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Comparative immune response of Typbar TCV® (typhoid conjugate vaccine) in extremes of age: An Indian experience
Krishna Mohan Vadrevu1, Siddharth Reddy Chiteti1, Raju Dugyala1
1Bharat Biotech International Ltd, Hyderabad, India.
Insights
Typhoid Conjugate Vaccine (TCV) demonstrated superior antibody titers compared to Typhim Vi in children. TCV also proved safe and effective in both children and elderly adults, highlighting its broad applicability.
Area of Science:
- Immunology
- Vaccinology
- Public Health
Background:
- Typhoid fever remains a critical global health issue, particularly in low- and middle-income countries.
- Typhoid Conjugate Vaccines (TCV) offer extended protection, especially for vulnerable young populations.
- Existing vaccines necessitate ongoing research for improved efficacy and broader age group application.
Purpose of the Study:
- To evaluate the immunogenicity and safety of Typbar TCV® in children compared to Typhim Vi®.
- To assess the safety and immunogenicity of Typbar TCV® in a broad age range, including elderly individuals.
- To investigate the impact of booster timing on the immune response to Typbar TCV®.
Main Methods:
- A comparator study enrolled 340 children, comparing Typbar TCV® to Typhim Vi®, with a subset receiving a booster dose.
- An age extension study involved 300 healthy volunteers across different age groups (18-85+ years) receiving a single Typbar TCV® dose.
- Antibody titers (anti-Vi-IgG) and adverse events were monitored in both studies.
Main Results:
- Typbar TCV® induced significantly higher anti-Vi-IgG titers than Typhim Vi® in children at days 28 and 90.
- No significant differences in adverse events were observed between vaccine groups in the comparator study.
- Typbar TCV® was well-tolerated and showed sustained antibody responses in children; a delayed booster (2 years) demonstrated enhanced immunogenicity compared to an early booster (6 months).
- In the age extension study, Typbar TCV® was safe and elicited comparable antibody titers in both younger and elderly adults.
Conclusions:
- Typbar TCV® is a safe and effective vaccine, demonstrating superior immunogenicity to Typhim Vi® in children.
- The vaccine is suitable for a wide age range, from 6 months to over 85 years.
- Optimal booster timing may enhance the long-term protective immune response.
Abstract:
Typhoid fever is a significant health concern in low- and middle-income countries, with millions of cases and thousands of deaths each year. Typhoid Conjugate Vaccines, such as Typbar TCV®, have been developed to provide longer-lasting protection for young children. This publication includes the readouts from two different studies in Children and elderly: a Comparator Study and Age Extension Study. In the first study, children are included, whereas the latter study also includes elderly subjects. A total of 340 children were enrolled, and a subset received a booster dose of Typbar TCV®, 180 days later. Results established that Typbar TCV® induced significantly higher antibody titer compared to Typhim Vi on days 28 and 90 (p < .001). No significant differences in adverse events were found between the two vaccine arms. Overall, Typbar TCV® was well tolerated, inducing higher anti-Vi-IgG titers than Typhim Vi®, with sustained response over the study period. The booster dose post-6 months in the Typbar TCV® group was significantly less immunogenic compared to a booster at 2 years (p < .001), suggesting a delayed booster might enhance the anamnestic response, a fact confirmed in our previous clinical studies of Typbar TCV®. In the Age Extension study, 300 healthy volunteers, including younger (18-65) and elderly adults (65 and older), received a single dose of Typbar TCV®. The vaccine is reported to be safe and induced similar anti Vi-Ab geometric mean titers (GMTs) in young and elderly adults. Thus, Typbar TCV® was studied effectively from 6 months to above 85 years, which is the upper age limit. CTRI Registration number: CTRI/2016/01/006476, CTRI/2024/06/069638.
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