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Impact of Different Dosing Schedules on the Immunogenicity of the Human Rotavirus Vaccine in Infants in Pakistan: A Randomized Trial
- Source :
- Journal of Infectious Diseases. 210:1772-1779
- Publication Year :
- 2014
- Publisher :
- Oxford University Press (OUP), 2014.
-
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.
- Subjects :
- Male
Rotavirus
Immunoglobulin A
Pediatrics
medicine.medical_specialty
Vaccination schedule
Antibodies, Viral
medicine.disease_cause
Rotavirus Infections
law.invention
Randomized controlled trial
law
Outcome Assessment, Health Care
medicine
Humans
Immunology and Allergy
Pakistan
Seroconversion
Child
Immunization Schedule
Intention-to-treat analysis
biology
business.industry
Immunogenicity
Rotavirus Vaccines
Infant
Antibodies, Neutralizing
Rotavirus vaccine
Infectious Diseases
Child, Preschool
biology.protein
Female
business
Subjects
Details
- ISSN :
- 15376613 and 00221899
- Volume :
- 210
- Database :
- OpenAIRE
- Journal :
- Journal of Infectious Diseases
- Accession number :
- edsair.doi.dedup.....15f84044cb56f4fb0625cde9a6f42cd5