidence Interval

percentage of subjects

up to Day 365 / Month 12

ID	Title	Description
OG000	VLA15 Low Dose	VLA15 low dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG001	VLA15 Medium Dose	VLA15 medium dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG002	VLA15 High Dose	VLA15 high dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG003	Placebo

Secondary

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.

Posted

Geometric Mean

95% Confidence Interval

Geometric Mean of the Fold Rise

up to Day 365 / Month 12

ID	Title	Description
OG000	VLA15 Low Dose	VLA15 low dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG001	VLA15 Medium Dose	VLA15 medium dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG002	VLA15 High Dose	VLA15 high dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG003	Placebo	Placebo: Placebo: PBS (Phosphate Buffered Saline)

Secondary

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.

Posted

Geometric Mean

95% Confidence Interval

U/mL

up to Day 365 / Month 12

ID	Title	Description
OG000	VLA15 Low Dose	VLA15 low dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG001	VLA15 Medium Dose	VLA15 medium dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG002	VLA15 High Dose	VLA15 high dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG003	Placebo	Placebo: Placebo: PBS (Phosphate Buffered Saline)

Secondary

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.

In the elderly age group no participants were included in the VLA15 low dose, that's the reason why the number of participants is zero.

Posted

Geometric Mean

95% Confidence Interval

U/mL

up to Day 365 / Month 12

ID	Title	Description
OG000	VLA15 Low Dose	VLA15 low dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG001	VLA15 Medium Dose	VLA15 medium dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG002	VLA15 High Dose	VLA15 high dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG003	Placebo

Secondary

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.

Posted

Number

95% Confidence Interval

percentage of subjects

up to Day 365 / Month 12

ID	Title	Description
OG000	VLA15 Low Dose	VLA15 low dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG001	VLA15 Medium Dose	VLA15 medium dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG002	VLA15 High Dose	VLA15 high dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG003	Placebo

Secondary

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.

In the elderly age group no participants were included in the VLA15 low dose, that's the reason why the number of participants is zero.

Posted

Number

95% Confidence Interval

percentage of subjects

up to Day 365 / Month 12

ID	Title	Description
OG000	VLA15 Low Dose	VLA15 low dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG001	VLA15 Medium Dose	VLA15 medium dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG002	VLA15 High Dose	VLA15 high dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate

Secondary

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.

Posted

Geometric Mean

95% Confidence Interval

Geometric Mean of the Fold Rise

up to Day 365 / Month 12

ID	Title	Description
OG000	VLA15 Low Dose	VLA15 low dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG001	VLA15 Medium Dose	VLA15 medium dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG002	VLA15 High Dose	VLA15 high dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG003	Placebo	Placebo: Placebo: PBS (Phosphate Buffered Saline)

Secondary

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

Calculations are based on number of subjects with non-missing results.

In the elderly age group no participants were included in the VLA15 low dose, that's the reason why the number of participants is zero.

Posted

Geometric Mean

95% Confidence Interval

Geometric Mean of the Fold Rise

up to Day 365 / Month 12

ID	Title	Description
OG000	VLA15 Low Dose	VLA15 low dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG001	VLA15 Medium Dose	VLA15 medium dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG002	VLA15 High Dose	VLA15 high dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate

Secondary

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.

Posted

Number

95% Confidence Interval

percentage of participants

up to Day 365 / Month 12

ID	Title	Description
OG000	VLA15 Low Dose	VLA15 low dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG001	VLA15 Medium Dose	VLA15 medium dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG002	VLA15 High Dose	VLA15 high dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG003	Placebo	Placebo: Placebo: PBS (Phosphate Buffered Saline)

Secondary

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.

Posted

Number

95% Confidence Interval

percentage of participants

up to Day 365 / Month 12

ID	Title	Description
OG000	VLA15 Low Dose	VLA15 low dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG001	VLA15 Medium Dose	VLA15 medium dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG002	VLA15 High Dose	VLA15 high dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG003	Placebo	Placebo: Placebo: PBS (Phosphate Buffered Saline)

Secondary

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.

Posted

Number

95% Confidence Interval

percentage of participants

up to Day 365 / Month 12

ID	Title	Description
OG000	VLA15 Low Dose	VLA15 low dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG001	VLA15 Medium Dose	VLA15 medium dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG002	VLA15 High Dose	VLA15 high dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG003	Placebo	Placebo: Placebo: PBS (Phosphate Buffered Saline)

Secondary

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.

Posted

Number

95% Confidence Interval

percentage of participants

up to Day 365 / Month 12

ID	Title	Description
OG000	VLA15 Low Dose	VLA15 low dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG001	VLA15 Medium Dose	VLA15 medium dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG002	VLA15 High Dose	VLA15 high dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG003	Placebo	Placebo: Placebo: PBS (Phosphate Buffered Saline)

Secondary

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.

Posted

Number

95% Confidence Interval

percentage of participants

up to Day 365 / Month 12

ID	Title	Description
OG000	VLA15 Low Dose	VLA15 low dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG001	VLA15 Medium Dose	VLA15 medium dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG002	VLA15 High Dose	VLA15 high dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG003	Placebo	Placebo: Placebo: PBS (Phosphate Buffered Saline)

Secondary

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.

Posted

Number

95% Confidence Interval

percentage of participants

up to Day 365 / Month 12

ID	Title	Description
OG000	VLA15 Low Dose	VLA15 low dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG001	VLA15 Medium Dose	VLA15 medium dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG002	VLA15 High Dose	VLA15 high dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG003	Placebo	Placebo: Placebo: PBS (Phosphate Buffered Saline)

Secondary

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.

Posted

Number

95% Confidence Interval

percentage of participants

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

ID	Title	Description
OG000	VLA15 Low Dose	VLA15 low dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG001	VLA15 Medium Dose	VLA15 medium dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG002	VLA15 High Dose	VLA15 high dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG003	Placebo	Placebo: Placebo: PBS (Phosphate Buffered Saline)

Secondary

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.

The overall number analyzed is for all participants. Below listed number of participants is for the different age groups.

Posted

Number

95% Confidence Interval

percentage of participants

up to Day 365 / Month 12

ID	Title	Description
OG000	VLA15 Low Dose	VLA15 low dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG001	VLA15 Medium Dose	VLA15 medium dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG002	VLA15 High Dose	VLA15 high dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG003

Secondary

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.

In the elderly age group no participants were included in the VLA15 low dose, that's the reason why the number of participants is zero.

Posted

Number

95% Confidence Interval

percentage of participants

up to Day 365 / Month 12

ID	Title	Description
OG000	VLA15 Low Dose	VLA15 low dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG001	VLA15 Medium Dose	VLA15 medium dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG002	VLA15 High Dose	VLA15 high dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG003

Secondary

Number of Participants With AESIs (Adverse Events of Special Interest) up to Study End

Posted

Number

Number of participants

up to Day 365 / Month 12

ID	Title	Description
OG000	VLA15 Low Dose	VLA15 low dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG001	VLA15 Medium Dose	VLA15 medium dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG002	VLA15 High Dose	VLA15 high dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate
OG003	Placebo	Placebo: Placebo: PBS (Phosphate Buffered Saline)

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	VLA15 Low Dose	VLA15 low dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate	29	0	29	26	29
EG001	VLA15 Medium Dose	VLA15 medium dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate	214	4	214	203	214
EG002	VLA15 High Dose	VLA15 high dose with Alum. VLA15: a multivalent Outer surface protein A (OspA) based vaccine candidate	205	5	205	202	205
EG003	Placebo	Placebo: Placebo: PBS (Phosphate Buffered Saline)	124	3	124	85	124

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Cellulitis	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected214 at risk EG0020 events0 affected205 at risk EG0030 events0 affected124 at risk
Herpes zoster	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected214 at risk EG0021 events1 affected205 at risk EG003
Multiple injuries	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected214 at risk EG0021 events1 affected205 at risk EG003
Urinary retention	Renal and urinary disorders	Non-systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected214 at risk EG0020 events0 affected205 at risk EG003
Appendicitis	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected214 at risk EG0020 events0 affected205 at risk EG003
Diverticulitis	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected214 at risk EG0020 events0 affected205 at risk EG003
Neurosyphilis	Infections and infestations	Non-systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected214 at risk EG0020 events0 affected205 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected214 at risk EG0021 events1 affected205 at risk EG003
Acute myocardial infarction	Cardiac disorders	Non-systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected214 at risk EG0020 events0 affected205 at risk EG003
Biliary colic	Hepatobiliary disorders	Non-systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected214 at risk EG0020 events0 affected205 at risk EG003
Plasmacytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected214 at risk EG0021 events1 affected205 at risk EG003
Psychotic disorder	Psychiatric disorders	Non-systematic Assessment	EG0000 events0 affected29 at risk EG0011 events1 affected214 at risk EG0020 events0 affected205 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	Non-systematic Assessment	EG0000 events0 affected29 at risk EG0010 events0 affected214 at risk EG0021 events1 affected205 at risk EG003

Other Adverse Events

Term	Organ System	Assessment Type	Notes	Statistical Information
Injection site pain	General disorders	Systematic Assessment	includes systematic and non-systematic assessments	EG000111 events26 affected29 at risk EG001924 events198 affected214 at risk EG002941 events196 affected205 at risk EG00357 events30 affected124 at risk
Fatigue	General disorders	Systematic Assessment	includes systematic and non-systematic assessments	EG00014 events8 affected29 at risk EG001111 events66 affected214 at risk EG002130 events81 affected205 at risk EG003
Injection site erythema	General disorders	Systematic Assessment		EG00010 events8 affected29 at risk EG001116 events68 affected214 at risk EG002123 events72 affected205 at risk EG003
Injection site induration	General disorders	Systematic Assessment		EG0006 events3 affected29 at risk EG001108 events64 affected214 at risk EG002108 events65 affected205 at risk EG003
Injection site swelling	General disorders	Systematic Assessment		EG0006 events4 affected29 at risk EG00184 events57 affected214 at risk EG002104 events68 affected205 at risk EG003
Influenza like illness	General disorders	Systematic Assessment	includes systematic and non-systematic assessments	EG0003 events3 affected29 at risk EG00144 events32 affected214 at risk EG00249 events42 affected205 at risk EG003
Pyrexia	General disorders	Non-systematic Assessment		EG0002 events2 affected29 at risk EG00110 events9 affected214 at risk EG0027 events7 affected205 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	includes systematic and non-systematic assessments	EG00022 events15 affected29 at risk EG001173 events106 affected214 at risk EG002156 events97 affected205 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	includes systematic and non-systematic assessments	EG0004 events2 affected29 at risk EG00167 events42 affected214 at risk EG00255 events37 affected205 at risk EG003
Headache	Nervous system disorders	Systematic Assessment	includes systematic and non-systematic assessments	EG00019 events10 affected29 at risk EG001115 events73 affected214 at risk EG002135 events84 affected205 at risk EG003
Nausea	Gastrointestinal disorders	Non-systematic Assessment		EG0005 events5 affected29 at risk EG00131 events23 affected214 at risk EG00236 events32 affected205 at risk EG003
Upper respiratory tract infection	Infections and infestations	Non-systematic Assessment		EG0001 events1 affected29 at risk EG00116 events14 affected214 at risk EG00212 events10 affected205 at risk EG003
Nasopharyngitis	Infections and infestations	Non-systematic Assessment		EG0000 events0 affected29 at risk EG00110 events9 affected214 at risk EG00211 events10 affected205 at risk EG003

First MCP Posted Date

ID	Term
D008193	Lyme Disease

Ancestor Terms

ID	Term
D016905	Gram-Negative Bacterial Infections
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections
D001899	Borrelia Infections
D013145	Spirochaetales Infections
D017282	Tick-Borne Diseases
D000079426	Vector Borne Diseases

Units	Counts
Participants	OG00029 OG001192 OG002194 OG003121

Placebo: Placebo: PBS (Phosphate Buffered Saline)

Units	Counts
Participants	OG00029 OG001214 OG002205 OG003124

Units	Counts
Participants	OG00029 OG001214 OG002205 OG003124

OG00029
OG001214
OG002205
OG003124