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

National Center for AIDS/STD Control and Prevention, China CDC1 site in 1 country150 target enrollmentAugust 2012

ConditionsAIDS

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: AIDS
Sponsor: National Center for AIDS/STD Control and Prevention, China CDC
Enrollment: 150
Locations: 1
Primary Endpoint: Occurrence, intensity and relationship to vaccination of local and general adverse events
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2012

End Date

January 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

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

Responsible Party

Sponsor

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:

Outcomes

Primary Outcomes

Occurrence, intensity and relationship to vaccination of local and general adverse events

Time Frame: 28-day follow-up after rTV vaccination

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)

Occurrence and relationship to vaccination of any serious AEs (SAEs)

Time Frame: During the study period (Month 0-20)

test HIV specific T cell response by ELISPOT

Time Frame: 2wk, 4wk, 14wk, 24wk after rTV vaccination

test HIV specific antibody by ELISA

Time Frame: 2wk, 4wk, 14wk, 24wk, 48wk after rTV vaccination

Secondary Outcomes

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)