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Volume 9 Supplement 2

AIDS Vaccine 2012

A dose-escalation clinical trial to evaluate the safety and immunogenicity of a replication-defective HIV-1 vaccine-HIVAX


Replication-defective SIV elicited protective immunity in animals. In this first-in-human therapeutic vaccination study, a replication-defective HIV-1 vaccine was tested in HIV-1 infected subjects under antiretroviral therapy.


A010 is an ongoing randomized, placebo-controlled dose-escalation clinical trial to evaluate the safety and the immunogenicity of two doses of a replication defective HIV-1 vaccine (HIVAX™) in subjects receiving stable highly active antiretroviral therapy (HAART) who have an HIV-1 RNA <50 copies/ml and CD4 cell count >500 cells/mm3. Following the randomized placebo-controlled vaccination phase subjects who received active vaccine and who meet eligibility will undergo a 12-week analytical antiretroviral treatment interruption.


HIVAX™ is well tolerated in HIV infected subjects. Only mild injection site reaction occurred with transient duration. No medical treatment is necessary. High level of cell-mediated immune responses measured by ELISPOT assay was noticed after vaccination.


The replication defective HIV vaccine appears no severe adverse effect in HIV-1 infected subjects. High level of cell-mediated immune response was elicited in the vaccinees. HIVAX™ is worth for further evaluation of protective efficacy.

Author information

Correspondence to F Tung.

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This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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About this article


  • Protective Efficacy
  • ELISPOT Assay
  • Injection Site Reaction
  • Infected Subject
  • Therapeutic Vaccination