Syed Asad Ali1, Abdul Momin Kazi1, Margaret M Cortese2, Jessica A Fleming3, Umesh D Parashar2, Baoming Jiang2, Monica Malone McNeal4, Duncan Steele5, Zulfiqar Bhutta1, Anita Zaidi1. 1. Department of Pediatrics and Child Health, Aga Khan University, Karachi, Pakistan. 2. Division of Viral Diseases, National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta, Georgia. 3. Vaccine Access and Delivery, Program for Appropriate Technology in Health (PATH), Seattle, Washington. 4. Department of Pediatrics, Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Ohio. 5. Vaccine Access and Delivery, Program for Appropriate Technology in Health (PATH), Seattle, Washington Now With The Bill & Melinda Gates Foundation, Seattle, Washington.
Abstract
BACKGROUND: Current oral rotavirus vaccines perform suboptimally in resource-poor settings. We investigated the effect of an additional dose and later schedule on the immunogenicity of monovalent rotavirus vaccine (RV1) in a developing country. METHODS: Infants received RV1 at 6 and 10, 10 and 14, or 6, 10, and 14 weeks of age. The primary objective was to compare antirotavirus immunoglobulin A (IgA) seroconversion at 18 weeks in the 6/10/14 arm to the cumulative seroconversion (highest result at 14 or 18 weeks) in the 6/10 arm. RESULTS: Overall, 480 (76.2%) of 630 randomized infants completed the trial per protocol. Seroconversion in the 6/10/14 arm was 36.7% (95% CI, 29.8, 44.2) compared to 36.1% (CI, 29.0, 43.9) in the 6/10 arm, (P=1.0); the result from the 10/14 arm was 38.5% (CI, 31.2, 46.3). Seroconversion in the 6/10 arm at 14 weeks (post hoc) was lower at 29.7% (CI, 23.1, 37.3). CONCLUSIONS: In Pakistani infants, the immunogenicity of RV1 did not increase significantly with 3 doses at 6, 10, and 14 weeks compared to 2 doses at 6 and 10 weeks. Additional strategies should be evaluated for improving rotavirus vaccine immunogenicity in high burden countries.
RCT Entities:
BACKGROUND: Current oral rotavirus vaccines perform suboptimally in resource-poor settings. We investigated the effect of an additional dose and later schedule on the immunogenicity of monovalent rotavirus vaccine (RV1) in a developing country. METHODS:Infants received RV1 at 6 and 10, 10 and 14, or 6, 10, and 14 weeks of age. The primary objective was to compare antirotavirus immunoglobulin A (IgA) seroconversion at 18 weeks in the 6/10/14 arm to the cumulative seroconversion (highest result at 14 or 18 weeks) in the 6/10 arm. RESULTS: Overall, 480 (76.2%) of 630 randomized infants completed the trial per protocol. Seroconversion in the 6/10/14 arm was 36.7% (95% CI, 29.8, 44.2) compared to 36.1% (CI, 29.0, 43.9) in the 6/10 arm, (P=1.0); the result from the 10/14 arm was 38.5% (CI, 31.2, 46.3). Seroconversion in the 6/10 arm at 14 weeks (post hoc) was lower at 29.7% (CI, 23.1, 37.3). CONCLUSIONS: In Pakistani infants, the immunogenicity of RV1 did not increase significantly with 3 doses at 6, 10, and 14 weeks compared to 2 doses at 6 and 10 weeks. Additional strategies should be evaluated for improving rotavirus vaccine immunogenicity in high burden countries.
Authors: J F Gruber; S Becker-Dreps; M G Hudgens; M A Brookhart; J C Thomas; M Jonsson Funk Journal: Epidemiol Infect Date: 2018-03-22 Impact factor: 2.451
Authors: Joann F Gruber; Sylvia Becker-Dreps; Michael G Hudgens; M Alan Brookhart; James C Thomas; Michele Jonsson Funk Journal: Epidemiology Date: 2018-11 Impact factor: 4.822
Authors: Rachel M Burke; Jacqueline E Tate; Kimberly D Pringle; Manish Patel; Lucia H De Oliveira; Umesh D Parashar Journal: Pediatr Infect Dis J Date: 2018-08 Impact factor: 2.129