Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2025-12-25 @ 7:37 PM
Study NCT ID:
NCT00002232
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of GENEVAX-HIV, a Possible Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1999-06', 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '1999-11-02', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Injections, Intradermal', 'Injections, Intramuscular', 'HIV Antibodies', 'Immunity, Cellular', 'AIDS Vaccines', 'HIV Seronegativity', 'Dose-Response Relationship, Immunologic', 'Vaccines, DNA', 'Immunity, Mucosal'], 'conditions': ['HIV Infections', 'HIV Seronegativity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to see if it is safe to give GENEVAX-HIV, a potential HIV vaccine, to HIV-negative volunteers. The study also compares the effects of GENEVAX-HIV injected into the muscle to the effects of the drug when injected into the skin.', 'detailedDescription': 'Volunteers receive either intradermal or intramuscular injections of GENEVAX-HIV; humoral and cellular responses are assessed accordingly.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\nPatients must have:\n\n* Good health.\n* Ability to understand the basis of HIV transmission and other common sexual and blood-borne infections.\n* The following parameters within normal range:\n* Hematopoietic:\n* total white blood cell, lymphocyte, granulocyte, and platelet count, hemoglobin and hematocrit.\n* Renal:\n* BUN and creatinine, urinalysis.\n* Hepatic:\n* total serum bilirubin.\n* Endocrine/Metabolic:\n* Serum calcium, serum glucose, total serum CPK.\n* Immunologic:\n* total serum immunoglobulin and absolute CD4 count.\n* Hepatitis B and Hepatitis C negative.\n* Urinalysis:\n* Normal screen with dipstick for esterase and nitrite.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* HIV-seropositive status.\n* Any positive result for anti-DNA antibodies considered of potential clinical significance as measured by anti-DNA antibody and/or anti-nuclear antibody (ANA) assays.\n* Any condition which, in the opinion of the principal investigator, might interfere with completion of the study or evaluation of the results.\n* Known hypersensitivity to bupivacaine or any amide-type local anesthetic (such as lidocaine, dibucaine, mepivacaine, and prilocaine) or a history of anaphylaxis or other serious adverse reactions to vaccines.\n\nConcurrent Medication:\n\nExcluded:\n\nAny medication which may affect immune function with the exception of low doses of nonprescription-strength NSAIDS, aspirin, or acetaminophen for acute conditions such as headache or trauma.\n\nPatients with the following prior conditions are excluded:\n\n* HIV-seropositive.\n* Known or suspected history of impairment or abnormality in immune functioning.\n* Exposure to potentially-infective HIV fluids within the prior 6 months or tested positive for HIV at any time.\n* History of any prior disease or therapy which would affect immune function including:\n* Prior malignancy, except curatively-treated basal cell or squamous cell carcinoma in situ of the cervix.\n* Immunodeficiency or autoimmune disease.\n* Acute infection or a recent (within 6 months) history of chronic infection.\n* History of serious allergic reaction to any substance requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension).\n\nPrior Medication:\n\nExcluded:\n\nCytotoxic chemotherapy that may affect immune function.\n\nPrior Treatment:\n\nExcluded:\n\n* Previous immunization with any experimental vaccines directed against HIV or receipt of any experimental agent within 30 days prior to enrollment.\n* Receipt of any blood products or immunoglobulin within 6 months prior to enrollment.\n* Exposure to live attenuated vaccines within 60 days of study.\n* Radiotherapy that may affect immune function.\n\nRisk Behavior:\n\nExcluded:\n\n* Active drug or alcohol abuse or uncontrolled (unstable) psychiatric disorders which, in the opinion of the investigator, would interfere with study participation.\n* Higher- or intermediate-risk sexual behavior (AVEG criteria)'}, 'identificationModule': {'nctId': 'NCT00002232', 'briefTitle': 'A Study of GENEVAX-HIV, a Possible Vaccine', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'GENEVAX-HIV (APL 400-003), a Candidate DNA Vaccine: A Pilot Study of GENEVAX-HIV Given by Intramuscular or Intradermal Administration in HIV Seronegative Volunteers', 'orgStudyIdInfo': {'id': '005'}, 'secondaryIdInfos': [{'id': '400-003-05'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'APL 400-003', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20307', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Walter Reed Army Institute of Research', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}], 'overallOfficials': [{'name': 'Merlin Robb', 'role': 'STUDY_CHAIR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth-Lederle Vaccines', 'class': 'INDUSTRY'}}}}