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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01881581
Other study ID # CDCPChina001
Secondary ID
Status Recruiting
Phase Phase 1
First received June 16, 2013
Last updated June 19, 2013
Start date June 2013
Est. completion date August 2014

Study information

Verified date June 2013
Source Centers for Disease Control and Prevention, China
Contact n/a
Is FDA regulated No
Health authority China: Food and Drug Administration
Study type Interventional

Clinical 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 cells count ≥ 350 cells/mm3.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 56
Est. completion date August 2014
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

- 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
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

Locations

Country Name City State
China Beijing Ditan Hospital of Capital Medical University Beijing

Sponsors (3)

Lead Sponsor Collaborator
Centers for Disease Control and Prevention, China Beijing Ditan Hospital, National Institutes for Food and Drug Control

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
8 months Yes
Secondary 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-?(IFN-?) 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 14 months No
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