Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2026-04-17 @ 3:58 PM
Study NCT ID:
NCT00103467
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2005-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial to Evaluate the Safety and Immunogenicity of an Anthrax Recombinant Protective Antigen Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06'}, 'statusVerifiedDate': '2005-02', 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '2005-02-08', 'studyFirstSubmitQcDate': '2005-02-08', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-02-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and immunogenicity of 3 doses over 4 different dose ranges.'}]}, 'conditionsModule': {'conditions': ['Prevention of Anthrax Infection']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Healthy male or female aged 18 to 40 years old (inclusive) without significant physical or clinical laboratory abnormalities.\n* Two intact upper arms with sufficient intramuscular (IM) tissue in the deltoid region for vaccine administration.\n* For females, negative serum pregnancy test at screening and agreement to use adequate birth control during the first 3 months of the study.\n* Willingness and ability to return for all follow-up visits and blood draws for the duration of the study.\n* Willingness to complete the Volunteer Diary and to report concomitant medications and adverse events (AEs) to the study site monitors during the study period.\n\nExclusion Criteria:\n\n* Prior history of, or known exposure to any form of B. anthracis or any anthrax immunization.\n* Member of the Armed Services (Active Duty or Reserve) since 1990, with history of previous anthrax vaccination.\n* Employment in an industry involved in contact with ruminant animals, veterinary sciences, or other exposure to B. anthracis.\n* Expected to be noncompliant with study visits or planning to move within 8 months.\n* Body mass index of \\>35 or \\<19.\n* Known allergy to aluminum hydroxide, formaldehyde, benzethonium chloride, latex, kanamycin, or any other aminoglycoside antibiotics (such as gentamycin).\n* Pregnancy (positive urine pregnancy test within 24 hours prior to vaccination), or lactation.\n* HIV positive (by history or screening ELISA).\n* Hepatitis B or C positive (by history or screening HBsAg/anti-HCV ELISA).\n* Active or past internal organ, hematologic malignancy, or metastatic cutaneous malignancy.\n* History of, or current autoimmune disease, including but not limited to systemic lupus erythematosus, scleroderma, and polyarteritis.\n* Immunodeficiency or unstable medical condition as determined by baseline medical history, physical exam, and laboratory assessment.\n* Received, or plans to receive, licensed live vaccines within 30 days of study vaccination.\n* Received, or plans to receive, licensed killed vaccines within 14 days of study vaccination.\n* Received, or plans to receive, immunoglobulin or other blood products within 60 days of study vaccination.\n* Received, or plans to receive, experimental drugs/vaccines within 30 days of study vaccination.\n* Received, or plans to receive, systemic immunosuppresive therapy, radiation therapy, or high-dose inhaled steroids within 30 days of study vaccination.\n* Use of systemic chemotherapy within 5 years prior to study.\n* History of Guillain-Barre Syndrome.\n* 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.'}, 'identificationModule': {'nctId': 'NCT00103467', 'briefTitle': 'Trial to Evaluate the Safety and Immunogenicity of an Anthrax Recombinant Protective Antigen Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'VaxGen'}, 'officialTitle': 'A Phase 1 Trial to Evaluate the Safety and Immunogenicity of an Anthrax Recombinant Protective Antigen Vaccine', 'orgStudyIdInfo': {'id': 'VAX005'}}, 'armsInterventionsModule': {'interventions': [{'name': 'rPA102 Vaccine', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University School of Medicine', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Dept. of International Health - Johns Hopkins University Bloomberg School of Public Health', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '63104', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis University - SoLutions/SLUtest', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VaxGen', 'class': 'INDUSTRY'}}}}