Delayed Dosing of Oral Rotavirus Vaccine Demonstrates Decreased Risk of Rotavirus Gastroenteritis Associated With Serum Zinc: A Randomized Controlled Trial
- PMID: 27217217
- DOI: 10.1093/cid/ciw346
Delayed Dosing of Oral Rotavirus Vaccine Demonstrates Decreased Risk of Rotavirus Gastroenteritis Associated With Serum Zinc: A Randomized Controlled Trial
Abstract
Background: Rotavirus is the world's leading cause of childhood diarrheal death. Despite successes, oral rotavirus vaccines are less effective in developing countries. In an urban slum of Dhaka, we performed active diarrhea surveillance to evaluate monovalent G1P[8] rotavirus vaccine (RV1) efficacy and understand variables contributing to risk of rotavirus diarrhea (RVD).
Methods: We performed a randomized controlled trial of monovalent oral rotavirus vaccine (RV1). Seven hundred healthy infants received RV1 or no RV1 (1:1) using delayed dosing (10 and 17 weeks) and were followed for 1 year. Intensive diarrhea surveillance was performed. The primary outcome was ≥1 episode of RVD. Nutritional, socioeconomic, and immunologic factors were assessed by logistic regression best-subsets analysis for association with risk of RVD and interactions with vaccine arm.
Results: Incidence of all RVD was 38.3 cases per 100 person-years. Per-protocol RV1 efficacy was 73.5% (95% confidence interval [CI], 45.8%-87.0%) against severe RVD and 51% (95% CI, 33.8%-63.7%) against all RVD. Serum zinc level (odds ratio [OR], 0.77; P = .002) and lack of rotavirus immunoglobulin A (IgA) seroconversion (OR, 1.95; P = .018) were associated with risk of RVD, independent of vaccination status. Water treatment and exclusive breastfeeding were of borderline significance. Factors not associated with RVD included height for age at 10 weeks, vitamin D, retinol binding protein, maternal education, household income, and sex.
Conclusions: In an urban slum with high incidence of RVD, the efficacy of RV1 against severe RVD was higher than anticipated in the setting of delayed dosing. Lower serum zinc level and lack of IgA seroconversion were associated with increased risk of RVD independent of vaccination.
Clinical trials registration: NCT01375647.
Keywords: developing countries; oral vaccine; rotavirus diarrhea; underperformance; zinc.
© The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.
Similar articles
-
Impact of withholding breastfeeding at the time of vaccination on the immunogenicity of oral rotavirus vaccine--a randomized trial.PLoS One. 2015 Jun 2;10(6):e0127622. doi: 10.1371/journal.pone.0127622. eCollection 2015. PLoS One. 2015. PMID: 26035743 Free PMC article. Clinical Trial.
-
Rotavirus-Specific Immunoglobulin A Responses Are Impaired and Serve as a Suboptimal Correlate of Protection Among Infants in Bangladesh.Clin Infect Dis. 2018 Jul 2;67(2):186-192. doi: 10.1093/cid/ciy076. Clin Infect Dis. 2018. PMID: 29394355 Free PMC article. Clinical Trial.
-
Effectiveness of monovalent rotavirus vaccine in a high-income, predominant-use setting.Vaccine. 2015 Dec 16;33(51):7307-7314. doi: 10.1016/j.vaccine.2015.10.118. Epub 2015 Nov 3. Vaccine. 2015. PMID: 26546262
-
Update on Rotarix: an oral human rotavirus vaccine.Expert Rev Vaccines. 2009 Dec;8(12):1627-41. doi: 10.1586/erv.09.136. Expert Rev Vaccines. 2009. PMID: 19943758 Review.
-
Current status of rotavirus vaccines.World J Pediatr. 2015 Nov;11(4):300-8. doi: 10.1007/s12519-015-0038-y. Epub 2015 Oct 11. World J Pediatr. 2015. PMID: 26454434 Review.
Cited by
-
Differences in Rotavirus Shedding and Duration by Infant Oral Rotavirus Vaccination Status in Dhaka, Bangladesh, 2011-2014.J Infect Dis. 2024 Jul 25;230(1):e75-e79. doi: 10.1093/infdis/jiad502. J Infect Dis. 2024. PMID: 39052701 Free PMC article.
-
Infant Non-Secretor Histoblood Group Antigen Phenotype Reduces Susceptibility to Both Symptomatic and Asymptomatic Rotavirus Infection.Pathogens. 2024 Mar 4;13(3):223. doi: 10.3390/pathogens13030223. Pathogens. 2024. PMID: 38535566 Free PMC article.
-
Immunological factors linked to geographical variation in vaccine responses.Nat Rev Immunol. 2024 Apr;24(4):250-263. doi: 10.1038/s41577-023-00941-2. Epub 2023 Sep 28. Nat Rev Immunol. 2024. PMID: 37770632 Review.
-
Causes and consequences of child growth faltering in low-resource settings.Nature. 2023 Sep;621(7979):568-576. doi: 10.1038/s41586-023-06501-x. Epub 2023 Sep 13. Nature. 2023. PMID: 37704722 Free PMC article.
-
Maternal Breast Milk Secretor Phenotype Does Not Affect Infant Susceptibility to Rotavirus Diarrhea.Open Forum Infect Dis. 2023 Jun 7;10(6):ofad299. doi: 10.1093/ofid/ofad299. eCollection 2023 Jun. Open Forum Infect Dis. 2023. PMID: 37333724 Free PMC article.
Publication types
MeSH terms
Substances
Associated data
LinkOut - more resources
Full Text Sources
Other Literature Sources
Medical
Miscellaneous