HIV InfectionsPhase 1NCT00111605
Study of an HIV Preventive Vaccine Given With or Without an Adjuvant in HIV Uninfected Adults
A Phase 1 study testing HIV-1 gag DNA, HIV-1 gag DNA plus IL-12 DNA adjuvant and CTL MEP/RC529-SE/GM-CSF (CTL MEP vaccine) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of an experimental HIV vaccine. The vaccine will be given with or without IL-12 DNA adjuvant (at three escalating doses of 100, 500, and 1,500 mcg respectively), a substance that helps the body respond to a 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?
- HIV-1 gag DNA, HIV-1 gag DNA plus IL-12 DNA adjuvant and CTL MEP/RC529-SE/GM-CSF (CTL MEP vaccine)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Start not givento May 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.
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- Hepatitis B surface antigen negative
- Anti-hepatitis C virus (anti-HCV) antibody negative or negative HCV PCR if anti-HCV antibody is positive
- Weighs of or greater than 110 pounds (50 kg)
Who cannot join
- HIV infection
- HIV vaccines or placebos in prior HIV trial
- Immunosuppressive medications within 168 days prior to first study vaccination
- Blood products within 120 days prior to first study vaccination
- Live attenuated vaccines within 30 days prior to first study vaccination
- Medically indicated subunit or killed vaccines within 14 days prior to first study vaccination
Show all 28Show fewer
- Pneumococcal vaccine 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
- 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
- Allergies to local amide-type anesthetics
- 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 over 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, with episodes requiring medication in the 2 years prior to study entry
- Hypertension that is not well controlled by medication OR blood pressure of 150/100 or higher at study entry
- Body mass index (BMI) of 40 or greater OR BMI of 35 or greater, if certain 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.
- Absence of the spleen
- Plans to become pregnant during the study
- Pregnancy or breastfeeding
- Allergies to yeast-derived products
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Project Brave HIV Vaccine CRS
Baltimore, Maryland, 21201
Alabama Vaccine CRS
Birmingham, Alabama, 35294-2041
Vanderbilt Vaccine CRS
Nashville, Tennessee, 37232
About this study
Official title: A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of an HIV-1 Gag DNA Vaccine With or Without IL-12 DNA Adjuvant, Boosted With Homologous Plasmids in Healthy, HIV-1 Uninfected Adult Participants
The purpose of this study is to evaluate the safety and tolerability of an experimental HIV vaccine. The vaccine will be given with or without IL-12 DNA adjuvant (at three escalating doses of 100, 500, and 1,500 mcg respectively), a substance that helps the body respond to a vaccine. This study will also determine the safety and tolerability of an experimental HIV vaccine boosted with two adjuvants.
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 study will determine the safety and immunogenicity of an experimental HIV vaccine, HIV-1 gag DNA, given with or without an IL-12 adjuvant and boosted HIV-1 gag DNA with or without IL-12 DNA adjuvant.
This study will comprise two parts (Parts A and B). Part A will last 9 months and Part B, 15 months. Part A will consist of 48 participants enrolled in 4 groups. Group 1 participants will be randomly assigned to receive the gag DNA vaccine or placebo. Participants in Groups 2, 3, and 4 will be randomly assigned to receive the gag DNA vaccine and either 100 mcg, 500 mcg, or 1,500 mcg IL-12 DNA or placebo. Vaccinations for Groups 1 through 4 will be given intramuscularly and will occur at study entry and at Months 1 and 3.
Part B will consist of 96 participants, enrolled in 3 groups. Participants in Part B will receive their first vaccination 2 weeks after Part A participants receive their second vaccination. Group 5 participants will receive either the HIV-1 gag DNA vaccine or placebo. Group 6 participants will receive either the HIV-1 gag DNA vaccine plus IL-12 DNA or placebo. Vaccinations for Groups 5 and 6 will occur at study entry and at Months 1, 3, 6, and 9. Group 7 participants will receive either the gag DNA vaccine plus IL-12 DNA or placebo at study entry and at Months 1 and 3. Throughout the study, blood and urine collections will occur, physical exams will be conducted, HIV testing and counseling will be offered, and interviews and questionnaires will be completed.
- Conditions
- HIV Infections
- Being tested
- HIV-1 gag DNA, HIV-1 gag DNA plus IL-12 DNA adjuvant, CTL MEP/RC529-SE/GM-CSF (CTL MEP vaccine), Sodium chloride injection (0.9%)
- Keywords
- AIDS Vaccines, HIV Vaccines, HIV Preventive Vaccine, HIV Seronegativity
- 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
A 0.75 mL intramuscular injection of HIV gag DNA vaccine into the deltoid
HIV-1 gag DNA plus IL-12 DNA adjuvantBiological
Injection IL-12 DNA adjuvant intramuscularly into the deltoid
CTL MEP/RC529-SE/GM-CSF (CTL MEP vaccine)Biological
A 1 mL intramuscular injection in the deltoid
Sodium chloride injection (0.9%)Biological
All placebo groups will receive an intramuscular injection of sodium chloride (0.9%) in the deltoid.
Group 1 will receive a 0.75 mL injection on Days 0, 28, and 84. Group 2 will receive a 0.8 mL injection on Days 0, 28, and 84. Group 3 will receive a 1.0 mL injection on Days 0, 28, and 84. Group 4 will receive a 1.5 mL injection on Days 0, 28, and 84. Group 5 will receive a 0.75 mL injection on Days 0, 28, 84, 168, and 273. Group 6 will receive a 1.5 mL injection on Days 0, 28, 84, 168, and 273. Group 7 will receive a 1.5 mL injection on Days 0, 28, and 84 and a 1 mL injection into the deltoid on Days 168 and 273.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | HIV gag DNA vaccine or placebo on Days 0, 28, and 84 Receives: Biological: HIV-1 gag DNA; Biological: Sodium chloride injection (0.9%) |
| 2 | Experimental | HIV gag DNA vaccine plus 100 mcg of IL-12 or placebo on Days 0, 28, and 84 Receives: Biological: HIV-1 gag DNA; Biological: HIV-1 gag DNA plus IL-12 DNA adjuvant; Biological: Sodium chloride injection (0.9%) |
| 3 | Experimental | HIV gag DNA vaccine plus 500 mcg of IL-12 or placebo on Days 0, 28, and 84 Receives: Biological: HIV-1 gag DNA; Biological: HIV-1 gag DNA plus IL-12 DNA adjuvant; Biological: Sodium chloride injection (0.9%) |
| 4 | Experimental | HIV gag DNA vaccine plus 1,500 mcg of IL-12 or placebo on Days 0, 28, and 84 Receives: Biological: HIV-1 gag DNA; Biological: HIV-1 gag DNA plus IL-12 DNA adjuvant; Biological: Sodium chloride injection (0.9%) |
| 5 | Experimental | HIV gag DNA vaccine or placebo on Days 0, 28, 84, 168, and 273 Receives: Biological: HIV-1 gag DNA; Biological: Sodium chloride injection (0.9%) |
| 6 | Experimental | HIV gag DNA vaccine plus IL-12 or placebo on Days 0, 28, and 84 plus CTL MEP/RC529-SE/GM-SCF booster vaccine on Days 168 and 273 Receives: Biological: HIV-1 gag DNA; Biological: HIV-1 gag DNA plus IL-12 DNA adjuvant; Biological: CTL MEP/RC529-SE/GM-CSF (CTL MEP vaccine); Biological: Sodium chloride injection (0.9%) |
| 7 | Experimental | HIV gag DNA vaccine plus IL-12 DNA adjuvant or placebo on Days 0 and 84 Receives: Biological: HIV-1 gag DNA; Biological: Sodium chloride injection (0.9%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, as judged by local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and adverse and serious experiences
Measured: Throughout the study
Secondary outcomes (1)
Immunogenicity, as judged by HIV-specific cellular responses assessed by interferon-gamma ELISpot assays and by intracellular cytokine staining (ICS)
Measured: Throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2005 (estimated)
- Study completionMay 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Spyros Kalams, MD, Study chair, Vanderbilt UniversityScott Parker, MD, Study chair, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00111605
- Sponsor's protocol ID
- HVTN 060
- Other IDs
- 10057
- Status last verified
- Oct 2021
- First submitted
- 23 May 2005
- Last updated
- 14 Oct 2021
- Results posted
- No
Publications
Bolesta E, Gzyl J, Wierzbicki A, Kmieciak D, Kowalczyk A, Kaneko Y, Srinivasan A, Kozbor D. Clustered epitopes within the Gag-Pol fusion protein DNA vaccine enhance immune responses and protection against challenge with recombinant vaccinia viruses expressing HIV-1 Gag and Pol antigens. Virology. 2005 Feb 20;332(2):467-79. doi: 10.1016/j.virol.2004.09.043.
PubMed 15680412Letvin NL. Progress toward an HIV vaccine. Annu Rev Med. 2005;56:213-23. doi: 10.1146/annurev.med.54.101601.152349.
PubMed 15660510Sha BE, Onorato M, Bartlett JA, Bosch RJ, Aga E, Nokta M, Adams EM, Li XD, Eldridge J, Pollard RB. Safety and immunogenicity of a polyvalent peptide C4-V3 HIV vaccine in conjunction with IL-12. AIDS. 2004 May 21;18(8):1203-6. doi: 10.1097/00002030-200405210-00015.
PubMed 15166537Jin 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 an HIV-1 Gag DNA Vaccine With or Without IL-12 DNA Adjuvant, Boosted With Homologous Plasmids in Healthy, HIV-1 Uninfected Adult Participants
- ClinicalTrials.gov ID
- NCT00111605
- Acronym / sponsor ID
- HVTN 060
- Conditions
- HIV Infections
- Keywords
- AIDS Vaccines, HIV Vaccines, HIV Preventive Vaccine, HIV Seronegativity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- May 2008 (actual)
- First posted
- 24 May 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 the safety and tolerability of an experimental HIV vaccine. The vaccine will be given with or without IL-12 DNA adjuvant (at three escalating doses of 100, 500, and 1,500 mcg respectively), a substance that helps the body respond to a vaccine. This study will also determine the safety and tolerability of an experimental HIV vaccine boosted with two adjuvants.
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 study will determine the safety and immunogenicity of an experimental HIV vaccine, HIV-1 gag DNA, given with or without an IL-12 adjuvant and boosted HIV-1 gag DNA with or without IL-12 DNA adjuvant.
This study will comprise two parts (Parts A and B). Part A will last 9 months and Part B, 15 months. Part A will consist of 48 participants enrolled in 4 groups. Group 1 participants will be randomly assigned to receive the gag DNA vaccine or placebo. Participants in Groups 2, 3, and 4 will be randomly assigned to receive the gag DNA vaccine and either 100 mcg, 500 mcg, or 1,500 mcg IL-12 DNA or placebo. Vaccinations for Groups 1 through 4 will be given intramuscularly and will occur at study entry and at Months 1 and 3.
Part B will consist of 96 participants, enrolled in 3 groups. Participants in Part B will receive their first vaccination 2 weeks after Part A participants receive their second vaccination. Group 5 participants will receive either the HIV-1 gag DNA vaccine or placebo. Group 6 participants will receive either the HIV-1 gag DNA vaccine plus IL-12 DNA or placebo. Vaccinations for Groups 5 and 6 will occur at study entry and at Months 1, 3, 6, and 9. Group 7 participants will receive either the gag DNA vaccine plus IL-12 DNA or placebo at study entry and at Months 1 and 3. Throughout the study, blood and urine collections will occur, physical exams will be conducted, HIV testing and counseling will be offered, and interviews and questionnaires will be completed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: HIV-1 gag DNA, Biological: Sodium chloride injection (0.9%)HIV gag DNA vaccine or placebo on Days 0, 28, and 84 |
| 2 | Experimental | Biological: HIV-1 gag DNA, Biological: HIV-1 gag DNA plus IL-12 DNA adjuvant, Biological: Sodium chloride injection (0.9%)HIV gag DNA vaccine plus 100 mcg of IL-12 or placebo on Days 0, 28, and 84 |
| 3 | Experimental | Biological: HIV-1 gag DNA, Biological: HIV-1 gag DNA plus IL-12 DNA adjuvant, Biological: Sodium chloride injection (0.9%)HIV gag DNA vaccine plus 500 mcg of IL-12 or placebo on Days 0, 28, and 84 |
| 4 | Experimental | Biological: HIV-1 gag DNA, Biological: HIV-1 gag DNA plus IL-12 DNA adjuvant, Biological: Sodium chloride injection (0.9%)HIV gag DNA vaccine plus 1,500 mcg of IL-12 or placebo on Days 0, 28, and 84 |
| 5 | Experimental | Biological: HIV-1 gag DNA, Biological: Sodium chloride injection (0.9%)HIV gag DNA vaccine or placebo on Days 0, 28, 84, 168, and 273 |
| 6 | Experimental | Biological: HIV-1 gag DNA, Biological: HIV-1 gag DNA plus IL-12 DNA adjuvant, Biological: CTL MEP/RC529-SE/GM-CSF (CTL MEP vaccine), Biological: Sodium chloride injection (0.9%)HIV gag DNA vaccine plus IL-12 or placebo on Days 0, 28, and 84 plus CTL MEP/RC529-SE/GM-SCF booster vaccine on Days 168 and 273 |
| 7 | Experimental | Biological: HIV-1 gag DNA, Biological: Sodium chloride injection (0.9%)HIV gag DNA vaccine plus IL-12 DNA adjuvant or placebo on Days 0 and 84 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 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 infection
- HIV vaccines or placebos in prior HIV trial
- Immunosuppressive medications within 168 days prior to first study vaccination
- Blood products within 120 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 |
|---|---|---|
| HIV-1 gag DNAA 0.75 mL intramuscular injection of HIV gag DNA vaccine into the deltoid | Biological | 1, 2, 3, 4, 5, 6, 7 |
| HIV-1 gag DNA plus IL-12 DNA adjuvantInjection IL-12 DNA adjuvant intramuscularly into the deltoid | Biological | 2, 3, 4, 6 |
| CTL MEP/RC529-SE/GM-CSF (CTL MEP vaccine)A 1 mL intramuscular injection in the deltoid | Biological | 6 |
| Sodium chloride injection (0.9%)All placebo groups will receive an intramuscular injection of sodium chloride (0.9%) in the deltoid. Group 1 will receive a 0.75 mL injection on Days 0, 28, and 84. Group 2 will receive a 0.8 mL injection on Days 0, 28, and 84. Group 3 will receive a 1.0 mL injection on Days 0, 28, and 84. Group 4 will receive a 1.5 mL injection on Days 0, 28, and 84. Group 5 will receive a 0.75 mL injection on Days 0, 28, 84, 168, and 273. Group 6 will receive a 1.5 mL injection on Days 0, 28, 84, 168, and 273. Group 7 will receive a 1.5 mL injection on Days 0, 28, and 84 and a 1 mL injection into the deltoid on Days 168 and 273. | Biological | 1, 2, 3, 4, 5, 6, 7 |
Primary outcome
Safety, as judged by local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and adverse and serious experiences
Time frame: Throughout the study
1 secondary outcome
Immunogenicity, as judged by HIV-specific cellular responses assessed by interferon-gamma ELISpot assays and by intracellular cytokine staining (ICS)
Time frame: Throughout 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 15680412Bolesta E, Gzyl J, Wierzbicki A, Kmieciak D, Kowalczyk A, Kaneko Y, Srinivasan A, Kozbor D. Clustered epitopes within the Gag-Pol fusion protein DNA vaccine enhance immune responses and protection against challenge with recombinant vaccinia viruses expressing HIV-1 Gag and Pol antigens. Virology. 2005 Feb 20;332(2):467-79. doi: 10.1016/j.virol.2004.09.043.
- Background: PubMed 15660510Letvin NL. Progress toward an HIV vaccine. Annu Rev Med. 2005;56:213-23. doi: 10.1146/annurev.med.54.101601.152349.
- Background: PubMed 15166537Sha BE, Onorato M, Bartlett JA, Bosch RJ, Aga E, Nokta M, Adams EM, Li XD, Eldridge J, Pollard RB. Safety and immunogenicity of a polyvalent peptide C4-V3 HIV vaccine in conjunction with IL-12. AIDS. 2004 May 21;18(8):1203-6. doi: 10.1097/00002030-200405210-00015.
- 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.
Spyros Kalams, MD study chair
Vanderbilt University
Scott Parker, MD study chair
University of Alabama at Birmingham
4 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, HIV-1 gag DNA plus IL-12 DNA adjuvant and CTL MEP/RC529-SE/GM-CSF (CTL MEP vaccine) in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 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 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 4 sites in United States, Thailand. 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, as judged by local and systemic reactogenicity signs and symptoms, laboratory measures of safety, and adverse and serious experiences (time frame: Throughout the study). 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 NCT00111605, 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.