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| ID | Type | Description | Link |
|---|---|---|---|
| 10540 | Registry Identifier | DAIDS ES Registry Number |
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| Name | Class |
|---|---|
| Protein Sciences Corporation | INDUSTRY |
To determine the reactivity and safety of HIV-1 recombinant envelope glycoprotein gp160. To determine the immunogenicity of gp160.
Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure. It is likely that ultimate control of the disease will depend on the development of safe and effective vaccines against HIV.
Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure. It is likely that ultimate control of the disease will depend on the development of safe and effective vaccines against HIV.
Healthy volunteers are injected on days 0, 30, and 180 with one of four preparations: gp160 vaccine (40 mcg), gp160 vaccine (80 mcg), hepatitis B vaccine, and placebo. The hepatitis B vaccine group will serve as an additional control for immunological evaluations. An optional fourth injection may be given 15-21 months following the initial inoculation.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hepatitis B Vaccine (Recombinant) | Biological | |||
| gp160 Vaccine (MicroGeneSys) | Biological |
Inclusion Criteria
Subjects must have:
Exclusion Criteria
Co-existing Condition:
Subjects with the following symptoms or conditions are excluded:
Subjects with the following prior conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
Identifiable high-risk behavior for HIV infection (as determined by prescreening questions designed to identify risk factors for HIV infection), including:
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| Name | Affiliation | Role |
|---|---|---|
| Belshe R | Study Chair | |
| Clements ML | Study Chair | |
| Couch R | Study Chair | |
| Dolin R | Study Chair | |
| Levine M | Study Chair | |
| Wright P | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| JHU AVEG | Pittsburgh | Pennsylvania | United States | |||
| Vanderbilt Univ. Hosp. AVEG |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1984386 | Background | Dolin R, Graham BS, Greenberg SB, Tacket CO, Belshe RB, Midthun K, Clements ML, Gorse GJ, Horgan BW, Atmar RL, et al. The safety and immunogenicity of a human immunodeficiency virus type 1 (HIV-1) recombinant gp160 candidate vaccine in humans. NIAID AIDS Vaccine Clinical Trials Network. Ann Intern Med. 1991 Jan 15;114(2):119-27. doi: 10.7326/0003-4819-114-2-119. | |
| 2204698 |
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| Nashville |
| Tennessee |
| 37232 |
| United States |
| Archibald DW, Hebert CA, Sun D, Tacket CO. Salivary antibodies to human immunodeficiency virus type 1 in a phase I AIDS vaccine trial. J Acquir Immune Defic Syndr (1988). 1990;3(10):954-8. |
| 2092787 | Background | Westblom TU, Belshe RB, Gorse GJ, Anderson EL, Berry CF. Characteristics of a population volunteering for human immunodeficiency virus immunization. NIAID AIDS Clinical Trials Network. Int J STD AIDS. 1990 Mar;1(2):126-8. doi: 10.1177/095646249000100211. |
| 9310283 | Background | Keefer MC, Wolff M, Gorse GJ, Graham BS, Corey L, Clements-Mann ML, Verani-Ketter N, Erb S, Smith CM, Belshe RB, Wagner LJ, McElrath MJ, Schwartz DH, Fast P. Safety profile of phase I and II preventive HIV type 1 envelope vaccination: experience of the NIAID AIDS Vaccine Evaluation Group. AIDS Res Hum Retroviruses. 1997 Sep 20;13(14):1163-77. doi: 10.1089/aid.1997.13.1163. |
| 2187503 | Background | Tacket CO, Baqar S, Munoz C, Murphy JR. Lymphoproliferative responses to mitogens and HIV-1 envelope glycoprotein among volunteers vaccinated with recombinant gp160. AIDS Res Hum Retroviruses. 1990 Apr;6(4):535-42. doi: 10.1089/aid.1990.6.535. |
| 1706607 | Background | Viscidi R, Ellerbeck E, Garrison L, Midthun K, Clements ML, Clayman B, Fernie B, Smith G. Characterization of serum antibody responses to recombinant HIV-1 gp160 vaccine by enzyme immunoassay. NIAID AIDS Vaccine Clinical Trials Network. AIDS Res Hum Retroviruses. 1990 Nov;6(11):1251-6. doi: 10.1089/aid.1990.6.1251. |
| 2190315 | Background | Orentas RJ, Hildreth JE, Obah E, Polydefkis M, Smith GE, Clements ML, Siliciano RF. Induction of CD4+ human cytolytic T cells specific for HIV-infected cells by a gp160 subunit vaccine. Science. 1990 Jun 8;248(4960):1234-7. doi: 10.1126/science.2190315. |
| 1829105 | Background | Clerici M, Berzofsky JA, Shearer GM, Tacket CO. Exposure to human immunodeficiency virus (HIV) type I indicated by HIV-specific T helper cell responses before detection of infection by polymerase chain reaction and serum antibodies [corrected]. J Infect Dis. 1991 Jul;164(1):178-82. doi: 10.1093/infdis/164.1.178. |
| 7906131 | Background | Bollinger RC, Quinn TC, Liu AY, Stanhope PE, Hammond SA, Viveen R, Clements ML, Siliciano RF. Cytokines from vaccine-induced HIV-1 specific cytotoxic T lymphocytes: effects on viral replication. AIDS Res Hum Retroviruses. 1993 Nov;9(11):1067-77. doi: 10.1089/aid.1993.9.1067. |
| 1968506 | Background | Polydefkis M, Koenig S, Flexner C, Obah E, Gebo K, Chakrabarti S, Earl PL, Moss B, Siliciano RF. Anchor sequence-dependent endogenous processing of human immunodeficiency virus 1 envelope glycoprotein gp160 for CD4+ T cell recognition. J Exp Med. 1990 Mar 1;171(3):875-87. doi: 10.1084/jem.171.3.875. |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D014615 | Vaccinia |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D011213 | Poxviridae Infections |
| D004266 | DNA Virus Infections |
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| ID | Term |
|---|---|
| D017325 | Hepatitis B Vaccines |
| C053473 | VaxSyn HIV-1 (gp160) vaccine |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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