Typhoid: Study confirms Vi-DT conjugate vaccine is safe and immunogenic
in children 6-23 months
Date:
September 17, 2020
Source:
International Vaccine Institute
Summary:
A new study shows that single-dose and two-dose regimens of Vi-DT
typhoid conjugate vaccine (TCV) are safe and immunogenic in children
6-23 months of age, a group with high rates of typhoid fever in
resource-limited settings.
FULL STORY ==========================================================================
A new study conducted by IVI in collaboration with SK bioscience shows
that single-dose and two-dose regimens of Vi-DT typhoid conjugate vaccine
(TCV) are safe and immunogenic in children 6-23 months of age, a group
with high rates of typhoid fever in resource-limited settings. The
findings from this study newly published online in The Lancet's EClinicalMedicine describe the successful completion and analysis of a
Phase II clinical trial of Vi-DT six months after vaccination.
==========================================================================
The World Health Organization (WHO) recommends TCVs for use in endemic
settings with Gavi, the Vaccine Alliance providing the vaccines to
eligible countries.
However, with only one TCV pre-qualified by the WHO, demand currently
exceeds supply. This study is a critical step toward gaining licensure
and WHO- prequalification of an additional TCV to increase the global stockpile.
"Our findings show that a single dose of conjugated Vi-DT vaccine is safe
and provides anti-Vi seroconversion rates similar to the two-dose regimen
in children between 6 months and 2 years of age," said Dr. Birkneh Tilahun Tadesse, a Research Scientist at the International Vaccine Institute
(IVI), which conducted the study at the Research Institute for Tropical Medicine in Manila, the Philippines.
"This is an important advance considering the significant burden of
disease in infants and young children, and our goal remains developing
a safe, single-dose vaccine with long-lasting immunogenicity to protect
more children against typhoid fever," said Dr. Sushant Sahastrabuddhe,
Director of the Typhoid Program at IVI.
Increasing global supply of typhoid conjugate vaccines Vi-DT was developed
at IVI and its technology was transferred in 2013 to SK bioscience in
South Korea for manufacturing and commercialization. A Phase I safety
trial of Vi-DT was first conducted in the Philippines with participants
2-45 years of age and showed that the vaccine was safe and immunogenic
four weeks after first dose. Following the successful completion of a
Phase II trial with infants under 2 years, large-scale Phase III studies
with a single-dose of Vi-DT have started in the Philippines and Nepal
in 2020.
The WHO recommends programmatic use of typhoid vaccines to prevent and
control typhoid fever with preference for TCVs for their longer-lasting protection, fewer doses, and suitability for children under 2. (1)
For treatment, antibiotics are currently the frontline intervention
for typhoid fever, but drug-resistant typhoid has emerged across Asia
and Africa, highlighting the need for sufficient supply of TCV and
sustainable vaccination programs.
========================================================================== Story Source: Materials provided by International_Vaccine_Institute. Note: Content may be edited for style and length.
========================================================================== Journal Reference:
1. Maria Rosario Capeding, Arijit Sil, Birkneh Tilahun Tadesse, Tarun
Saluja, Samuel Teshome, Edison Alberto, Deok Ryun Kim, Eun
Lyeong Park, Ju Yeon Park, Jae Seung Yang, Suchada Chinaworapong,
Jiwook Park, Sue- Kyoung Jo, Yun Chon, Seon-Young Yang, Ji Hwa
Ryu, Inho Cheong, Kyu-Young Shim, Yoonyeong Lee, Hun Kim, Julia
A. Lynch, Jerome H. Kim, Jean-Louis Excler, T. Anh Wartel, Sushant
Sahastrabuddhe. Safety and immunogenicity of Vi-DT conjugate
vaccine among 6-23-month-old children: Phase II, randomized,
dose-scheduling, observer-blind Study. EClinicalMedicine, 2020;
100540 DOI: 10.1016/j.eclinm.2020.100540 ==========================================================================
Link to news story:
https://www.sciencedaily.com/releases/2020/09/200917084052.htm
--- up 3 weeks, 3 days, 6 hours, 50 minutes
* Origin: -=> Castle Rock BBS <=- Now Husky HPT Powered! (1337:3/111)