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Trial of Antibody Responses by Vitamin Supplementation

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ClinicalTrials.gov Identifier: NCT03859687
Recruitment Status : Not yet recruiting
First Posted : March 1, 2019
Last Update Posted : April 5, 2019
Sponsor:
Collaborator:
The Gerber Foundation
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

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.

Condition or disease Intervention/treatment Phase
Healthy Participants Biological: Vitamin A supplementation Biological: No vitamin A supplementation Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Antibody Responses by Vitamin Supplementation at the Time of Pneumococcus Vaccination in Children
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 12, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin A

Arm Intervention/treatment
Experimental: Intervention group
PCV (Prevnar-13 Vaccine) and the hepatitis A vaccine (Havrix Vaccine) plus a liquid oral vitamin A supplementation
Biological: Vitamin A supplementation
liquid oral vitamin A supplementation

Experimental: Control group
PCV (Prevnar-13 Vaccine) and the hepatitis A vaccine (Havrix Vaccine) only, 'No vitamin A supplementation'
Biological: No vitamin A supplementation
No vitamin A supplementation




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859687


Contacts
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Contact: Nehali Patel, MD 1-866-278-5833 referralinfo@stjude.org

Locations
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United States, Tennessee
St. Jude Children's Research Hospital Not yet recruiting
Memphis, Tennessee, United States, 38105
Contact: Nehali Patel, MD    866-278-5833    referralinfo@stjude.org   
Principal Investigator: Nehali Patel, MD         
Sponsors and Collaborators
St. Jude Children's Research Hospital
The Gerber Foundation
Investigators
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Principal Investigator: Nehali Patel, MD St. Jude Children's Research Hospital

Additional Information:
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Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT03859687     History of Changes
Other Study ID Numbers: PCVIT
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by St. Jude Children's Research Hospital:
Children
Vitamin Supplements
PCV13
Hepatitis A vaccine

Additional relevant MeSH terms:
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Vaccines
Antibodies
Vitamins
Vitamin A
Retinol palmitate
Immunologic Factors
Physiological Effects of Drugs
Micronutrients
Nutrients
Growth Substances
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents