HIV InfectionsPhase 1NCT00384787
Safety of and Immune Response to a DNA HIV Vaccine Followed by an Adenoviral Vaccine Boost Given Three Different Ways to HIV Uninfected Adults
A Phase 1 study testing VRC-HIVDNA009-00-VP and VRC-HIVADV014-00-VP in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 7 sites in 2 countries.
Trial summary
The purpose of this study is to determine the safety of, immune response to, and tolerability of an adenoviral vector HIV vaccine given after a three-dose regimen of a DNA HIV vaccine. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- VRC-HIVDNA009-00-VP and VRC-HIVADV014-00-VP
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Nov 2006to Dec 2012
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- HIV-1 and -2 uninfected
- Good general health
- Pre-existing adenovirus 5 (Ad5) neutralizing antibody titers of a 1:12 ratio or greater
- Hepatitis B surface antigen negative
- Anti-hepatitis C virus (anti-HCV) antibody negative or negative HCV PCR if anti-HCV antibody is positive
- Have access to a participating HIV Vaccine Trials Unit (HVTU) and are willing to be followed during the study
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- Willing to receive HIV test results
- Able to understand the vaccination procedure
- Willing to use acceptable forms of contraception
Who cannot join
- HIV vaccines or placebos in prior HIV trial. Participants who can provide documentation that they received a placebo in a prior HIV trial may be eligible.
- Immunosuppressive medications within 168 days prior to first study vaccination
- Blood products within 120 days prior to first study vaccination
- Immunoglobulin within 60 days prior to first study vaccination
- Live attenuated vaccines within 30 days prior to first study vaccination
- Investigational research agents within 30 days prior to first study vaccination
Show all 27Show fewer
- Medically indicated subunit or killed vaccines within 14 days prior to first study vaccination
- Allergy treatment with antigen injections within 30 days prior to first study vaccination
- Current anti-tuberculosis (TB) preventive therapy or treatment
- Clinically significant medical condition, abnormal physical exam findings, abnormal laboratory results, or past medical history that may affect current health. More information about this criterion can be found in the protocol.
- Any medical, psychiatric, or social condition that would interfere with the study. More information about this criterion can be found in the protocol.
- Any job-related responsibility that would interfere with the study
- Serious adverse reactions to vaccines, including hypersensitivity and related symptoms. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.
- Autoimmune disease or immunodeficiency
- Active syphilis infection. Participants who have been fully treated for syphilis more than 6 months prior to study entry are not excluded.
- Moderate to severe asthma. More information on this criterion can be found in the protocol.
- Type 1 or type 2 diabetes mellitus. Participants with histories of isolated gestational diabetes are not excluded.
- Thyroid disease or surgical removal of the thyroid requiring medication during the 12 months prior to study entry
- Accumulation of fluid in the blood vessels (angioedema) within 3 years prior to study entry if episodes are considered serious or have required medication in the 2 years prior to study entry
- Uncontrolled hypertension
- Body mass index (BMI) of 40 or greater OR BMI of 35 or greater if certain other criteria apply. More information about these criteria can be found in the protocol.
- Bleeding disorder
- Cancer. Participants with surgically removed cancer that is unlikely to recur are not excluded.
- Seizure disorder
- Absence of the spleen
- Mental illness that would interfere with the study
- Pregnancy, breastfeeding, or plan to become pregnant during the study
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Alabama Vaccine CRS
Birmingham, Alabama, 35294
Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
Boston, Massachusetts, 02115-6110
NY Blood Ctr./Union Square CRS
New York, New York, 10003
Columbia P&S CRS
New York, New York, 10032-3732
Seattle Vaccine and Prevention CRS
Seattle, Washington, 98109-1024
NY Blood Ctr./Bronx CRS
The Bronx, New York, 10455
About this study
Official title: A Phase Ib Clinical Trial to Compare the Safety, Tolerability, and Immunogenicity of an HIV-1 Adenoviral Vector Boost Administered Intramuscularly, Intradermally, or Subcutaneously After an HIV-1 DNA Plasmid Vaccine Prime Administered Intramuscularly to Healthy Adenovirus Type 5 Seropositive HIV-1-Uninfected Adults
The purpose of this study is to determine the safety of, immune response to, and tolerability of an adenoviral vector HIV vaccine given after a three-dose regimen of a DNA HIV vaccine. The adenoviral vaccine will be given into arm muscle (intramuscularly), between skin layers (intradermally), or under the skin (subcutaneously).
NOTE: In October 2007, vaccinations with the adenoviral vaccine, VRC-HIVADV014-00-VP, were discontinued. In December 2007, vaccinations with the DNA vaccine were also discontinued. Participants will be followed for safety and immune responses at regular study visits.
Read the detailed description
One factor that may affect safety and immunogenicity to an HIV vaccine is the route of vaccine administration. Administration into the skin (intradermal) or subcutaneous tissue may be more immunogenic or provide a different pattern of immune responses than administration by the intramuscular route. Previous studies with other preventive vaccines suggest that the resulting immunogenicity following intradermal or subcutaneous vaccine administration is comparable or better than immunogenicity observed following intramuscular administration. Increased immunogenicity though use of a particular route will likely result in greater demonstrated efficacy, requiring fewer or lower doses of vaccine to elicit a sufficient immune response.
The DNA HIV vaccine VRC-HIVDNA009-00-VP has shown immunogenicity in multiple clinical trials; in one trial, the DNA vaccine demonstrated a nearly 100% CD4 T-cell response rate. The adenoviral vector HIV vaccine VRC-HIVADV014-00-VP has shown immunogenicity when given intramuscularly and has appeared safe and well tolerated in prior vaccine trials in HIV uninfected adults. The DNA plasmids in both vaccines code for proteins from HIV subtypes A, B, and C. This study will evaluate the safety, immunogenicity, and tolerability to a DNA HIV vaccine, followed by an adenoviral vaccine boost given either intramuscularly, intradermally, or subcutaneously, in HIV uninfected adults.
All participants will receive three doses of the DNA vaccine intramuscularly at study entry and Months 1 and 2. Participants will be randomly assigned to one of three groups, differing by how they will receive the adenoviral vaccine boost:
- Group 1 participants will receive the vaccine boost intramuscularly at Month 6
- Group 2 participants will receive the vaccine boost intradermally at Month 6
- Group 3 participants will receive the vaccine boost subcutaneously at Month 6
This study will last 1 year. There will be 12 study visits; a physical exam, medication history, and risk reduction/pregnancy prevention compliance counseling will occur at all visits. Urine and blood collection will occur at selected visits. Participants will be asked to complete a social impact assessment at Months 2, 6, and 12 and an outside testing and belief questionnaire at Months 6 and 12. Participants will be asked to record their temperature and other side effects in a symptom log on the day of each vaccination and for 3 days thereafter to report any side effects.
NOTE: In October 2007, vaccinations with the adenoviral vaccine, VRC-HIVADV014-00-VP, were discontinued. In December 2007, vaccinations with the DNA vaccine were also discontinued. Participants will be followed for safety and immune responses at regular study visits and will be asked to continue in long term follow-up for purposes of safety surveillance to a total of 5 years following initial vaccination
- Conditions
- HIV Infections
- Being tested
- VRC-HIVDNA009-00-VP, VRC-HIVADV014-00-VP
- Keywords
- HIV Seronegativity, Adenoviral Vector Vaccine, DNA Plasmid Vaccine, HIV Preventive 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
HIV DNA vaccine containing the HIV genes gag, pol, nef, and env A,B, and C. The HIV DNA vaccine will be given in three doses intramuscularly at study entry and Months 1 and 2
VRC-HIVADV014-00-VPBiological
Adenoviral vector HIV booster vaccine containing the HIV genes gag, pol, and env. The adenoviral vector HIV booster vaccine will be administered intramuscularly (Group 1), intradermally (Group 2), or subcutaneously (Group 3) at Month 6
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Group 1 will receive three vaccinations with the HIV DNA vaccine. Vaccinations will be given at study entry and Months 1 and 2. Participants will also receive an adenoviral vaccine boost intramuscularly at Month 6. Receives: Biological: VRC-HIVDNA009-00-VP; Biological: VRC-HIVADV014-00-VP |
| 2 | Experimental | Group 2 will receive three vaccinations with the HIV DNA vaccine. Vaccinations will be given at study entry and Months 1 and 2. Participants will also receive an adenoviral vaccine boost intradermally at Month 6. Receives: Biological: VRC-HIVDNA009-00-VP; Biological: VRC-HIVADV014-00-VP |
| 3 | Experimental | Group 3 will receive three vaccinations with the HIV DNA vaccine. Vaccinations will be given at study entry and Months 1 and 2. Participants will also receive an adenoviral vaccine boost subcutaneously at Month 6. Receives: Biological: VRC-HIVDNA009-00-VP; Biological: VRC-HIVADV014-00-VP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (local and systemic reactogenicity signs and symptoms, laboratory measures, and adverse events)
Measured: After each injection and for 12 months after the first injection
Magnitude of HIV-specific T-cell responses assessed by the magnitude of IFN-gamma enzyme-linked immunosorbent spot (ELISpot) responses
Measured: 4 weeks after adenoviral vaccine boost
Secondary outcomes (1)
Titer of HIV-specific binding antibodies assessed by enzyme-linked immunosorbent assay (ELISA)
Measured: 4 weeks after adenoviral vaccine boost
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2006 (estimated)
- Study startNov 2006
- Primary completionNov 2008
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- HIV Vaccine Trials Network
- Responsible party
- Sponsor
- Investigators
- Beryl Koblin, PhD, Study chair, New York Blood CenterMartin Casapia, MD, Study chair, Asociación Civil Impacta Salud y Educación (IMPACTA), Peru
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00384787
- Sponsor's protocol ID
- HVTN 069
- Other IDs
- 10391
- Status last verified
- Oct 2021
- First submitted
- 4 Oct 2006
- Last updated
- 14 Oct 2021
- Results posted
- No
Publications
Barouch DH, Nabel GJ. Adenovirus vector-based vaccines for human immunodeficiency virus type 1. Hum Gene Ther. 2005 Feb;16(2):149-56. doi: 10.1089/hum.2005.16.149.
PubMed 15761255Kenney RT, Frech SA, Muenz LR, Villar CP, Glenn GM. Dose sparing with intradermal injection of influenza vaccine. N Engl J Med. 2004 Nov 25;351(22):2295-301. doi: 10.1056/NEJMoa043540. Epub 2004 Nov 3.
PubMed 15525714Pittman PR, Kim-Ahn G, Pifat DY, Coonan K, Gibbs P, Little S, Pace-Templeton JG, Myers R, Parker GW, Friedlander AM. Anthrax vaccine: immunogenicity and safety of a dose-reduction, route-change comparison study in humans. Vaccine. 2002 Jan 31;20(9-10):1412-20. doi: 10.1016/s0264-410x(01)00462-5.
PubMed 11818160Shiver JW, Emini EA. Recent advances in the development of HIV-1 vaccines using replication-incompetent adenovirus vectors. Annu Rev Med. 2004;55:355-72. doi: 10.1146/annurev.med.55.091902.104344.
PubMed 14746526Jin X, Morgan C, Yu X, DeRosa S, Tomaras GD, Montefiori DC, Kublin J, Corey L, Keefer MC; NIAID HIV Vaccine Trials Network. Multiple factors affect immunogenicity of DNA plasmid HIV vaccines in human clinical trials. Vaccine. 2015 May 11;33(20):2347-53. doi: 10.1016/j.vaccine.2015.03.036. Epub 2015 Mar 25.
PubMed 25820067Koblin BA, Casapia M, Morgan C, Qin L, Wang ZM, Defawe OD, Baden L, Goepfert P, Tomaras GD, Montefiori DC, McElrath MJ, Saavedra L, Lau CY, Graham BS; NIAID HIV Vaccine Trials Network. Safety and immunogenicity of an HIV adenoviral vector boost after DNA plasmid vaccine prime by route of administration: a randomized clinical trial. PLoS One. 2011;6(9):e24517. doi: 10.1371/journal.pone.0024517. Epub 2011 Sep 12.
PubMed 21931737
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Clinical Trial to Compare the Safety, Tolerability, and Immunogenicity of an HIV-1 Adenoviral Vector Boost Administered Intramuscularly, Intradermally, or Subcutaneously After an HIV-1 DNA Plasmid Vaccine Prime Administered Intramuscularly to Healthy Adenovirus Type 5 Seropositive HIV-1-Uninfected Adults
- ClinicalTrials.gov ID
- NCT00384787
- Acronym / sponsor ID
- HVTN 069
- Conditions
- HIV Infections
- Keywords
- HIV Seronegativity, Adenoviral Vector Vaccine, DNA Plasmid Vaccine, HIV Preventive Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- HIV Vaccine Trials Network
- Study start
- Nov 2006
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 6 Oct 2006 (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 determine the safety of, immune response to, and tolerability of an adenoviral vector HIV vaccine given after a three-dose regimen of a DNA HIV vaccine. The adenoviral vaccine will be given into arm muscle (intramuscularly), between skin layers (intradermally), or under the skin (subcutaneously).
NOTE: In October 2007, vaccinations with the adenoviral vaccine, VRC-HIVADV014-00-VP, were discontinued. In December 2007, vaccinations with the DNA vaccine were also discontinued. Participants will be followed for safety and immune responses at regular study visits.
Detailed description
One factor that may affect safety and immunogenicity to an HIV vaccine is the route of vaccine administration. Administration into the skin (intradermal) or subcutaneous tissue may be more immunogenic or provide a different pattern of immune responses than administration by the intramuscular route. Previous studies with other preventive vaccines suggest that the resulting immunogenicity following intradermal or subcutaneous vaccine administration is comparable or better than immunogenicity observed following intramuscular administration. Increased immunogenicity though use of a particular route will likely result in greater demonstrated efficacy, requiring fewer or lower doses of vaccine to elicit a sufficient immune response.
The DNA HIV vaccine VRC-HIVDNA009-00-VP has shown immunogenicity in multiple clinical trials; in one trial, the DNA vaccine demonstrated a nearly 100% CD4 T-cell response rate. The adenoviral vector HIV vaccine VRC-HIVADV014-00-VP has shown immunogenicity when given intramuscularly and has appeared safe and well tolerated in prior vaccine trials in HIV uninfected adults. The DNA plasmids in both vaccines code for proteins from HIV subtypes A, B, and C. This study will evaluate the safety, immunogenicity, and tolerability to a DNA HIV vaccine, followed by an adenoviral vaccine boost given either intramuscularly, intradermally, or subcutaneously, in HIV uninfected adults.
All participants will receive three doses of the DNA vaccine intramuscularly at study entry and Months 1 and 2. Participants will be randomly assigned to one of three groups, differing by how they will receive the adenoviral vaccine boost:
- Group 1 participants will receive the vaccine boost intramuscularly at Month 6
- Group 2 participants will receive the vaccine boost intradermally at Month 6
- Group 3 participants will receive the vaccine boost subcutaneously at Month 6
This study will last 1 year. There will be 12 study visits; a physical exam, medication history, and risk reduction/pregnancy prevention compliance counseling will occur at all visits. Urine and blood collection will occur at selected visits. Participants will be asked to complete a social impact assessment at Months 2, 6, and 12 and an outside testing and belief questionnaire at Months 6 and 12. Participants will be asked to record their temperature and other side effects in a symptom log on the day of each vaccination and for 3 days thereafter to report any side effects.
NOTE: In October 2007, vaccinations with the adenoviral vaccine, VRC-HIVADV014-00-VP, were discontinued. In December 2007, vaccinations with the DNA vaccine were also discontinued. Participants will be followed for safety and immune responses at regular study visits and will be asked to continue in long term follow-up for purposes of safety surveillance to a total of 5 years following initial vaccination
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: VRC-HIVDNA009-00-VP, Biological: VRC-HIVADV014-00-VPGroup 1 will receive three vaccinations with the HIV DNA vaccine. Vaccinations will be given at study entry and Months 1 and 2. Participants will also receive an adenoviral vaccine boost intramuscularly at Month 6. |
| 2 | Experimental | Biological: VRC-HIVDNA009-00-VP, Biological: VRC-HIVADV014-00-VPGroup 2 will receive three vaccinations with the HIV DNA vaccine. Vaccinations will be given at study entry and Months 1 and 2. Participants will also receive an adenoviral vaccine boost intradermally at Month 6. |
| 3 | Experimental | Biological: VRC-HIVDNA009-00-VP, Biological: VRC-HIVADV014-00-VPGroup 3 will receive three vaccinations with the HIV DNA vaccine. Vaccinations will be given at study entry and Months 1 and 2. Participants will also receive an adenoviral vaccine boost subcutaneously at Month 6. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- HIV-1 and -2 uninfected
- Good general health
- Pre-existing adenovirus 5 (Ad5) neutralizing antibody titers of a 1:12 ratio or greater
- Hepatitis B surface antigen negative
- Anti-hepatitis C virus (anti-HCV) antibody negative or negative HCV PCR if anti-HCV antibody is positive
Key exclusion criteria (27 listed)
- HIV vaccines or placebos in prior HIV trial. Participants who can provide documentation that they received a placebo in a prior HIV trial may be eligible.
- Immunosuppressive medications within 168 days prior to first study vaccination
- Blood products within 120 days prior to first study vaccination
- Immunoglobulin within 60 days prior to first study vaccination
- Live attenuated vaccines within 30 days prior to first study vaccination
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-VPHIV DNA vaccine containing the HIV genes gag, pol, nef, and env A,B, and C. The HIV DNA vaccine will be given in three doses intramuscularly at study entry and Months 1 and 2 | Biological | 1, 2, 3 |
| VRC-HIVADV014-00-VPAdenoviral vector HIV booster vaccine containing the HIV genes gag, pol, and env. The adenoviral vector HIV booster vaccine will be administered intramuscularly (Group 1), intradermally (Group 2), or subcutaneously (Group 3) at Month 6 | Biological | 1, 2, 3 |
Primary outcome
Safety (local and systemic reactogenicity signs and symptoms, laboratory measures, and adverse events)
Time frame: After each injection and for 12 months after the first injection
Magnitude of HIV-specific T-cell responses assessed by the magnitude of IFN-gamma enzyme-linked immunosorbent spot (ELISpot) responses
Time frame: 4 weeks after adenoviral vaccine boost
1 secondary outcome
Titer of HIV-specific binding antibodies assessed by enzyme-linked immunosorbent assay (ELISA)
Time frame: 4 weeks after adenoviral vaccine boost
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 14 Oct 2021.
- Background: PubMed 15761255Barouch DH, Nabel GJ. Adenovirus vector-based vaccines for human immunodeficiency virus type 1. Hum Gene Ther. 2005 Feb;16(2):149-56. doi: 10.1089/hum.2005.16.149.
- Background: PubMed 15525714Kenney RT, Frech SA, Muenz LR, Villar CP, Glenn GM. Dose sparing with intradermal injection of influenza vaccine. N Engl J Med. 2004 Nov 25;351(22):2295-301. doi: 10.1056/NEJMoa043540. Epub 2004 Nov 3.
- Background: PubMed 11818160Pittman PR, Kim-Ahn G, Pifat DY, Coonan K, Gibbs P, Little S, Pace-Templeton JG, Myers R, Parker GW, Friedlander AM. Anthrax vaccine: immunogenicity and safety of a dose-reduction, route-change comparison study in humans. Vaccine. 2002 Jan 31;20(9-10):1412-20. doi: 10.1016/s0264-410x(01)00462-5.
- Background: PubMed 14746526Shiver JW, Emini EA. Recent advances in the development of HIV-1 vaccines using replication-incompetent adenovirus vectors. Annu Rev Med. 2004;55:355-72. doi: 10.1146/annurev.med.55.091902.104344.
- Derived from this study: PubMed 25820067Jin X, Morgan C, Yu X, DeRosa S, Tomaras GD, Montefiori DC, Kublin J, Corey L, Keefer MC; NIAID HIV Vaccine Trials Network. Multiple factors affect immunogenicity of DNA plasmid HIV vaccines in human clinical trials. Vaccine. 2015 May 11;33(20):2347-53. doi: 10.1016/j.vaccine.2015.03.036. Epub 2015 Mar 25.
- Derived from this study: PubMed 21931737Koblin BA, Casapia M, Morgan C, Qin L, Wang ZM, Defawe OD, Baden L, Goepfert P, Tomaras GD, Montefiori DC, McElrath MJ, Saavedra L, Lau CY, Graham BS; NIAID HIV Vaccine Trials Network. Safety and immunogenicity of an HIV adenoviral vector boost after DNA plasmid vaccine prime by route of administration: a randomized clinical trial. PLoS One. 2011;6(9):e24517. doi: 10.1371/journal.pone.0024517. Epub 2011 Sep 12.
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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.
Beryl Koblin, PhD study chair
New York Blood Center
Martin Casapia, MD study chair
Asociación Civil Impacta Salud y Educación (IMPACTA), Peru
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VRC-HIVDNA009-00-VP and VRC-HIVADV014-00-VP in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 7 sites in 2 countries.
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 9 inclusion and 27 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 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Peru. 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 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.
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?
Safety (local and systemic reactogenicity signs and symptoms, laboratory measures, and adverse events) (time frame: After each injection and for 12 months after the first injection). The study lists 2 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 NCT00384787, which also lists 6 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 14 Oct 2021.