Safety Evaluation of GX-12. A New DNA Vaccine for HIV Infection in Rodents

  title={Safety Evaluation of GX-12. A New DNA Vaccine for HIV Infection in Rodents},
  author={Seul Min Choi and Dong Sop Lee and Mi-Kyung Son and Young Sung Sohn and Kyung Koo Kang and Chae -Young Kim and Byung Moon Kim and Won Bae Kim},
  journal={Drug and Chemical Toxicology},
  pages={271 - 284}
Abstract Toxicity studies for the evaluation of the safety of GX-12, a naked DNA vaccine for the treatment of human immunodeficiency virus (HIV) infection, were performed in rodents. In a single dose intramuscular or intravenous toxicity study, animals were treated with up to 4000 µg/kg of GX-12. During the experimental period, no abnormalities in mortality, clinical finding, or body weight change were observed. For subacute toxicity study, GX-12 was administered intramuscularly once a week for… 

Initial preclinical safety of non‐replicating human endogenous retrovirus envelope protein‐coated baculovirus vector‐based vaccines against human papillomavirus

In an acute toxicity study, a single administration of AcHERV‐HPV16L1 DNA vaccine given intramuscularly to mice at a dose of 1 × 108 plaque‐forming units (PFU) did not cause significant changes in body weight compared with vehicle‐treated controls, and repeated administration did not induce myosin‐specific autoantibody in serum, anddid not cause immune complex deposition or tissue damage at injection sites.

Preclinical and Clinical Safety Studies on DNA Vaccines

The potential risks of DNA vaccines are minimal, however, their safety issues may differ case-by-case, and they should be treated accordingly.

Preclinical Safety Evaluation of Viral Vaccines

The preclinical safety evaluation strategy for vaccine approaches to the prophylaxis and treatment of viral diseases and adjuvants is focused on.

Plasmid Biopharmaceuticals.

This review provides a concise coverage of the scientific progress that has been made since the emergence of what are called today plasmid biopharmaceuticals.

Ethical and Safety Issues



The safety and immunogenicity of a human immunodeficiency virus type 1 (HIV-1) recombinant gp160 candidate vaccine in humans. NIAID AIDS Vaccine Clinical Trials Network.

The administration of rgp160 was well tolerated and safe, resulted in a high rate of antibody response by Western blot after the administration of the third and fourth doses, and generated serum neutralizing activity and complement-mediated antibody-dependent enhancement in some subjects after the fourth dose.

Advancing AIDSVAX to phase 3. Safety, immunogenicity, and plans for phase 3.

AIDSVAX (VaxGen, Inc., South San Francisco, CA), a possible vaccine to protect against human immunodeficiency virus type 1 (HIV-1) infection, is being tested for efficacy in phase 3 studies. It has

Plasmid DNA: a new era in vaccinology.

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Protection of Macaca nemestrina from Disease following Pathogenic Simian Immunodeficiency Virus (SIV) Challenge: Utilization of SIV Nucleocapsid Mutant DNA Vaccines with and without an SIV Protein Boost

Immunization of macaques with DNA that codes for replication-defective but structurally complete virions appears to protect from or at least delay the onset of AIDS after infection with a pathogenic immunodeficiency virus.

DNA vaccines: Future strategies and relevance to intracellular pathogens

The T‐cell populations and the type of immunity that should be activated by successful DNA vaccines against intracellular pathogens are described and future approaches for DNA vaccination against diseases in which cell‐mediated immune responses are essential for providing protection are discussed.

Vaccination of Macaques against Pathogenic Simian Immunodeficiency Virus with Venezuelan Equine Encephalitis Virus Replicon Particles

The extent of reduction in challenge virus replication was directly correlated with the strength of the immune response induced by the vectors, which suggests that vaccination was effective.

Do DNA vaccines induce autoimmune disease?

It is suggested that DNA vaccines neither initiate nor accelerate the development of systemic autoimmunity.

Assuring the quality, safety, and efficacy of DNA vaccines

The regulatory process with respect to the development of a DNA vaccine is examined, which presents unusual safety considerations that must be addressed during preclinical safety studies, including adverse immunopathology, genotoxicity through integration into a vaccinees chromosomes, and the formation of anti-DNA antibodies.

Comparative Efficacy of Recombinant Modified Vaccinia Virus Ankara Expressing Simian Immunodeficiency Virus (SIV) Gag-Pol and/or Env in Macaques Challenged with Pathogenic SIV

Results suggest that recombinant MVA has considerable potential as a vaccine vector for human AIDS, and the reduction in levels of viremia in animals that received the MVA-SIV recombinant vaccines is suggested.