Safety, Tolerability and Immunogenicity of Recombinant Anthrax Vaccine Compared With Anthrax Vaccine Adsorbed
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
2 other identifiers
interventional
226
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2005
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2007
CompletedSeptember 15, 2008
September 1, 2008
1.9 years
September 9, 2005
September 12, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of rPA vaccine
Secondary Outcomes (1)
Immunogenicity of rPA vaccine
Study Arms (3)
1
EXPERIMENTALLow dose rPA vaccine
2
EXPERIMENTALHigh dose rPA vaccine
3
ACTIVE COMPARATORActive vaccine control
Interventions
Eligibility Criteria
You may qualify if:
- 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:
- 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.
You may not qualify if:
- 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.
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Greater Huntsville Family Practice, PC
Huntsville, Alabama, 35802, United States
Discovery Alliance, Inc.
Mobile, Alabama, 36606, United States
Accelovance
San Diego, California, 92108, United States
Accelovance
Washington D.C., District of Columbia, 20006, United States
Florida Medical Research Institute
Gainesville, Florida, 32607, United States
Accelovance
Melbourne, Florida, 32935, United States
Miami Research Associates
South Miami, Florida, 33143, United States
Accelovance
Orland Park, Illinois, 60462, United States
Accelovance
South Bend, Indiana, 46601, United States
Accelovance
Oklahoma City, Oklahoma, 73112, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73120, United States
McKenzie Medical Center
McKenzie, Tennessee, 38201, United States
PharamTex Research, Inc.
Amarillo, Texas, 79106, United States
Accelovance
Houston, Texas, 77024, United States
Metropolitan Research
Fairfax, Virginia, 22031, United States
Carilion Medical Associates
Galax, Virginia, 24333, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lawrence Currie, MD
Accelovance
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 15, 2005
Study Start
March 1, 2005
Primary Completion
February 1, 2007
Study Completion
February 1, 2007
Last Updated
September 15, 2008
Record last verified: 2008-09