Acquired Immunodeficiency SyndromePhase 1NCT01881581
Safety and Immunogenicity of Recombinant HIV Vaccines for HIV/AIDS
A Phase 1 study testing Saline Solution, D-GPEi and M-GPE in people with Acquired Immunodeficiency Syndrome, run by Centers for Disease Control and Prevention, China at 1 site in China.
Trial summary
This is a randomized, double-blind placebo-controlled dose-escalation clinical trial to evaluate the safety and the immunogenicity of DNA and modified vaccinia virus Ankara (MVA) HIV-1 vaccines in subjects receiving stable highly active antiretroviral therapy (HAART) who have an HIV-1 RNA < 50 copies/mm3 and CD4+ T… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Acquired Immunodeficiency Syndrome
- What is being tested?
- Saline Solution, D-GPEi and M-GPE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- Jun 2013to Aug 2014
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Are willing to participate this study and available for follow-up for the duration of the study.
- Men and women aged 18-50 years.
- Are HIV-positive.
- Have been taking stable anti-HIV drugs for at least 6 months.
- CD4 count ≥ 350 cells/mm3
- Plasma viral load < 50 copies/ml.
- Willing to use acceptable forms of contraception at least 21 days prior to first vaccination until 56 days after the last vaccination.
Who cannot join
- Pregnancy or breast-feeding.
- History of previous vaccination with an HIV-1 vaccine.
- Use of immunoinhibitory agents, such as corticosteroids or cytotoxic drugs by oral administration, injection route or inhalation route within 6 months of study entry (But corticosteroids used for allergic rhinitis and skin topical application of corticosteroids were not included); Use of immunomodulatory agents including but not limited to interleukin-2(IL-2） and granulocyte-macrophage colony-stimulating factor (GM-CSF) within 30 days of study entry.
- Use of blood products within 3 months of study entry.
- Use of other experimental drugs within 3 months of study entry.
- Any immunization within 3 months of study entry.
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- Comply with any of the following items： Active pulmonary tuberculosis； History of serious adverse reaction to other vaccines； Serious asthma； Have untreated thyroid disease; Syphilis
- Laboratory values（Comply with any of the following items）:
- Hemoglobin < 100 g/L (male subjects)，<90 g/L (female subjects)； Absolute neutrophil count ≤ 1000 cells/mm3； Serum creatinine ≥15 mg/L，endogenous creatinine clearance rate <50 ml/min； alanine aminotransferase（ALT）, aspartate aminotransferase(AST) ≥3× upper limit of normal range； Total bilirubin ≥2× upper limit of normal range
- Clinically significant electrocardiogram changes.
- Hypertension ( If it is well controlled by medication and is less than 150/100mmHg , should not be excluded) and other cardiac disease；
- Any medical, psychiatric, social condition, occupational reason judged by the investigator that would limit the evaluation of a subject.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Ditan Hospital of Capital Medical University
Beijing
Xingwang Li, 15611973658, ditanlxw@yahoo.com.cn
Xingwang Li
About this study
Official title: A Phase I Double-Blind Study to Evaluate the Safety and Immunogenicity of HIV Prime/Boost Vaccine Using DNA and MVA for HIV-1/AIDS
This is a randomized, double-blind placebo-controlled dose-escalation clinical trial to evaluate the safety and the immunogenicity of DNA and modified vaccinia virus Ankara (MVA) HIV-1 vaccines in subjects receiving stable highly active antiretroviral therapy (HAART) who have an HIV-1 RNA < 50 copies/mm3 and CD4+ T cells count ≥ 350 cells/mm3.
Read the detailed description
HIV-infected patients treated with antiretroviral therapy for prolonged periods of time may show decreased levels of HIV-specific immune responses. In these patients, a prime-boost vaccine strategy may induce both humoral and cell-mediated immunity. The hypothesis of this study is that the vaccine strategy selected will be both safe and immunogenic in the patient population being tested.
Patients continue antiretroviral medications throughout the course of this study. Three groups of patients receive dose-escalation (0.5mg, 2mg or 4mg) intramuscular injections of DNA vaccine (D-GPEi) respectively, the other three groups of patients receive dose-escalation (3×10^7pfu, 1×10^8pfu or 3×10^8pfu) intradermal injections of MVA vaccine (M-GPE), two weeks post immunization of lower dose, if the vaccine is safe and well tolerant, the next dose of immunization will begin. After the maximum tolerated dose of DNA and MVA is identified, DNA prime/ MVA boosting will be tested in another two groups of patients. Lower or the maximum tolerated dose of D-GPEi was used at week 0 and 1, lower or the maximum tolerated dose of M-GPE was used at week 2 and 3, patients are monitored for safety 72 hours after each immunization. In addition, each patient records adverse events in a diary. Patients have regular physical exams, pregnancy tests, and blood drawn for virologic and immunologic assessments. The induction of HIV-specific responses will be measured.
- Conditions
- Acquired Immunodeficiency Syndrome
- Being tested
- Saline Solution, D-GPEi, M-GPE
- Keywords
- Therapeutic, Vaccine, HIV, MVA, DNA
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline SolutionBiological
Saline Solution is used as control in all arms.
D-GPEiBiological
D-GPEi is used in Arm A,B,C,G and H.
M-GPEBiological
M-GPE is used in Arm D,E,F,G and H
| Study group | Role | What they receive |
|---|---|---|
| Lower dose DNA or Placebo | Experimental | 2.0 mL lower dose D-GPEi (0.5mg) or Saline solution at weeks 0 Receives: Biological: Saline Solution; Biological: D-GPEi |
| Medium dose DNA or Placebo | Experimental | 2.0 mL medium dose D-GPEi (2mg) or Saline solution at weeks 0 Receives: Biological: Saline Solution; Biological: D-GPEi |
| High dose DNA or Placebo | Experimental | 2.0 mL high dose D-GPEi (4mg) or Saline solution at weeks 0 Receives: Biological: Saline Solution; Biological: D-GPEi |
| Lower dose MVA or Placebo | Experimental | 100μL lower dose M-GPE (3×10^7pfu) or Saline solution at weeks 0 Receives: Biological: Saline Solution; Biological: M-GPE |
| Medium dose MVA or Placebo | Experimental | 100μL medium dose M-GPE (1×10^8pfu) or Saline solution at weeks 0 Receives: Biological: Saline Solution; Biological: M-GPE |
| High dose MVA or Placebo | Experimental | 300μL high dose M-GPE (3×10^8pfu) or Saline solution at weeks 0 Receives: Biological: Saline Solution; Biological: M-GPE |
| Low dose DNA+MVA or Placebo control | Experimental | The dose below the maximum tolerated dose of D-GPEi or 2.0 mL Saline solution at week 0,1; The dose below the maximum tolerated dose of M-GPE or 100/300μL Saline solution at week 2,3 Receives: Biological: Saline Solution; Biological: D-GPEi; Biological: M-GPE |
| High dose DNA+MVA or Placebo control | Experimental | The maximum tolerated dose of D-GPEi or 2.0 mL Saline solution at week 0,1;The maximum tolerated dose of M-GPE or 100/300μL Saline solution at week 2,3 Receives: Biological: Saline Solution; Biological: D-GPEi; Biological: M-GPE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence, intensity and relationship to vaccination of local and systemic adverse events
To evaluate the safety and tolerance of a DNA and a replication-defective MVA vaccine expressing HIV-1 gag-pol and env in HIV-1 infected subjects on highly active antiretroviral therapy.
Frequency and severity of adverse events, laboratory abnormalities, and local and systemic reactogenicity signs and symptoms following vaccinations
Measured: 8 months
Secondary outcomes (1)
Immunogenicity of vaccine
Changes in CD4+ and CD8+ T-cell counts pre- and post-immunization and between the vaccine and placebo groups Changes in viral load pre- and post-immunization and between the vaccine and placebo groups Magnitude and breadth of HIV-1 specific CD8+ T cell responses as determined by interferon-γ(IFN-γ) enzyme-linked immunospot (ELISPOT) using overlapping HIV peptides for gag, pol and env Changes in HIV-1 Gp160-specific antibody responses pre- and post-immunization and between the vaccine and placebo groups
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionMar 2014 (estimated)
- Study completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Immunodeficiency SyndromeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention, China
- Sponsor type
- Other government
- Collaborators
- Beijing Ditan Hospital, National Institutes for Food and Drug Control, China
- Responsible party
- Principal investigator, Yi Zeng, Centers for Disease Control and Prevention, China
- Investigators
- Xingwang Li, M.D., Principal investigator, Beijng Ditan Hospital of Capital Medical UniversityRongmeng Jiang, M.D., Principal investigator, Beijng Ditan Hospital of Capital Medical UniversityYi Zeng, Principal investigator, National Institute for Viral Disease Control and Prevention, China CDCXia Feng, Ph.D, Principal investigator, National Institute for Viral Disease Control and Prevention, China CDCKe Xu, Ph.D, Principal investigator, National Institute for Viral Disease Control and Prevention, China CDC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881581
- Sponsor's protocol ID
- CDCPChina001
- Status last verified
- Jun 2013
- First submitted
- 16 Jun 2013
- Last updated
- 20 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Double-Blind Study to Evaluate the Safety and Immunogenicity of HIV Prime/Boost Vaccine Using DNA and MVA for HIV-1/AIDS
- ClinicalTrials.gov ID
- NCT01881581
- Acronym / sponsor ID
- CDCPChina001
- Conditions
- Acquired Immunodeficiency Syndrome
- Keywords
- Therapeutic, Vaccine, HIV, MVA, DNA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Centers for Disease Control and Prevention, ChinaOther government
- Collaborators
- Beijing Ditan Hospital, National Institutes for Food and Drug Control, China
- Study start
- Jun 2013
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Aug 2014 (estimated)
- First posted
- 19 Jun 2013 (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.
This is a randomized, double-blind placebo-controlled dose-escalation clinical trial to evaluate the safety and the immunogenicity of DNA and modified vaccinia virus Ankara (MVA) HIV-1 vaccines in subjects receiving stable highly active antiretroviral therapy (HAART) who have an HIV-1 RNA < 50 copies/mm3 and CD4+ T cells count ≥ 350 cells/mm3.
Detailed description
HIV-infected patients treated with antiretroviral therapy for prolonged periods of time may show decreased levels of HIV-specific immune responses. In these patients, a prime-boost vaccine strategy may induce both humoral and cell-mediated immunity. The hypothesis of this study is that the vaccine strategy selected will be both safe and immunogenic in the patient population being tested.
Patients continue antiretroviral medications throughout the course of this study. Three groups of patients receive dose-escalation (0.5mg, 2mg or 4mg) intramuscular injections of DNA vaccine (D-GPEi) respectively, the other three groups of patients receive dose-escalation (3×10^7pfu, 1×10^8pfu or 3×10^8pfu) intradermal injections of MVA vaccine (M-GPE), two weeks post immunization of lower dose, if the vaccine is safe and well tolerant, the next dose of immunization will begin. After the maximum tolerated dose of DNA and MVA is identified, DNA prime/ MVA boosting will be tested in another two groups of patients. Lower or the maximum tolerated dose of D-GPEi was used at week 0 and 1, lower or the maximum tolerated dose of M-GPE was used at week 2 and 3, patients are monitored for safety 72 hours after each immunization. In addition, each patient records adverse events in a diary. Patients have regular physical exams, pregnancy tests, and blood drawn for virologic and immunologic assessments. The induction of HIV-specific responses will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Lower dose DNA or Placebo | Experimental | Biological: Saline Solution, Biological: D-GPEi2.0 mL lower dose D-GPEi (0.5mg) or Saline solution at weeks 0 |
| Medium dose DNA or Placebo | Experimental | Biological: Saline Solution, Biological: D-GPEi2.0 mL medium dose D-GPEi (2mg) or Saline solution at weeks 0 |
| High dose DNA or Placebo | Experimental | Biological: Saline Solution, Biological: D-GPEi2.0 mL high dose D-GPEi (4mg) or Saline solution at weeks 0 |
| Lower dose MVA or Placebo | Experimental | Biological: Saline Solution, Biological: M-GPE100μL lower dose M-GPE (3×10^7pfu) or Saline solution at weeks 0 |
| Medium dose MVA or Placebo | Experimental | Biological: Saline Solution, Biological: M-GPE100μL medium dose M-GPE (1×10^8pfu) or Saline solution at weeks 0 |
| High dose MVA or Placebo | Experimental | Biological: Saline Solution, Biological: M-GPE300μL high dose M-GPE (3×10^8pfu) or Saline solution at weeks 0 |
| Low dose DNA+MVA or Placebo control | Experimental | Biological: Saline Solution, Biological: D-GPEi, Biological: M-GPEThe dose below the maximum tolerated dose of D-GPEi or 2.0 mL Saline solution at week 0,1; The dose below the maximum tolerated dose of M-GPE or 100/300μL Saline solution at week 2,3 |
| High dose DNA+MVA or Placebo control | Experimental | Biological: Saline Solution, Biological: D-GPEi, Biological: M-GPEThe maximum tolerated dose of D-GPEi or 2.0 mL Saline solution at week 0,1;The maximum tolerated dose of M-GPE or 100/300μL Saline solution at week 2,3 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Are willing to participate this study and available for follow-up for the duration of the study.
- Men and women aged 18-50 years.
- Are HIV-positive.
- Have been taking stable anti-HIV drugs for at least 6 months.
- CD4 count ≥ 350 cells/mm3
Key exclusion criteria (12 listed)
- Pregnancy or breast-feeding.
- History of previous vaccination with an HIV-1 vaccine.
- Use of immunoinhibitory agents, such as corticosteroids or cytotoxic drugs by oral administration, injection route or inhalation route within 6 months of study entry (But corticosteroids used for allergic rhinitis and skin topical application of corticosteroids were not included); Use of immunomodulatory agents including but not limited to interleukin-2(IL-2） and granulocyte-macrophage colony-stimulating factor (GM-CSF) within 30 days of study entry.
- Use of blood products within 3 months of study entry.
- Use of other experimental drugs within 3 months of study entry.
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 |
|---|---|---|
| Saline SolutionSaline Solution is used as control in all arms. | Biological | High dose DNA or Placebo, High dose DNA+MVA or Placebo control, High dose MVA or Placebo, Low dose DNA+MVA or Placebo control, Lower dose DNA or Placebo, Lower dose MVA or Placebo, Medium dose DNA or Placebo, Medium dose MVA or Placebo |
| D-GPEiD-GPEi is used in Arm A,B,C,G and H. | Biological | High dose DNA or Placebo, High dose DNA+MVA or Placebo control, Low dose DNA+MVA or Placebo control, Lower dose DNA or Placebo, Medium dose DNA or Placebo |
| M-GPEM-GPE is used in Arm D,E,F,G and H | Biological | High dose DNA+MVA or Placebo control, High dose MVA or Placebo, Low dose DNA+MVA or Placebo control, Lower dose MVA or Placebo, Medium dose MVA or Placebo |
Primary outcome
Occurrence, intensity and relationship to vaccination of local and systemic adverse events
Time frame: 8 months
To evaluate the safety and tolerance of a DNA and a replication-defective MVA vaccine expressing HIV-1 gag-pol and env in HIV-1 infected subjects on highly active antiretroviral therapy. Frequency and severity of adverse events, laboratory abnormalities, and local and systemic reactogenicity signs and symptoms following vaccinations
1 secondary outcome
Immunogenicity of vaccine
Time frame: 14 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2013.
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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.
Xingwang Li, M.D. principal investigator
Beijng Ditan Hospital of Capital Medical University
Rongmeng Jiang, M.D. principal investigator
Beijng Ditan Hospital of Capital Medical University
Yi Zeng principal investigator
National Institute for Viral Disease Control and Prevention, China CDC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Saline Solution, D-GPEi and M-GPE in people with Acquired Immunodeficiency Syndrome, run by Centers for Disease Control and Prevention, China at 1 site in China.
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 12 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: status not confirmed, as of the sponsor's last update on 20 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence, intensity and relationship to vaccination of local and systemic adverse events (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jun 2013.