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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Selecta Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT01478893
First received: November 18, 2011
Last updated: May 6, 2014
Last verified: May 2014

November 18, 2011
May 6, 2014
November 2011
March 2013   (final data collection date for primary outcome measure)
To assess the safety and tolerability of multiple subcutaneous injections of SEL-068 as assessed by frequency of vaccine related adverse events, graded by severity [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
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 ]
Complete list of historical versions of study NCT01478893 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Safety and Pharmacodynamics of SEL-068 Vaccine in Smokers and Non-Smokers
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Smoking Cessation
  • Biological: SEL-068
    Sub-cutaneous injection, multiple dose
  • Biological: Saline
    Sub-cutaneous injection, multiple dose
  • Experimental: SEL-068
    Intervention: Biological: SEL-068
  • Placebo Comparator: Saline
    Intervention: Biological: Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
Not Provided
March 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01478893
SEL-068/101, 2011-003272-37
Not Provided
Selecta Biosciences, Inc.
Selecta Biosciences, Inc.
Not Provided
Principal Investigator: Eva Vets, MD SGS LSS Clinical Pharmacology Unit - Antwerpen
Selecta Biosciences, Inc.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP