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

Phase IIa Study of AIDS Vaccine (Combined Use of DNA Vaccine and Recombinant Vaccinia Virus Tiantan)

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.

Study Overview

• Status: Completed
• Conditions: AIDS
• Intervention / Treatment: Biological: DNA vaccine; Biological: rTV boost; Biological: rTV boost; Biological: rTV boost; Biological: DNA vaccine prime with the addition of electroporation

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Beijing youan hospital，capital medical university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Biological: rTV boost; at week 24; Biological: rTV boost; at week 32
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 16; Biological: rTV boost; at week 24; Biological: rTV boost; at week 32
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 16; Biological: rTV boost; at week 24; 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: rTV boost; at week 16; Biological: rTV boost; at week 24; Biological: rTV boost; at week 32; Biological: DNA vaccine prime with the addition of electroporation; 4mg/dose, three doses at week 0,4,8

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence, intensity and relationship to vaccination of local and general adverse events	14-day follow-up after DNA vaccine vaccination
Occurrence and relationship to vaccination of any serious AEs (SAEs)	During the study period (Month 0-20)
Occurrence, intensity and relationship to vaccination of clinically significant abnormal haematology and biochemistry values (grade 4)	During the study period (Month 0-20)
test HIV specific T cell response by ELISPOT	2wk, 4wk, 14wk, 24wk after rTV vaccination
test HIV specific antibody by ELISA	2wk, 4wk, 14wk, 24wk, 48wk after rTV vaccination
Occurrence, intensity and relationship to vaccination of local and general adverse events	28-day follow-up after rTV vaccination

Secondary Outcome Measures

Outcome Measure	Time Frame
test HIV specific T cell response by ICS	4wk, 8wk, 14wk, 48wk after rTV vaccination
HIV neutralizing antibody test	4wk, 14wk, 48wk after rTV vaccination
vaccinia virus antibody test	2wk, 4wk, 24wk after rTV vaccination

Collaborators and Investigators

• Sponsor: National Center for AIDS/STD Control and Prevention, China CDC
• Investigators: Principal Investigator: Hao Wu, M.D., Beijing Youan Hospital; Principal Investigator: Tong Zhang, M.D., Beijing Youan Hospital; Principal Investigator: Yiming Shao, Ph.D., NCAIDS, China CDC

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: September 12, 2012
• First Submitted That Met QC Criteria: October 11, 2012
• First Posted (Estimate): October 12, 2012

Study Record Updates

• Last Update Posted (Estimate): May 6, 2015
• Last Update Submitted That Met QC Criteria: May 5, 2015
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: vaccine; prophylactic
• Additional Relevant MeSH Terms: Virus Diseases; Infections; DNA Virus Infections; Poxviridae Infections; Vaccinia; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: X111012202