Safety and Pharmacodynamcis of SELA-070 Nicotine Vaccine in Smokers

A Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Pharmacodynamics of Increasing Subcutaneous Doses of SELA-070 in Healthy Adult Smokers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03148925

Enrollment

Registered

2017-05-11

Start date

2017-05-11

Completion date

2018-10-18

Last updated

2018-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Keywords

nicotine vaccine, smoking vaccine, smoking cessation, SELA-070

Brief summary

The purpose of this study is to evaluate the safety and pharmacodynamics of SELA-070. Increasing subcutaneous doses of SELA-070 will be administered to healthy smoker volunteers. The resulting safety profile and anti-nicotine antibody levels will be evaluated.

Interventions

BIOLOGICALSELA-070

Sub-cutaneous injection, multiple dose

BIOLOGICALSaline

Sub-cutaneous injection, multiple dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

Primary Inclusion Criteria: * Healthy Smokers * Subjects must smoke a minimum of 10 but not more than 25 cigarettes per day for at least 3 months prior to enrollment * 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.

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of multiple subcutaneous injections of SELA-070 as assessed by frequency of vaccine related adverse events, graded by severity	21 weeks

Secondary

Measure	Time frame
Immunogenicity of SELA-070 by measuring anti-nicotine antibody titers by Enzyme-Linked Immunosorbent Assay (ELISA).	21 weeks

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026