AnthraxPhase 2NCT00100724
Trial of rPA-102 Vaccine in Healthy Adult Volunteers
A Phase 2 study testing rPA102 in people with Anthrax, run by VaxGen at 12 sites in United States.
Trial summary
The purpose of this study is to assess the safety and immunogenicity of rPA102 vaccine given intramuscularly at 0 and 4 weeks over 2 dose ranges and 4 adjuvant levels. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Anthrax
- What is being tested?
- rPA102
- How many people
- 480 participants
- Where
- 12 sitesUnited States
- Study dates
- Apr 2004to Jul 2005
- Phase
- Phase 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 55 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 before the initiation of any study interventions.
- Healthy male or female aged 18-55 years old (inclusive) without significant physical or clinical laboratory abnormalities.
- Two intact upper arms with sufficient intramuscular (IM) tissue in the deltoid region for vaccine administration.
- For females, negative serum pregnancy test at screening and agreement to use adequate birth control during the first 2 months of the study.
- Willingness and ability to return for all follow-up visits and blood draws for the duration of the study.
- Willingness to complete the Volunteer Diary and to report concomitant medications and adverse events (AEs) to the study site monitors during the study period.
Who cannot join
- Prior history of, or known exposure to any form of B. anthracis or any anthrax immunization.
- Member of the Armed Services (Active Duty or Reserve) since 1990, with history of previous anthrax vaccination.
- Employment in an industry involved in contact with ruminant animals, veterinary sciences, or other exposure to B. anthracis, or emergency first responders.
- Expected to be noncompliant with study visits or planning to move within 12 months.
- Body mass index of >35 or <19.
- Known allergy to aluminum hydroxide, kanamycin, or any other aminoglycoside antibiotics (such as gentamicin).
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- Pregnancy (positive urine pregnancy test within 24 hours prior to vaccination), or lactation.
- HIV positive (by history or screening ELISA).
- Hepatitis B or C positive (by history or screening HBsAg/anti-HCV ELISA).
- Active or past internal organ, hematologic malignancy, or metastatic cutaneous malignancy.
- History of, or current autoimmune disease, including but not limited to systemic lupus erythematosus, scleroderma, and polyarteritis.
- Immunodeficiency or unstable medical condition as determined by baseline medical history, physical exam, and laboratory assessment.
- Received or plans to receive licensed live vaccines within 30 days of study vaccination.
- Received or plans to receive licensed killed vaccines within 14 days of study vaccination.
- Received or plans to receive immunoglobulin or other blood products within 60 days of study vaccination.
- Received or plans to receive experimental drugs/vaccines within 30 days prior to, and for the duration of the study.
- Received or plans to receive systemic immunosuppressive therapy, radiation therapy, or high-dose inhaled steroids within 30 days of study vaccination.
- Use of systemic chemotheraphy within 5 years prior to study.
- History of Guillain-Barre Syndrome.
- In addition to the conditions listed above, the following may qualify as a reason to exclude a volunteer from the study: fever along with moderate or serious illness within 3 days of vaccination or any condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the study evaluations. Pending resolution of these symptoms, a volunteer may be reconsidered for vaccination.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Emory Children's Clinic, Pediatric Infectious Disease
Atlanta, Georgia, 30322
Johns Hopkins University, Bloomberg School of Public Health
Baltimore, Maryland, 21205
University of Vermont College of Medicine, Vermont Vaccine Evaluation Center
Burlington, Vermont, 05405
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
Pediatric Clinical Trials Int'l, Inc. (PCTI)
Columbus, Ohio, 43205
University of Kentucky, Markey Cancer Center
Lexington, Kentucky, 40536-0093
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Primary Physicians Research, Inc.
Pittsburgh, Pennsylvania, 15241
Mayo Clinic College of Medicine
Rochester, Minnesota, 55905
Infectious Disease Unit, University of Rochester Medical Center
Rochester, New York, 14642
St. Louis University, SoLUtions
St Louis, Missouri, 63104
UCLA Ctr for Vaccine Research, LA Biomedical Research Institute
Torrance, California, 90502
About this study
Official title: A Phase 2 Multi-Center, Randomized Dose-Finding Trial of rPA-102 Vaccine in Healthy Adult Volunteers
The purpose of this study is to assess the safety and immunogenicity of rPA102 vaccine given intramuscularly at 0 and 4 weeks over 2 dose ranges and 4 adjuvant levels.
- Conditions
- Anthrax
- Being tested
- rPA102
- Keywords
- Anthrax, rPA102, vaccine
- Medical subject headings
- Anthrax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rPA102Biological
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and immune response to vaccine.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2005 (estimated)
- Study startApr 2004
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnthraxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 480 participants
Sponsor and investigators
- Lead sponsor
- VaxGen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00100724
- Sponsor's protocol ID
- VAX006
- Status last verified
- Jan 2006
- First submitted
- 5 Jan 2005
- Last updated
- 12 Jan 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multi-Center, Randomized Dose-Finding Trial of rPA-102 Vaccine in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT00100724
- Acronym / sponsor ID
- VAX006
- Conditions
- Anthrax
- Keywords
- Anthrax, rPA102, vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants
- Lead sponsor
- VaxGenIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Centers for Disease Control and Prevention
- Study start
- Apr 2004
- Study completion
- Jul 2005
- First posted
- 6 Jan 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and immunogenicity of rPA102 vaccine given intramuscularly at 0 and 4 weeks over 2 dose ranges and 4 adjuvant levels.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Able to understand the study and give written informed consent. A signed informed consent must be in place before the initiation of any study interventions.
- Healthy male or female aged 18-55 years old (inclusive) without significant physical or clinical laboratory abnormalities.
- Two intact upper arms with sufficient intramuscular (IM) tissue in the deltoid region for vaccine administration.
- For females, negative serum pregnancy test at screening and agreement to use adequate birth control during the first 2 months of the study.
- Willingness and ability to return for all follow-up visits and blood draws for the duration of the study.
Key exclusion criteria (20 listed)
- Prior history of, or known exposure to any form of B. anthracis or any anthrax immunization.
- Member of the Armed Services (Active Duty or Reserve) since 1990, with history of previous anthrax vaccination.
- Employment in an industry involved in contact with ruminant animals, veterinary sciences, or other exposure to B. anthracis, or emergency first responders.
- Expected to be noncompliant with study visits or planning to move within 12 months.
- Body mass index of >35 or <19.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rPA102 | Biological | – |
Primary outcome
Safety and immune response to vaccine.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rPA102 in people with Anthrax, run by VaxGen at 12 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 6 inclusion and 20 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: finished, as of the sponsor's last update on 12 Jan 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 immune response to vaccine.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2006.