Status:
UNKNOWN
Safety and Immunogenicity of Recombinant HIV Vaccines for HIV/AIDS
Lead Sponsor:
Centers for Disease Control and Prevention, China
Collaborating Sponsors:
Beijing Ditan Hospital
National Institutes for Food and Drug Control, China
Conditions:
Acquired Immunodeficiency Syndrome
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief 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 sub...
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 ma...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2014
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT01881581
Start Date
June 1 2013
End Date
August 1 2014
Last Update
June 20 2013
Active Locations (1)
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1
Beijing Ditan Hospital of Capital Medical University
Beijing, China