Phase 3, Placebo-Controlled, Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Trial of a 6-Valent OspA-Based Lyme Disease Vaccine

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Pfizer Inc.

Participant type

Pediatric, Healthy volunteers

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

10 Aug 2022 → 7 Jan 2026

Decision date (initial)

2024-10-07

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Pfizer Inc.

External identifiers

EU CT number

2023-509105-72-00

EudraCT number

2021-005427-20

ClinicalTrials.gov

NCT05477524

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis, Others, Safety, Efficacy

Primary Efficacy
• To demonstrate the efficacy of VLA15 in preventing confirmed Lyme disease in the Lyme disease season after completion of the primary series vaccination and booster dose.

Primary Safety
• To describe the safety profile of VLA15 as measured by the percentage of participants reporting local reactions, systemic events, AEs, NDCMCs, and SAEs.

Primary Immunogenicity
• To demonstrate that the immune responses to the 6 serotypes induced by VLA15 are equivalent across 3 independent lots.
• To demonstrate that the immune responses to the 6 serotypes induced by VLA15 in children 5-17 years of age are noninferior to those in adults 18-44 years of age after the booster dose.

Secondary objectives 2

1. To demonstrate the efficacy of VLA15 in preventing confirmed Lyme disease in the Lyme disease season after completion of the primary series vaccination and booster dose in NA.
2. To demonstrate the efficacy of VLA15 in preventing confirmed Lyme disease in the Lyme disease season after completion of the primary series vaccination.

Conditions and MedDRA coding

Active immunization against Lyme disease

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

EMA paediatric investigation plan (PIP)

EMEA-003130-PIP02-23

Plan to share IPD

Yes

IPD plan description

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.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 1. Male or female participants ≥5 years of age at enrollment (signing of ICD or assent) in all countries where pediatric enrollment is permitted. In countries or sites where enrollment of children is not permitted, male or female participants ≥18 years of age at the time of informed consent. Refer to Protocol Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.
2. 2. 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. • Any other risk factors determined at the discretion of the investigators.
3. 3. Participants or participants’ parent(s)/legal guardian(s), as age appropriate, who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures; are expected to be available for the duration of the study; and can be contacted by telephone during study participation.
4. 4. Healthy male and female participants at enrollment who are determined by medical history and clinical judgment of the investigator to be eligible for inclusion in the study. Participants with preexisting chronic medical conditions determined to be stable may be included.
5. 5. Capable of giving signed informed consent, and assent (as appropriate), as described in Protocol Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol. The investigator, or a person designated by the investigator, will obtain informed consent (and assent, as appropriate) from each study participant or study participant’s parent(s)/legal guardian (as defined in Protocol Appendix 1) before any study-specific activity is performed. All parent(s)/legal guardians should be fully informed, and participants should be informed to the fullest extent possible, about the study in language and terms they are able to understand. The investigator will retain the original copy of each participant's signed consent (and assent, as appropriate) document(s).

Exclusion criteria 21

1. 1. Pregnant female participants; breastfeeding female participants; positive urine pregnancy test for female participants at Visit 1 (prior to vaccination); WOCBP who are, in the opinion of the investigator, sexually active and at risk for pregnancy; and fertile men and WOCBP who are unwilling or unable to use effective methods of contraception as outlined in this protocol from the signing of the informed consent through 28 days after completion of the primary vaccination series and from the booster dose through 28 days after the booster vaccination.
2. 2. Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components.
3. 3. Any diagnosis of Lyme disease within the past 3 months.
4. 4. Any history of Lyme carditis, neuroborreliosis, arthritis, or other disseminated Lyme disease regardless of when diagnosed.
5. 5. Known tick bite within the past 4 weeks.
6. 6. 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.
7. 7. Underlying clotting deficiency (eg, bleeding disorder, thrombocytopenia) that may increase the risk of excessive bleeding following required study procedures.
8. 8. Congenital or acquired immunodeficiency or treatments that would inhibit the ability to mount an immune response to a vaccine.
9. 9. Any unstable autoimmune condition with a manifestation (eg, arthritic and neurologic) that may interfere with the assessment of Lyme disease (Potential participants with well-controlled, stable autoimmune conditions under the care of a rheumatologist are eligible).
10. 10. Underlying bone marrow disorder such as myelodysplasia, myeloma, or myeloproliferative disorder, treated within the past year, or any history of bone marrow transplant.
11. 11. Malignancy that required treatment with chemotherapy (including the use of adjunctive and hormonal therapy), immunotherapy, radiation therapy, or antineoplastic target therapies within the past 24 months.
12. 12. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
13. 13. Receipt of a previous vaccination for Lyme disease. Note: This includes Lyme vaccine clinical trials where study intervention was received or is unknown.
14. 14. Treatment for Lyme disease in the 3 months prior to study intervention administration.
15. 15. Chronic systemic doxycycline or minocycline or other tetracycline class drug use for acne or any other chronic suppressive antibiotics used to treat other conditions.
16. 16. Receipt of blood/plasma products or immunoglobulins within 6 months before study intervention administration through conclusion of the study.
17. 17. Receipt of systemic corticosteroids (≥20 mg/day of prednisone or equivalent) for ≥14 days within 28 days before study intervention administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
18. 18. Receipt of chronic systemic treatment with other known immunosuppressant medications or radiotherapy within 6 months before study intervention administration.
19. 19. Receipt of anticoagulant therapy within 1 month before study intervention administration. Monotherapy with aspirin or standard-dose antiplatelet medications (eg, clopidogrel, ticagrelor, prasugrel, dipyridamole, ticlopidine, eptifibatide) is permitted.
20. 20. Participation in other studies involving investigational drug(s), investigational vaccines, or investigational devices within 28 days prior to study entry and/or during study participation. Participation in purely observational studies is acceptable.
21. 21. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Primary Efficacy: • Clinically and laboratory confirmed Lyme disease caused by B burgdorferi sensu lato (as determined by the AC). Primary Safety • Local reactions (pain at the injection site, redness, and swelling). • Systemic events (fever, headache, fatigue, muscle pain, and joint pain). • AEs. • NDCMCs. • SAEs. Primary Immunogenicity • Anti-OspA quantitative immunological assay titer.

Secondary endpoints 2

1. Secondary Efficacy 1. Clinically and laboratory confirmed Lyme disease caused by B burgdorferi sensu lato (as determined by the AC).
2. Secondary Efficacy 2. Clinically and laboratory confirmed Lyme disease caused by B burgdorferi sensu lato (as determined by the AC).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Pfizer Inc.

Sponsor organisation

Pfizer Inc.

Address

66 Hudson Boulevard East

City

New York

Postcode

10001-2189

Country

United States

Scientific contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Public contact point

Organisation

Pfizer Inc.

Contact name

Clinical Medical Lead

Third parties 10

Locations

5 EU/EEA countries · 34 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 82 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications