Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031109
Status:
COMPLETED
Last Update Posted:
2021-10-15
First Post:
2002-02-25
Brief Title:
The Effectiveness of Human Antibodies in Influencing an AIDS-Like Disease in Monkeys
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
An Open-Label Passive Antibody Trial to Assess Efficacy in the Pathogenic SHIV-896P Macaque Model of Human Antibodies Generated by a Candidate HIV-1 Vaccine in a Phase I Clinical Trial
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
AIDS caused by infection with the human immunodeficiency virus type 1 HIV-1 is associated with enormous morbidity and mortality worldwide Although recent advances have been made in antiretroviral therapy for AIDS there is no cure for HIV infection or AIDS and drug therapy is too expensive for most infected populations The development of safe effective vaccines to prevent HIV infection and AIDS worldwide is a commitment of some health-oriented organizations A major goal in the effort to design an effective vaccine has been the identification of the immunologic correlates of protective immunity Non-neutralizing antibodies might possess clinically important anti-HIV activities that remain to be defined and warrant investigation The role played by antibody with minimal neutralizing activity induced by various HIV vaccination strategies is unknown It is possible that low-level neutralization or other activities may lead to an improvement or worsening in disease course following infection For this reason it is proposed that a challenge trial in the rhesus macaque SHIV model be performed in which the role of such antibodies which are derived from non-infected human vaccinees will be evaluated
This is a 2-part study Part I involves human participants Part II involves rhesus macaques
Part 1 Human participants are divided into 2 groups
Group I Participants who previously were enrolled in specific AIDS Vaccine Evaluation Group AVEG protocols are immunized with a single dose of the recombinant gp160MNLAI-2 vaccine in alum aluminum hydroxide adjuvant on Day 0 of the study
Group II Participants who are vaccine naive receive no immunization Each participant will have 5 clinic visits during the study Blood is drawn at each visit for routine testing and immune system check Sera is drawn from participants for neutralizing antibody determination Approximately 3 weeks after immunization Day 18 blood is drawn from participants of both groups for a plasmapheresis procedure in which platelets and plasma are removed This process is repeated 1 week later Immunoglobulin G IgG is purified from the plasma of vaccinated participants
Part II Juvenile rhesus macaques are divided into 4 groups and are infused with IgG from human participants of Groups I and II at Day 0 At Day 1 the macaques are exposed to SHIV-896P At Days 3 7 10 and weekly up to Day 73 the CD4 lymphocyte count plasma viremia and antibodies of the macaques are measured
This is a 2-part study Part I involves human participants Part II involves rhesus macaques
Part 1 Human participants are divided into 2 groups
Group I Participants who previously were enrolled in specific AIDS Vaccine Evaluation Group AVEG protocols are immunized with a single dose of the recombinant gp160MNLAI-2 vaccine in alum aluminum hydroxide adjuvant on Day 0 of the study
Group II Participants who are vaccine naive receive no immunization Each participant will have 5 clinic visits during the study Blood is drawn at each visit for routine testing and immune system check Sera is drawn from participants for neutralizing antibody determination Approximately 3 weeks after immunization Day 18 blood is drawn from participants of both groups for a plasmapheresis procedure in which platelets and plasma are removed This process is repeated 1 week later Immunoglobulin G IgG is purified from the plasma of vaccinated participants
Part II Juvenile rhesus macaques are divided into 4 groups and are infused with IgG from human participants of Groups I and II at Day 0 At Day 1 the macaques are exposed to SHIV-896P At Days 3 7 10 and weekly up to Day 73 the CD4 lymphocyte count plasma viremia and antibodies of the macaques are measured
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 11636 | REGISTRY | DAIDS ES Registry Number | None |