Safety and Immunogenicity Study of AIDS Vaccine (Combined Use of DNA Vaccine and Recombinant Vaccinia Virus Tiantan)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Vaccine and Serum Institute
Information provided by (Responsible Party):
National Center for AIDS/STD Control and Prevention, China CDC
ClinicalTrials.gov Identifier:
NCT01705223
First received: September 12, 2012
Last updated: July 14, 2013
Last verified: July 2013
  Purpose

This trial studies the safety and immunogenicity of a HIV clade B'/C DNA vaccine followed by recombinant vaccinia virus rTV boost in HIV-uninfected healthy volunteers at low or high risk of HIV infection. In addition, the effect of different intervals of the prime-boost will be studied.


Condition Intervention Phase
AIDS
Biological: DNA vaccine
Biological: DNA vaccine prime with the addition of electroporation
Biological: rTV boost at week 16
Biological: rTV boost at week 24
Biological: rTV boost at week 32
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase IIa Study of AIDS Vaccine (Combined Use of DNA Vaccine and Recombinant Vaccinia Virus Tiantan)

Resource links provided by NLM:


Further study details as provided by National Center for AIDS/STD Control and Prevention, China CDC:

Primary Outcome Measures:
  • Occurrence, intensity and relationship to vaccination of local and general adverse events [ Time Frame: 14-day follow-up after DNA vaccine vaccination ] [ Designated as safety issue: Yes ]
  • Occurrence and relationship to vaccination of any serious AEs (SAEs) [ Time Frame: During the study period (Month 0-20) ] [ Designated as safety issue: Yes ]
  • Occurrence, intensity and relationship to vaccination of clinically significant abnormal haematology and biochemistry values (grade 4) [ Time Frame: During the study period (Month 0-20) ] [ Designated as safety issue: Yes ]
  • test HIV specific T cell response by ELISPOT [ Time Frame: 2wk, 4wk, 14wk, 48wk after rTV vaccination ] [ Designated as safety issue: No ]
  • test HIV specific antibody by ELISA [ Time Frame: 2wk, 4wk, 14wk, 24wk, 48wk after rTV vaccination ] [ Designated as safety issue: No ]
  • Occurrence, intensity and relationship to vaccination of local and general adverse events [ Time Frame: 28-day follow-up after rTV vaccination ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • test HIV specific T cell response by ICS [ Time Frame: 4wk, 8wk, 14wk, 48wk after rTV vaccination ] [ Designated as safety issue: No ]
  • HIV neutralizing antibody test [ Time Frame: 4wk, 14wk, 48wk after rTV vaccination ] [ Designated as safety issue: No ]
  • vaccinia virus antibody test [ Time Frame: 2wk, 4wk, 14wk, 48wk after rTV vaccination ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: August 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: group A
DNA vaccine prime at week 0,4,8 and rTV boost at week 16
Biological: DNA vaccine
4mg/dose, three doses at week 0,4,8
Biological: rTV boost at week 16
Experimental: group B
DNA vaccine prime at week 0,4,8 and rTV boost at week 24
Biological: DNA vaccine
4mg/dose, three doses at week 0,4,8
Biological: rTV boost at week 24
Experimental: group C
DNA vaccine prime at week 0,4,8 and rTV boost at week 32
Biological: DNA vaccine
4mg/dose, three doses at week 0,4,8
Biological: rTV boost at week 32
Experimental: group D
DNA vaccine prime with the addition of electroporation at week 0, 4, 8 and rTV boost at week 24
Biological: DNA vaccine prime with the addition of electroporation
4mg/dose, three doses at week 0,4,8
Biological: rTV boost at week 24

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Willing to be followed for the planned duration of the study, and receive intravenous blood collection and sample storage in the 16~20 months after first vaccination;
  • Understand and agree with the content of informed consent;
  • Volunteers at low risk of HIV infection, or high-risk men who have sex with men (MSM), who had have oral sex or anal sex with another man in the past 6 months ;
  • Willing to be tested for HIV and syphilis;
  • Before 2 weeks of the first vaccination and after 12 months of the last vaccination, willing to use an effective method of contraception with sexual partner. Female subjects are willing to undergo urine pregnancy test before each vaccination and at the follow-up visit.

Exclusion Criteria:

  • Have close contact with people who are pregnant or lactating in the one month after vaccination of rTV vaccine;
  • Have listed diseases or medical history:

    • Have innate or acquired immune deficiency disease or have close contact with patients suffering from the above-mentioned diseases within 1 month of rTV vaccination;
    • Need treatment affecting immunization, e.g. use corticosteroids for more than 2 weeks or use immunosuppressives, e.g. alkylating, anti-metabolite or radiotherapy, etc.; or have close contact with patients suffering from the above-mentioned diseases within 1 month of rTV vaccination;
    • Suffering from immunosuppressive diseases such as cancer, organ or stem cell transplants, non-agammaglobulinemia, etc.; or have close contact with patients suffering from the above-mentioned diseases within 1 month of rTV vaccination;
    • Past or current suffering from eczema or atopic dermatitis; currently suffering from diseases that cause skin damage such as: burns, scald, chicken pox, impetigo, shingles, psoriasis, etc.; or have close contact with patients suffering from the above-mentioned diseases within 1 month of rTV vaccination;
    • Past or current high blood pressure, heart disease, diabetes, thyroid disease, asthma, angioedema, asplenia syndrome, mental illness, epilepsy, severe anemia, leukopenia and thrombocytopenia, etc.;
    • History of syncope after vaccination or allergies;
    • Currently suffering from acute infectious diseases and febrile diseases;
  • The following circumstances are:

    • Live attenuated vaccine received within 2 months or other vaccine within 2 weeks prior to enrollment;
    • Immunoglobin or blood products received within 4 months prior to enrollment;
    • Participation in another trial of a medicinal product, completed less than 30 days prior to enrollment;
    • Drug abuse, alcoholism, heavy smokers;
  • The following laboratory test abnormalities, except for the results that are assessed by researchers as being no clinical significance:

    • HIV diagnostic assay positive or suspicious, HIV RNA diagnostic assay positive;
    • Anti-DNA antibody or anti-nuclear antibody positive;
    • Other laboratory test abnormalities;
  • Not complying with study protocol or not obtaining informed consent because of medical, spiritual, social, occupational, and/or other reasons.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01705223

Locations
China, Beijing
Beijing Youan Hospital,Capital Medical University
Beijing, Beijing, China
Sponsors and Collaborators
National Center for AIDS/STD Control and Prevention, China CDC
National Vaccine and Serum Institute
Investigators
Principal Investigator: Hao Wu, M.D. Beijing You'an Hospital, Capital Medical University
Principal Investigator: Tong Zhang, M.D. Beijing You'an Hospital, Capital Medical University
Principal Investigator: Yiming Shao, Ph.D. NCAIDS, China CDC
  More Information

No publications provided

Responsible Party: National Center for AIDS/STD Control and Prevention, China CDC
ClinicalTrials.gov Identifier: NCT01705223     History of Changes
Other Study ID Numbers: X111012202
Study First Received: September 12, 2012
Last Updated: July 14, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by National Center for AIDS/STD Control and Prevention, China CDC:
prophylactic
vaccine

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Vaccinia
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Poxviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on July 20, 2014