Prevention of Anthrax InfectionPhase 1NCT00103467
Trial to Evaluate the Safety and Immunogenicity of an Anthrax Recombinant Protective Antigen Vaccine
A Phase 1 study testing rPA102 Vaccine in people with Prevention of Anthrax Infection, run by VaxGen at 4 sites in United States.
Trial summary
The purpose of this phase 1 study is to evaluate the safety and immunogenicity of rPA102 vaccine, using anthrax vaccine adsorbed (AVA) as a comparator. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Prevention of Anthrax Infection
- What is being tested?
- rPA102 Vaccine
- Type of treatment
- Vaccines
- How many people
- 100 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2003to not given
- Phase
- Phase 1
- 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 40 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 to 40 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 3 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.
- Expected to be noncompliant with study visits or planning to move within 8 months.
- Body mass index of >35 or <19.
- Known allergy to aluminum hydroxide, formaldehyde, benzethonium chloride, latex, kanamycin, or any other aminoglycoside antibiotics (such as gentamycin).
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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 of study vaccination.
- Received, or plans to receive, systemic immunosuppresive therapy, radiation therapy, or high-dose inhaled steroids within 30 days of study vaccination.
- Use of systemic chemotherapy 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
4 sites in 1 country.
United States4 sites
Emory University School of Medicine
Atlanta, Georgia, 30322
Dept. of International Health - Johns Hopkins University Bloomberg School of Public Health
Baltimore, Maryland, 21205
Baylor College of Medicine
Houston, Texas, 77030
St. Louis University - SoLutions/SLUtest
St Louis, Missouri, 63104
About this study
Official title: A Phase 1 Trial to Evaluate the Safety and Immunogenicity of an Anthrax Recombinant Protective Antigen Vaccine
The purpose of this phase 1 study is to evaluate the safety and immunogenicity of rPA102 vaccine, using anthrax vaccine adsorbed (AVA) as a comparator.
- Conditions
- Prevention of Anthrax Infection
- Being tested
- rPA102 Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rPA102 VaccineBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and immunogenicity of 3 doses over 4 different dose ranges.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2005 (estimated)
- Study startJun 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Anthrax InfectionStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- VaxGen
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00103467
- Sponsor's protocol ID
- VAX005
- Status last verified
- Feb 2005
- First submitted
- 8 Feb 2005
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Trial to Evaluate the Safety and Immunogenicity of an Anthrax Recombinant Protective Antigen Vaccine
- ClinicalTrials.gov ID
- NCT00103467
- Acronym / sponsor ID
- VAX005
- Conditions
- Prevention of Anthrax Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- VaxGenIndustry (pharma, biotech, devices)
- Study start
- Jun 2003
- First posted
- 9 Feb 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 phase 1 study is to evaluate the safety and immunogenicity of rPA102 vaccine, using anthrax vaccine adsorbed (AVA) as a comparator.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 40 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 to 40 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 3 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.
- Expected to be noncompliant with study visits or planning to move within 8 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 Vaccine | Biological | – |
Primary outcome
Safety and immunogenicity of 3 doses over 4 different dose ranges.
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 24 Jun 2005.
Related trials for Prevention of Anthrax Infection
Not yet recruitingObservational study
Evaluation of Clinical Benefit and Safety Following CYFENDUS Administration for Post-Exposure Prophylaxis of Anthrax Disease.
Anthrax
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rPA102 Vaccine in people with Prevention of Anthrax Infection, 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 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 24 Jun 2005. 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 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.
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 immunogenicity of 3 doses over 4 different dose ranges.. 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 24 Jun 2005.