HIV InfectionsPhase 1NCT00115960
Safety of and Immune Response to an HIV Preventive Vaccine (HIV-1 Gag DNA Alone or With IL-15 DNA) Given With or Without 2 Different Booster Vaccinations in HIV Uninfected Adults
A Phase 1 study testing HIV-1 gag DNA, IL-15 DNA adjuvant and IL-12 DNA adjuvant 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 and immune response to an experimental HIV vaccine, HIV-1 gag DNA, with and without an IL-15 DNA adjuvant (at escalating doses of 100, 500, and 1500 mcg). 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?
- HIV-1 gag DNA, IL-15 DNA adjuvant and IL-12 DNA adjuvant
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Start not givento Jul 2008
- 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 uninfected
- Access to a participating HIV Vaccine Trials Unit (HVTU)
- Willing to receive HIV test results
- Willing and able to comply with all study requirements
- In good general health
- Willing to use acceptable methods of contraception for at least 21 days prior to study entry and until the last study visit. More information about this criterion can be found in the protocol.
- Hepatitis B surface antigen negative
- Anti-hepatitis C virus (anti-HCV) antibody negative or negative HCV PCR if anti-HCV antibody is positive
Who cannot join
- HIV vaccines in prior HIV vaccine trial
- Immunosuppressive medications within 168 days prior to first vaccination
- Blood products within 120 days prior to first vaccination
- Immunoglobulin within 60 days prior to first vaccination
- Live attenuated vaccines within 30 days prior to first vaccination
- Investigational research agents within 30 days prior to first vaccination
Show all 28Show fewer
- Medically indicated subunit or killed vaccines within 14 days prior to first study vaccine administration, or allergy treatment with antigen injections within 30 days prior to first vaccination
- Current tuberculosis (TB) prophylaxis or therapy
- Clinically significant medical condition, physical exam findings, abnormal laboratory results, or past medical history with clinically significant implications for current health
- Any medical, psychiatric, or social condition that, in the opinion of the investigator, may interfere with the study
- Any occupational or other responsibility that, in the opinion of the investigator, may interfere with the study
- Diagnosis of allergy to amide-type local anesthetics
- Serious adverse reaction to vaccines, including anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, or abdominal pain. A person who had an adverse reaction to pertussis vaccine as a child is not excluded.
- Autoimmune disease or immunodeficiency
- Unstable asthma
- Diabetes mellitus Type 1 or Type 2. Participants with histories of isolated gestational diabetes are not excluded.
- Thyroid disease requiring treatment in the past 12 months
- Serious angioedema within the last 3 years
- Uncontrolled hypertension
- Body mass index (BMI) of 40 or greater OR BMI of 35 or greater, when certain other criteria are met. More information about these criteria can be found in the protocol.
- Bleeding disorder
- Cancer. Participants with surgically removed cancer that, in the opinion of the investigator, is unlikely to recur are not excluded.
- Seizure disorder requiring medication within the past 3 years
- Absence of the spleen
- Psychiatric condition, including psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years
- Pregnant or breastfeeding, or plan to become pregnant during the study
- Diagnosis of allergy to egg products
- Diagnosis of allergy to yeast-derived products
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Brigham and Women's Hosp. CRS
Boston, Massachusetts, 02115
NY Blood Ctr./Union Square CRS
New York, New York, 10003
HIV Prevention & Treatment CRS
New York, New York, 10032
Miriam Hospital's HVTU
Providence, Rhode Island
Univ. of Rochester HVTN CRS
Rochester, New York, 14642-0001
NY Blood Ctr./Bronx CRS
The Bronx, New York, 10456
About this study
Official title: A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of HIV-1 Gag DNA Vaccine Alone or With IL-15 DNA, Boosted With HIV-1 Gag DNA + IL-15 DNA or HIV-1 Gag DNA + IL-12 DNA, in Healthy, HIV-1 Uninfected Adult Participants
The purpose of this study is to determine the safety of and immune response to an experimental HIV vaccine, HIV-1 gag DNA, with and without an IL-15 DNA adjuvant (at escalating doses of 100, 500, and 1500 mcg). This study will also test the safety of and immune response to the HIV-1 gag DNA vaccine plus IL-15 DNA adjuvant given with or without 2 other adjuvant-containing booster vaccines.
Read the detailed description
The HIV epidemic is a major global health challenge, causing tremendous human suffering and economic loss throughout the world. The need for a safe, effective, and affordable HIV preventive vaccine is critical. This 2-part study will determine the safety and immunogenicity of the experimental HIV vaccine HIV-1 gag DNA with or without IL-15 adjuvant, boosted with either the HIV-1 gag DNA and IL-15 adjuvant vaccine or the HIV-1 gag DNA and IL-12 adjuvant vaccine.
There are two parts to this study. Part A will last 12 months. In Part A, 48 participants will be randomly assigned to 1 of 4 groups in sequential order (dose escalation). All participants will receive 3 vaccinations. Group 1 will receive 3 vaccinations of the HIV-1 gag DNA vaccine or placebo. Group 2 will receive 3 vaccinations of either the HIV-1 gag DNA vaccine with a low dose of IL-15 adjuvant or a placebo. Group 3 will receive 3 vaccinations of either the HIV-1 gag vaccine with a medium dose of IL-15 adjuvant or a placebo. Group 4 will receive 3 vaccinations of either the HIV-1 gag vaccine with a high dose of IL-15 adjuvant or a placebo. Vaccinations will be given at Months 0, 1, and 3. There will be 11 study visits in Part A. A physical exam, pregnancy prevention counseling, medication history, and adverse event reporting will occur at most visits. Urine and blood collection will occur at some visits. Participants will also be asked to complete questionnaires at certain visits.
Part B will last 15 months. In Part B, 72 participants will be randomly assigned to 1 of 2 groups. All Part B participants will receive 5 vaccinations. Group 5 will receive 5 vaccinations of either the HIV-1 gag vaccine plus IL-15 DNA or placebo; the vaccinations will occur at Months 0, 1, 3, 6, and 9. Group 7 will receive 3 vaccinations of the HIV-1 gag vaccine with a high dose of IL-15 adjuvant (maximum tolerated dose from Part A) followed by 2 vaccinations of the gag DNA vaccine with IL-12 DNA adjuvant. Some participants will receive placebo instead of this vaccine regimen. For Group 7, the HIV-1 gag vaccine with IL-15 adjuvant vaccinations will be given at Months 0, 1, and 3, and booster vaccinations will be given at Months 6 and 9. There will be 13 study visits in Part B. A physical exam, pregnancy prevention counseling, medication history, and adverse event reporting will occur at most visits. Urine and blood collection will occur at some visits. Participants will also be asked to complete questionnaires at certain visits.
- Conditions
- HIV Infections
- Being tested
- HIV-1 gag DNA, IL-15 DNA adjuvant, IL-12 DNA adjuvant
- Keywords
- IL-12, IL-15, HIV Seronegativity, 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.
HIV-1 gag DNABiological
DNA vaccine containing the HIV gene gag
IL-15 DNA adjuvantBiological
Cytokine injection
IL-12 DNA adjuvantBiological
Cytokine injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Group 1 will receive 3 vaccinations of the HIV-1 gag DNA vaccine, or placebo. Vaccinations will be given at Months 0, 1, and 3. Receives: Biological: HIV-1 gag DNA |
| 2 | Experimental | Group 2 will receive 3 vaccinations of either the HIV-1 gag DNA vaccine with a low dose of IL-15 adjuvant, or a placebo. Vaccinations will be given at Months 0, 1, and 3. Receives: Biological: HIV-1 gag DNA; Biological: IL-15 DNA adjuvant |
| 3 | Experimental | Group 3 will receive 3 vaccinations of either the HIV-1 gag vaccine with a medium dose of IL-15 adjuvant, or a placebo. Vaccinations will be given at Months 0, 1, and 3. Receives: Biological: HIV-1 gag DNA; Biological: IL-15 DNA adjuvant |
| 4 | Experimental | Group 4 will receive 3 vaccinations of either the HIV-1 gag vaccine with a high dose of IL-15 adjuvant, or a placebo. Vaccinations will be given at Months 0, 1, and 3. Receives: Biological: HIV-1 gag DNA; Biological: IL-15 DNA adjuvant |
| 5 | Experimental | In Part B, Group 5 will receive 5 vaccinations of either the HIV-1 gag vaccine plus IL-15 DNA, or placebo. Vaccinations will occur at Months 0, 1, 3, 6, and 9. Receives: Biological: HIV-1 gag DNA; Biological: IL-15 DNA adjuvant |
| 7 | Experimental | In Part B, Group 7 will receive 3 vaccinations of the HIV-1 gag vaccine with a high dose of IL-15 adjuvant (maximum tolerated dose from Part A) followed by 2 vaccinations of the gag DNA vaccine with IL-12 DNA adjuvant. Some participants will receive placebo instead of this vaccine regimen. For Group 7, the HIV-1 gag vaccine with IL-15 adjuvant vaccinations will be given at Months 0, 1, and 3, and booster vaccinations will be given at Months 6 and 9. Receives: Biological: HIV-1 gag DNA; Biological: IL-15 DNA adjuvant; Biological: IL-12 DNA adjuvant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local and systemic reactogenicity signs and symptoms, as assessed after each injection
Measured: 12 months postinjection for Part A, and 15 months after the first injection in Part B
Laboratory measures of safety, as assessed after each injection
Measured: 12 months postinjection for Part A, and 15 months after the first injection in Part B
Adverse and serious adverse experiences, as assessed after each injection
Measured: 12 months postinjection for Part A, and 15 months after the first injection in Part B
Secondary outcomes (3)
HIV-specific cellular responses by IFN-gamma ELISpot
Measured: 12 months postinjection for Part A, and 15 months after the first injection in Part B
HIV binding antibody by ELISA
Measured: 12 months postinjection for Part A, and 15 months after the first injection in Part B
Social impact variables
Measured: At the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2005 (estimated)
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Lindsey Baden, MD, Study chair, Harvard UniversityXia Jin, MD, PhD, Study chair, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00115960
- Sponsor's protocol ID
- HVTN 063
- Other IDs
- 10058
- Status last verified
- Oct 2021
- First submitted
- 26 Jun 2005
- Last updated
- 14 Oct 2021
- Results posted
- No
Publications
Boyer JD, Chattergoon M, Muthumani K, Kudchodkar S, Kim J, Bagarazzi M, Pavlakis G, Sekaly R, Weiner DB. Next generation DNA vaccines for HIV-1. J Liposome Res. 2002 Feb-May;12(1-2):137-42. doi: 10.1081/lpr-120004786.
PubMed 12604047Stratov I, DeRose R, Purcell DF, Kent SJ. Vaccines and vaccine strategies against HIV. Curr Drug Targets. 2004 Jan;5(1):71-88. doi: 10.2174/1389450043490686.
PubMed 14738219Xin KQ, Hamajima K, Sasaki S, Tsuji T, Watabe S, Okada E, Okuda K. IL-15 expression plasmid enhances cell-mediated immunity induced by an HIV-1 DNA vaccine. Vaccine. 1999 Feb 26;17(7-8):858-66. doi: 10.1016/s0264-410x(98)00271-0.
PubMed 10067692Jin 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 25820067Kalams SA, Parker S, Jin X, Elizaga M, Metch B, Wang M, Hural J, Lubeck M, Eldridge J, Cardinali M, Blattner WA, Sobieszczyk M, Suriyanon V, Kalichman A, Weiner DB, Baden LR; NIAID HIV Vaccine Trials Network. Safety and immunogenicity of an HIV-1 gag DNA vaccine with or without IL-12 and/or IL-15 plasmid cytokine adjuvant in healthy, HIV-1 uninfected adults. PLoS One. 2012;7(1):e29231. doi: 10.1371/journal.pone.0029231. Epub 2012 Jan 5.
PubMed 22242162
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 I Clinical Trial to Evaluate the Safety and Immunogenicity of HIV-1 Gag DNA Vaccine Alone or With IL-15 DNA, Boosted With HIV-1 Gag DNA + IL-15 DNA or HIV-1 Gag DNA + IL-12 DNA, in Healthy, HIV-1 Uninfected Adult Participants
- ClinicalTrials.gov ID
- NCT00115960
- Acronym / sponsor ID
- HVTN 063
- Conditions
- HIV Infections
- Keywords
- IL-12, IL-15, HIV Seronegativity, HIV Preventive Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Jul 2008 (actual)
- First posted
- 27 Jun 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 determine the safety of and immune response to an experimental HIV vaccine, HIV-1 gag DNA, with and without an IL-15 DNA adjuvant (at escalating doses of 100, 500, and 1500 mcg). This study will also test the safety of and immune response to the HIV-1 gag DNA vaccine plus IL-15 DNA adjuvant given with or without 2 other adjuvant-containing booster vaccines.
Detailed description
The HIV epidemic is a major global health challenge, causing tremendous human suffering and economic loss throughout the world. The need for a safe, effective, and affordable HIV preventive vaccine is critical. This 2-part study will determine the safety and immunogenicity of the experimental HIV vaccine HIV-1 gag DNA with or without IL-15 adjuvant, boosted with either the HIV-1 gag DNA and IL-15 adjuvant vaccine or the HIV-1 gag DNA and IL-12 adjuvant vaccine.
There are two parts to this study. Part A will last 12 months. In Part A, 48 participants will be randomly assigned to 1 of 4 groups in sequential order (dose escalation). All participants will receive 3 vaccinations. Group 1 will receive 3 vaccinations of the HIV-1 gag DNA vaccine or placebo. Group 2 will receive 3 vaccinations of either the HIV-1 gag DNA vaccine with a low dose of IL-15 adjuvant or a placebo. Group 3 will receive 3 vaccinations of either the HIV-1 gag vaccine with a medium dose of IL-15 adjuvant or a placebo. Group 4 will receive 3 vaccinations of either the HIV-1 gag vaccine with a high dose of IL-15 adjuvant or a placebo. Vaccinations will be given at Months 0, 1, and 3. There will be 11 study visits in Part A. A physical exam, pregnancy prevention counseling, medication history, and adverse event reporting will occur at most visits. Urine and blood collection will occur at some visits. Participants will also be asked to complete questionnaires at certain visits.
Part B will last 15 months. In Part B, 72 participants will be randomly assigned to 1 of 2 groups. All Part B participants will receive 5 vaccinations. Group 5 will receive 5 vaccinations of either the HIV-1 gag vaccine plus IL-15 DNA or placebo; the vaccinations will occur at Months 0, 1, 3, 6, and 9. Group 7 will receive 3 vaccinations of the HIV-1 gag vaccine with a high dose of IL-15 adjuvant (maximum tolerated dose from Part A) followed by 2 vaccinations of the gag DNA vaccine with IL-12 DNA adjuvant. Some participants will receive placebo instead of this vaccine regimen. For Group 7, the HIV-1 gag vaccine with IL-15 adjuvant vaccinations will be given at Months 0, 1, and 3, and booster vaccinations will be given at Months 6 and 9. There will be 13 study visits in Part B. A physical exam, pregnancy prevention counseling, medication history, and adverse event reporting will occur at most visits. Urine and blood collection will occur at some visits. Participants will also be asked to complete questionnaires at certain visits.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: HIV-1 gag DNAGroup 1 will receive 3 vaccinations of the HIV-1 gag DNA vaccine, or placebo. Vaccinations will be given at Months 0, 1, and 3. |
| 2 | Experimental | Biological: HIV-1 gag DNA, Biological: IL-15 DNA adjuvantGroup 2 will receive 3 vaccinations of either the HIV-1 gag DNA vaccine with a low dose of IL-15 adjuvant, or a placebo. Vaccinations will be given at Months 0, 1, and 3. |
| 3 | Experimental | Biological: HIV-1 gag DNA, Biological: IL-15 DNA adjuvantGroup 3 will receive 3 vaccinations of either the HIV-1 gag vaccine with a medium dose of IL-15 adjuvant, or a placebo. Vaccinations will be given at Months 0, 1, and 3. |
| 4 | Experimental | Biological: HIV-1 gag DNA, Biological: IL-15 DNA adjuvantGroup 4 will receive 3 vaccinations of either the HIV-1 gag vaccine with a high dose of IL-15 adjuvant, or a placebo. Vaccinations will be given at Months 0, 1, and 3. |
| 5 | Experimental | Biological: HIV-1 gag DNA, Biological: IL-15 DNA adjuvantIn Part B, Group 5 will receive 5 vaccinations of either the HIV-1 gag vaccine plus IL-15 DNA, or placebo. Vaccinations will occur at Months 0, 1, 3, 6, and 9. |
| 7 | Experimental | Biological: HIV-1 gag DNA, Biological: IL-15 DNA adjuvant, Biological: IL-12 DNA adjuvantIn Part B, Group 7 will receive 3 vaccinations of the HIV-1 gag vaccine with a high dose of IL-15 adjuvant (maximum tolerated dose from Part A) followed by 2 vaccinations of the gag DNA vaccine with IL-12 DNA adjuvant. Some participants will receive placebo instead of this vaccine regimen. For Group 7, the HIV-1 gag vaccine with IL-15 adjuvant vaccinations will be given at Months 0, 1, and 3, and booster vaccinations will be given at Months 6 and 9. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- HIV uninfected
- Access to a participating HIV Vaccine Trials Unit (HVTU)
- Willing to receive HIV test results
- Willing and able to comply with all study requirements
- In good general health
Key exclusion criteria (28 listed)
- HIV vaccines in prior HIV vaccine trial
- Immunosuppressive medications within 168 days prior to first vaccination
- Blood products within 120 days prior to first vaccination
- Immunoglobulin within 60 days prior to first vaccination
- Live attenuated vaccines within 30 days prior to first 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 |
|---|---|---|
| HIV-1 gag DNADNA vaccine containing the HIV gene gag | Biological | 1, 2, 3, 4, 5, 7 |
| IL-15 DNA adjuvantCytokine injection | Biological | 2, 3, 4, 5, 7 |
| IL-12 DNA adjuvantCytokine injection | Biological | 7 |
Primary outcome
Local and systemic reactogenicity signs and symptoms, as assessed after each injection
Time frame: 12 months postinjection for Part A, and 15 months after the first injection in Part B
Laboratory measures of safety, as assessed after each injection
Time frame: 12 months postinjection for Part A, and 15 months after the first injection in Part B
Adverse and serious adverse experiences, as assessed after each injection
Time frame: 12 months postinjection for Part A, and 15 months after the first injection in Part B
3 secondary outcomes
HIV-specific cellular responses by IFN-gamma ELISpot
Time frame: 12 months postinjection for Part A, and 15 months after the first injection in Part B
HIV binding antibody by ELISA
Time frame: 12 months postinjection for Part A, and 15 months after the first injection in Part B
Social impact variables
Time frame: At the end of the study
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 12604047Boyer JD, Chattergoon M, Muthumani K, Kudchodkar S, Kim J, Bagarazzi M, Pavlakis G, Sekaly R, Weiner DB. Next generation DNA vaccines for HIV-1. J Liposome Res. 2002 Feb-May;12(1-2):137-42. doi: 10.1081/lpr-120004786.
- Background: PubMed 14738219Stratov I, DeRose R, Purcell DF, Kent SJ. Vaccines and vaccine strategies against HIV. Curr Drug Targets. 2004 Jan;5(1):71-88. doi: 10.2174/1389450043490686.
- Background: PubMed 10067692Xin KQ, Hamajima K, Sasaki S, Tsuji T, Watabe S, Okada E, Okuda K. IL-15 expression plasmid enhances cell-mediated immunity induced by an HIV-1 DNA vaccine. Vaccine. 1999 Feb 26;17(7-8):858-66. doi: 10.1016/s0264-410x(98)00271-0.
- 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 22242162Kalams SA, Parker S, Jin X, Elizaga M, Metch B, Wang M, Hural J, Lubeck M, Eldridge J, Cardinali M, Blattner WA, Sobieszczyk M, Suriyanon V, Kalichman A, Weiner DB, Baden LR; NIAID HIV Vaccine Trials Network. Safety and immunogenicity of an HIV-1 gag DNA vaccine with or without IL-12 and/or IL-15 plasmid cytokine adjuvant in healthy, HIV-1 uninfected adults. PLoS One. 2012;7(1):e29231. doi: 10.1371/journal.pone.0029231. Epub 2012 Jan 5.
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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.
Lindsey Baden, MD study chair
Harvard University
Xia Jin, MD, PhD study chair
University of Rochester
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 HIV-1 gag DNA, IL-15 DNA adjuvant and IL-12 DNA adjuvant 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 8 inclusion and 28 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, Brazil. 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?
Local and systemic reactogenicity signs and symptoms, as assessed after each injection (time frame: 12 months postinjection for Part A, and 15 months after the first injection in Part B). The study lists 3 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 NCT00115960, which also lists 5 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.