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

Sponsor

Pfizer (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05477524

Collaborator

Valneva Austria GmbH (Industry)

18,000

Enrollment

Locations

Arms

28.9

Anticipated Duration (Months)

375

Patients Per Site

Patients Per Site Per Month

Study Details

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 18,000 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 1 telephone contact. It is expected that each participant will take part in this study for up to about 2 and a half years.

Condition or Disease	Intervention/Treatment	Phase
Lyme Disease	Biological: VLA15 Other: Saline	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

18000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Aug 4, 2022

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
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)	Other: Saline Shot in the deltoid muscle (preferable in the nondominant arm)

Outcome Measures

Primary Outcome Measures

Relative risk reduction of confirmed Lyme disease cases in the VLA15 group compared to the placebo group [In the Lyme disease season beginning 1 month after completing the primary series (28 days after completion of the primary series until 31 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 [In the Lyme disease season beginning 1 month after receiving the booster dose (28 days after completion of the booster dose until 31 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
Percentage of participants reporting prompted local reactions [Within 7 days following each study intervention administration]
Percentage of participants reporting prompted systemic events [Within 7 days following each study intervention administration]
Percentage of participants reporting adverse events (AEs) [Through 1 month following each study intervention administration]
Percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs) [Through study completion, up to approximately 30 months.]
Percentage of participants reporting serious adverse events (SAEs) [Through study completion, up to approximately 30 months.]
Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6) for Lot 1 to Lot 2 [At 1 month after completion of the primary series]
Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6) for Lot 1 to Lot 3 [At 1 month after completion of the primary series]
Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6) for Lot 2 to Lot 3 [At 1 month after completion of the primary series]

Secondary Outcome Measures

Relative risk reduction of Lyme disease-specific seroconversion in otherwise-undiagnosed Lyme disease cases in the VLA15 group compared to the placebo group [In the Lyme disease season beginning 1 month after completing the primary series (28 days after completion of the primary series until 31 October)]
Nonvaccine-antigen seroconversion as measured at the central laboratory
Relative risk reduction of Lyme disease-specific seroconversion in otherwise-undiagnosed Lyme disease cases in the VLA15 group compared to the placebo group [In the Lyme disease season beginning 1 month after receiving the booster dose (28 days after completion of the booster dose until 31 October)]
Nonvaccine-antigen seroconversion as measured at the central laboratory
Vaccine efficacy among participants enrolled from North American sites [In the Lyme disease season beginning 1 month after completing the primary series (28 days after completion of the primary series until 31 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 European sites [In the Lyme disease season beginning 1 month after completing the primary series (28 days after completion of the primary series until 31 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 [In the Lyme disease season beginning 1 month after receiving the booster dose (28 days after completion of the booster dose until 31 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 European sites [In the Lyme disease season beginning 1 month after receiving the booster dose (28 days after completion of the booster dose until 31 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 Criteria

Criteria

Ages Eligible for Study:

5 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 diagnosis of Lyme disease within the past 3 months.
Any history of Lyme carditis, neuroborreliosis, or arthritis, 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 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 and Locations

Locations

	Site	City	State	Country	Postal Code
1	Care Access Mobile Site	New London	Connecticut	United States	06320
2	Care Access Mobile Site	Norwich	Connecticut	United States	06360
3	Care Access Mobile Site	Old Saybrook	Connecticut	United States	06475
4	Stamford Health Medical Group	Stamford	Connecticut	United States	06902
5	Stamford Hospital	Stamford	Connecticut	United States	06902
6	Stamford Hospital	Stamford	Connecticut	United States	06904
7	Care Access Mobile Site	Wilton	Connecticut	United States	06897
8	Care Access Mobile Site	Vassalboro	Maine	United States	04989
9	Pediatric Associates of Fall River	Fall River	Massachusetts	United States	02721
10	Care Access Mobile Site	Oak Bluffs	Massachusetts	United States	02557
11	Care Access - Hoboken	Hoboken	New Jersey	United States	07030
12	Care Access Mobile Site	Mountain Lakes	New Jersey	United States	07046
13	Bassett Medical Center	Cooperstown	New York	United States	13326
14	Care Access - Albany	Halfmoon	New York	United States	12065
15	Care Access - Albany	Halfmoon	New York	United States	12065
16	Care Access Mobile Site	Aliquippa	Pennsylvania	United States	15001
17	Care Access Mobile Site	Clarion	Pennsylvania	United States	16214
18	Altoona Center For Clinical Research	Duncansville	Pennsylvania	United States	16635
19	Care Access Mobile Site	Grove City	Pennsylvania	United States	16127
20	Richard M Kastelic M.D. and Associates, PC / Berkley Hills Clinicals	Johnstown	Pennsylvania	United States	16641
21	Care Access - Pottsville	Pottsville	Pennsylvania	United States	17901
22	Guthrie Medical Group, P. C.	Sayre	Pennsylvania	United States	18840
23	Robert Packer Hospital	Sayre	Pennsylvania	United States	18840
24	Frontier Clinical Research, LLC	Scottdale	Pennsylvania	United States	15683
25	Care Access - Scranton	Scranton	Pennsylvania	United States	18508
26	Care Access Mobile Site	Sharon	Pennsylvania	United States	16146
27	Preferred Primary Care Physicians	Uniontown	Pennsylvania	United States	15401
28	Care Access - Wilkes-Barre	Wilkes-Barre	Pennsylvania	United States	18702
29	Velocity Clinical Research, Providence	East Greenwich	Rhode Island	United States	02818
30	Care Access Mobile Site	New Shoreham	Rhode Island	United States	02807
31	Care Access Mobile Site	Providence	Rhode Island	United States	02906
32	Care Access - Warwick	Warwick	Rhode Island	United States	02886
33	AmBeNet GmbH	Leipzig	Sachsen	Germany	04107
34	Internistische Gemeinschaftspraxis Mainz	Mainz		Germany	55116
35	Szpital im. Św. Jadwigi Śląskiej w Trzebnicy	Trzebnica	Dolnośląskie	Poland	55-100
36	Futuremeds spolka z ograniczona odpowiedzialnoscia	Wroclaw	Dolnośląskie	Poland	50-088
37	MICS Centrum Medyczne Torun	Torun	Kujawsko-pomorskie	Poland	87-100
38	SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym	Lomianki	Mazowieckie	Poland	05-092
39	Przylądek Zdrowia	Krakow	Małopolskie	Poland	30-644
40	Krakowski Szpital Specjalistyczny im. Jana Pawa II	Krakow	Małopolskie	Poland	31-202
41	ALERGO-MED Specjalistyczna Przychodnia Lekarska	Tarnow	Małopolskie	Poland	33-100
42	Centrum Medyczne Lucyna Andrzej Dymek	Strzelce Opolskie	Opolskie	Poland	47-100
43	Indywidualna Specjalistyczna Praktyka Lekarska Roman SPYRA	Katowice		Poland	40-018
44	Krakowskie Centrum Medyczne	Krakow		Poland	31-501
45	NZOZ Praktyka Lekarza Rodzinnego Eskulap	Lublin		Poland	20-044
46	EMC Instytut Medyczny	Wroclaw		Poland	50-220
47	Blekinge Tekniska Hogskola (BTH) (Blekinge Institute of Technology) - Karlskrona	Karlskrona	Blekinge LÄN [se-10]	Sweden	371 79
48	ProbarE	Lund		Sweden	222 22

Sponsors and Collaborators

Pfizer
Valneva Austria GmbH

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT05477524

Other Study ID Numbers:

C4601003
2021-005427-20

First Posted:

Jul 28, 2022

Last Update Posted:

Aug 23, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Pfizer

VLA15

Lyme Borreliosis

Vaccine

Additional relevant MeSH terms:

Lyme Disease

Study Results

No Results Posted as of Aug 23, 2022