The effect of probiotics and zinc supplementation on the immune response to oral rotavirus vaccine: A randomized, factorial design, placebo-controlled study among Indian infants
•Oral rotavirus vaccines are less immunogenic and effective in low-income settings.•Infant gut microbiota and micronutrient status may contribute to this phenomenon.•We did a randomised controlled trial of probiotic and zinc supplementation in India.•Probiotic was associated with a modest (7.5%) imp...
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| Published in | Vaccine Vol. 36; no. 2; pp. 273 - 279 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Netherlands
Elsevier Ltd
04.01.2018
Elsevier Limited |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0264-410X 1873-2518 1873-2518 |
| DOI | 10.1016/j.vaccine.2017.07.116 |
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| Abstract | •Oral rotavirus vaccines are less immunogenic and effective in low-income settings.•Infant gut microbiota and micronutrient status may contribute to this phenomenon.•We did a randomised controlled trial of probiotic and zinc supplementation in India.•Probiotic was associated with a modest (7.5%) improvement in vaccine immunogenicity.•Zinc supplementation (5mg/day) did not alter zinc status or vaccine immunogenicity.
Strategies are needed to improve oral rotavirus vaccine (RV), which provides suboptimal protection in developing countries. Probiotics and zinc supplementation could improve RV immunogenicity by altering the intestinal microbiota and immune function.
Infants 5weeks old living in urban Vellore, India were enrolled in a randomized, double-blind, placebo-controlled trial with a 4-arm factorial design to assess the effects of daily zinc (5mg), probiotic (1010Lactobacillus rhamnosus GG) or placebo on the immunogenicity of two doses of RV (Rotarix®, GlaxoSmithKline Biologicals) given at 6 and 10weeks of age. Infants were eligible for participation if healthy, available for the study duration and without prior receipt of RV or oral poliovirus vaccine other than the birth dose. The primary outcome was seroconversion to rotavirus at 14weeks of age based on detection of VP6-specific IgA at ≥20U/ml in previously seronegative infants or a fourfold rise in concentration.
The study took place during July 2012 to February 2013. 620 infants were randomized equally between study arms and 551 (88.9%) completed per protocol. Seroconversion was recorded in 54/137 (39.4%), 42/136 (30.9%), 40/143 (28.0%), and 37/135 (27.4%) infants receiving (1) probiotic and zinc, (2) probiotic and placebo, (3) placebo and zinc, (4) two placebos. Seroconversion showed a modest improvement among infants receiving probiotic (difference between groups 1, 2 and 3, 4 was 7.5% (97.5% Confidence Interval (CI): −1.4%, 16.2%), p=0.066) but not zinc (difference between groups 1, 3 and 2, 4 was 4.4% (97.5% CI: −4.4%, 13.2%), p=0.272). 16 serious adverse events were recorded, none related to study interventions.
Zinc or probiotic supplementation did not significantly improve the low immunogenicity of rotavirus vaccine given to infants in a poor urban community in India. A modest effect of combined supplementation deserves further investigation.
The trial was registered in India (CTRI/2012/05/002677). |
|---|---|
| AbstractList | Strategies are needed to improve oral rotavirus vaccine (RV), which provides suboptimal protection in developing countries. Probiotics and zinc supplementation could improve RV immunogenicity by altering the intestinal microbiota and immune function.
Infants 5weeks old living in urban Vellore, India were enrolled in a randomized, double-blind, placebo-controlled trial with a 4-arm factorial design to assess the effects of daily zinc (5mg), probiotic (10
Lactobacillus rhamnosus GG) or placebo on the immunogenicity of two doses of RV (Rotarix®, GlaxoSmithKline Biologicals) given at 6 and 10weeks of age. Infants were eligible for participation if healthy, available for the study duration and without prior receipt of RV or oral poliovirus vaccine other than the birth dose. The primary outcome was seroconversion to rotavirus at 14weeks of age based on detection of VP6-specific IgA at ≥20U/ml in previously seronegative infants or a fourfold rise in concentration.
The study took place during July 2012 to February 2013. 620 infants were randomized equally between study arms and 551 (88.9%) completed per protocol. Seroconversion was recorded in 54/137 (39.4%), 42/136 (30.9%), 40/143 (28.0%), and 37/135 (27.4%) infants receiving (1) probiotic and zinc, (2) probiotic and placebo, (3) placebo and zinc, (4) two placebos. Seroconversion showed a modest improvement among infants receiving probiotic (difference between groups 1, 2 and 3, 4 was 7.5% (97.5% Confidence Interval (CI): -1.4%, 16.2%), p=0.066) but not zinc (difference between groups 1, 3 and 2, 4 was 4.4% (97.5% CI: -4.4%, 13.2%), p=0.272). 16 serious adverse events were recorded, none related to study interventions.
Zinc or probiotic supplementation did not significantly improve the low immunogenicity of rotavirus vaccine given to infants in a poor urban community in India. A modest effect of combined supplementation deserves further investigation.
The trial was registered in India (CTRI/2012/05/002677). BackgroundStrategies are needed to improve oral rotavirus vaccine (RV), which provides suboptimal protection in developing countries. Probiotics and zinc supplementation could improve RV immunogenicity by altering the intestinal microbiota and immune function.MethodsInfants 5weeks old living in urban Vellore, India were enrolled in a randomized, double-blind, placebo-controlled trial with a 4-arm factorial design to assess the effects of daily zinc (5mg), probiotic (1010Lactobacillus rhamnosus GG) or placebo on the immunogenicity of two doses of RV (Rotarix®, GlaxoSmithKline Biologicals) given at 6 and 10weeks of age. Infants were eligible for participation if healthy, available for the study duration and without prior receipt of RV or oral poliovirus vaccine other than the birth dose. The primary outcome was seroconversion to rotavirus at 14weeks of age based on detection of VP6-specific IgA at ≥20U/ml in previously seronegative infants or a fourfold rise in concentration.ResultsThe study took place during July 2012 to February 2013. 620 infants were randomized equally between study arms and 551 (88.9%) completed per protocol. Seroconversion was recorded in 54/137 (39.4%), 42/136 (30.9%), 40/143 (28.0%), and 37/135 (27.4%) infants receiving (1) probiotic and zinc, (2) probiotic and placebo, (3) placebo and zinc, (4) two placebos. Seroconversion showed a modest improvement among infants receiving probiotic (difference between groups 1, 2 and 3, 4 was 7.5% (97.5% Confidence Interval (CI): −1.4%, 16.2%), p=0.066) but not zinc (difference between groups 1, 3 and 2, 4 was 4.4% (97.5% CI: −4.4%, 13.2%), p=0.272). 16 serious adverse events were recorded, none related to study interventions.ConclusionsZinc or probiotic supplementation did not significantly improve the low immunogenicity of rotavirus vaccine given to infants in a poor urban community in India. A modest effect of combined supplementation deserves further investigation.Trial registrationThe trial was registered in India (CTRI/2012/05/002677). Strategies are needed to improve oral rotavirus vaccine (RV), which provides suboptimal protection in developing countries. Probiotics and zinc supplementation could improve RV immunogenicity by altering the intestinal microbiota and immune function.BACKGROUNDStrategies are needed to improve oral rotavirus vaccine (RV), which provides suboptimal protection in developing countries. Probiotics and zinc supplementation could improve RV immunogenicity by altering the intestinal microbiota and immune function.Infants 5weeks old living in urban Vellore, India were enrolled in a randomized, double-blind, placebo-controlled trial with a 4-arm factorial design to assess the effects of daily zinc (5mg), probiotic (1010Lactobacillus rhamnosus GG) or placebo on the immunogenicity of two doses of RV (Rotarix®, GlaxoSmithKline Biologicals) given at 6 and 10weeks of age. Infants were eligible for participation if healthy, available for the study duration and without prior receipt of RV or oral poliovirus vaccine other than the birth dose. The primary outcome was seroconversion to rotavirus at 14weeks of age based on detection of VP6-specific IgA at ≥20U/ml in previously seronegative infants or a fourfold rise in concentration.METHODSInfants 5weeks old living in urban Vellore, India were enrolled in a randomized, double-blind, placebo-controlled trial with a 4-arm factorial design to assess the effects of daily zinc (5mg), probiotic (1010Lactobacillus rhamnosus GG) or placebo on the immunogenicity of two doses of RV (Rotarix®, GlaxoSmithKline Biologicals) given at 6 and 10weeks of age. Infants were eligible for participation if healthy, available for the study duration and without prior receipt of RV or oral poliovirus vaccine other than the birth dose. The primary outcome was seroconversion to rotavirus at 14weeks of age based on detection of VP6-specific IgA at ≥20U/ml in previously seronegative infants or a fourfold rise in concentration.The study took place during July 2012 to February 2013. 620 infants were randomized equally between study arms and 551 (88.9%) completed per protocol. Seroconversion was recorded in 54/137 (39.4%), 42/136 (30.9%), 40/143 (28.0%), and 37/135 (27.4%) infants receiving (1) probiotic and zinc, (2) probiotic and placebo, (3) placebo and zinc, (4) two placebos. Seroconversion showed a modest improvement among infants receiving probiotic (difference between groups 1, 2 and 3, 4 was 7.5% (97.5% Confidence Interval (CI): -1.4%, 16.2%), p=0.066) but not zinc (difference between groups 1, 3 and 2, 4 was 4.4% (97.5% CI: -4.4%, 13.2%), p=0.272). 16 serious adverse events were recorded, none related to study interventions.RESULTSThe study took place during July 2012 to February 2013. 620 infants were randomized equally between study arms and 551 (88.9%) completed per protocol. Seroconversion was recorded in 54/137 (39.4%), 42/136 (30.9%), 40/143 (28.0%), and 37/135 (27.4%) infants receiving (1) probiotic and zinc, (2) probiotic and placebo, (3) placebo and zinc, (4) two placebos. Seroconversion showed a modest improvement among infants receiving probiotic (difference between groups 1, 2 and 3, 4 was 7.5% (97.5% Confidence Interval (CI): -1.4%, 16.2%), p=0.066) but not zinc (difference between groups 1, 3 and 2, 4 was 4.4% (97.5% CI: -4.4%, 13.2%), p=0.272). 16 serious adverse events were recorded, none related to study interventions.Zinc or probiotic supplementation did not significantly improve the low immunogenicity of rotavirus vaccine given to infants in a poor urban community in India. A modest effect of combined supplementation deserves further investigation.CONCLUSIONSZinc or probiotic supplementation did not significantly improve the low immunogenicity of rotavirus vaccine given to infants in a poor urban community in India. A modest effect of combined supplementation deserves further investigation.The trial was registered in India (CTRI/2012/05/002677).TRIAL REGISTRATIONThe trial was registered in India (CTRI/2012/05/002677). Strategies are needed to improve oral rotavirus vaccine (RV), which provides suboptimal protection in developing countries. Probiotics and zinc supplementation could improve RV immunogenicity by altering the intestinal microbiota and immune function.Infants 5weeks old living in urban Vellore, India were enrolled in a randomized, double-blind, placebo-controlled trial with a 4-arm factorial design to assess the effects of daily zinc (5mg), probiotic (10¹⁰Lactobacillus rhamnosus GG) or placebo on the immunogenicity of two doses of RV (Rotarix®, GlaxoSmithKline Biologicals) given at 6 and 10weeks of age. Infants were eligible for participation if healthy, available for the study duration and without prior receipt of RV or oral poliovirus vaccine other than the birth dose. The primary outcome was seroconversion to rotavirus at 14weeks of age based on detection of VP6-specific IgA at ≥20U/ml in previously seronegative infants or a fourfold rise in concentration.The study took place during July 2012 to February 2013. 620 infants were randomized equally between study arms and 551 (88.9%) completed per protocol. Seroconversion was recorded in 54/137 (39.4%), 42/136 (30.9%), 40/143 (28.0%), and 37/135 (27.4%) infants receiving (1) probiotic and zinc, (2) probiotic and placebo, (3) placebo and zinc, (4) two placebos. Seroconversion showed a modest improvement among infants receiving probiotic (difference between groups 1, 2 and 3, 4 was 7.5% (97.5% Confidence Interval (CI): −1.4%, 16.2%), p=0.066) but not zinc (difference between groups 1, 3 and 2, 4 was 4.4% (97.5% CI: −4.4%, 13.2%), p=0.272). 16 serious adverse events were recorded, none related to study interventions.Zinc or probiotic supplementation did not significantly improve the low immunogenicity of rotavirus vaccine given to infants in a poor urban community in India. A modest effect of combined supplementation deserves further investigation.The trial was registered in India (CTRI/2012/05/002677). •Oral rotavirus vaccines are less immunogenic and effective in low-income settings.•Infant gut microbiota and micronutrient status may contribute to this phenomenon.•We did a randomised controlled trial of probiotic and zinc supplementation in India.•Probiotic was associated with a modest (7.5%) improvement in vaccine immunogenicity.•Zinc supplementation (5mg/day) did not alter zinc status or vaccine immunogenicity. Strategies are needed to improve oral rotavirus vaccine (RV), which provides suboptimal protection in developing countries. Probiotics and zinc supplementation could improve RV immunogenicity by altering the intestinal microbiota and immune function. Infants 5weeks old living in urban Vellore, India were enrolled in a randomized, double-blind, placebo-controlled trial with a 4-arm factorial design to assess the effects of daily zinc (5mg), probiotic (1010Lactobacillus rhamnosus GG) or placebo on the immunogenicity of two doses of RV (Rotarix®, GlaxoSmithKline Biologicals) given at 6 and 10weeks of age. Infants were eligible for participation if healthy, available for the study duration and without prior receipt of RV or oral poliovirus vaccine other than the birth dose. The primary outcome was seroconversion to rotavirus at 14weeks of age based on detection of VP6-specific IgA at ≥20U/ml in previously seronegative infants or a fourfold rise in concentration. The study took place during July 2012 to February 2013. 620 infants were randomized equally between study arms and 551 (88.9%) completed per protocol. Seroconversion was recorded in 54/137 (39.4%), 42/136 (30.9%), 40/143 (28.0%), and 37/135 (27.4%) infants receiving (1) probiotic and zinc, (2) probiotic and placebo, (3) placebo and zinc, (4) two placebos. Seroconversion showed a modest improvement among infants receiving probiotic (difference between groups 1, 2 and 3, 4 was 7.5% (97.5% Confidence Interval (CI): −1.4%, 16.2%), p=0.066) but not zinc (difference between groups 1, 3 and 2, 4 was 4.4% (97.5% CI: −4.4%, 13.2%), p=0.272). 16 serious adverse events were recorded, none related to study interventions. Zinc or probiotic supplementation did not significantly improve the low immunogenicity of rotavirus vaccine given to infants in a poor urban community in India. A modest effect of combined supplementation deserves further investigation. The trial was registered in India (CTRI/2012/05/002677). Highlights•Oral rotavirus vaccines are less immunogenic and effective in low-income settings. •Infant gut microbiota and micronutrient status may contribute to this phenomenon. •We did a randomised controlled trial of probiotic and zinc supplementation in India. •Probiotic was associated with a modest (7.5%) improvement in vaccine immunogenicity. •Zinc supplementation (5 mg/day) did not alter zinc status or vaccine immunogenicity. |
| Author | Parker, Edward P.K. Grassly, Nicholas C. Muliyil, Jayaprakash Kang, Gagandeep Parashar, Umesh D. Raman, Uma Paranjpe, Meghana Kaliappan, P. Saravankumar John, Jacob Venugopal, Srinivasan Abraham, Asha M. Lazarus, Robin P. Giri, Sidhartha Thiagarajan, S. Fleming, Jessica A. Praharaj, Ira Tate, Jacqueline E. Rajan, Anand K. Steele, A. Duncan Sarkar, Rajiv Shanmugasundaram, E. Babji, Sudhir |
| AuthorAffiliation | 1 Division of Gastrointestinal Sciences, Christian Medical College, Vellore, India 6 PATH 7 Bill and Melinda Gates Foundation, Seattle, WA, USA 4 Imperial College of Medicine, London 5 Centers for Disease Control and Prevention, Atlanta, GA, USA 2 Department of Community Health, Christian Medical College, Vellore, India 3 Department of Clinical Virology, Christian Medical College, Vellore, India |
| AuthorAffiliation_xml | – name: 4 Imperial College of Medicine, London – name: 1 Division of Gastrointestinal Sciences, Christian Medical College, Vellore, India – name: 2 Department of Community Health, Christian Medical College, Vellore, India – name: 5 Centers for Disease Control and Prevention, Atlanta, GA, USA – name: 6 PATH – name: 7 Bill and Melinda Gates Foundation, Seattle, WA, USA – name: 3 Department of Clinical Virology, Christian Medical College, Vellore, India |
| Author_xml | – sequence: 1 givenname: Robin P. surname: Lazarus fullname: Lazarus, Robin P. organization: Division of Gastrointestinal Sciences, Christian Medical College, Vellore, India – sequence: 2 givenname: Jacob surname: John fullname: John, Jacob organization: Department of Community Health, Christian Medical College, Vellore, India – sequence: 3 givenname: E. surname: Shanmugasundaram fullname: Shanmugasundaram, E. organization: Division of Gastrointestinal Sciences, Christian Medical College, Vellore, India – sequence: 4 givenname: Anand K. surname: Rajan fullname: Rajan, Anand K. organization: Department of Clinical Virology, Christian Medical College, Vellore, India – sequence: 5 givenname: S. surname: Thiagarajan fullname: Thiagarajan, S. organization: Department of Clinical Virology, Christian Medical College, Vellore, India – sequence: 6 givenname: Sidhartha surname: Giri fullname: Giri, Sidhartha organization: Division of Gastrointestinal Sciences, Christian Medical College, Vellore, India – sequence: 7 givenname: Sudhir surname: Babji fullname: Babji, Sudhir organization: Division of Gastrointestinal Sciences, Christian Medical College, Vellore, India – sequence: 8 givenname: Rajiv surname: Sarkar fullname: Sarkar, Rajiv organization: Division of Gastrointestinal Sciences, Christian Medical College, Vellore, India – sequence: 9 givenname: P. Saravankumar surname: Kaliappan fullname: Kaliappan, P. Saravankumar organization: Division of Gastrointestinal Sciences, Christian Medical College, Vellore, India – sequence: 10 givenname: Srinivasan surname: Venugopal fullname: Venugopal, Srinivasan organization: Division of Gastrointestinal Sciences, Christian Medical College, Vellore, India – sequence: 11 givenname: Ira surname: Praharaj fullname: Praharaj, Ira organization: Division of Gastrointestinal Sciences, Christian Medical College, Vellore, India – sequence: 12 givenname: Uma surname: Raman fullname: Raman, Uma organization: Division of Gastrointestinal Sciences, Christian Medical College, Vellore, India – sequence: 13 givenname: Meghana surname: Paranjpe fullname: Paranjpe, Meghana organization: Division of Gastrointestinal Sciences, Christian Medical College, Vellore, India – sequence: 14 givenname: Nicholas C. surname: Grassly fullname: Grassly, Nicholas C. organization: Department of Infectious Disease Epidemiology, Imperial College London, London, UK – sequence: 15 givenname: Edward P.K. surname: Parker fullname: Parker, Edward P.K. organization: Department of Infectious Disease Epidemiology, Imperial College London, London, UK – sequence: 16 givenname: Umesh D. surname: Parashar fullname: Parashar, Umesh D. organization: Centers for Disease Control and Prevention, Atlanta, GA, USA – sequence: 17 givenname: Jacqueline E. surname: Tate fullname: Tate, Jacqueline E. organization: Centers for Disease Control and Prevention, Atlanta, GA, USA – sequence: 18 givenname: Jessica A. surname: Fleming fullname: Fleming, Jessica A. organization: PATH, Seattle, WA, USA – sequence: 19 givenname: A. Duncan surname: Steele fullname: Steele, A. Duncan organization: Bill and Melinda Gates Foundation, Seattle, WA, USA – sequence: 20 givenname: Jayaprakash surname: Muliyil fullname: Muliyil, Jayaprakash organization: Division of Gastrointestinal Sciences, Christian Medical College, Vellore, India – sequence: 21 givenname: Asha M. surname: Abraham fullname: Abraham, Asha M. organization: Department of Clinical Virology, Christian Medical College, Vellore, India – sequence: 22 givenname: Gagandeep surname: Kang fullname: Kang, Gagandeep email: gkang@cmcvellore.ac.in organization: Division of Gastrointestinal Sciences, Christian Medical College, Vellore, India |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/28874323$$D View this record in MEDLINE/PubMed |
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| Copyright | 2017 The Author(s) The Author(s) Copyright © 2017 The Author(s). Published by Elsevier Ltd.. All rights reserved. 2017. The Author(s) |
| Copyright_xml | – notice: 2017 The Author(s) – notice: The Author(s) – notice: Copyright © 2017 The Author(s). Published by Elsevier Ltd.. All rights reserved. – notice: 2017. The Author(s) |
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| Keywords | Poliovirus vaccine Lactobacillus GG Rotavirus vaccines Zinc India |
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| Snippet | •Oral rotavirus vaccines are less immunogenic and effective in low-income settings.•Infant gut microbiota and micronutrient status may contribute to this... Highlights•Oral rotavirus vaccines are less immunogenic and effective in low-income settings. •Infant gut microbiota and micronutrient status may contribute to... Strategies are needed to improve oral rotavirus vaccine (RV), which provides suboptimal protection in developing countries. Probiotics and zinc supplementation... BackgroundStrategies are needed to improve oral rotavirus vaccine (RV), which provides suboptimal protection in developing countries. Probiotics and zinc... |
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| SubjectTerms | Administration, Oral Age Allergy and Immunology Antibodies, Viral - blood Cholera Clinical trials confidence interval Confidence intervals Developing countries dietary mineral supplements Dietary supplements Double-Blind Method Enterovirus C Factorial design Female Hepatitis High income Humans Immune response Immune system Immunogenicity Immunoglobulin A Immunoglobulin A - blood India Infant Infants Infections Intestinal microflora intestinal microorganisms Intestine Lacticaseibacillus rhamnosus - immunology Lactobacillus Lactobacillus GG LDCs Low income groups Male Microbiota oral vaccination placebos Placebos - administration & dosage Poliovirus vaccine Probiotics Probiotics - administration & dosage Randomization Rotavirus Rotavirus vaccines Rotavirus Vaccines - administration & dosage Rotavirus Vaccines - immunology Seroconversion Treatment Outcome Urban areas urban population Vaccines Vaccines, Attenuated - administration & dosage Vaccines, Attenuated - immunology Viruses Zinc Zinc - administration & dosage |
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| Title | The effect of probiotics and zinc supplementation on the immune response to oral rotavirus vaccine: A randomized, factorial design, placebo-controlled study among Indian infants |
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