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Immunogenicity, safety and reactogenicity of a Phase II trial of Vi-DT typhoid conjugate vaccine in healthy Filipino infants and toddlers: A preliminary report

التفاصيل البيبلوغرافية
العنوان: Immunogenicity, safety and reactogenicity of a Phase II trial of Vi-DT typhoid conjugate vaccine in healthy Filipino infants and toddlers: A preliminary report
المؤلفون: Sue-Kyoung Jo, Seon-Young Yang, Suchada Chinaworapong, Jiwook Park, Dong Soo Ham, Edison Alberto, Sushant Sahastrabuddhe, Jean-Louis Excler, Arijit Sil, Yun Chon, Maria Rosario Capeding, Ju Yeon Park, Jerome H. Kim, T. Anh Wartel, Julia Lynch, Deok Ryun Kim, Jae Seung Yang, Samuel Teshome, Ji Hwa Ryu, Tarun Saluja, Hun Kim
المصدر: Vaccine
بيانات النشر: Elsevier BV, 2020.
سنة النشر: 2020
مصطلحات موضوعية: Diphtheria-Tetanus Vaccine, Pediatrics, medicine.medical_specialty, Asia, Philippines, 030231 tropical medicine, Phases of clinical research, Placebo, Article, Typhoid fever, Typhoid conjugate vaccine, 03 medical and health sciences, Immunogenicity, Vaccine, 0302 clinical medicine, Conjugate vaccine, medicine, Humans, 030212 general & internal medicine, Typhoid Fever, Toddlers, Vaccines, Conjugate, Reactogenicity, General Veterinary, General Immunology and Microbiology, business.industry, Immunogenicity, Incidence (epidemiology), Public health, Typhoid-Paratyphoid Vaccines, Public Health, Environmental and Occupational Health, Infant, medicine.disease, Antibodies, Bacterial, Infectious Diseases, Child, Preschool, Africa, Molecular Medicine, Vi-DT, Safety, business, Infants
الوصف: Highlights • Vi-DT is safe and well tolerated in infants and toddlers aged 6–23 months. • Vi-DT showed >1000-fold higher Geometric Mean Titer (GMT) compared to Placebo. • 100% seroconversion reported in Vi-DT group in all age strata.
Background Typhoid fever remains an important public health problem in developing countries and is endemic in many parts of Asia and Africa where the incidence of disease typically peaks in school-aged children. Age restrictions and other limitations of existing oral live-attenuated typhoid and parenteral Vi polysaccharide vaccines have triggered the development of Vi conjugate vaccines with improved immunological properties, use in younger age range, and longer durability of protection. We present the safety, reactogenicity, and immunogenicity data from a Phase II study after a single dose of Vi polysaccharide conjugated to diphtheria toxoid (Vi-DT) conducted in 6–23-month old Filipino children. Methods This is a randomized, observer-blinded Phase II study to assess the immunogenicity, safety and reactogenicity of Vi-DT compared to placebo, conducted in Muntinlupa City, The Philippines. Participants aged 6–23 months were enrolled and randomized to Vi-DT (25 µg) or placebo (0.9% sodium chloride) and evaluated for immunogenicity and overall safety 28 days post vaccination. Results A total of 285 participants were enrolled and age-stratified: 6 to < 9 months, 9–12 months, and 13–23 months. Seventy-six (76) participants received Vi-DT and 19 received placebo per each strata. All participants seroconverted after a single dose of Vi-DT versus 7% of placebo recipients. Anti-Vi IgG GMT was 444.38 [95% CI (400.28; 493.34)] after a single dose of Vi-DT; there was no change in GMT after placebo administration, 0.41 [95% CI (0.33; 0.51), p
تدمد: 0264-410X
URL الوصول: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0ab1674b1c2c0490128ef8d71f8550d7
https://doi.org/10.1016/j.vaccine.2019.09.074
حقوق: OPEN
رقم الأكسشن: edsair.doi.dedup.....0ab1674b1c2c0490128ef8d71f8550d7
قاعدة البيانات: OpenAIRE
الوصف
تدمد:0264410X