Safety and Immunogenicity of Recombinant HIV Vaccines for HIV/AIDS
NCT ID: NCT01881581
Last Updated: 2013-06-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1
56 participants
INTERVENTIONAL
2013-06-30
2014-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Immunogenicity Study of AIDS Vaccine (Combined Use of DNA Vaccine and Recombinant Vaccinia Virus Tiantan)
NCT01705223
"Prime-Boost" Vaccine Schedule for Prevention of HIV Infection
NCT00109629
Safety of and Immune Response to Two Different HIV Vaccines, Each Followed by a Adenoviral Vaccine Boost, in HIV Uninfected Adults
NCT00270218
Evaluating the Safety and Immune Response to Three Different DNA HIV Vaccines Administered With a MVA-CMDR Boost Vaccine in Healthy, HIV-Uninfected Adults
NCT02296541
Safety and Effectiveness of an HIV DNA Vaccine Followed by an HIV Adenoviral Vector Vaccine for Prevention of HIV Infection in the Americas and Africa
NCT00498056
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Lower dose DNA or Placebo
2.0 mL lower dose D-GPEi (0.5mg) or Saline solution at weeks 0
Saline Solution
Saline Solution is used as control in all arms.
D-GPEi
D-GPEi is used in Arm A,B,C,G and H.
Medium dose DNA or Placebo
2.0 mL medium dose D-GPEi (2mg) or Saline solution at weeks 0
Saline Solution
Saline Solution is used as control in all arms.
D-GPEi
D-GPEi is used in Arm A,B,C,G and H.
High dose DNA or Placebo
2.0 mL high dose D-GPEi (4mg) or Saline solution at weeks 0
Saline Solution
Saline Solution is used as control in all arms.
D-GPEi
D-GPEi is used in Arm A,B,C,G and H.
Lower dose MVA or Placebo
100μL lower dose M-GPE (3×10\^7pfu) or Saline solution at weeks 0
Saline Solution
Saline Solution is used as control in all arms.
M-GPE
M-GPE is used in Arm D,E,F,G and H
Medium dose MVA or Placebo
100μL medium dose M-GPE (1×10\^8pfu) or Saline solution at weeks 0
Saline Solution
Saline Solution is used as control in all arms.
M-GPE
M-GPE is used in Arm D,E,F,G and H
High dose MVA or Placebo
300μL high dose M-GPE (3×10\^8pfu) or Saline solution at weeks 0
Saline Solution
Saline Solution is used as control in all arms.
M-GPE
M-GPE is used in Arm D,E,F,G and H
Low dose DNA+MVA or Placebo control
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
Saline Solution
Saline Solution is used as control in all arms.
D-GPEi
D-GPEi is used in Arm A,B,C,G and H.
M-GPE
M-GPE is used in Arm D,E,F,G and H
High dose DNA+MVA or Placebo control
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
Saline Solution
Saline Solution is used as control in all arms.
D-GPEi
D-GPEi is used in Arm A,B,C,G and H.
M-GPE
M-GPE is used in Arm D,E,F,G and H
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Saline Solution
Saline Solution is used as control in all arms.
D-GPEi
D-GPEi is used in Arm A,B,C,G and H.
M-GPE
M-GPE is used in Arm D,E,F,G and H
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* 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.
18 Years
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Beijing Ditan Hospital
OTHER
National Institutes for Food and Drug Control, China
OTHER
Centers for Disease Control and Prevention, China
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Yi Zeng
Departement Director
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Xingwang Li, M.D.
Role: PRINCIPAL_INVESTIGATOR
Beijng Ditan Hospital of Capital Medical University
Rongmeng Jiang, M.D.
Role: PRINCIPAL_INVESTIGATOR
Beijng Ditan Hospital of Capital Medical University
Yi Zeng
Role: PRINCIPAL_INVESTIGATOR
National Institute for Viral Disease Control and Prevention, China CDC
Xia Feng, Ph.D
Role: PRINCIPAL_INVESTIGATOR
National Institute for Viral Disease Control and Prevention, China CDC
Ke Xu, Ph.D
Role: PRINCIPAL_INVESTIGATOR
National Institute for Viral Disease Control and Prevention, China CDC
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing Ditan Hospital of Capital Medical University
Beijing, , China
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CDCPChina001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.