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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
  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: Saline
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:


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

Primary Outcome Measures:
  • 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 ]

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 ]

Enrollment: 82
Study Start Date: November 2011
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SEL-068 Biological: SEL-068
Sub-cutaneous injection, multiple dose
Placebo Comparator: Saline Biological: Saline
Sub-cutaneous injection, multiple dose

  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
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, see Learn About Clinical Studies.

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: May 6, 2014
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

ClinicalTrials.gov processed this record on November 24, 2014