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

NCT ID: NCT01705223

Last Updated: 2015-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2015-01-31

Brief Summary

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.

Conditions

AIDS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

group A

DNA vaccine prime at week 0,4,8 and rTV boost at week 16

Group Type: EXPERIMENTAL

DNA vaccine

Intervention Type: BIOLOGICAL

4mg/dose, three doses at week 0,4,8

rTV boost

Intervention Type: BIOLOGICAL

at week 16

group B

DNA vaccine prime at week 0,4,8 and rTV boost at week 24

Group Type: EXPERIMENTAL

DNA vaccine

Intervention Type: BIOLOGICAL

4mg/dose, three doses at week 0,4,8

rTV boost

Intervention Type: BIOLOGICAL

at week 24

group C

DNA vaccine prime at week 0,4,8 and rTV boost at week 32

Group Type: EXPERIMENTAL

DNA vaccine

Intervention Type: BIOLOGICAL

4mg/dose, three doses at week 0,4,8

rTV boost

Intervention Type: BIOLOGICAL

at week 32

group D

DNA vaccine prime with the addition of electroporation at week 0, 4, 8 and rTV boost at week 24

Group Type: EXPERIMENTAL

DNA vaccine prime with the addition of electroporation

Intervention Type: BIOLOGICAL

4mg/dose, three doses at week 0,4,8

rTV boost

Intervention Type: BIOLOGICAL

at week 24

Interventions

DNA vaccine

4mg/dose, three doses at week 0,4,8

Intervention Type: BIOLOGICAL

DNA vaccine prime with the addition of electroporation

4mg/dose, three doses at week 0,4,8

Intervention Type: BIOLOGICAL

rTV boost

at week 16

Intervention Type: BIOLOGICAL

rTV boost

at week 24

Intervention Type: BIOLOGICAL

rTV boost

at week 32

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Center for AIDS/STD Control and Prevention, China CDC

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hao Wu, M.D.

Role: PRINCIPAL_INVESTIGATOR

Beijing YouAn Hospital

Tong Zhang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Beijing YouAn Hospital

Yiming Shao, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

NCAIDS, China CDC

Locations

Beijing Youan Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

X111012202

Identifier Type: -

Identifier Source: org_study_id