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Trial of Antibody Responses by Vitamin Supplementation

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ClinicalTrials.gov Identifier: NCT03859687
Recruitment Status : Active, not recruiting
First Posted : March 1, 2019
Last Update Posted : March 2, 2021
Sponsor:
Collaborator:
The Gerber Foundation
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Tracking Information
First Submitted Date  ICMJE February 22, 2019
First Posted Date  ICMJE March 1, 2019
Last Update Posted Date March 2, 2021
Actual Study Start Date  ICMJE August 19, 2019
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2019)
  • Seroconversion rate in two arms [ Time Frame: Measured at Day 21 ]
    The seroconversion rate, defined as the proportion of 4X increases or conversion from undetectable to detectable response in vaccine-specific antibody after vaccinations (Day 21) versus the baseline (Day 0) antibody level in intervention and control groups will be estimated and 95% confidence interval will be described for both groups. The 95% confidence interval will serve as a measure of precision of the seroconversion rate estimate. Chi-square test will be performed to make the comparison between two arms.
  • Sera titer ratio [ Time Frame: Measured at Day 21 ]
    Titer ratios will be summarized with descriptive statistics. Two-sample tests (t-test or Wilcoxon rank-sum test) will be applied whenever appropriate
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2019)
  • Spearman's correlation coefficient of vaccine antibody responses at days 0 with baseline vitamin levels for each arm. [ Time Frame: Measured at Day 21 ]
    Spearman's correlation coefficient.
  • Spearman's correlation coefficient of vaccine antibody responses at days 21 with baseline vitamin levels for each arm. [ Time Frame: Measured at Day 21 ]
    Spearman's correlation coefficient.
  • Proportion of subjects showing 4X increases or conversion from undetectable to detectable response in B cell responses after vaccinations for both groups, and by VA/VD stratum. [ Time Frame: Measured at Day 21 ]
    The proportion difference with 95% confidence interval will be reported via Chi-square test or Fisher's test.
  • Correlation of immunoglobulin M (IgM) antibody (measured by Luminex assay) [ Time Frame: Measured at Day 21 ]
    Correlation will be expressed as Spearman's correlation coefficient.
  • Correlation of immunoglobulin G subclass 1 (IgG1) antibody (measured by Luminex assay) [ Time Frame: Measured at Day 21 ]
    Correlation will be expressed as Spearman's correlation coefficient.
  • Correlation of immunoglobulin G subclass 2 (IgG2) antibody (measured by Luminex assay [ Time Frame: Measured at Day 21 ]
    Correlation will be expressed as Spearman's correlation coefficient.
  • Correlation of immunoglobulin G subclass 3 (IgG3) antibody(measured by Luminex assay) [ Time Frame: Measured at Day 21 ]
    Correlation will be expressed as Spearman's correlation coefficient.
  • Correlation of immunoglobulin G subclass 4 (IgG4)antibody(measured by Luminex assay) [ Time Frame: Measured at Day 21 ]
    Correlation will be expressed as Spearman's correlation coefficient.
  • Correlation of immunoglobulin A (IgA) antibody(measured by Luminex assay) [ Time Frame: Measured at Day 21 ]
    Correlation will be expressed as Spearman's correlation coefficient
  • Correlation of immunoglobulin M (IgM) antibody(measured by Luminex assay) [ Time Frame: Measured at Day 21 ]
    Correlation will be expressed as Spearman's correlation coefficient.
  • Correlation of immunoglobulin G subclass 2 (IgG2) antibody(measured by Luminex assay) [ Time Frame: Measured at Day 21 ]
    Correlation will be expressed as Spearman's correlation coefficient.
  • Correlation of immunoglobulin G subclass 3 (IgG3) antibody (measured by Luminex assay) [ Time Frame: Measured at Day 21 ]
    Correlation will be expressed as Spearman's correlation coefficient.
  • Correlation of immunoglobulin G subclass 4 (IgG4) antibody(measured by Luminex assay) [ Time Frame: Measured at Day 21 ]
    Correlation will be expressed as Spearman's correlation coefficient.
  • Correlation of immunoglobulin A (IgA) antibody(measured by Luminex assay) [ Time Frame: Measured at Day 21 ]
    Correlation will be expressed as Spearman's correlation coefficient.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2019)
  • Spearman's correlation coefficient of vaccine antibody responses at days 0 with baseline vitamin levels for each arm. [ Time Frame: Measured at Day 21 ]
    Spearman's correlation coefficient.
  • Spearman's correlation coefficient of vaccine antibody responses at days 21 with baseline vitamin levels for each arm. [ Time Frame: Measured at Day 21 ]
    Spearman's correlation coefficient.
  • Proportion of subjects showing 4X increases or conversion from undetectable to detectable response in B cell responses after vaccinations for both groups, and by VA/VD stratum. [ Time Frame: Measured at Day 21 ]
    The proportion difference with 95% confidence interval will be reported via Chi-square test or Fisher's test.
  • Spearman's correlation coefficient of IgM score (Luminex assay) at day 0 with baseline vitamin levels overall, by treatment groups, and stratified by baseline vitamin levels. [ Time Frame: Measured at Day 21 ]
    Spearman's correlation coefficient.
  • Spearman's correlation coefficient of IgG1 score (Luminex assay) at day 0 with baseline vitamin levels overall, by treatment groups, and stratified by baseline vitamin levels. [ Time Frame: Measured at Day 21 ]
    Spearman's correlation coefficient.
  • Spearman's correlation coefficient of IgG2 score (Luminex assay) at day 0 with baseline vitamin levels overall, by treatment groups, and stratified by baseline vitamin levels. [ Time Frame: Measured at Day 21 ]
    Spearman's correlation coefficient.
  • Spearman's correlation coefficient of IgG3 score (Luminex assay) at day 0 with baseline vitamin levels overall, by treatment groups, and stratified by baseline vitamin levels. [ Time Frame: Measured at Day 21 ]
    Spearman's correlation coefficient.
  • Spearman's correlation coefficient of IgG4 score (Luminex assay) at day 0 with baseline vitamin levels overall, by treatment groups, and stratified by baseline vitamin levels. [ Time Frame: Measured at Day 21 ]
    Spearman's correlation coefficient.
  • Spearman's correlation coefficient of IgA score (Luminex assay) at day 0 with baseline vitamin levels overall, by treatment groups, and stratified by baseline vitamin levels. [ Time Frame: Measured at Day 21 ]
    Spearman's correlation coefficient.
  • Spearman's correlation coefficient of IgM score (Luminex assay) at day 21 with baseline vitamin levels overall, by treatment groups, and stratified by baseline vitamin levels. [ Time Frame: Measured at Day 21 ]
    Spearman's correlation coefficient.
  • Spearman's correlation coefficient of IgG1 score (Luminex assay) at day 21 with baseline vitamin levels overall, by treatment groups, and stratified by baseline vitamin levels. [ Time Frame: Measured at Day 21 ]
    Spearman's correlation coefficient.
  • Spearman's correlation coefficient of IgG2 score (Luminex assay) at day 21 with baseline vitamin levels overall, by treatment groups, and stratified by baseline vitamin levels. [ Time Frame: Measured at Day 21 ]
    Spearman's correlation coefficient.
  • Spearman's correlation coefficient of IgG3 score (Luminex assay) at day 21 with baseline vitamin levels overall, by treatment groups, and stratified by baseline vitamin levels. [ Time Frame: Measured at Day 21 ]
    Spearman's correlation coefficient.
  • Spearman's correlation coefficient of IgG4 score (Luminex assay) at day 21 with baseline vitamin levels overall, by treatment groups, and stratified by baseline vitamin levels [ Time Frame: Measured at Day 21 ]
    Spearman's correlation coefficient.
  • Spearman's correlation coefficient of IgA score (Luminex assay) at day 21 with baseline vitamin levels overall, by treatment groups, and stratified by baseline vitamin levels. [ Time Frame: Measured at Day 21 ]
    Spearman's correlation coefficient.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Antibody Responses by Vitamin Supplementation
Official Title  ICMJE A Randomized Controlled Trial of Antibody Responses by Vitamin Supplementation at the Time of Pneumococcus Vaccination in Children
Brief Summary

Streptococcus pneumoniae, commonly called pneumococcus, can cause a wide range of diseases in children from mild ear infections to deadly pneumonia or meningitis. Vaccination is currently the single best way to protect children. Nutrition, especially the amount of vitamin A, may play a role in how well your body responds to infection or a vaccine. We call this an immune response. This research will look to see if children who take a vitamin with their vaccine have a better immune response than children who do not take a vitamin with their vaccine.

Primary Objective

To evaluate the influence of vitamin A supplementation on Prevnar vaccine immunogenicity based on changes in antibody scores in a commercial ELISA at Day 21 (after a booster vaccine dose) compared to pre-vaccine values.

Secondary Objectives

  • To evaluate the relationship between baseline vitamin levels and pneumococcal or hepatitis A vaccine antibody responses (based on in commercial ELISAs) at Days 0 and 21.
  • To evaluate the influence of vitamin A supplementation on hepatitis vaccine immunogenicity based on changes in antibody scores in a commercial ELISA at Day 21 compared to pre-vaccine values.
  • To evaluate relationships between total serum antibodies (based on individual IgM, IgG1, IgG2, IgG3, IgG4, and IgA scores in a Luminex assay) at Day 0 and changes between Days 0 and 21 with baseline (Day 0) vitamin levels in young children, and with vitamin A supplementation.
Detailed Description Children between the ages of 1 and 4 years old (inclusive) will be enrolled. All will receive PCV and hepatitis A vaccination. Those randomized to the treatment arm will receive 10,000 IU orally at the time of vaccination, while those randomized to the control arm will only receive vaccines. Vitamin levels and antibody responses towards the vaccines will be measured at screening, Day 0 (vaccination day) and Day +21. Children will be randomized using a stratified permuted block method.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Healthy Participants
Intervention  ICMJE
  • Biological: Vitamin A supplementation
    liquid oral vitamin A supplementation
  • Biological: No vitamin A supplementation
    No vitamin A supplementation
Study Arms  ICMJE
  • Experimental: Intervention group
    PCV (Prevnar-13 Vaccine) and the hepatitis A vaccine (Havrix Vaccine) plus a liquid oral vitamin A supplementation
    Intervention: Biological: Vitamin A supplementation
  • Experimental: Control group
    PCV (Prevnar-13 Vaccine) and the hepatitis A vaccine (Havrix Vaccine) only, 'No vitamin A supplementation'
    Intervention: Biological: No vitamin A supplementation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 27, 2019)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 12, 2024
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Between 1 and 4 years old (inclusive) at the time of enrollment
  • Fully weaned from breast-feeding or formula-feeding for at least 4 weeks prior to vaccination date (Day 0).
  • Received at least 2 doses of Prevnar-13 vaccination
  • Parent or legal guardian willing and able to provide informed consent.

Exclusion Criteria:

  • Current use of investigational or immunosuppressive drugs (e.g., steroids) at the time of enrollment
  • Parent/guardian planning to continue (or initiate) the administration of daily vitamin A, vitamin D, or multivitamin to the child during the study period.
  • Evidence of developmental delay or evolving neurological disorders at screening.
  • Current use of antibiotics or antivirals at enrollment.
  • Currently receiving cancer related treatment.
  • History of heart, kidney, or chronic respiratory condition (e.g., asthma) conditions.
  • History of diabetes.
  • Acute febrile illness [e.g., >100.0F (37.8oC) oral] illness within 3 days prior to enrollment.
  • Received a previous PCV13 vaccine within 2 months of the enrollment date (Day 0).
  • Received hepatitis A vaccine previously.
  • Ever had a life-threatening allergic reaction to a dose of PCV13 vaccine, to an earlier pneumococcal vaccine called PCV7, or to any vaccine containing diptheria toxoid (for example, DTaP).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 4 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03859687
Other Study ID Numbers  ICMJE PCVIT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party St. Jude Children's Research Hospital
Study Sponsor  ICMJE St. Jude Children's Research Hospital
Collaborators  ICMJE The Gerber Foundation
Investigators  ICMJE
Principal Investigator: Nehali Patel, MD St. Jude Children's Research Hospital
PRS Account St. Jude Children's Research Hospital
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP