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Safety and Immunogenicity Study of LC16m8, a Modified Smallpox Vaccine, in Healthy, Previously Unvaccinated Volunteers

Primary Purpose

Smallpox

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LC16m8 Smallpox Vaccine
Sponsored by
VaxGen
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Smallpox

Eligibility Criteria

18 Years - 34 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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. Neurological or psychological condition that may place volunteer at heightened risk from vaccination. Psychiatric condition that precludes compliance with the protocol. Received or plan to receive live vaccines 30 days before or after study vaccination. Received or plan to receive subunit or killed vaccines 14 days before or after study vaccination. Received or plan to receive immunoglobulin or other blood products 60 days prior to HIV screening or study vaccination. Received or plan to receive experimental drugs/vaccines 30 days before study vaccination or prior to study completion. Received or plan to receive systemic immunosuppressive therapy or radiation therapy 30 days before study vaccination or prior to study completion. Served in military conflicts and received smallpox vaccination, or military service prior to 1989. As determined by the Principal Investigator (PI). Close contact = frequent physical contact or sharing linen/clothing.

Sites / Locations

  • Stanford University, General Clinical Research Center
  • University of Kentucky, Kentucky Clinic
  • St. Louis University, Center for Vaccine Development
  • Vanderbilt University Medical Center, General Clinical Research Center

Outcomes

Primary Outcome Measures

Safety and immunogenicity

Secondary Outcome Measures

Full Information

First Posted
February 10, 2005
Last Updated
January 11, 2007
Sponsor
VaxGen
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1. Study Identification

Unique Protocol Identification Number
NCT00103584
Brief Title
Safety and Immunogenicity Study of LC16m8, a Modified Smallpox Vaccine, in Healthy, Previously Unvaccinated Volunteers
Official Title
A Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of LC16m8, A Modified Vaccinia Vaccine, in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Unknown status
Study Start Date
October 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
VaxGen

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smallpox

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
150 (false)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
LC16m8 Smallpox Vaccine
Primary Outcome Measure Information:
Title
Safety and immunogenicity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. Neurological or psychological condition that may place volunteer at heightened risk from vaccination. Psychiatric condition that precludes compliance with the protocol. Received or plan to receive live vaccines 30 days before or after study vaccination. Received or plan to receive subunit or killed vaccines 14 days before or after study vaccination. Received or plan to receive immunoglobulin or other blood products 60 days prior to HIV screening or study vaccination. Received or plan to receive experimental drugs/vaccines 30 days before study vaccination or prior to study completion. Received or plan to receive systemic immunosuppressive therapy or radiation therapy 30 days before study vaccination or prior to study completion. Served in military conflicts and received smallpox vaccination, or military service prior to 1989. As determined by the Principal Investigator (PI). Close contact = frequent physical contact or sharing linen/clothing.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Gurwith, MD, JD
Organizational Affiliation
VaxGen
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University, General Clinical Research Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Kentucky, Kentucky Clinic
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
St. Louis University, Center for Vaccine Development
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Vanderbilt University Medical Center, General Clinical Research Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-2195
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21921208
Citation
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.
Results Reference
derived

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Safety and Immunogenicity Study of LC16m8, a Modified Smallpox Vaccine, in Healthy, Previously Unvaccinated Volunteers

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