Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-28 @ 4:36 AM
Study NCT ID:
NCT00002350
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Trial of APL 400-003 Vaccine: Safety and Immune Response Evaluations of Multiple Injections at Escalating Doses in Asymptomatic HIV-Infected Patients
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': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '1997-07', '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': ['Vaccines, Synthetic', 'AIDS Vaccines', 'DNA, Viral'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'MacGregor RR, Gluckman S, Lacy K, Kaniefski B, Boyer J, Wang B, Bagarazzi M, William WV, Francher D, Ginsberg R, Higgins T, Weiner D. First human trial of a facilitated DNA plasmid vaccine for HIV-1: safety and host response. Int Conf AIDS. 1996 Jul 7-12;11(2):23 (abstract no WeB293)'}, {'type': 'BACKGROUND', 'citation': 'MacGregor R, Gluckman S, Lacy K, Wang B, Ugen K, Chattergoon M, Bagarazzi J, Williams W, Ginsberg R, Higgins T, Boyer J, Weiner D. A DNA plasmid vaccine for HIV-1: experience in the first human trial indicates humoral and cell-immune responses. Conf Retroviruses Opportunistic Infect. 1997 Jan 22-26;4th:142 (abstract no 421)'}]}, 'descriptionModule': {'briefSummary': "To evaluate safety and immune response in HIV-infected patients treated with multiple injections of APL 400-003 vaccine.\n\nPER 2/27/96 AMENDMENT: To evaluate the safety of the vaccine when administered via the Biojector 2000 Needle-Free Injection Management System.\n\nFacilitated DNA inoculation, a new type of DNA vaccine, involves direct injection of non-infectious HIV genes into a patient's muscle, along with agents that promote uptake of the genes into host cells. Host cells that have taken up these genes then produce viral proteins in a form that elicits immune responses in the form of antibodies, killer T-cells, and helper T-cells. The safety of this new vaccine approach needs to be assessed.\n\nPER 2/27/96 AMENDMENT: The Biojector 2000 provides an option for delivering the vaccine without a needle and employs a single-use syringe to avoid cross-contamination.", 'detailedDescription': "Facilitated DNA inoculation, a new type of DNA vaccine, involves direct injection of non-infectious HIV genes into a patient's muscle, along with agents that promote uptake of the genes into host cells. Host cells that have taken up these genes then produce viral proteins in a form that elicits immune responses in the form of antibodies, killer T-cells, and helper T-cells. The safety of this new vaccine approach needs to be assessed.\n\nPER 2/27/96 AMENDMENT: The Biojector 2000 provides an option for delivering the vaccine without a needle and employs a single-use syringe to avoid cross-contamination.\n\nPatients are given intramuscular injections of APL 400-003 at one of three doses (30, 100, or 300 mcg) on day 0 and again at weeks 10 and 20, and followed for 16 weeks after the final dose. An 8-week period prior to initial dosing is required for immortalizing the patient's PBMCs.\n\nPER 2/27/96 AMENDMENT: Five patients will be evaluated at the 300 mcg dose with the Biojector 2000."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Low doses of nonprescription NSAIDS, acetaminophen, ibuprofen, aspirin, replacement hormone therapy, and vitamin supplements.\n\nPatients must have:\n\n* Asymptomatic HIV infection with no acute related infection.\n* CD4 count \\>= 500 cells/mm3.\n* Normal hematologic, renal, hepatic, metabolic, and endocrine function.\n\nNOTE:\n\n* No more than one patient over 50 years of age is permitted at each dose level.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Residual toxicity from prior drug treatment.\n* Hypersensitivity to bupivacaine or amide-type local anesthetic.\n* Active viral hepatitis, autoimmune disorders, or other debilitating chronic diseases.\n\nConcurrent Medication:\n\nExcluded:\n\n* Medications that affect immune function.\n* Antiretrovirals.\n\nPatients with the following prior conditions are excluded:\n\n* Malignancies other than curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.\n* History of anaphylaxis to vaccines.\n\nPrior Medication:\n\nExcluded:\n\n* Prior immunization with any experimental HIV vaccines.\n* Other experimental therapy within 30 days prior to study entry.\n* Prior cancer chemotherapy.\n* Antiretrovirals within 3 months prior to study entry.\n\nPrior Treatment:\n\nExcluded:\n\n* Prior radiotherapy. IV drug use or any other high-risk behavior.'}, 'identificationModule': {'nctId': 'NCT00002350', 'briefTitle': 'A Phase I Trial of APL 400-003 Vaccine: Safety and Immune Response Evaluations of Multiple Injections at Escalating Doses in Asymptomatic HIV-Infected Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'NIH AIDS Clinical Trials Information Service'}, 'officialTitle': 'A Phase I Trial of APL 400-003 Vaccine: Safety and Immune Response Evaluations of Multiple Injections at Escalating Doses in Asymptomatic HIV-Infected Patients', 'orgStudyIdInfo': {'id': '089'}, 'secondaryIdInfos': [{'id': 'APL 400-003RX101'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'APL 400-003', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Univ of Pennsylvania Med Ctr', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Apollon', 'class': 'INDUSTRY'}}}}