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)

NCT00001021 | Completed Phase 1

• 2 other identifiers: AVEG 009V0385g
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

HIV Infections

Keywords

Vaccines, Synthetic; HIV-1; HIV Envelope Protein gp120; AIDS Vaccines; HIV Seronegativity; HIV Preventive Vaccine

Interventions

rgp120/HIV-1IIIB BIOLOGICAL

rgp120/HIV-1MN BIOLOGICAL

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients must have:
• Documented HIV seronegativity.
• Negative HIV-1 culture.
• Normal history and physical exam.
• No high-risk behavior for HIV infection.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead
• Genentech, Inc.: collaborator

Study Sites (3)

St Louis Univ School of Medicine

St Louis, Missouri, 63104, United States

Location

Univ of Rochester Med Ctr

Rochester, New York, 14642, United States

Location

Vanderbilt Univ Hosp

Nashville, Tennessee, 37232, United States

Location

Related Publications (7)

• 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)

  BACKGROUND

• 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. doi: 10.1089/088922299310638.

  PMID: 10408729 BACKGROUND

• 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. doi: 10.1001/jama.272.6.475.

  PMID: 7913731 BACKGROUND

• 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. doi: 10.1128/cdli.3.6.769-773.1996.

  PMID: 8914773 BACKGROUND

• 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. doi: 10.1128/cdli.3.4.378-386.1996.

  PMID: 8807200 BACKGROUND

• 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. doi: 10.1086/513969.

  PMID: 9086128 BACKGROUND

• 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.

  PMID: 9814961 BACKGROUND

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Belshe R

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Last Updated: June 24, 2005

Record last verified: 2002-10

Locations

US (3)