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

AIDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01705223
• Other study ID #: X111012202
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2012
• Last updated: May 5, 2015
• Start date: August 2012
• Est. completion date: January 2015

Study information

• Verified date: October 2014
• Source: National Center for AIDS/STD Control and Prevention, China CDC
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• AIDS
• Vaccinia

Intervention

Biological:
• DNA vaccine
4mg/dose, three doses at week 0,4,8
• DNA vaccine prime with the addition of electroporation
4mg/dose, three doses at week 0,4,8
• rTV boost
at week 16
• rTV boost
at week 24
• rTV boost
at week 32

Locations

Country	Name	City	State
China	Beijing Youan Hospital,Capital Medical University	Beijing	Beijing

Sponsors (1)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence, intensity and relationship to vaccination of local and general adverse events		14-day follow-up after DNA vaccine vaccination	Yes
Primary	Occurrence and relationship to vaccination of any serious AEs (SAEs)		During the study period (Month 0-20)	Yes
Primary	Occurrence, intensity and relationship to vaccination of clinically significant abnormal haematology and biochemistry values (grade 4)		During the study period (Month 0-20)	Yes
Primary	test HIV specific T cell response by ELISPOT		2wk, 4wk, 14wk, 24wk after rTV vaccination	No
Primary	test HIV specific antibody by ELISA		2wk, 4wk, 14wk, 24wk, 48wk after rTV vaccination	No
Primary	Occurrence, intensity and relationship to vaccination of local and general adverse events		28-day follow-up after rTV vaccination	Yes
Secondary	test HIV specific T cell response by ICS		4wk, 8wk, 14wk, 48wk after rTV vaccination	No
Secondary	HIV neutralizing antibody test		4wk, 14wk, 48wk after rTV vaccination	No
Secondary	vaccinia virus antibody test		2wk, 4wk, 24wk after rTV vaccination	No