History of Changes for Study: NCT05477524

An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15) (VALOR)

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Study Record Versions

Version	Submitted Date	Changes
1	July 25, 2022	None (earliest Version on record)
2	July 28, 2022	Study Status, Contacts/Locations and Oversight
3	August 2, 2022	Study Status and Contacts/Locations
4	August 19, 2022	Recruitment Status, Contacts/Locations and Study Status
5	October 20, 2022	Contacts/Locations and Study Status
6	December 14, 2022	Contacts/Locations and Study Status
7	February 16, 2023	Contacts/Locations, Study Status and Study Identification
8	March 8, 2023	Contacts/Locations and Study Status
9	March 13, 2023	Contacts/Locations and Study Status
10	March 20, 2023	Study Status and Contacts/Locations
11	July 7, 2023	Outcome Measures, Contacts/Locations, Study Status, Eligibility, Conditions, Study Description and Oversight
12	July 11, 2023	Contacts/Locations, Study Design and Study Status
13	July 31, 2023	Contacts/Locations, Oversight, Study Design and Study Status
14	August 25, 2023	Contacts/Locations and Study Status
15	September 8, 2023	Contacts/Locations and Study Status
16	October 12, 2023	Contacts/Locations, Study Status, Study Design, Study Description and Oversight
17	October 26, 2023	Contacts/Locations and Study Status
18	November 27, 2023	Study Status and Contacts/Locations
19	December 20, 2023	Study Status and Contacts/Locations
20	March 21, 2024	Recruitment Status, Study Status, Contacts/Locations, Study Design and Oversight

Comparison Format:

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	July 11, 2023	July 31, 2023

Study Identification


Unique Protocol ID:	C4601003	C4601003
Brief Title:	An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15) (VALOR)	An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15) (VALOR)
Official Title:	A Phase 3, Multicenter, Placebo-Controlled, Randomized, Observer-Blinded Trial to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity, and Lot Consistency of a 6-Valent OspA-Based Lyme Disease Vaccine in Healthy Participants ≥5 Years of Age	A Phase 3, Multicenter, Placebo-Controlled, Randomized, Observer-Blinded Trial to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity, and Lot Consistency of a 6-Valent OspA-Based Lyme Disease Vaccine in Healthy Participants ≥5 Years of Age
Secondary IDs:	2021-005427-20 [EudraCT Number] 2021-005427-20 [Registry Identifier: CTIS (EU)]	2021-005427-20 [EudraCT Number] 2021-005427-20 [Registry Identifier: CTIS (EU)]

Study Status


Record Verification:	July 2023	July 2023
Overall Status:	Recruiting	Recruiting
Study Start:	August 4, 2022	August 4, 2022
Primary Completion:	December 31, 2025 [Anticipated]	December 31, 2025 [Anticipated]
Study Completion:	December 31, 2025 [Anticipated]	December 31, 2025 [Anticipated]

First Submitted:	July 5, 2022	July 5, 2022
First Submitted that Met QC Criteria:	July 25, 2022	July 25, 2022
First Posted:	July 28, 2022 [Actual]	July 28, 2022 [Actual]

Last Update Submitted that Met QC Criteria:	July 11, 2023	July 31, 2023
Last Update Posted:	July 12, 2023 [Actual]	August 2, 2023 [Actual]

Sponsor/Collaborators


Sponsor:	Pfizer	Pfizer
Responsible Party:	Sponsor	Sponsor
Collaborators:	Valneva Austria GmbH	Valneva Austria GmbH

Oversight


U.S. FDA-regulated Drug:	Yes	Yes
U.S. FDA-regulated Device:	No	No
Data Monitoring:	Yes	Yes

Study Description

Brief Summary:

The main purpose of this clinical study is to evaluate a 6-valent OspA-based Lyme disease vaccine (VLA15) for prevention of Lyme disease within North America and Europe. Approximately 6,400 healthy participants 5 years and older will be recruited from areas with high levels of endemic Lyme disease to receive VLA15 or placebo (an inactive substance consisting of saltwater). Each participant will have about a 50% chance of receiving VLA15 and about a 50% chance of receiving placebo. A subset of participants will receive VLA15 from 3 different lots or placebo (1:1:1:3 ratio) to assess lot equivalence.

Participants will receive a 3-dose primary vaccination series at about 0, 2, and 5 to 9 months and then receive a booster dose about 12 months later. Vaccination of participants will occur at a time of year such that the primary series is completed before the peak Lyme disease season followed by a booster dose just prior to the beginning of the second Lyme disease season.

Comparison will be made between the Lyme disease cases of people receiving the study vaccine to those of the people who are not. This will help us determine if the study vaccine is safe and effective.

If enrolled, participants will need to visit the research site at least 7 times during the study. There will also be at least 3 telephone contacts. It is expected that each participant will take part in this study for up to about 2 and a half years.

Detailed Description:

Conditions


Conditions:	Lyme Disease	Lyme Disease
Keywords:	VLA15 Lyme Borreliosis Vaccine Tick	VLA15 Lyme Borreliosis Vaccine Tick

Study Design


Study Type:	Interventional	Interventional
Primary Purpose:	Prevention	Prevention
Study Phase:	Phase 3	Phase 3
Interventional Study Model:	Parallel Assignment	Parallel Assignment
Number of Arms:	4	4
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:	Randomized	Randomized
Enrollment:	6400 [Anticipated]	18000 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Experimental: VLA15 Lot 1 (3-dose primary vaccination series and booster dose) Shot in the deltoid muscle (preferable in the nondominant arm)	Biological: VLA15 Shot in the deltoid muscle (preferable in the nondominant arm)
Experimental: VLA15 Lot 2 (3-dose primary vaccination series and booster dose) Shot in the deltoid muscle (preferable in the nondominant arm)	Biological: VLA15 Shot in the deltoid muscle (preferable in the nondominant arm)
Experimental: VLA15 Lot 3 (3-dose primary vaccination series and booster dose) Shot in the deltoid muscle (preferable in the nondominant arm)	Biological: VLA15 Shot in the deltoid muscle (preferable in the nondominant arm)
Placebo Comparator: Placebo (3-dose primary vaccination series and booster dose) Shot in the deltoid muscle (preferable in the nondominant arm)	Saline Shot in the deltoid muscle (preferable in the nondominant arm)

Outcome Measures


Primary Outcome Measures:
1.	Relative risk reduction of confirmed Lyme disease cases in the VLA15 group compared to the placebo group [ Time Frame: Beginning 1 month after receiving the booster dose (28 days after receiving the booster dose through the end of the Lyme disease season following the booster dose (end of October)). ] A confirmed case of Lyme disease, caused by B burgdorferi sensu lato, is defined as a clinically suspected case of Lyme disease that is confirmed by PCR, culture, microbial cell-free B burgdorferi-specific DNA sequencing, or serological antiborrelial antibody assay, and finally assessed and confirmed to be a case by the Endpoint Adjudication Committee	Relative risk reduction of confirmed Lyme disease cases in the VLA15 group compared to the placebo group [ Time Frame: Beginning 1 month after receiving the booster dose (28 days after receiving the booster dose through the end of the Lyme disease season following the booster dose (end of October)). ] A confirmed case of Lyme disease, caused by B burgdorferi sensu lato, is defined as a clinically suspected case of Lyme disease that is confirmed by PCR, culture, microbial cell-free B burgdorferi-specific DNA sequencing, or serological antiborrelial antibody assay, and finally assessed and confirmed to be a case by the Endpoint Adjudication Committee
2.	Percentage of participants reporting local reactions [ Time Frame: Within 7 days following each study intervention administration ]	Percentage of participants reporting local reactions [ Time Frame: Within 7 days following each study intervention administration ]
3.	Percentage of participants reporting systemic events [ Time Frame: Within 7 days following each study intervention administration ]	Percentage of participants reporting systemic events [ Time Frame: Within 7 days following each study intervention administration ]
4.	Percentage of participants reporting adverse events (AEs) [ Time Frame: Through 1 month following each study intervention administration ]	Percentage of participants reporting adverse events (AEs) [ Time Frame: Through 1 month following each study intervention administration ]
5.	Percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs) [ Time Frame: Through study completion, up to approximately 30 months. ]	Percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs) [ Time Frame: Through study completion, up to approximately 30 months. ]
6.	Percentage of participants reporting serious adverse events (SAEs) [ Time Frame: Through study completion, up to approximately 30 months. ]	Percentage of participants reporting serious adverse events (SAEs) [ Time Frame: Through study completion, up to approximately 30 months. ]
7.	Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6) for Lot 1 to Lot 2 [ Time Frame: At 1 month after completion of the primary series and the booster dose ]	Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6) for Lot 1 to Lot 2 [ Time Frame: At 1 month after completion of the primary series and the booster dose ]
8.	Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6) for Lot 1 to Lot 3 [ Time Frame: At 1 month after completion of the primary series and the booster dose ]	Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6) for Lot 1 to Lot 3 [ Time Frame: At 1 month after completion of the primary series and the booster dose ]
9.	Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6) for Lot 2 to Lot 3 [ Time Frame: At 1 month after completion of the primary series and the booster dose ]	Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6) for Lot 2 to Lot 3 [ Time Frame: At 1 month after completion of the primary series and the booster dose ]
10.	Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6) [ Time Frame: At 1 month after completion of the booster dose ] Immunobridging objective to determine non-inferiority between 5-17 year old and 18-44 year old participant strata.	Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6) [ Time Frame: At 1 month after completion of the booster dose ] Immunobridging objective to determine non-inferiority between 5-17 year old and 18-44 year old participant strata.
Secondary Outcome Measures:
1.	Vaccine efficacy among participants enrolled from North American sites [ Time Frame: Through the end of the Lyme disease season beginning 1 month after receiving the booster dose (28 days after completion of the booster dose until end of October) ] A confirmed case of Lyme disease, caused by B burgdorferi sensu lato, is defined as a clinically suspected case of Lyme disease that is confirmed by PCR, culture, microbial cell-free B burgdorferi-specific DNA sequencing, or serological antiborrelial antibody assay, and finally assessed and confirmed to be a case by the Endpoint Adjudication Committee	Vaccine efficacy among participants enrolled from North American sites [ Time Frame: Through the end of the Lyme disease season beginning 1 month after receiving the booster dose (28 days after completion of the booster dose until end of October) ] A confirmed case of Lyme disease, caused by B burgdorferi sensu lato, is defined as a clinically suspected case of Lyme disease that is confirmed by PCR, culture, microbial cell-free B burgdorferi-specific DNA sequencing, or serological antiborrelial antibody assay, and finally assessed and confirmed to be a case by the Endpoint Adjudication Committee
2.	Vaccine efficacy among participants after primary series [ Time Frame: Through the end of the Lyme disease season beginning 1 month after completing the primary series (28 days after completion of the primary series until end of October) ] A confirmed case of Lyme disease, caused by B burgdorferi sensu lato, is defined as a clinically suspected case of Lyme disease that is confirmed by PCR, culture, microbial cell-free B burgdorferi-specific DNA sequencing, or serological antiborrelial antibody assay, and finally assessed and confirmed to be a case by the Endpoint Adjudication Committee	Vaccine efficacy among participants after primary series [ Time Frame: Through the end of the Lyme disease season beginning 1 month after completing the primary series (28 days after completion of the primary series until end of October) ] A confirmed case of Lyme disease, caused by B burgdorferi sensu lato, is defined as a clinically suspected case of Lyme disease that is confirmed by PCR, culture, microbial cell-free B burgdorferi-specific DNA sequencing, or serological antiborrelial antibody assay, and finally assessed and confirmed to be a case by the Endpoint Adjudication Committee

Eligibility


Minimum Age:	5 Years	5 Years
Maximum Age:
Sex:	All	All
Gender Based:
Accepts Healthy Volunteers:	Yes	Yes
Criteria:	Key Inclusion Criteria: Participants who reside in areas with endemic Lyme disease and who lead lifestyles that put them at increased risk for Lyme disease. For example, this could include, but not be limited to: Individuals who work in B burgdorferi-infected/tick-infested areas, especially those with occupations that may be associated with higher risk of exposure, such as landscaping, forestry, and wildlife and parks management. Individuals who pursue recreational activities such as hiking, camping, fishing, hunting, jogging, or gardening in such areas. Individuals who live on land plots with tree lines and come into contact with these trees regularly. Individuals who have dogs that regularly are outdoors and frequently return with attached ticks. Individuals who participate in activities in areas with tall grass, smaller wooded areas beside forests, open fields, lakesides, and riversides. Key Exclusion Criteria: Any female participants that are pregnant (or have a positive urine pregnancy test) or are breastfeeding. Any diagnosis of Lyme disease within the past 3 months. Any history of Lyme carditis, neuroborreliosis, or arthritis, or other disseminated Lyme disease regardless of when diagnosed. Known tick bite within the past 4 weeks. Newly developed or unstable underlying conditions that may interfere with the assessment of Lyme disease, including but not limited to chronic arthralgia/arthritis, second/third-degree AV heart block, chronic pain syndromes, and chronic skin conditions that reduce the ability to detect cutaneous manifestations of Lyme disease. Any unstable autoimmune condition with a manifestation (eg, arthritic and neurologic) that may interfere with the assessment of Lyme disease. Chronic systemic doxycycline or minocycline or other tetracycline class drug use for acne or any other chronic suppressive antibiotics used to treat other conditions.	Key Inclusion Criteria: Participants who reside in areas with endemic Lyme disease and who lead lifestyles that put them at increased risk for Lyme disease. For example, this could include, but not be limited to: Individuals who work in B burgdorferi-infected/tick-infested areas, especially those with occupations that may be associated with higher risk of exposure, such as landscaping, forestry, and wildlife and parks management. Individuals who pursue recreational activities such as hiking, camping, fishing, hunting, jogging, or gardening in such areas. Individuals who live on land plots with tree lines and come into contact with these trees regularly. Individuals who have dogs that regularly are outdoors and frequently return with attached ticks. Individuals who participate in activities in areas with tall grass, smaller wooded areas beside forests, open fields, lakesides, and riversides. Key Exclusion Criteria: Any female participants that are pregnant (or have a positive urine pregnancy test) or are breastfeeding. Any diagnosis of Lyme disease within the past 3 months. Any history of Lyme carditis, neuroborreliosis, or arthritis, or other disseminated Lyme disease regardless of when diagnosed. Known tick bite within the past 4 weeks. Newly developed or unstable underlying conditions that may interfere with the assessment of Lyme disease, including but not limited to chronic arthralgia/arthritis, second/third-degree AV heart block, chronic pain syndromes, and chronic skin conditions that reduce the ability to detect cutaneous manifestations of Lyme disease. Any unstable autoimmune condition with a manifestation (eg, arthritic and neurologic) that may interfere with the assessment of Lyme disease. Chronic systemic doxycycline or minocycline or other tetracycline class drug use for acne or any other chronic suppressive antibiotics used to treat other conditions.

Contacts/Locations

IPDSharing


Plan to Share IPD:	Yes Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.	Yes Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
	Supporting Information:	Supporting Information:
	Time Frame:	Time Frame:
	Access Criteria:	Access Criteria:
	URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests	URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

References


Citations:
Links:
	URL: https://pmiform.com/clinical-trial-info-request?StudyID=C4601003	URL: https://pmiform.com/clinical-trial-info-request?StudyID=C4601003
	Description: To obtain contact information for a study center near you, click here.	Description: To obtain contact information for a study center near you, click here.
Available IPD/Information: