Osong Public Health and Research Perspectives

Original Article

Development of a New Approach to Determine the Potency of Bacille Calmette–Guérin Vaccines Using Flow Cytometry: Eunjeong Gweon, Chanwoong Choi, Jaeok Kim, Byungkuk Kim, Hyunkyung Kang, Taejun Park, Sangja Ban, Minseok Bae, Sangjin Park, Jayoung Jeong; Osong Public Health Res Perspect. 2017;8(6):389-396. Published online December 31, 2017; DOI: https://doi.org/10.24171/j.phrp.2017.8.6.06

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Objectives

To circumvent the limitations of the current golden standard method, colony-forming unit (CFU) assay, for viability of Bacille Calmette–Guérin (BCG) vaccines, we developed a new method to rapidly and accurately determine the potency of BCG vaccines.

Methods

Based on flow cytometry (FACS) and fluorescein diacetate (FDA) as the most appropriate fluorescent staining reagent, 17 lots of BCG vaccines for percutaneous administration and 5 lots of BCG vaccines for intradermal administration were analyzed in this study. The percentage of viable cells measured by flow cytometry along with the total number of organisms in BCG vaccines, as determined on a cell counter, was used to quantify the number of viable cells.

Results

Pearson correlation coefficients of FACS and CFU assays for percutaneous and intradermal BCG vaccines were 0.6962 and 0.7428, respectively, indicating a high correlation. The coefficient of variation value of the FACS assay was less than 7%, which was 11 times lower than that of the CFU assay.

Conclusion

This study contributes to the evaluation of new potency test method for FACS-based determination of viable cells in BCG vaccines. Accordingly, quality control of BCG vaccines can be significantly improved.

Citations

Citations to this article as recorded by

Quality analysis of BCG vaccine for bladder cancer immunotherapy using Shewhart control charts
A. A. Savina, A. A. Voropaev, A. A. Alesina
Biological Products. Prevention, Diagnosis, Treatm.2024; 24(1): 76. CrossRef
Evaluation of the viability of the Bulgarian BCG vaccine by the adenosine triphosphate assay
Elitsa Pavlova, Alexander Mihaylov, Tzvetelina Stefanova
Biotechnology & Biotechnological Equipment.2024;[Epub] CrossRef
Development of a fast and precise potency test for BCG vaccine viability using flow cytometry compared to MTT and colony-forming unit assays
Hend M. Moghawry, Mohamed E. Rashed, Kareeman Gomaa, Sameh AbdelGhani, Tarek Dishisha
Scientific Reports.2023;[Epub] CrossRef
Prospects for using flow cytometry in the quality control of live plague vaccines
N. V. Abzaeva, I. V. Kuznetsova, S. E. Gostischeva, A. M. Zhirov, D. A. Kovalev, A. V. Kostrominov, A. A. Fisun, G. F. Ivanova
Biological Products. Prevention, Diagnosis, Treatm.2023; 23(4): 560. CrossRef
Recent Developments in the Application of Flow Cytometry to Advance our Understanding of Mycobacteriumtuberculosis Physiology and Pathogenesis
Trisha Parbhoo, Samantha L. Sampson, Jacoba M. Mouton
Cytometry Part A.2020; 97(7): 683. CrossRef

Article

Effect of Maternal Immune Status on Responsiveness of Bacillus Calmette-Gurin Vaccination in Mouse Neonates: Jong Su Choi, Ryang Yeo Kim, Semi Rho, Fanny Ewann, Nathalie Mielcarek, Man Ki Song, Cecil Czerkinsky, Jae-Ouk Kim; Osong Public Health Res Perspect. 2012;3(2):68-73. Published online June 30, 2012; DOI: https://doi.org/10.1016/j.phrp.2012.01.008

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20 Download
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Abstract PDF

Objectives
Bacillus Calmette-Guérin (BCG) vaccination has proven to be efficient in immunologically naïve infants; however, it has not been investigated that maternal natural exposure to Mycobacterium and/or BCG vaccine could influence the characteristics of immune responses to BCG in newborns. In this study, we analyzed whether the maternal immune status to M tuberculosis (M tb) can affect neonatal immunity to BCG using a mouse model.
Methods
Neonates were obtained from mice that were previously exposed to live BCG, to live M avium, or to heat-killed M tb H37Rv, and from naïve control mothers. One week after birth, the neonates were divided into two subgroups: one group immunized with live BCG via the subcutaneous route and the other group of neonates sham-treated. Interferon-gamma (IFNγ) secretion in response to in vitro stimulation with heat-killed BCG or purified protein derivative (PPD) was examined. Protection against M tb infection was evaluated by challenging mice nasally with live M tb H37Rv followed by counting colonies from spleen and lung homogenates.
Results
BCG-immunized neonates showed increased IFNγ secretion in response to heat-killed BCG or PPD. All mice in BCG-immunized neonates subgroups showed reduced bacterial burden (colony forming unit) in the lungs when compared with control naive neonate mice. However, no statistically significant difference was observed when comparing BCG-immunized mice born from mothers previously exposed to M avium or immunized with either heat-killed H37Rv or live BCG and mice born from naïve mothers.
Conclusion
The maternal immune status to M tb does not appear to impact on the immunogenicity of BCG vaccine in their progeny in our experimental conditions

Citations

Citations to this article as recorded by

BCG Vaccination at Birth and Rate of Hospitalization for Infection Until 15 Months of Age in Danish Children: A Randomized Clinical Multicenter Trial
Lone Graff Stensballe, Henrik Ravn, Nina Marie Birk, Jesper Kjærgaard, Thomas Nørrelykke Nissen, Gitte Thybo Pihl, Lisbeth Marianne Thøstesen, Gorm Greisen, Dorthe Lisbeth Jeppesen, Poul-Erik Kofoed, Ole Pryds, Signe Sørup, Peter Aaby, Christine Stabell B
Journal of the Pediatric Infectious Diseases Socie.2019; 8(3): 213. CrossRef
Adverse reactions to the Bacillus Calmette–Guérin (BCG) vaccine in new-born infants—an evaluation of the Danish strain 1331 SSI in a randomized clinical trial
Thomas Nørrelykke Nissen, Nina Marie Birk, Jesper Kjærgaard, Lisbeth Marianne Thøstesen, Gitte Thybo Pihl, Thomas Hoffmann, Dorthe Lisbeth Jeppesen, Poul-Erik Kofoed, Gorm Greisen, Christine Stabell Benn, Peter Aaby, Ole Pryds, Lone Graff Stensballe
Vaccine.2016; 34(22): 2477. CrossRef

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