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International immunopharmacology2007; 7(13); 1834-1840; doi: 10.1016/j.intimp.2007.09.011

Evaluation of the safety, immunogenicity and pharmacokinetics of equine anti-SARS-CoV F(ab’)(2) in macaque.

Abstract: To warrant potential clinical testing, the equine anti-SARS-CoV F(ab')(2) requires evaluation in as many animal models as possible and a safety test in a primate model. In this study, we evaluated the pharmacokinetics, tolerance and immunity of this kind of antibody in macaques and rats. Results showed that the F(ab')(2) fragments had a normal metabolism in injected animals. The general physiological indexes did not differ between animals injected with anti-SARS-CoV F(ab')(2) or saline. However, a mild inflammatory response in local injection site and a moderate immune response against this antibody in the successively injected animals were observed, which however recovered 3 weeks after the last injection. The antibody titring from 1:100 to 400 against the equine anti-SARS-CoV F(ab')(2) in the inoculated hosts could be detected at week 2 during the successive injections of the equine F(ab')(2). The considerable safety of this antibody used in primates and the fact that the immune system of the host can be motivated by post-injection of the F(ab')(2) indicate that this type of anti-SARS-CoV antibody can be used for prevention and treatment of SASR, especially at the early stage of this virus infection. In addition, it can also provide the precious time for the combined use of other anti-SARS-CoV agents such as antiviral drug and vaccine.
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Publication Date: 2007-10-04 PubMed ID: 17996696PubMed Central: PMC7106090DOI: 10.1016/j.intimp.2007.09.011Google Scholar: Lookup
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  • Journal Article
  • Research Support
  • Non-U.S. Gov't

Summary

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The research examines the safety, immune response, and how the body processes equine anti-SARS-CoV F(ab’)(2) – an antibody – in macaques and rats, with a focus on the potential for its use in preventing and treating Severe Acute Respiratory Syndrome (SARS), especially in the early stages of infection.

Research Aim and Method

  • This research aimed to evaluate the safety, tolerance, how the body processes the function (pharmacokinetics), and immune response to the equine anti-SARS-CoV F(ab’)(2) antibodies in two animal models, macaques and rats. This was considered important in validating its further testing in clinical trials.
  • The antibody was injected into the animal subjects and physiological changes were monitored over a period of time, comparing to those injected with a saline solution.

Main Findings

  • The results indicated that the F(ab’)(2) fragments had a regular metabolism, meaning that the body processed the antibody normally in the animals that received it. The general physiological parameters between the group of animals injected with anti-SARS-CoV F(ab’)(2) and those injected with saline did not exhibit significant differences.
  • However, a mild inflammation at the injection site and a moderate immune response against the antibody in animals that were successively injected were observed, but these symptoms were shown to recover three weeks after the last injection.
  • The antibody titration from 1:100 to 400 against equine anti-SARS-CoV F(ab’)(2) was observed in the hosts at the second week of consecutive equine F(ab’)(2) injections.

Implications

  • These findings suggested that the equine anti-SARS-CoV F(ab’)(2) antibody could potentially be used for prevention and treatment of SARS, especially at the early stages of viral infection. This is due to the relatively good safety profile demonstrated by the antibody in the primate study.
  • Beyond its direct application, the antibody could also potentially offer valuable time for the combined use of other anti-SARS-CoV interventions, like antiviral drugs and vaccines, thereby enhancing the overall effectiveness of the SARS treatment strategy.

Cite This Article

APA
Xu Y, Jia Z, Zhou L, Wang L, Li J, Liang Y, Zhao T, Ni B, Wu Y. (2007). Evaluation of the safety, immunogenicity and pharmacokinetics of equine anti-SARS-CoV F(ab’)(2) in macaque. Int Immunopharmacol, 7(13), 1834-1840. https://doi.org/10.1016/j.intimp.2007.09.011

Publication

International immunopharmacology
ISSN: 1567-5769
NlmUniqueID: 100965259
Country: Netherlands
Language: English
Volume: 7
Issue: 13
Pages: 1834-1840

Researcher Affiliations

Xu, Yunsheng
  • Department of Dermatology, the First Affiliated Hospital of Wenzhou Medical College, Wenzhou 325000, People's Republic of China.
Jia, Zhengcai
    Zhou, Liyun
      Wang, Li
        Li, Jintao
          Liang, Yunfei
            Zhao, Tingting
              Ni, Bing
                Wu, Yuzhang

                  MeSH Terms

                  • Animals
                  • Antibodies, Viral / immunology
                  • Antibodies, Viral / metabolism
                  • Antibodies, Viral / therapeutic use
                  • Antibodies, Viral / toxicity
                  • Horses
                  • Immunoglobulin Fab Fragments / immunology
                  • Immunoglobulin Fab Fragments / metabolism
                  • Immunoglobulin Fab Fragments / therapeutic use
                  • Immunoglobulin Fab Fragments / toxicity
                  • Macaca
                  • Rats
                  • Severe acute respiratory syndrome-related coronavirus / immunology
                  • Severe Acute Respiratory Syndrome / prevention & control
                  • Severe Acute Respiratory Syndrome / therapy

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