Nha Trang National Institute of Vaccine had produced successfully BCG vaccine of local norm standard (5mg/ampulla) met the criterion issued by Hanoi National Centre of biopreparation quality control. Living units: 3.33  0.51 x 106 units; rate of thermo-stability 78.8  4.7%; photo density 0.23  0.018; dispersive density 1.11  0.075 and residual humidity 215  0.21%
BCG Vaccine ; Vaccines ; immunization

BCG vaccine produced by Nha Trang Institute of Vaccine has reached a high stability, after 36 months of preserve at the temperature of 4oC, the quality criteria were guaranteed with the mean living level of 1.76  0.62 x 106 living units/mg (with survival rate of 59.68%). The validity of this vaccine from 24 months increasing to 30 months was recommended
BCG Vaccine ; Vaccines ; immunization

A survey conducted on 15 consecutive lots of purified sera showed that SO2-4 content in hydrolyzed fluid as satisfying the requirement, then was quantified as small value in purified sera. However, among the lots of high SO2-4 content in purified sera (SAR 12,13, SAT 13,14), it was always lower than 0.15g/l. In comparing with the SO4 standard of China’s SAT;  1g/l, the SO4 content of our preparation was 7 times lower purified sera
BCG Vaccine ; Biology ; Vaccines

The study was carried out at Tiªn S¬n district on 121 infants aged 1-60 days who were immunized by a dose of 0.05mg intradermal BCG vaccine. The result showed that the tuberculin conversion rate in these infants was satisfactory (96.69%), non-suppurative adenitis developed in 2.48% and suppurative adenitis developed in 1.65% of the infants
Immune System ; BCG Vaccine ; infant

The study was carried out in Thanh Tri district on 109 infants aged 0-3 months who received a dose of 0.05mg of intradermal BCG vaccine. The result showed that: the tuberculin conversion rate in infants was satisfactory (96.33%), the rate of non-suppurative adenitis was 3.67% and the rate of suppurative adenitis was 0.917%.
Immune System ; BCG Vaccine ; infant

The study was performed in two children groups after 3 - 4 years receiving intradermal immunized BCG vaccine with the different doses of 0.05mg (216 children: group I) and 0.025mg (232 childern: group II) at some communes in Tu Son, Bac Ninh province and Thanh Tri district, Hanoi city. Results showed that the children malnutrition rate and tuberculosis exposure were the same and there was no statistically significance (P>0.05) in both groups. There were children with IDR (+), IDR > 15 mm, IgM, IgG and IgM antituberculosis, PCR (+) in the rate of children, delayed sensitivity reaction with tuberculin, the abnormal lung X-ray, IgG and IgM antibodies, and the rate of PCR (+). The rate of morbidity of tuberculosis in two children groups was the similar (0.46% and 0.43%, P=0.519). There was no case with meningitis and no statistical difference between two tuberculosis cases.
Tuberculosis ; Child ; BCG Vaccine ; Vaccination

The study was conducted in 796 newborns and infants aged 1-90 days. The newborns were randomly divided into three groups receiving different doses (0.05mg and 0.025mg) of Nha Trang BCG vaccine and 0.05mg of Pasteur BCG vaccine, intradermally. The results showed that the tuberculin conversion was satisfactory in both groups (receiving 0.05mg and 0.025mg dose of Nha Trang BCG vaccine), while the percentage of suppurative adenitis was found significantly higher in the group receiving 0.05mg BCG vaccine
BCG Vaccine ; Pharmaceutical Preparations ; child ; Infant, Newborn

The study was carried out on 469 infants aged 1-90 days in Tien Son and Thanh Tri districts. The infants were randomly divided into 2 groups receiving different doses (0.05 mg and 0.025 mg) of intradermal BCG vaccine. It showed that the tuberculin conversion was satisfactory in both groups (96.9% and 96.7%), while the percentage of suppurative adenitis was found higher in the group receiving 0.05 mg BCG (1.35%) versus the group receiving 0.025 mg BCG (0.41%).
BCG Vaccine ; Pharmaceutical Preparations ; child ; Infant, Newborn

A study on 3631 children with ages of 1-14 without the family transmission resource and 683 children with the family transmission resource in Hai Phong during 1992-1995 was carried out. Methods: direct interview of parents; direct examinations of the transmission resources, history of the respiratory diseases, measles, BCG scar, current body weight, the clinical examinations, X-ray, tuberculine reaction; and the basic tests. The results haves shown that the morbidity rate of tuberculosis in children with ages of 1-14 and exposured the transmission resource and without the transmission resource were 16.3% and 12%, respectively. The morbidity rate of tuberculosis in children exposured with the transmission resource without BCG scar. The morbidity rate of tuberculosis in children exposured with the transmission recource and malnutrion in grade II- III was 36.4%, higher 4.6 times than this in children without malnutrition and children without the transmission resources.
Tuberculosis ; transmission ; Malnutrition ; child ; Mycobacterium bovis ; BCG Vaccine

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.
Administration, Cutaneous ; BCG Vaccine ; Cell Count ; Flow Cytometry* ; Fluorescein ; Methods ; Mycobacterium bovis ; Quality Control ; Stem Cells ; Vaccine Potency ; Vaccines*