HIV InfectionsNCT00031109
The Effectiveness of Human Antibodies in Influencing an AIDS-Like Disease in Monkeys
A study testing gp160 MN/LAI-2 and Aluminum hydroxide in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- gp160 MN/LAI-2 and Aluminum hydroxide
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Start not givento May 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
About this study
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
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.
Read the 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 gp160MN/LAI-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-89.6P. At Days 3, 7, 10, and weekly up to Day 73, the CD4 lymphocyte count, plasma viremia, and antibodies of the macaques are measured.
- Conditions
- HIV Infections
- Being tested
- gp160 MN/LAI-2, Aluminum hydroxide
- 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
- Medical subject headings
- HIV Infections, Disease Models, Animal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gp160 MN/LAI-2Biological
Aluminum hydroxideBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2002 (estimated)
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Enrolment
- 10 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Tom Evans, Study chairSharon Frey, Study chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00031109
- Sponsor's protocol ID
- HVTN 803
- Other IDs
- 11636
- Status last verified
- Oct 2021
- First submitted
- 25 Feb 2002
- Last updated
- 15 Oct 2021
- Results posted
- No
Publications
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.
PubMed 15193388
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00031109
- Acronym / sponsor ID
- HVTN 803
- Conditions
- HIV Infections
- Keywords
- HIV Antibodies, HIV-1, HIV Envelope Protein gp160, Adjuvants, Immunologic, AIDS Vaccines, CD4 Lymphocyte Count, Disease Models, Animal, Antibody Formation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- May 2005 (actual)
- First posted
- 26 Feb 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 gp160MN/LAI-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-89.6P. 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 design
- Primary purpose
- Prevention
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gp160 MN/LAI-2 | Biological | – |
| Aluminum hydroxide | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Background: PubMed 15193388Evans 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Evans study chair
Sharon Frey study chair
Questions about this trial
What is this clinical trial studying?
A study testing gp160 MN/LAI-2 and Aluminum hydroxide in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00031109, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.