HIV Infections Clinical Trial
Official title:
A Phase I Multicenter Study of the Safety and Immunogenicity of MN rgp120/HIV-1 Vaccine Given Either Alone or in Combination With IIIB rgp120/HIV-1 Vaccine in Healthy Adult Subjects (NOTE: Original Study Extended ONLY for Patients Previously Enrolled on VEU 009)
NCT number | NCT00001021 |
Other study ID # | AVEG 009 |
Secondary ID | V0385g |
Status | Completed |
Phase | Phase 1 |
First received | November 2, 1999 |
Last updated | June 23, 2005 |
AMENDED 10/1/93: To evaluate the influence of prior immunization with an rgp120 vaccine on
immune response to a subsequent immunization with a different strain of rgp120 (VEU 009X
extension - in patients previously enrolled on VEU 009).
ORIGINAL DESIGN: To evaluate the clinical and immunologic safety of MN rgp120/HIV-1 vaccine
(MN rgp120 vaccine) given alone or concurrently with the IIIB rgp120/HIV-1 vaccine (IIIB
rgp120 vaccine) in healthy HIV-1 seronegative adult subjects. To compare the immune response
to MN rgp120 vaccine given at 100, 300, or 600 mcg. To determine the immune response to 300
mcg MN rgp120 vaccine and 300 mcg IIIB rgp120 vaccine given concurrently.
Recent studies suggest that immunity to the HIV-1 rgp120 protein may prevent primary
infection. MN rgp120 vaccine and IIIB rgp120 vaccine are both prepared by recombinant DNA
technology. Because the two vaccines are derived from distinct HIV-1 strains, they may
elicit some immunologic responses that differ. Unlike IIIB rgp120 vaccine, the MN rgp120
vaccine has not yet been evaluated in humans, although it is expected that the MN type will
result in similar safety and immunogenicity as the IIIB type.
Status | Completed |
Enrollment | 57 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
Inclusion Criteria Patients must have: - Documented HIV seronegativity. - Negative HIV-1 culture. - Normal history and physical exam. - No high-risk behavior for HIV infection. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: - Clinically significant cardiac, pulmonary, neoplastic, hepatic, renal, neurologic, or autoimmune disease. - Serologic evidence of current Hepatitis B or C infection. - Positive PPD (unless subject has a clear chest x-ray with no suggestion of active or old pulmonary tuberculosis and is not eligible for tuberculosis prophylaxis. - Positive HBsAb (unless positive result is caused by hepatitis vaccination OR infection occurred more than 2 years ago and subjects are HBsAg, HBeAg, and HBcAb negative with no elevation of liver enzymes within the past 2 years). - Positive VDRL. - Febrile illness within 1 week prior to study entry. Concurrent Medication: Excluded: - Concomitant corticosteroids or other known immunosuppressive drugs. - Any experimental agent. - Any anti-tuberculosis medication (e.g., isoniazid). Patients with the following prior conditions are excluded: - History of clinically significant cardiac, pulmonary, neoplastic, hepatic, renal, neurologic, or autoimmune disease. - Recent (within past 2 years) evidence of Hepatitis B infection. - Past serologic evidence of Hepatitis C infection. - Prior history of receiving HIV vaccine. Prior Medication: Excluded: - Other immunization within 4 weeks prior to study entry. Identifiable high-risk behavior for HIV infection. |
Endpoint Classification: Safety Study, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt Univ Hosp | Nashville | Tennessee |
United States | Univ of Rochester Med Ctr | Rochester | New York |
United States | St Louis Univ School of Medicine | St Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) | Genentech, Inc. |
United States,
Belshe R, Keefer M, Graham B, Mathews T, Twaddell T, Fast P. Safety and immunogenicity of HIV-1 (MN or combination MN/IIIB) rgp120 vaccines in low risk volunteers. The NIAID AIDS Vaccine Evaluation Network. Int Conf AIDS. 1993 Jun 6-11;9(1):70 (abstract no WS-B27-1)
Belshe RB, Graham BS, Keefer MC, Gorse GJ, Wright P, Dolin R, Matthews T, Weinhold K, Bolognesi DP, Sposto R, et al. Neutralizing antibodies to HIV-1 in seronegative volunteers immunized with recombinant gp120 from the MN strain of HIV-1. NIAID AIDS Vaccine Clinical Trials Network. JAMA. 1994 Aug 10;272(6):475-80. — View Citation
Francis DP, Gregory T, McElrath MJ, Belshe RB, Gorse GJ, Migasena S, Kitayaporn D, Pitisuttitham P, Matthews T, Schwartz DH, Berman PW. Advancing AIDSVAX to phase 3. Safety, immunogenicity, and plans for phase 3. AIDS Res Hum Retroviruses. 1998 Oct;14 Suppl 3:S325-31. Review. — View Citation
Gorse GJ, Patel GB, Mandava M, Berman PW, Belshe RB. MN and IIIB recombinant glycoprotein 120 vaccine-induced binding antibodies to native envelope glycoprotein of human immunodeficiency virus type 1 primary isolates. National Institute of Allergy and Infectious Disease Aids Vaccine Evaluation Group. AIDS Res Hum Retroviruses. 1999 Jul 1;15(10):921-30. — View Citation
Gorse GJ, Patel GB, Newman FK, Belshe RB, Berman PW, Gregory TJ, Matthews TJ. Antibody to native human immunodeficiency virus type 1 envelope glycoproteins induced by IIIB and MN recombinant gp120 vaccines. The NIAID AIDS Vaccine Evaluation Group. Clin Diagn Lab Immunol. 1996 Jul;3(4):378-86. — View Citation
Gorse GJ, Yang EY, Belshe RB, Berman PW. Salivary binding antibodies induced by human immunodeficiency virus type 1 recombinant gp120 vaccine. The NIAID AIDS Vaccine Evaluation Group. Clin Diagn Lab Immunol. 1996 Nov;3(6):769-73. — View Citation
Zolla-Pazner S, Alving C, Belshe R, Berman P, Burda S, Chigurupati P, Clements ML, Duliege AM, Excler JL, Hioe C, Kahn J, McElrath MJ, Sharpe S, Sinangil F, Steimer K, Walker MC, Wassef N, Xu S. Neutralization of a clade B primary isolate by sera from human immunodeficiency virus-uninfected recipients of candidate AIDS vaccines. J Infect Dis. 1997 Apr;175(4):764-74. — View Citation
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05454514 -
Automated Medication Platform With Video Observation and Facial Recognition to Improve Adherence to Antiretroviral Therapy in Patients With HIV/AIDS
|
N/A | |
Completed |
NCT03760458 -
The Pharmacokinetics, Safety, and Tolerability of Abacavir/Dolutegravir/Lamivudine Dispersible and Immediate Release Tablets in HIV-1-Infected Children Less Than 12 Years of Age
|
Phase 1/Phase 2 | |
Completed |
NCT03141918 -
Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS
|
N/A | |
Completed |
NCT03067285 -
A Phase IV, Open-label, Randomised, Pilot Clinical Trial Designed to Evaluate the Potential Neurotoxicity of Dolutegravir/Lamivudine/Abacavir in Neurosymptomatic HIV Patients and Its Reversibility After Switching to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide. DREAM Study
|
Phase 4 | |
Recruiting |
NCT04579146 -
Coronary Artery Disease (CAD) in Patients HIV-infected
|
||
Completed |
NCT06212531 -
Papuan Indigenous Model of Male Circumcision
|
N/A | |
Active, not recruiting |
NCT03256422 -
Antiretroviral Treatment Taken 4 Days Per Week Versus Continuous Therapy 7/7 Days Per Week in HIV-1 Infected Patients
|
Phase 3 | |
Completed |
NCT03256435 -
Retention in PrEP Care for African American MSM in Mississippi
|
N/A | |
Completed |
NCT00517803 -
Micronutrient Supplemented Probiotic Yogurt for HIV/AIDS and Other Immunodeficiencies
|
N/A | |
Active, not recruiting |
NCT03572335 -
Systems Biology of Diffusion Impairment in Human Immunodeficiency Virus (HIV)
|
||
Completed |
NCT04165200 -
Fecal Microbiota Transplantation as a Therapeutic Strategy for Patients Infected With HIV
|
N/A | |
Recruiting |
NCT03854630 -
Hepatitis B Virus Vaccination in HIV-positive Patients and Individuals at High Risk for HIV Infection
|
Phase 4 | |
Terminated |
NCT03275571 -
HIV, Computerized Depression Therapy & Cognition
|
N/A | |
Completed |
NCT02234882 -
Study on Pharmacokinetics
|
Phase 1 | |
Completed |
NCT01618305 -
Evaluating the Response to Two Antiretroviral Medication Regimens in HIV-Infected Pregnant Women, Who Begin Antiretroviral Therapy Between 20 and 36 Weeks of Pregnancy, for the Prevention of Mother-to-Child Transmission
|
Phase 4 | |
Recruiting |
NCT05043129 -
Safety and Immune Response of COVID-19 Vaccination in Patients With HIV Infection
|
||
Not yet recruiting |
NCT05536466 -
The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine
|
N/A | |
Recruiting |
NCT04985760 -
Evaluation of Trimer 4571 Therapeutic Vaccination in Adults Living With HIV on Suppressive Antiretroviral Therapy
|
Phase 1 | |
Completed |
NCT05916989 -
Stimulant Use and Methylation in HIV
|
||
Terminated |
NCT02116660 -
Evaluation of Renal Function, Efficacy, and Safety When Switching From Tenofovir/Emtricitabine Plus a Protease Inhibitor/Ritonavir, to a Combination of Raltegravir (MK-0518) Plus Nevirapine Plus Lamivudine in HIV-1 Participants With Suppressed Viremia and Impaired Renal Function (MK-0518-284)
|
Phase 2 |