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SmallpoxPhase 1/2NCT00103584

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

A Phase 1/2 study testing LC16m8 Smallpox Vaccine in people with Smallpox, run by VaxGen at 4 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 34 yearsHealthy volunteers can take part
Conditions the study is for
Smallpox
What is being tested?
LC16m8 Smallpox Vaccine
Type of treatment
Vaccines
How many people
150 participants
Where
4 sitesUnited States
Study dates
Oct 2004to Jul 2006
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 34 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • University of Kentucky, Kentucky Clinic

    Lexington, Kentucky, 40536

  • Vanderbilt University Medical Center, General Clinical Research Center

    Nashville, Tennessee, 37232-2195

  • St. Louis University, Center for Vaccine Development

    St Louis, Missouri, 63110

  • Stanford University, General Clinical Research Center

    Stanford, California, 94305

Other trials in United States

About this study

Official title: A Phase I/II Clinical Trial to Evaluate the Safety and Immunogenicity of LC16m8, A Modified Vaccinia Vaccine, in Healthy Volunteers

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.

Conditions
Smallpox
Being tested
LC16m8 Smallpox Vaccine
Medical subject headings
Smallpox

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LC16m8 Smallpox VaccineBiological

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and immunogenicity

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2005 (estimated)
  2. Study startOct 2004
  3. Study completionJul 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
150 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00103584
Sponsor's protocol ID
VAX012
Status last verified
Jan 2007
First submitted
10 Feb 2005
Last updated
15 Jan 2007
Results posted
No

Publications

  • 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.

    PubMed 21921208

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing LC16m8 Smallpox Vaccine in people with Smallpox, run by VaxGen at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and immunogenicity. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00103584, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2007.

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