HIV Infections Clinical Trial
Official title:
An Open-Label, Passive Antibody Trial to Assess Efficacy in the Pathogenic SHIV-89.6P Macaque Model of Human Antibodies Generated by a Candidate HIV-1 Vaccine in a Phase I Clinical Trial
NCT number | NCT00031109 |
Other study ID # | HVTN 803 |
Secondary ID | 11636 |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Est. completion date | May 2005 |
Verified date | October 2021 |
Source | National Institute of Allergy and Infectious Diseases (NIAID) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | May 2005 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria 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. Exclusion Criteria 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. - Are taking anti-tuberculosis (TB) prophylaxis or therapy. - Have a seizure disorder. - Have a bleeding disorder diagnosed by a doctor. - Have had a splenectomy. - Have serious angioedema. - Have active syphilis. - Have high blood pressure. - Have a mental condition that will affect their participation in the protocol. - Have any clinically significant condition for which plasmapheresis would pose additional risk to the participant. - Participants in Group I may not be eligible for this study if they: - Have received an HIV vaccine or placebo in a vaccine trial other than AVEG 022, 022A, 026, 029, or 202. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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National Institute of Allergy and Infectious Diseases (NIAID) |
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. — View Citation
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