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CompletedNCT00170456Updated Sep 15, 2008

Phase II Study of Range and Schedule of rPA Doses

A Phase 2 interventional study of rPA vaccine containing alhydrogel in Prevention of Bacillus Anthracis (Anthrax) Infection, sponsored by PharmAthene UK Limited. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-09-15.

Sponsored by PharmAthene UK Limited · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
415
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

This is a dose ranging study comparing different vaccine schedules of rPA vaccine for anthrax. 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. 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. In the USA, the annual incidence of human anthrax has declined. However, in the USA, shortly after September 11th 2001, there were 22 cases (18 confirmed) of inhaled and cutaneous anthrax infections that were related to contaminated mail. This is a double blind, parallel-group, dose ranging study of rPA anthrax vaccine. The subjects will be blinded as to which dose of rPA vaccine is administered. The primary objectives of this clinical trial are 1.) To evaluate the safety and tolerability associated with different primary immunization doses and schedules of rPA vaccine to enable determination of the optimum dose for future clinical trials and 2.) To evaluate the immunogenicity of different primary immunization doses and schedules of rPA vaccine to enable determination of the optimum schedule for future clinical trials.

02

Conditions studied

  • Prevention of Bacillus Anthracis (Anthrax) Infection

Keywords

  • Anthrax vaccine
03

In context

Anthrax

65 studies on the registry are indexed under Anthrax; 11 are open to participants now.

This study's enrollment of 415 is above the median of 100 across 51 interventional studies indexed under Anthrax.

Browse Anthrax studies →

Lead sponsor

PharmAthene UK Limited is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Healthy males or females.
  2. Aged between 18-55 years (inclusive).
  3. A body mass index (BMI) of 18-35.
  4. Signed informed consent, which includes information about the potential risks and effects of rPA.
  5. 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).
  6. 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 recognised 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 sterilised (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).

  7. 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.
  8. Able to understand the informed consent form and other documents required to be read by the subject.

Exclusion criteria

Exclusion Criteria:

  1. Presence of any clinically significant medical condition as determined by the Investigator.
  2. Medically significant hypersensitivity or idiosyncratic reaction related to any medical product including vaccines.
  3. History or evidence of drug abuse.
  4. 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.
  5. 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.
  6. History or suspicion of inability to co-operate adequately.
  7. Donation of blood or blood products for a period of 4 weeks prior to participation in the study.
  8. Immunodeficiency or clinically active autoimmune disease.
  9. Positive urine alcohol and drug screen for drugs of abuse (opiates, methadone, cocaine, amphetamines, cannabinoids, and barbiturates).
  10. Positive test for human immunodeficiency virus (HIV), and/or hepatitis B and/or hepatitis C.
  11. Vaccination(s) with a live vaccine in the previous 4 weeks or killed / inactivated vaccines in the previous 3 weeks.
  12. Blood or plasma transfusions, or pooled gamma-globulin in the previous 3 months and need for blood or plasma transfusions during this study.
  13. Received anthrax vaccine or anthrax immune globulin or been otherwise exposed to B. anthracis.
  14. Clinically relevant abnormal findings on routine physical examination.
  15. Clinically significant out-of-range laboratory tests at screening including: urinalysis, serum creatinine, lactate dehydrogenase (LDH), potassium, glucose, liver function tests (LFT); absolute neutrophil count, platelet count, white blood cell count, electrolytes, clotting and blood haemoglobin.
  16. Twelve-lead ECG recording with clinically relevant signs of pathology and conduction disturbances as judged by the investigator.
  17. Presence of tattoos that cover or partially cover the upper arm.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
415 participants (actual)

Study arms

  • Active comparator
    1

    Low dose rPA vaccine regime 1

    Biological: rPA vaccine containing alhydrogel

  • Active comparator
    2

    Low dose rPA vaccine regime 2

    Biological: rPA vaccine containing alhydrogel

  • Active comparator
    3

    High dose rPA vaccine regime 1

    Biological: rPA vaccine containing alhydrogel

  • Active comparator
    4

    High dose rPA vaccine regime 2

    Biological: rPA vaccine containing alhydrogel

Interventions

  • BiologicalrPA vaccine containing alhydrogel
06

What researchers measure

Primary outcomes

  1. Safety of rPA vaccine

Secondary outcomes

  1. Immunogenicity of rPA vaccine

07

Study locations

2 sites
  • GDRU, Quintiles Ltd
    London, United Kingdom
  • Simbec Research Limited
    Merthyr Tydfil, CF48 4DR, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00170456
Lead sponsor
PharmAthene UK Limited
First posted
Sep 15, 2005
Start date
Mar 2005
Primary completion
Jan 2007
Completion
Feb 2007
Last update
Sep 15, 2008

Study contacts

Timothy Mant, MD
principal investigator · GDRU, London, UK

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.

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