HIV InfectionsPhase 1/2NCT00125099
Safety of and Immune Response to a DNA HIV Vaccine (VRC-HIVDNA009-00-VP) in HIV Infected Individuals With Acute HIV Infection
A Phase 1/2 study testing VRC-HIVDNA009-00-VP in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.
Trial summary
The purpose of this study is to evaluate whether the HIV vaccine VRC-HIVDNA009-00-VP will be safe in individuals who started antiretroviral therapy during acute HIV-1 infection. The study will also test whether the vaccine can increase the immune system function in these participants. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- VRC-HIVDNA009-00-VP
- How many people
- 21 participants
- Where
- 5 sitesUnited States
- Study dates
- Start not givento Sep 2007
- Phase
- Phase 1/2
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Treated acute HIV-1 infection (initiated HAART during the acute retroviral syndrome AND were diagnosed by a positive HIV-1 viral load and a negative or indeterminate Western blot)
- Minimum of 6 months of HAART, defined as 2 or more antiretroviral drugs in combination
- At least three CD4 cell counts over 350 cells/mm3 for a period of 6 months prior to study entry
- Screening CD4 cell count over 350 cells/mm3 within 30 days prior to study entry
- HIV-1 RNA levels over 50 copies/ml for a period of 6 months prior to study entry
- Screening HIV-1 RNA level less than 50 copies/ml within 30 days prior to study entry
- Agrees to use acceptable methods of contraception
Who cannot join
- History of serious adverse reactions to vaccines
- History of CD4 cell count less than 250 cells/mm3, opportunistic infections, or AIDS-defining illnesses. Patients who have had one CD4 count less than 250 cells/mm3 or who have had CD4 counts less than 250 cells/mm3 for not more than 2 weeks during acute infection are not excluded.
- History of autoimmune disease, immunodeficiency, asthma, diabetes requiring insulin or oral hypoglycemics, thyroid disease, bleeding disorder, active malignancy, viral hepatitis, or asplenia
- Positive HBV, HCV, or syphilis test
- Suspected allergy or adverse reaction to any component of the study agent
- Changes in antiretroviral regimen within 6 months prior to entry due to virologic failure (not including toxicities)
Show all 18Show fewer
- Previous participation in STIs
- Pregnancy or breast-feeding
- Live attenuated vaccines or investigational research agents within the 30 days prior to study entry
- Blood products within the 120 days prior to study entry
- Immunoglobulin within the 60 days prior to study entry
- Subunit or killed vaccines or allergy treatments with antigen injections within the 14 days prior to study entry
- Prior experimental HIV vaccines
- Certain immunosuppressive medications within the 6 months prior to study entry
- Current TB prophylaxis or therapy
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
- Serious illness requiring systemic treatment and/or hospitalization. An individual who has either completed therapy OR is clinically stable for at least 14 days prior to study entry is eligible.
- Anti-dsDNA antibody greater than the upper limit of normal
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Massachusetts General Hospital ACTG CRS
Boston, Massachusetts, 02114
Brigham and Women's Hosp. ACTG CRS
Boston, Massachusetts, 02115
Aaron Diamond AIDS Research Ctr. AIEDRP
New York, New York, 10021
Ucsd, Avrc Crs
San Diego, California, 92103
UW Primary Infection Clinic CRS
Seattle, Washington, 98104
About this study
Official title: Safety and Immunogenicity of the HIV-1 DNA Vaccine VRC-HIVDNA009-00-VP (GAG-POL-NEF-MULTICLADE ENV) in HIV-1 Infected Subjects Treated During Acute HIV Infection
The purpose of this study is to evaluate whether the HIV vaccine VRC-HIVDNA009-00-VP will be safe in individuals who started antiretroviral therapy during acute HIV-1 infection. The study will also test whether the vaccine can increase the immune system function in these participants.
Read the detailed description
Highly active antiretroviral therapy (HAART) has greatly improved mortality and morbidity rates associated with HIV and AIDS. However, many HIV-1 infected individuals are unable to access HAART. It is therefore important to develop a safe and effective therapeutic vaccine to improve immune control of viral replication and reduce the need for antiretroviral medication. This study will evaluate the safety and immunogenicity of the HIV-1 DNA vaccine VRC-HIVDNA009-00-VP in treating HIV-1 infected individuals who initiated antiretroviral therapy during acute infection. This study will involve a supervised treatment interruption (STI) in order to determine whether therapeutic vaccination results in improved immune control of viral replication.
Participants in this study will be randomly assigned to receive either the therapeutic vaccine or placebo in addition to their regular HAART regimens. During the first part of the study, participants will receive 4 vaccinations at Weeks 0, 4, 8 and 24. All individuals completing the therapeutic vaccination phase (defined as completing at least 3 immunizations, including the Week 24 immunization) will be given the opportunity to participate in the second part of the study and undergo a supervised discontinuation of HAART. At Week 30, these participants will discontinue all antiretroviral treatment and will be closely monitored. Participants will restart HAART if they experience a significant decline in their CD4 count, an increase in their viral loads, or if their physicians recommend they resume HAART. At Week 52, all other participants can restart HAART at the discretion of their primary physician.
21 study visits will occur over a period of 52 weeks. After Week 52, monthly study visits will occur through Week 72. Study visits will last approximately two hours and will include physical exams and blood and urine collection.
- Conditions
- HIV Infections
- Being tested
- VRC-HIVDNA009-00-VP
- Keywords
- Acute Infection, Treatment Experienced, Treatment Interruption, HIV Therapeutic Vaccine
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VRC-HIVDNA009-00-VPBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
Grade 3 or 4 sign/symptom, laboratory abnormality, or death that may be related to the vaccine
2 consecutive viral loads of 400 copies/ml or more while receiving HAART
2 consecutive absolute CD4 cell counts of 250 cells/mm3 or more while receiving HAART
2 consecutive CD4 cell counts more than 50% below the baseline CD4 cell count
Secondary outcomes (4)
Tolerability (receipt of the full schedule of 4 vaccines)
viral load setpoint: average of the log10 viral load measures at Weeks 18, 20, and 22 after HAART withdrawl (study Weeks 48, 50, and 52)
Positive vaccine-elicited ELISPOT response as defined by a twofold increase from baseline that is also 100 or more spots/1,000,000 PBMCs
Positive vaccine-elicited intracellular cytokine staining response as defined by a twofold increase from baseline AND 300 or more spots/1,000,000 PBMCs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2005 (estimated)
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Dan H. Barouch, MD, PhD, Study chair, Beth Israel Deaconess Medical Center, Division of Viral PathogenesisEric S. Rosenberg, MD, Study chair, Massachusetts General Hospital, Division of Infectious Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00125099
- Sponsor's protocol ID
- A5187
- Other IDs
- 10010, ACTG A5187
- Status last verified
- Oct 2021
- First submitted
- 27 Jul 2005
- Last updated
- 1 Nov 2021
- Results posted
- No
Publications
Altfeld M, Rosenberg ES, Shankarappa R, Mukherjee JS, Hecht FM, Eldridge RL, Addo MM, Poon SH, Phillips MN, Robbins GK, Sax PE, Boswell S, Kahn JO, Brander C, Goulder PJ, Levy JA, Mullins JI, Walker BD. Cellular immune responses and viral diversity in individuals treated during acute and early HIV-1 infection. J Exp Med. 2001 Jan 15;193(2):169-80. doi: 10.1084/jem.193.2.169.
PubMed 11148221Rosenberg ES, Altfeld M, Poon SH, Phillips MN, Wilkes BM, Eldridge RL, Robbins GK, D'Aquila RT, Goulder PJ, Walker BD. Immune control of HIV-1 after early treatment of acute infection. Nature. 2000 Sep 28;407(6803):523-6. doi: 10.1038/35035103.
PubMed 11029005Rosenberg ES, Graham BS, Chan ES, Bosch RJ, Stocker V, Maenza J, Markowitz M, Little S, Sax PE, Collier AC, Nabel G, Saindon S, Flynn T, Kuritzkes D, Barouch DH; AIDS Clinical Trials Group A5187 Team. Safety and immunogenicity of therapeutic DNA vaccination in individuals treated with antiretroviral therapy during acute/early HIV-1 infection. PLoS One. 2010 May 10;5(5):e10555. doi: 10.1371/journal.pone.0010555.
PubMed 20479938
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of the HIV-1 DNA Vaccine VRC-HIVDNA009-00-VP (GAG-POL-NEF-MULTICLADE ENV) in HIV-1 Infected Subjects Treated During Acute HIV Infection
- ClinicalTrials.gov ID
- NCT00125099
- Acronym / sponsor ID
- A5187
- Conditions
- HIV Infections
- Keywords
- Acute Infection, Treatment Experienced, Treatment Interruption, HIV Therapeutic Vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Sep 2007 (actual)
- First posted
- 29 Jul 2005 (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 evaluate whether the HIV vaccine VRC-HIVDNA009-00-VP will be safe in individuals who started antiretroviral therapy during acute HIV-1 infection. The study will also test whether the vaccine can increase the immune system function in these participants.
Detailed description
Highly active antiretroviral therapy (HAART) has greatly improved mortality and morbidity rates associated with HIV and AIDS. However, many HIV-1 infected individuals are unable to access HAART. It is therefore important to develop a safe and effective therapeutic vaccine to improve immune control of viral replication and reduce the need for antiretroviral medication. This study will evaluate the safety and immunogenicity of the HIV-1 DNA vaccine VRC-HIVDNA009-00-VP in treating HIV-1 infected individuals who initiated antiretroviral therapy during acute infection. This study will involve a supervised treatment interruption (STI) in order to determine whether therapeutic vaccination results in improved immune control of viral replication.
Participants in this study will be randomly assigned to receive either the therapeutic vaccine or placebo in addition to their regular HAART regimens. During the first part of the study, participants will receive 4 vaccinations at Weeks 0, 4, 8 and 24. All individuals completing the therapeutic vaccination phase (defined as completing at least 3 immunizations, including the Week 24 immunization) will be given the opportunity to participate in the second part of the study and undergo a supervised discontinuation of HAART. At Week 30, these participants will discontinue all antiretroviral treatment and will be closely monitored. Participants will restart HAART if they experience a significant decline in their CD4 count, an increase in their viral loads, or if their physicians recommend they resume HAART. At Week 52, all other participants can restart HAART at the discretion of their primary physician.
21 study visits will occur over a period of 52 weeks. After Week 52, monthly study visits will occur through Week 72. Study visits will last approximately two hours and will include physical exams and blood and urine collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Treated acute HIV-1 infection (initiated HAART during the acute retroviral syndrome AND were diagnosed by a positive HIV-1 viral load and a negative or indeterminate Western blot)
- Minimum of 6 months of HAART, defined as 2 or more antiretroviral drugs in combination
- At least three CD4 cell counts over 350 cells/mm3 for a period of 6 months prior to study entry
- Screening CD4 cell count over 350 cells/mm3 within 30 days prior to study entry
- HIV-1 RNA levels over 50 copies/ml for a period of 6 months prior to study entry
Key exclusion criteria (18 listed)
- History of serious adverse reactions to vaccines
- History of CD4 cell count less than 250 cells/mm3, opportunistic infections, or AIDS-defining illnesses. Patients who have had one CD4 count less than 250 cells/mm3 or who have had CD4 counts less than 250 cells/mm3 for not more than 2 weeks during acute infection are not excluded.
- History of autoimmune disease, immunodeficiency, asthma, diabetes requiring insulin or oral hypoglycemics, thyroid disease, bleeding disorder, active malignancy, viral hepatitis, or asplenia
- Positive HBV, HCV, or syphilis test
- Suspected allergy or adverse reaction to any component of the study agent
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 |
|---|---|---|
| VRC-HIVDNA009-00-VP | Biological | – |
Primary outcome
Grade 3 or 4 sign/symptom, laboratory abnormality, or death that may be related to the vaccine
2 consecutive viral loads of 400 copies/ml or more while receiving HAART
2 consecutive absolute CD4 cell counts of 250 cells/mm3 or more while receiving HAART
2 consecutive CD4 cell counts more than 50% below the baseline CD4 cell count
4 secondary outcomes
Tolerability (receipt of the full schedule of 4 vaccines)
viral load setpoint: average of the log10 viral load measures at Weeks 18, 20, and 22 after HAART withdrawl (study Weeks 48, 50, and 52)
Positive vaccine-elicited ELISPOT response as defined by a twofold increase from baseline that is also 100 or more spots/1,000,000 PBMCs
Positive vaccine-elicited intracellular cytokine staining response as defined by a twofold increase from baseline AND 300 or more spots/1,000,000 PBMCs
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 1 Nov 2021.
- Background: PubMed 11148221Altfeld M, Rosenberg ES, Shankarappa R, Mukherjee JS, Hecht FM, Eldridge RL, Addo MM, Poon SH, Phillips MN, Robbins GK, Sax PE, Boswell S, Kahn JO, Brander C, Goulder PJ, Levy JA, Mullins JI, Walker BD. Cellular immune responses and viral diversity in individuals treated during acute and early HIV-1 infection. J Exp Med. 2001 Jan 15;193(2):169-80. doi: 10.1084/jem.193.2.169.
- Background: PubMed 11029005Rosenberg ES, Altfeld M, Poon SH, Phillips MN, Wilkes BM, Eldridge RL, Robbins GK, D'Aquila RT, Goulder PJ, Walker BD. Immune control of HIV-1 after early treatment of acute infection. Nature. 2000 Sep 28;407(6803):523-6. doi: 10.1038/35035103.
- Results publication: PubMed 20479938Rosenberg ES, Graham BS, Chan ES, Bosch RJ, Stocker V, Maenza J, Markowitz M, Little S, Sax PE, Collier AC, Nabel G, Saindon S, Flynn T, Kuritzkes D, Barouch DH; AIDS Clinical Trials Group A5187 Team. Safety and immunogenicity of therapeutic DNA vaccination in individuals treated with antiretroviral therapy during acute/early HIV-1 infection. PLoS One. 2010 May 10;5(5):e10555. doi: 10.1371/journal.pone.0010555.
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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.
Dan H. Barouch, MD, PhD study chair
Beth Israel Deaconess Medical Center, Division of Viral Pathogenesis
Eric S. Rosenberg, MD study chair
Massachusetts General Hospital, Division of Infectious Diseases
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing VRC-HIVDNA009-00-VP in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 5 sites in United States.
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 7 inclusion and 18 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 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Grade 3 or 4 sign/symptom, laboratory abnormality, or death that may be related to the vaccine. The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00125099, which also lists 3 linked publications.
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 1 Nov 2021.