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Standardization of Quality Control Protocol for Evaluation of Recombinant HVT-H5 Vaccine

ola youssef mohamed, Ayman Hany Mahmoud, Samir Abdel- Moez Nasif, Ahmed Abdel El-Ghani El-Sanousi.

Abstract
The present study was conducted to standardize a protocol for quality control and evaluation of the recombinant HVT-H5 vaccine. The protocol was designed for evaluation of H5 identity besides regular vaccine safety, purity and potency. The identity of H5 insert was evaluated using real-time PCR while the vaccine potency was evaluated using HVT virus titration, reduction of viral shedding during challenge test. Five vaccine batches were selected randomly and coded as A, B, C, D and E; these were examined and proved to be identical by quantitative real- time PCR in which the H5 gene titer was 7.364, 7.499, 7.767, 8.049, 8.000 logs 10 copies / ml respectively. The result of in- house ELISA was not significant for H5 gene detection and titration using polyclonal monospecific H5 serum. The HVT titer in CEF was 3045, 3200, 3400, 3750 & 4000 PFU/dose for batch A, B, C, D, and E respectively. The selected batches safety was satisfactory by 10 fold field doses injection in SPF chicks. The challenge test results revealed 80% protection for A, B and C batches while D and E batches gave 90% protection. The shedding of challenge virus was significantly low with mean of 2 logs 10 in the vaccinated group compared with control group.

Key words: Recombinant HVT-H5 Vaccine, evaluation, identity, potency, real-time PCR, Safety.


 
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How to Cite this Article
Pubmed Style

ola youssef mohamed, Ayman Hany Mahmoud, Samir Abdel- Moez Nasif, Ahmed Abdel El-Ghani El-Sanousi. Standardization of Quality Control Protocol for Evaluation of Recombinant HVT-H5 Vaccine. JVS. 2017; 1(Vol. 1, Jan. 2017): 27-39.


Web Style

ola youssef mohamed, Ayman Hany Mahmoud, Samir Abdel- Moez Nasif, Ahmed Abdel El-Ghani El-Sanousi. Standardization of Quality Control Protocol for Evaluation of Recombinant HVT-H5 Vaccine. http://www.j-virol-sci.com/?mno=245860 [Access: March 29, 2020].


AMA (American Medical Association) Style

ola youssef mohamed, Ayman Hany Mahmoud, Samir Abdel- Moez Nasif, Ahmed Abdel El-Ghani El-Sanousi. Standardization of Quality Control Protocol for Evaluation of Recombinant HVT-H5 Vaccine. JVS. 2017; 1(Vol. 1, Jan. 2017): 27-39.



Vancouver/ICMJE Style

ola youssef mohamed, Ayman Hany Mahmoud, Samir Abdel- Moez Nasif, Ahmed Abdel El-Ghani El-Sanousi. Standardization of Quality Control Protocol for Evaluation of Recombinant HVT-H5 Vaccine. JVS. (2017), [cited March 29, 2020]; 1(Vol. 1, Jan. 2017): 27-39.



Harvard Style

ola youssef mohamed, Ayman Hany Mahmoud, Samir Abdel- Moez Nasif, Ahmed Abdel El-Ghani El-Sanousi (2017) Standardization of Quality Control Protocol for Evaluation of Recombinant HVT-H5 Vaccine. JVS, 1 (Vol. 1, Jan. 2017), 27-39.



Turabian Style

ola youssef mohamed, Ayman Hany Mahmoud, Samir Abdel- Moez Nasif, Ahmed Abdel El-Ghani El-Sanousi. 2017. Standardization of Quality Control Protocol for Evaluation of Recombinant HVT-H5 Vaccine. Journal of Virological Sciences, 1 (Vol. 1, Jan. 2017), 27-39.



Chicago Style

ola youssef mohamed, Ayman Hany Mahmoud, Samir Abdel- Moez Nasif, Ahmed Abdel El-Ghani El-Sanousi. "Standardization of Quality Control Protocol for Evaluation of Recombinant HVT-H5 Vaccine." Journal of Virological Sciences 1 (2017), 27-39.



MLA (The Modern Language Association) Style

ola youssef mohamed, Ayman Hany Mahmoud, Samir Abdel- Moez Nasif, Ahmed Abdel El-Ghani El-Sanousi. "Standardization of Quality Control Protocol for Evaluation of Recombinant HVT-H5 Vaccine." Journal of Virological Sciences 1.Vol. 1, Jan. 2017 (2017), 27-39. Print.



APA (American Psychological Association) Style

ola youssef mohamed, Ayman Hany Mahmoud, Samir Abdel- Moez Nasif, Ahmed Abdel El-Ghani El-Sanousi (2017) Standardization of Quality Control Protocol for Evaluation of Recombinant HVT-H5 Vaccine. Journal of Virological Sciences, 1 (Vol. 1, Jan. 2017), 27-39.








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