NCT00103584

Brief Summary

This is a Phase I/II study evaluating the safety and immunogenicity of LC16m8, a modified vaccinia vaccine. After consent and thorough screening (including safety labs, EKG, and medical history), healthy, previously unvaccinated volunteers between the ages of 18-34 will receive a single vaccination of either LC16m8 or the current US-licensed smallpox vaccine, Dryvax. Volunteers will be blindly randomized to a treatment group in a 4:1 ratio (4 LC16m8 to 1 Dryvax recipient). Follow-up clinical evaluations, laboratory testing, EKGs and cardiac assessments will be done at regularly scheduled follow-up visits for 1 year after vaccination.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2004

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2005

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

January 15, 2007

Status Verified

January 1, 2007

First QC Date

February 10, 2005

Last Update Submit

January 11, 2007

Conditions

Smallpox

Outcome Measures

Primary Outcomes (1)

  • Safety and immunogenicity

Interventions

LC16m8 Smallpox VaccineBIOLOGICAL

Eligibility Criteria

Age18 Years - 34 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Able to understand the study and give written informed consent. A signed informed consent must be in place prior to any study procedures being performed.
  • Male or female aged 18-34 years old (inclusive; year of birth = 1971-1987).
  • No history of smallpox vaccination or evidence of vaccine site scar.
  • Willing and able to return for all follow-up visits, study procedures, and blood draws for the duration of the study.
  • In good health, as ascertained by medical history, clinical assessment, and baseline (screening) laboratory assessments.
  • Negative ELISA for HIV or, if indeterminate, Western blot or other assay confirming that the serostatus does not reflect HIV infection.
  • Negative Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) serology.
  • Negative urine glucose by urinalysis (UA).
  • ALT \<1.5 times upper limit of normal.
  • Adequate renal function as defined by serum creatinine ≤1.5 mg/dL; urine protein \<100 mg/dL, or trace or negative proteinuria by UA, and an estimated creatinine clearance of \>55 mL/min. Renal function is measured to ensure that subjects could meet criteria for use of Vistide, should this be needed.
  • Hematocrit, hemoglobin, platelets, and white blood cell count (WBC) within normal limits for males and females.
  • EKG and EEG (for those being tested) baseline readings within normal limits (these will be read at a central site).
  • Willing to refrain from donating blood (other than study-related) throughout the study and for a period of at least 21 days (or until scab separation) after vaccination. In some cases, state laws are more restrictive.
  • Negative serum pregnancy test for females at screening and within 2 days prior to vaccination.
  • If the volunteer is female and of childbearing potential, she must agree to use effective birth control methods and not become pregnant during the course of the study. A female is considered to have childbearing potential unless post-menopausal or surgically sterilized. Effective birth control methods include licensed, approved hormonal methods such as pills, patch, injection, or implant.

You may not qualify if:

  • Planning to move within 52 weeks from the time of vaccination.
  • Known allergy to any materials used in this study or components of the vaccines, which may include erythromycin, streptomycin, chlortetracycline, polymyxin B, neomycin, phenol, glycerin, Vaccinia Immune Globulin (VIG), immunoglobulin, blood products containing immunoglobulin preparations, cidofovir, probenecid, and/or bandage adhesive tape.
  • Pregnant or breastfeeding, or have close contact\*\* with someone who is pregnant or breastfeeding.
  • Active or past history of atopic dermatitis or eczema, or close contact\*\* with someone with active or past history of atopic dermatitis or eczema.
  • Presence of (or close contact\*\* or sharing a household with) a skin condition with extensive breaks in the skin such as burns, impetigo, contact dermatitis, or zoster (shingles) not likely to heal by the day of vaccination.
  • Darier's disease or close contact\*\* with Darier's disease.
  • Immunosuppression (including HIV), or close contact\*\* with an immunosuppressed individual.
  • Using immunosuppressive medications, in eye drops, by mouth, or topically (corticosteroid nasal sprays and inhalers are permissible at low doses after discussion with VaxGen Medical Monitor).
  • Close contact\*\* with children under 1 year old.
  • Active or past malignancy with the exception of non-metastatic skin cancers.
  • History of exuberant keloid formation.\*
  • Known cardiac disease or three or more cardiac risk factors (high blood pressure, diabetes mellitus, smoking, hypercholesterolemia, heart disease at age 50 or earlier in a first-degree relative, or obesity \[defined as Body Mass Index (BMI)\>30\]).
  • Currently under treatment for high blood pressure.
  • History of solid organ or bone marrow transplantation.
  • Evidence of immunosuppression or autoimmune disease, cardiac disease, renal disease, splenectomy, or unstable medical condition as determined by baseline medical history, physical assessment, or laboratory assessments.
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Stanford University, General Clinical Research Center

Stanford, California, 94305, United States

Location

University of Kentucky, Kentucky Clinic

Lexington, Kentucky, 40536, United States

Location

St. Louis University, Center for Vaccine Development

St Louis, Missouri, 63110, United States

Location

Vanderbilt University Medical Center, General Clinical Research Center

Nashville, Tennessee, 37232-2195, United States

Location

Related Publications (1)

  • Kennedy JS, Gurwith M, Dekker CL, Frey SE, Edwards KM, Kenner J, Lock M, Empig C, Morikawa S, Saijo M, Yokote H, Karem K, Damon I, Perlroth M, Greenberg RN. Safety and immunogenicity of LC16m8, an attenuated smallpox vaccine in vaccinia-naive adults. J Infect Dis. 2011 Nov;204(9):1395-402. doi: 10.1093/infdis/jir527. Epub 2011 Sep 15.

    PMID: 21921208DERIVED

MeSH Terms

Conditions

Smallpox

Interventions

smallpox vaccine LC16m8

Condition Hierarchy (Ancestors)

Poxviridae InfectionsDNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Marc Gurwith, MD, JD

    VaxGen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 10, 2005

First Posted

February 11, 2005

Study Start

October 1, 2004

Study Completion

July 1, 2006

Last Updated

January 15, 2007

Record last verified: 2007-01

Locations

US(4)