Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2026-01-05 @ 3:08 AM
Study NCT ID:
NCT00000866
Status:
COMPLETED
Last Update Posted:
2021-10-28
First Post:
1999-11-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of the Therion Recombinant Vaccinia-HIV-1 IIIB ENV/GAG/POL Vaccine (TCB-3B) and MN RGP 120/HIV-1 In Alum.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D014615', 'term': 'Vaccinia'}], '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'}, {'id': 'D011213', 'term': 'Poxviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION'}, 'enrollmentInfo': {'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '1999-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-10-27', 'studyFirstSubmitDate': '1999-11-02', 'studyFirstSubmitQcDate': '2001-08-30', 'lastUpdatePostDateStruct': {'date': '2021-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2001-08-31', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Vaccines, Synthetic', 'Vaccinia Virus', 'Placebos', 'HIV-1', 'AIDS Vaccines', 'HIV Seronegativity', 'Genes, env', 'Genes, pol', 'Genes, gag', 'HIV Preventive Vaccine'], 'conditions': ['HIV Infections']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Keefer MC, McElrath MJ, Weinhold K, Gorse GJ, Mulligan M, Francis D, Panicali D. A phase I trial of vaccina-eng/gag/pol (TBC-3B) given by alternative routes, boosted with rgp120. Int Conf AIDS. 1998;12:278 (abstract no 496/21199)'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the safety of administering Therion Recombinant Vaccinia-HIV-1 IIIB env/gag/pol Vaccine (TBC-3B) vaccinations to vaccinia-naive individuals. To evaluate the immunogenicity of priming with TBC-3B by the scarification, intradermal, and subcutaneous routes, followed by booster immunization of MN rgp120 HIV-1. To compare the immunogenicity of priming with TBC-3B in vaccinia-naive individuals to vaccinia-immune individuals.\n\nIn prior trials evaluating alternative methods of vaccine administration, scarification has been found to be an imprecise method of administration and allows only 1.0 - 2.5 microliters of immunogen to be given. Since it is not feasible to produce vaccine at concentrations higher than 10 to the 10th pfu/ml, this method limits the maximum deliverable dose. Intradermal and subcutaneous injection routes allow larger volumes of vaccinia to be given, i.e.: up to 200 microliters intradermally and up to 100 ml subcutaneously. In the present study, the initial priming dose will be the same administered by all 3 methods; however, the second priming dose administered at 2 months intradermally and subcutaneously will be 2 logs higher in order to achieve boosting of immune responses, particularly to gag and pol components of TBC-3B.', 'detailedDescription': 'In prior trials evaluating alternative methods of vaccine administration, scarification has been found to be an imprecise method of administration and allows only 1.0 - 2.5 microliters of immunogen to be given. Since it is not feasible to produce vaccine at concentrations higher than 10 to the 10th pfu/ml, this method limits the maximum deliverable dose. Intradermal and subcutaneous injection routes allow larger volumes of vaccinia to be given, i.e.: up to 200 microliters intradermally and up to 100 ml subcutaneously. In the present study, the initial priming dose will be the same administered by all 3 methods; however, the second priming dose administered at 2 months intradermally and subcutaneously will be 2 logs higher in order to achieve boosting of immune responses, particularly to gag and pol components of TBC-3B.\n\nAfter volunteers are recruited, screened and enrolled in the study, they will be randomized to group C, D, or E. Each group will enroll 10 patients and 2 controls. The placebo control for TBC-3B will be standard vaccinia vaccination administered at doses no higher than that administered by scarification; the placebo control for MN rgp120 will be alum. Group C will receive undiluted TBC-3B by scarification, at months 0 and 2. Group D will receive diluted TBC-3B intradermally at month 0 and undiluted TBC-3B at month 2. Group E will receive diluted TBC-3B subcutaneously at month 0 and undiluted TBC-3B at month 2. At months 8 and 12 all groups will receive MN rgp 120/HIV-1 in alum intramuscularly.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\nPatients must have:\n\n* Negative FDA-approved ELISA for HIV within 8 weeks of immunization.\n* Normal history and physical examination.\n* Negativity for Hepatitis B surface antigen.\n* Availability for follow-up for planned duration of the study (18 months).\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\n* Medical or psychiatric condition or occupational responsibilities that preclude subject compliance with the protocol. Specifically excluded are people with a history of suicide attempts, recent suicidal ideation or who have past or present psychosis.\n* Active syphilis. NOTE: If the serology is documented to be a false positive or due to a remote (\\> 6 months) treated infection, the volunteer is eligible.\n* Active tuberculosis. NOTE: Patients with a positive PPD and a normal chest X-ray showing no evidence of TB and not requiring INH therapy are eligible.\n* Household contacts with, or occupational exposure to, people with any of the following:\n\nPregnancy. \\<12 months of age. Eczema or Immunodeficiency disease. Use of immunosuppressive medications.\n\nPatients with the following prior conditions are excluded:\n\n* History of immunodeficiency, chronic illness, malignancy or autoimmune disease.\n* History of cancer, unless there has been surgical excision followed by a sufficient observation period to give a reasonable assurance of cure.\n* Any history of anaphylaxis or history of other serious adverse reactions to vaccines.\n* History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension).\n* Eczema within the past year.\n* History of smallpox vaccination.\n* Envelope bands on HIV-1 Western blot within 8 weeks of immunization.\n\nPrior Medication: Excluded:\n\n* Use of immunosuppressive.\n* Live attenuated vaccines within 60 days of study.\n* NOTE: Medically indicated subunit or killed vaccines (e.g. influenza, pneumococcal) do not exclude, but should be given at least 2 weeks prior to HIV immunizations.\n* Experimental agents within 30 days prior to study.\n* Prior receipt of HIV-1 vaccines or placebo recipient in a previous HIV vaccine trial.\n\nReceipt of blood products or immunoglobulin within past 6 months.\n\nRisk Behavior: Excluded:\n\n* History of injection drug use within the last 12 months prior to enrollment.\n* Higher or intermediate risk sexual behavior as defined by the AVEG.\n* Lower risk sexual behavior as defined by AIDS Vaccine Evaluation Group (AVEG) procedures.'}, 'identificationModule': {'nctId': 'NCT00000866', 'briefTitle': 'A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of the Therion Recombinant Vaccinia-HIV-1 IIIB ENV/GAG/POL Vaccine (TCB-3B) and MN RGP 120/HIV-1 In Alum.', 'organization': {'class': 'NIH', 'fullName': 'National Institute of Allergy and Infectious Diseases (NIAID)'}, 'officialTitle': 'A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of the Therion Recombinant Vaccinia-HIV-1 IIIB ENV/GAG/POL Vaccine (TCB-3B) and MN RGP 120/HIV-1 In Alum.', 'orgStudyIdInfo': {'id': 'AVEG 014C'}, 'secondaryIdInfos': [{'id': '10562', 'type': 'REGISTRY', 'domain': 'DAIDS ES Registry Number'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'MN rgp120/HIV-1', 'type': 'BIOLOGICAL'}, {'name': 'TBC-3B Vaccine', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'JHU AVEG', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis Univ. School of Medicine AVEG', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Univ. Hosp. AVEG', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '98144', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'UW - Seattle AVEG', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Smith C', 'role': 'STUDY_CHAIR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}