Comparison of the immunogenicity and safety of two different brands of Salmonella typhi Vi capsular polysaccharide vaccine

P. Sabitha, M. R Prabha Adhikari, Abhijit Chowdary, Malathi Prabhu, Mohammad Soofi, Meenakshi Shetty, Asha Kamath, S. S. Lokaranjan, S. S. Bangera

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Abstract

BACKGROUND: The recent emergence of multi-drug-resistant Salmonella strains highlights the need for better preventive measures, including vaccination. Safeand immunologic vaccines have been developed based on purified Vi polysaccharide. OBJECTIVE: To compare the immune response elicited by two different brands of Salmonella Vi capsular polysaccharide vaccine (ViCPS). SETTING AND DESIGN: Double blind, randomized (3:1), controlled, parallel, phase III study was conducted at two centres in India to compare the safety and immunogenicity of Typbar™, the investigational vaccine with an already marketed vaccine "X", in healthy subjects aged between 12-25 years. MATERIAL AND METHODS: A sample size of 184 subjects was calculated. Subjects were randomly distributed in two groups, immunized with single dose of Typbar™ or Vaccine "X". Serum samples were taken before 7 days and 4 weeks after immunization for the determination of antibodies to Vi polysaccharide, by ELISA method. Safety was assessed by physical examination, laboratory parameters before and after vaccination and by monitoring adverse events. Statistics: The geometric mean antibody titre (GMT) 4 weeks after vaccination was compared from respective pre-vaccination values by Wilcoxon signed rank test. Geometric mean of antibody levels before and after immunization and the ratio between them (Mann-Whitney test), the Seroconversion rates (Z test of proportions) and the adverse events (Fisher's exact testand Chi square test), were compared between two groups. P value < 0.05 was considered statistically significant. P values and 95% confidence intervals were estimated in two-tailed fashion. RESULTS: 153 subjects (Typbar™ =116 and Vaccine "X" =37) were studied. 71.6% (95% CI=63.4%-79.8%) and 75.7% (95% CI=64.9%-89.5%) were the seroconversion rates with Typbar™ and vaccine "X" respectively. The GMT values for Vi antibodies induced after Typbar™ and vaccine "X" were 10.23 Typbar™ and 13.46 mg/mL respectively and these values showed high significance when compared to their respective pre-immunization GMT values (P< 0.0001) at 95% CI (-10.49 to -7.19 mg/mL for TypbarTM and -14.69 to -8.86 mg/mL for Vaccine "X"). The induction of antibody response appeared to be slightly stronger (P= 0.032) with vaccine "X" when compared to that of TypbarTM. This is justifiable as the same group also had high pre-immunization GMT values (P= 0.021). CONCLUSION: The immunogenicity and safety of the investigational vaccine TypbarTM was found to be similar to that of already marketed brand of Vi CPS, Vaccine "X"The availability of a single dose of vaccine that is safe and effective enhances the prospective for control of typhoid fever.

Original languageEnglish
Pages (from-to)141-149
Number of pages9
JournalIndian Journal of Medical Sciences
Volume58
Issue number4
Publication statusPublished - 04-2004

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Vaccines
Safety
Antibodies
Immunization
Vaccination
Salmonella capsular polysaccharide
Polysaccharides
Typhoid Fever
Chi-Square Distribution
Nonparametric Statistics
Salmonella
Sample Size
Physical Examination
Antibody Formation
India
Healthy Volunteers
Enzyme-Linked Immunosorbent Assay
Confidence Intervals

All Science Journal Classification (ASJC) codes

  • Medicine(all)

Cite this

Sabitha, P., Adhikari, M. R. P., Chowdary, A., Prabhu, M., Soofi, M., Shetty, M., ... Bangera, S. S. (2004). Comparison of the immunogenicity and safety of two different brands of Salmonella typhi Vi capsular polysaccharide vaccine. Indian Journal of Medical Sciences, 58(4), 141-149.
Sabitha, P. ; Adhikari, M. R Prabha ; Chowdary, Abhijit ; Prabhu, Malathi ; Soofi, Mohammad ; Shetty, Meenakshi ; Kamath, Asha ; Lokaranjan, S. S. ; Bangera, S. S. / Comparison of the immunogenicity and safety of two different brands of Salmonella typhi Vi capsular polysaccharide vaccine. In: Indian Journal of Medical Sciences. 2004 ; Vol. 58, No. 4. pp. 141-149.
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title = "Comparison of the immunogenicity and safety of two different brands of Salmonella typhi Vi capsular polysaccharide vaccine",
abstract = "BACKGROUND: The recent emergence of multi-drug-resistant Salmonella strains highlights the need for better preventive measures, including vaccination. Safeand immunologic vaccines have been developed based on purified Vi polysaccharide. OBJECTIVE: To compare the immune response elicited by two different brands of Salmonella Vi capsular polysaccharide vaccine (ViCPS). SETTING AND DESIGN: Double blind, randomized (3:1), controlled, parallel, phase III study was conducted at two centres in India to compare the safety and immunogenicity of Typbar™, the investigational vaccine with an already marketed vaccine {"}X{"}, in healthy subjects aged between 12-25 years. MATERIAL AND METHODS: A sample size of 184 subjects was calculated. Subjects were randomly distributed in two groups, immunized with single dose of Typbar™ or Vaccine {"}X{"}. Serum samples were taken before 7 days and 4 weeks after immunization for the determination of antibodies to Vi polysaccharide, by ELISA method. Safety was assessed by physical examination, laboratory parameters before and after vaccination and by monitoring adverse events. Statistics: The geometric mean antibody titre (GMT) 4 weeks after vaccination was compared from respective pre-vaccination values by Wilcoxon signed rank test. Geometric mean of antibody levels before and after immunization and the ratio between them (Mann-Whitney test), the Seroconversion rates (Z test of proportions) and the adverse events (Fisher's exact testand Chi square test), were compared between two groups. P value < 0.05 was considered statistically significant. P values and 95{\%} confidence intervals were estimated in two-tailed fashion. RESULTS: 153 subjects (Typbar™ =116 and Vaccine {"}X{"} =37) were studied. 71.6{\%} (95{\%} CI=63.4{\%}-79.8{\%}) and 75.7{\%} (95{\%} CI=64.9{\%}-89.5{\%}) were the seroconversion rates with Typbar™ and vaccine {"}X{"} respectively. The GMT values for Vi antibodies induced after Typbar™ and vaccine {"}X{"} were 10.23 Typbar™ and 13.46 mg/mL respectively and these values showed high significance when compared to their respective pre-immunization GMT values (P< 0.0001) at 95{\%} CI (-10.49 to -7.19 mg/mL for TypbarTM and -14.69 to -8.86 mg/mL for Vaccine {"}X{"}). The induction of antibody response appeared to be slightly stronger (P= 0.032) with vaccine {"}X{"} when compared to that of TypbarTM. This is justifiable as the same group also had high pre-immunization GMT values (P= 0.021). CONCLUSION: The immunogenicity and safety of the investigational vaccine TypbarTM was found to be similar to that of already marketed brand of Vi CPS, Vaccine {"}X{"}The availability of a single dose of vaccine that is safe and effective enhances the prospective for control of typhoid fever.",
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Sabitha, P, Adhikari, MRP, Chowdary, A, Prabhu, M, Soofi, M, Shetty, M, Kamath, A, Lokaranjan, SS & Bangera, SS 2004, 'Comparison of the immunogenicity and safety of two different brands of Salmonella typhi Vi capsular polysaccharide vaccine', Indian Journal of Medical Sciences, vol. 58, no. 4, pp. 141-149.

Comparison of the immunogenicity and safety of two different brands of Salmonella typhi Vi capsular polysaccharide vaccine. / Sabitha, P.; Adhikari, M. R Prabha; Chowdary, Abhijit; Prabhu, Malathi; Soofi, Mohammad; Shetty, Meenakshi; Kamath, Asha; Lokaranjan, S. S.; Bangera, S. S.

In: Indian Journal of Medical Sciences, Vol. 58, No. 4, 04.2004, p. 141-149.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Comparison of the immunogenicity and safety of two different brands of Salmonella typhi Vi capsular polysaccharide vaccine

AU - Sabitha, P.

AU - Adhikari, M. R Prabha

AU - Chowdary, Abhijit

AU - Prabhu, Malathi

AU - Soofi, Mohammad

AU - Shetty, Meenakshi

AU - Kamath, Asha

AU - Lokaranjan, S. S.

AU - Bangera, S. S.

PY - 2004/4

Y1 - 2004/4

N2 - BACKGROUND: The recent emergence of multi-drug-resistant Salmonella strains highlights the need for better preventive measures, including vaccination. Safeand immunologic vaccines have been developed based on purified Vi polysaccharide. OBJECTIVE: To compare the immune response elicited by two different brands of Salmonella Vi capsular polysaccharide vaccine (ViCPS). SETTING AND DESIGN: Double blind, randomized (3:1), controlled, parallel, phase III study was conducted at two centres in India to compare the safety and immunogenicity of Typbar™, the investigational vaccine with an already marketed vaccine "X", in healthy subjects aged between 12-25 years. MATERIAL AND METHODS: A sample size of 184 subjects was calculated. Subjects were randomly distributed in two groups, immunized with single dose of Typbar™ or Vaccine "X". Serum samples were taken before 7 days and 4 weeks after immunization for the determination of antibodies to Vi polysaccharide, by ELISA method. Safety was assessed by physical examination, laboratory parameters before and after vaccination and by monitoring adverse events. Statistics: The geometric mean antibody titre (GMT) 4 weeks after vaccination was compared from respective pre-vaccination values by Wilcoxon signed rank test. Geometric mean of antibody levels before and after immunization and the ratio between them (Mann-Whitney test), the Seroconversion rates (Z test of proportions) and the adverse events (Fisher's exact testand Chi square test), were compared between two groups. P value < 0.05 was considered statistically significant. P values and 95% confidence intervals were estimated in two-tailed fashion. RESULTS: 153 subjects (Typbar™ =116 and Vaccine "X" =37) were studied. 71.6% (95% CI=63.4%-79.8%) and 75.7% (95% CI=64.9%-89.5%) were the seroconversion rates with Typbar™ and vaccine "X" respectively. The GMT values for Vi antibodies induced after Typbar™ and vaccine "X" were 10.23 Typbar™ and 13.46 mg/mL respectively and these values showed high significance when compared to their respective pre-immunization GMT values (P< 0.0001) at 95% CI (-10.49 to -7.19 mg/mL for TypbarTM and -14.69 to -8.86 mg/mL for Vaccine "X"). The induction of antibody response appeared to be slightly stronger (P= 0.032) with vaccine "X" when compared to that of TypbarTM. This is justifiable as the same group also had high pre-immunization GMT values (P= 0.021). CONCLUSION: The immunogenicity and safety of the investigational vaccine TypbarTM was found to be similar to that of already marketed brand of Vi CPS, Vaccine "X"The availability of a single dose of vaccine that is safe and effective enhances the prospective for control of typhoid fever.

AB - BACKGROUND: The recent emergence of multi-drug-resistant Salmonella strains highlights the need for better preventive measures, including vaccination. Safeand immunologic vaccines have been developed based on purified Vi polysaccharide. OBJECTIVE: To compare the immune response elicited by two different brands of Salmonella Vi capsular polysaccharide vaccine (ViCPS). SETTING AND DESIGN: Double blind, randomized (3:1), controlled, parallel, phase III study was conducted at two centres in India to compare the safety and immunogenicity of Typbar™, the investigational vaccine with an already marketed vaccine "X", in healthy subjects aged between 12-25 years. MATERIAL AND METHODS: A sample size of 184 subjects was calculated. Subjects were randomly distributed in two groups, immunized with single dose of Typbar™ or Vaccine "X". Serum samples were taken before 7 days and 4 weeks after immunization for the determination of antibodies to Vi polysaccharide, by ELISA method. Safety was assessed by physical examination, laboratory parameters before and after vaccination and by monitoring adverse events. Statistics: The geometric mean antibody titre (GMT) 4 weeks after vaccination was compared from respective pre-vaccination values by Wilcoxon signed rank test. Geometric mean of antibody levels before and after immunization and the ratio between them (Mann-Whitney test), the Seroconversion rates (Z test of proportions) and the adverse events (Fisher's exact testand Chi square test), were compared between two groups. P value < 0.05 was considered statistically significant. P values and 95% confidence intervals were estimated in two-tailed fashion. RESULTS: 153 subjects (Typbar™ =116 and Vaccine "X" =37) were studied. 71.6% (95% CI=63.4%-79.8%) and 75.7% (95% CI=64.9%-89.5%) were the seroconversion rates with Typbar™ and vaccine "X" respectively. The GMT values for Vi antibodies induced after Typbar™ and vaccine "X" were 10.23 Typbar™ and 13.46 mg/mL respectively and these values showed high significance when compared to their respective pre-immunization GMT values (P< 0.0001) at 95% CI (-10.49 to -7.19 mg/mL for TypbarTM and -14.69 to -8.86 mg/mL for Vaccine "X"). The induction of antibody response appeared to be slightly stronger (P= 0.032) with vaccine "X" when compared to that of TypbarTM. This is justifiable as the same group also had high pre-immunization GMT values (P= 0.021). CONCLUSION: The immunogenicity and safety of the investigational vaccine TypbarTM was found to be similar to that of already marketed brand of Vi CPS, Vaccine "X"The availability of a single dose of vaccine that is safe and effective enhances the prospective for control of typhoid fever.

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