We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03010228
First Posted: January 4, 2017
Last Update Posted: November 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Valneva Austria GmbH
  Purpose

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.


Condition Intervention Phase
Lyme Borreliosis, Nervous System Biological: VLA15 with Alum Biological: VLA15 without Alum Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Valneva Austria GmbH:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 179
Actual Study Start Date: January 2017
Estimated Study Completion Date: September 2018
Primary Completion Date: September 28, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: VLA15 12 µg with Alum
VLA15 12 µg (microgram) with Alum has an injection volume of 100 µl (microliter). The amount of Alum per injection is 0.05 mg (microgram).
Biological: VLA15 with Alum
I.M. vaccination with a multivalent outer surface protein A (OspA) based vaccine candidate on days 0, 28 and 56; three different doses
Active Comparator: VLA15 12 µg w/o Alum
VLA15 12 µg (microgram) without (w/o) Alum (aluminum hydroxide) has an injection volume of 100 µl (microliter).
Biological: VLA15 without Alum
I.M. vaccination with a multivalent outer surface protein A (OspA) based vaccine candidate on days 0, 28 and 56; three different doses
Active Comparator: VLA15 48 µg with Alum
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 (microgram).
Biological: VLA15 with Alum
I.M. vaccination with a multivalent outer surface protein A (OspA) based vaccine candidate on days 0, 28 and 56; three different doses
Active Comparator: VLA15 48 µg w/o Alum
VLA15 48 µg (microgram) without (w/o) Alum (aluminum hydroxide) has an injection volume of 400 µl (microliter).
Biological: VLA15 without Alum
I.M. vaccination with a multivalent outer surface protein A (OspA) based vaccine candidate on days 0, 28 and 56; three different doses
Active Comparator: VLA15 90 µg with Alum
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 (microgram).
Biological: VLA15 with Alum
I.M. vaccination with a multivalent outer surface protein A (OspA) based vaccine candidate on days 0, 28 and 56; three different doses
Active Comparator: VLA15 90 µg w/o Alum
VLA15 90 µg (microgram) without (w/o) Alum (aluminum hydroxide) has an injection volume of 750 µl (microliter).
Biological: VLA15 without Alum
I.M. vaccination with a multivalent outer surface protein A (OspA) based vaccine candidate on days 0, 28 and 56; three different doses

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03010228


Locations
United States, California
eStudy Site
Oceanside, California, United States, 92056
United States, Nebraska
Celerion Inc.
Lincoln, Nebraska, United States, 68502
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
Valneva Austria GmbH
Investigators
Study Director: Nicole Bezay Valneva Austria GmbH
  More Information

Responsible Party: Valneva Austria GmbH
ClinicalTrials.gov Identifier: NCT03010228     History of Changes
Other Study ID Numbers: VLA15-101
First Submitted: December 21, 2016
First Posted: January 4, 2017
Last Update Posted: November 7, 2017
Last Verified: November 2017

Keywords provided by Valneva Austria GmbH:
VLA15
Lyme Borreliosis
Multivalent Recombinant OspA Vaccine

Additional relevant MeSH terms:
Borrelia Infections
Lyme Neuroborreliosis
Gram-Negative Bacterial Infections
Bacterial Infections
Spirochaetales Infections
Central Nervous System Bacterial Infections
Lyme Disease
Tick-Borne Diseases
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Vaccines
Aluminum sulfate
Aluminum Hydroxide
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents