The Effects of Increased Inoculum on Oral Rotavirus Vaccine Take and Immunogenicity

Summary

Rotavirus is the leading cause of diarrhea in children worldwide. Oral rotavirus vaccines work remarkably well in high-income countries, but for unclear reasons they underperform in low-income countries. A double-blind, randomized control trial will be performed to evaluate whether using a higher dose of a currently licensed vaccine (Rotarix, GlaxoSmithKline) can improve immune responses among infants in Dhaka, Bangladesh. Infants will be randomized 1:1 to receive either a standard or a double dose of Rotarix at 6 and 10 weeks of life. Infants will be assessed for fecal vaccine shedding and serum rotavirus-specific IgA responses to determine vaccine immunogenicity.

Timeline

Start

2017-06-12

Primary completion

2018-06-07

Completion

2018-06-07

Publications

• Lee B, Dickson DM, Alam M, Afreen S, Kader A, Afrin F, Ferdousi T, Damon CF, Gullickson SK, McNeal MM, Bak DM, Tolba M, Carmolli MP, Taniuchi M, Haque R, Kirkpatrick BD. The effect of increased inoculum on oral rotavirus vaccine take among infants in Dhaka, Bangladesh: A double-blind, parallel group, randomized, controlled trial. Vaccine. 2020 Jan 3;38(1):90-99. doi: 10.1016/j.vaccine.2019.09.088. Epub 2019 Oct 10.

Drugs

Indications