Bacillus Anthracis (Anthrax)Phase 2NCT00170469
Safety, Tolerability and Immunogenicity of Recombinant Anthrax Vaccine Compared With Anthrax Vaccine Adsorbed
A Phase 2 study testing AVA and rPA vaccine containing alhydrogel in people with Bacillus Anthracis (Anthrax), run by PharmAthene UK Limited at 16 sites in United States.
Trial summary
This is a dose ranging study comparing different vaccine schedules of rPA vaccine, for Anthrax, to the licensed dose of AVA, another Anthrax vaccine. Safety and the capability to induce an immune response will be evaluated. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bacillus Anthracis (Anthrax)
- What is being tested?
- AVA and rPA vaccine containing alhydrogel
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 16 sitesUnited States
- Study dates
- Mar 2005to Feb 2007
- 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
- Healthy males or females.
- Aged between 18-55 years (inclusive).
- A body mass index (BMI) of 18-35.
- Signed informed consent, which includes information about the potential risks and effects of rPA and AVA.
- A medical history without major organ pathology (e.g. cardiac, immunological, psychiatric, endocrine or neurological disorders, cancer or other wasting diseases - (adequately treated actinic keratosis, or basal cell carcinoma [BCC], or carcinoma in situ [CIS] of the cervix are permitted).
- A female may be enrolled if one of the following criteria applies:
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- Either If of child-bearing capacity then: A female is not pregnant or breast feeding AND is routinely using adequate injectable or transdermal (administered at the recommended frequency) or oral contraception (at a stable dose for at least three months prior to the first dose of vaccine) and will continue to do so during the study, augmenting this contraceptive measure with a barrier method OR is sexually abstinent OR is monogamous and has a partner who has had a vasectomy (>1 month previously) OR is using a commonly recognized copper and hormone implanted intrauterine device (IUD) such as TCu-380A, TCu-220C, MLCu-375, Nova-T, or LNG-20. In addition, the subject must have a negative blood pregnancy test prior to enrolment into the study and negative urine pregnancy test pre-dose.
- Or A female is post menopausal (defined as a female with no menstrual cycle for at least 24 months and of menopausal age (>45 years) Or A female with no menstrual cycle for between 12 and 24 months and of menopausal age (>45 years) who has a negative blood pregnancy test prior to enrolment into the study and a negative urine pregnancy test pre-dose.
- Or A female has been surgically sterilized (confirmed by review of medical record).
- Or A female has had a total hysterectomy at least 3 months prior to the start of the study (confirmed by review of medical record).
- A male may be enrolled if willing to use barrier methods of contraception and whose partner is using an acceptable form of contraception for 3 months post each dose.
Who cannot join
- Presence of any clinically significant medical condition as determined by the Investigator.
- Medically significant hypersensitivity or idiosyncratic reaction related to any medical product including vaccines.
- History or evidence of drug abuse 1 year prior to enrollment.
- Participation in a clinical study of an investigational vaccine within 3 months prior to the start of the study or an investigational drug product within 30 days prior to the start of the study.
- Use of any prescription or non-prescription medication within 7 days prior to the first dosing with the exception of over-the-counter (OTC) antihistamine, non-steroidal anti-inflammatory drugs (NSAID), acetaminophen, OTC decongestants or oral/injectable/transdermal contraceptives. Any medication taken within 7 days of the first dosing will be recorded.
- History or suspicion of inability to co-operate adequately.
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- Donation of blood or blood products for a period of 4 weeks prior to participation in the study.
- Immunodeficiency or clinically active autoimmune disease.
- Positive urine alcohol and drug screen for drugs of abuse (opiates, methadone, cocaine, amphetamines, cannabinoids, and barbiturates).
- Positive test for human immunodeficiency virus (HIV), and/or hepatitis B and/or hepatitis C.
- Vaccination(s) with a live vaccine in the previous 4 weeks or killed / inactivated vaccines in the previous 3 weeks.
- Blood or plasma transfusions, or pooled gamma-globulin in the previous 3 months and need for blood or plasma transfusions during this study.
- Received anthrax vaccine or anthrax immune globulin or been otherwise exposed to B. anthracis.
- Clinically relevant abnormal findings on routine physical examination.
- Clinically significant out-of-range laboratory tests at screening including: urinalysis, serum creatine, lactate dehydrogenase (LDH), potassium, glucose, liver function tests (LFT); absolute neutrophil count, platelet count, white blood cell count, electrolytes, clotting and blood hemoglobin.
- Twelve-lead ECG recording with clinically relevant signs of pathology and conduction disturbances as judged by the investigator.
- Presence of tattoos that cover or partially cover the injection sites on the upper arm.
- Known sensitivity to Latex.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
PharamTex Research, Inc.
Amarillo, Texas, 79106
Metropolitan Research
Fairfax, Virginia, 22031
Florida Medical Research Institute
Gainesville, Florida, 32607
Carilion Medical Associates
Galax, Virginia, 24333
Accelovance
Houston, Texas, 77024
Greater Huntsville Family Practice, PC
Huntsville, Alabama, 35802
McKenzie Medical Center
McKenzie, Tennessee, 38201
Accelovance
Melbourne, Florida, 32935
Discovery Alliance, Inc.
Mobile, Alabama, 36606
Accelovance
Oklahoma City, Oklahoma, 73112
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73120
Accelovance
Orland Park, Illinois, 60462
Accelovance
San Diego, California, 92108
Accelovance
South Bend, Indiana, 46601
Miami Research Associates
South Miami, Florida, 33143
Accelovance
Washington D.C., District of Columbia, 20006
About this study
Official title: A Phase II, Dose Ranging Multi-Centre, Single Blind, Parallel-Group, Controlled Study of the Safety, Tolerability and Immunogenicity of Recombinant (rPA Based) Anthrax Vaccine Compared With Anthrax Vaccine Adsorbed in a Healthy Population
This is a dose ranging study comparing different vaccine schedules of rPA vaccine, for Anthrax, to the licensed dose of AVA, another Anthrax vaccine. Safety and the capability to induce an immune response will be evaluated.
Read the detailed description
Anthrax is a zoonotic disease, occurring in wild and domestic mammals, caused by the spore-forming bacterium Bacillus anthracis (B. anthracis). Anthrax occurs in humans when they are exposed to infected animals, tissue from infected animals or when they are directly exposed to B. anthracis or its spores. Depending on the route of infection, anthrax disease can occur in three forms: cutaneous, gastrointestinal, and inhalation. In the United States of America (USA), the annual incidence of human anthrax has declined from approximately 130 cases annually in the early 1900s to no cases during 1999 to 2000. However, in the USA, shortly after September 11th, 2001, there were 22 cases (18 confirmed) of inhaled and cutaneous anthrax infection that were related to contaminated mail. The development of a new anthrax vaccine is necessary because the current AVA vaccine requires the growth of B. anthracis in its manufacturing process and has a complex administration regimen of six administrators of vaccine in 18 months. As protective antigen (PA) is a central virulence factor in anthrax pathogenesis and a major immunogen in the current vaccine, a recombinant, acellular, protective antigen-based anthrax vaccine, could offer an improved manufacturing process and a simpler dosing schedule. Furthermore, the vaccine could offer improved protection against inhaled B. anthracis, and could, when used in conjunction with antibiotics, form part of the management of anthrax exposed individuals. This is a dose ranging study comparing different primary vaccine schedules of rPA Anthrax vaccine to the licensed dose of Anthrax Vaccine Adsorbed. The study is designed to measure the immune response, and to evaluate the safety and tolerability of different doses of rPA Anthrax Vaccine. After subjects have given informed consent, they will undergo physical exams, medical history screening, pregnancy tests, ECG, HIV, Hepatitis B \& C tests, safety blood tests, and urine drug and alcohol screen. Subjects will be asked to complete a diary card to record any symptoms they may experience. The subjects that receive AVA will be offered the opportunity to complete the licensed course of vaccination which would involve AVA vaccinations at 6, 12 and 18 months.
- Conditions
- Bacillus Anthracis (Anthrax)
- Being tested
- AVA, rPA vaccine containing alhydrogel
- Keywords
- Anthrax
- Medical subject headings
- Anthrax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVABiological
rPA vaccine containing alhydrogelBiological
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Low dose rPA vaccine Receives: Biological: rPA vaccine containing alhydrogel |
| 2 | Experimental | High dose rPA vaccine Receives: Biological: rPA vaccine containing alhydrogel |
| 3 | Active comparator | Active vaccine control Receives: Biological: AVA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of rPA vaccine
Secondary outcomes (1)
Immunogenicity of rPA vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacillus Anthracis (Anthrax)Studies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmAthene UK Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Lawrence Currie, MD, Principal investigator, Accelovance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00170469
- Sponsor's protocol ID
- 05-0002
- Other IDs
- PA-8645-02
- Status last verified
- Sep 2008
- First submitted
- 9 Sep 2005
- Last updated
- 15 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Dose Ranging Multi-Centre, Single Blind, Parallel-Group, Controlled Study of the Safety, Tolerability and Immunogenicity of Recombinant (rPA Based) Anthrax Vaccine Compared With Anthrax Vaccine Adsorbed in a Healthy Population
- ClinicalTrials.gov ID
- NCT00170469
- Acronym / sponsor ID
- 05-0002
- Conditions
- Bacillus Anthracis (Anthrax)
- Keywords
- Anthrax
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- PharmAthene UK LimitedIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Mar 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 15 Sep 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.
This is a dose ranging study comparing different vaccine schedules of rPA vaccine, for Anthrax, to the licensed dose of AVA, another Anthrax vaccine. Safety and the capability to induce an immune response will be evaluated.
Detailed description
Anthrax is a zoonotic disease, occurring in wild and domestic mammals, caused by the spore-forming bacterium Bacillus anthracis (B. anthracis). Anthrax occurs in humans when they are exposed to infected animals, tissue from infected animals or when they are directly exposed to B. anthracis or its spores. Depending on the route of infection, anthrax disease can occur in three forms: cutaneous, gastrointestinal, and inhalation. In the United States of America (USA), the annual incidence of human anthrax has declined from approximately 130 cases annually in the early 1900s to no cases during 1999 to 2000. However, in the USA, shortly after September 11th, 2001, there were 22 cases (18 confirmed) of inhaled and cutaneous anthrax infection that were related to contaminated mail. The development of a new anthrax vaccine is necessary because the current AVA vaccine requires the growth of B. anthracis in its manufacturing process and has a complex administration regimen of six administrators of vaccine in 18 months. As protective antigen (PA) is a central virulence factor in anthrax pathogenesis and a major immunogen in the current vaccine, a recombinant, acellular, protective antigen-based anthrax vaccine, could offer an improved manufacturing process and a simpler dosing schedule. Furthermore, the vaccine could offer improved protection against inhaled B. anthracis, and could, when used in conjunction with antibiotics, form part of the management of anthrax exposed individuals. This is a dose ranging study comparing different primary vaccine schedules of rPA Anthrax vaccine to the licensed dose of Anthrax Vaccine Adsorbed. The study is designed to measure the immune response, and to evaluate the safety and tolerability of different doses of rPA Anthrax Vaccine. After subjects have given informed consent, they will undergo physical exams, medical history screening, pregnancy tests, ECG, HIV, Hepatitis B \& C tests, safety blood tests, and urine drug and alcohol screen. Subjects will be asked to complete a diary card to record any symptoms they may experience. The subjects that receive AVA will be offered the opportunity to complete the licensed course of vaccination which would involve AVA vaccinations at 6, 12 and 18 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: rPA vaccine containing alhydrogelLow dose rPA vaccine |
| 2 | Experimental | Biological: rPA vaccine containing alhydrogelHigh dose rPA vaccine |
| 3 | Active comparator | Biological: AVAActive vaccine control |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Healthy males or females.
- Aged between 18-55 years (inclusive).
- A body mass index (BMI) of 18-35.
- Signed informed consent, which includes information about the potential risks and effects of rPA and AVA.
- A medical history without major organ pathology (e.g. cardiac, immunological, psychiatric, endocrine or neurological disorders, cancer or other wasting diseases - (adequately treated actinic keratosis, or basal cell carcinoma [BCC], or carcinoma in situ [CIS] of the cervix are permitted).
Key exclusion criteria (18 listed)
- Presence of any clinically significant medical condition as determined by the Investigator.
- Medically significant hypersensitivity or idiosyncratic reaction related to any medical product including vaccines.
- History or evidence of drug abuse 1 year prior to enrollment.
- Participation in a clinical study of an investigational vaccine within 3 months prior to the start of the study or an investigational drug product within 30 days prior to the start of the study.
- Use of any prescription or non-prescription medication within 7 days prior to the first dosing with the exception of over-the-counter (OTC) antihistamine, non-steroidal anti-inflammatory drugs (NSAID), acetaminophen, OTC decongestants or oral/injectable/transdermal contraceptives. Any medication taken within 7 days of the first dosing will be recorded.
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 |
|---|---|---|
| AVA | Biological | 3 |
| rPA vaccine containing alhydrogel | Biological | 1, 2 |
Primary outcome
Safety of rPA vaccine
1 secondary outcome
Immunogenicity of rPA 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 15 Sep 2008.
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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.
Lawrence Currie, MD principal investigator
Accelovance
16 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 AVA and rPA vaccine containing alhydrogel in people with Bacillus Anthracis (Anthrax), run by PharmAthene UK Limited at 16 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 11 inclusion and 18 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 15 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 of rPA 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 15 Sep 2008.