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Safety and Pharmacodynamics of SEL-068 Vaccine in Smokers and Non-Smokers

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Selecta Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT01478893
First received: November 18, 2011
Last updated: December 5, 2012
Last verified: December 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the safety and pharmacodynamics of SEL-068. Increasing subcutaneous doses of SEL-068 will be administered to healthy non-smoker and smoker volunteers. The resulting safety profile and anti-nicotine antibody levels will be evaluated.


Condition Intervention Phase
Smoking Cessation
 Biological: SEL-068
Biological: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Pharmacodynamics of Increasing Subcutaneous Doses of SEL-068 in Healthy Non-Smoker and Smoker Adults

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Selecta Biosciences, Inc.:

Primary Outcome Measures:
  • To assess the safety and tolerability of 2 subcutaneous injections of SEL-068, a prime and a boost injection 28 days apart, as assessed by frequency of vaccine related adverse events, graded by severity [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immunogenicity of SEL-068 by measuring anti-nicotine antibody titers by Enzyme-Linked Immunosorbent Assay (ELISA). [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: November 2011
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose A SEL-068 in each of 2 injections Biological: SEL-068
SEL-068 injected subcutaneously twice on a 28 day interval, each subject receiving the same dosage level for both injections
Experimental: Dose B SEL-068 in each of 2 injections Biological: SEL-068
SEL-068 injected subcutaneously twice on a 28 day interval, each subject receiving the same dosage level for both injections
Experimental: Dose C SEL-068 in each of 2 injections Biological: SEL-068
SEL-068 injected subcutaneously twice on a 28 day interval, each subject receiving the same dosage level for both injections
Experimental: Dose D SEL-068 in each of 2 injections Biological: SEL-068
SEL-068 injected subcutaneously twice on a 28 day interval, each subject receiving the same dosage level for both injections
Experimental: Dose E SEL-068 in each of 2 injections Biological: SEL-068
SEL-068 injected subcutaneously twice on a 28 day interval, each subject receiving the same dosage level for both injections
Placebo Comparator: Placebo in each of 2 injections Biological: Placebo
Placebo injected subcutaneously twice on a 28 day interval

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Primary Inclusion Criteria:

  • Healthy Smokers
  • Healthy non-smokers
  • Written informed consent

Primary Exclusion Criteria:

  • Prior exposure to nicotine vaccines
  • Female subjects of childbearing potential
  • Current use of immunosuppressive agents
  • History of or current autoimmune disorder of immunosuppressive condition (e.g. HIV infection)
  • Concurrent participation or participation within 8 weeks prior to the initial study drug administration in a drug/device or biologic investigational research study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01478893

Locations
Belgium
SGS LSS Clinical Pharmacology Unit
Antwerpen, Belgium
Sponsors and Collaborators
Selecta Biosciences, Inc.
Investigators
Principal Investigator: Eva Vets, MD SGS LSS Clinical Pharmacology Unit - Antwerpen
  More Information

No publications provided

Responsible Party: Selecta Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT01478893     History of Changes
Other Study ID Numbers: SEL-068/101, 2011-003272-37
Study First Received: November 18, 2011
Last Updated: December 5, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Selecta Biosciences, Inc.:
nicotine vaccine
smoking vaccine
smoking cessation
SEL-068

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on June 18, 2013