The Effectiveness of Human Antibodies in Influencing an AIDS-Like Disease in Monkeys

NCT00031109 | Completed

• 2 other identifiers: HVTN 80311636
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to see if an investigational vaccine can make antibodies (proteins found in blood) in humans that will influence the course of an AIDS-like disease in monkeys. Hopefully, the results of this study can be applied to humans. AIDS, which is caused by infection with HIV, is associated with many deaths and occurrences of disease. Although recent advances have been made in anti-HIV therapy for AIDS, there is no cure for HIV infection or AIDS, and drug therapy is too expensive for most infected populations. Some organizations are trying to make safe and effective vaccines that may prevent HIV infection and AIDS worldwide. Certain vaccines can generate specific antibodies in humans, but they do not inhibit HIV infection in laboratory tests. It is possible, however, that these antibodies may make HIV disease less severe following infection. For this reason, monkeys will be used to evaluate the role of specific human antibodies.

Conditions

HIV Infections

Keywords

HIV Antibodies; HIV-1; HIV Envelope Protein gp160; Adjuvants, Immunologic; AIDS Vaccines; CD4 Lymphocyte Count; Disease Models, Animal; Antibody Formation; Macaca; Neutralization Tests; Viral Load; aluminum hydroxide; HIV Preventive Vaccine

Interventions

gp160 MN/LAI-2 BIOLOGICAL

Aluminum hydroxide BIOLOGICAL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants in Groups I and II may be eligible for this study if they:
• Are in good general health.
• Have a negative HIV blood test within 8 weeks prior to enrollment.
• Agree to use acceptable methods of contraception for at least 21 days prior to enrollment until the last protocol visit, if a woman is participating in sexual activity that could lead to pregnancy. A woman who cannot have children, is not sexually active, or whose male partner(s) has undergone successful vasectomy does not have to use contraception.
• Have access to a participating HIV vaccine trials unit (HVTU) and are willing to be followed for 4 months, the planned study duration.
• Participants in Group I may be eligible for this study if they:
• Have participated in AVEG trial 022, 022A, 026, 029, or 202 and received full immunization schedule of ALVAC-HIV (vCP205 or vCP300) and HIV-1 SF-2 rgp120 combination.
• Have a peak concentration of neutralizing antibody to MN greater than 1:800 during AVEG 022, 022A, 026, 029, or 202.
• Participants in Group II may be eligible for this study if they:
• Are 18-60 years old.

You may not qualify if:

• Participants in Groups I and II may not be eligible for this study if they:
• Are pregnant or breast-feeding.
• Have received live attenuated vaccines within 30 days prior to enrollment.
• Have received certain vaccines (e.g., flu, pneumococcal, allergy) within 14 days of study vaccine administration.
• Have used investigational research agents within 30 days prior to enrollment.
• Have received HIV vaccines or placebo in a vaccine trial. Note: not required for participants in Group I.
• Have received blood products within 120 days prior to HIV screening.
• Have received immunoglobulin within 60 days prior to HIV screening.
• Have had serious harmful reactions to vaccines.
• Have immunodeficiency or autoimmune disease.
• Have cancer.
• Have taken (within the last 6 months) or are currently taking immunosuppressive drugs.
• Have type I or type II diabetes mellitus including cases controlled with diet alone.
• Have a thyroid disease including thyroidectomy and diagnoses requiring drugs.
• Have unstable asthma.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Related Publications (1)

• Evans TG, Frey S, Israel H, Chiu J, El-Habib R, Gilbert P, Gaitan A, Montefiori DC; HIV Vaccine Trials Network (HVTN 803). Long-term memory B-cell responses in recipients of candidate human immunodeficiency virus type 1 vaccines. Vaccine. 2004 Jun 30;22(20):2626-30. doi: 10.1016/j.vaccine.2003.12.011.

  PMID: 15193388 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Disease Models, Animal

Interventions

Aluminum Hydroxide

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; Animal Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Aluminum Compounds; Anions; Ions; Electrolytes

Study Officials

• Tom Evans

  STUDY CHAIR

• Sharon Frey

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: PREVENTION
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2002
• First Posted: February 26, 2002
• Study Completion: May 1, 2005
• Last Updated: October 15, 2021

Record last verified: 2021-10