Trial of Antibody Responses by Vitamin Supplementation

Healthy Participants Clinical Trial

Official title:

A Randomized Controlled Trial of Antibody Responses by Vitamin Supplementation at the Time of Pneumococcus Vaccination in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03859687
• Other study ID #: PCVIT
• Status: Recruiting
• Phase: Phase 1
• Start date: August 19, 2019
• Est. completion date: January 12, 2026

Study information

• Verified date: February 2024
• Source: St. Jude Children's Research Hospital
• Contact: Nehali Patel, MD
• Phone: 1-866-278-5833
• Email: referralinfo[@]stjude.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 12, 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 4 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Biological:
• Vitamin A supplementation
liquid oral vitamin A supplementation
• No vitamin A supplementation
No vitamin A supplementation

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital	The Gerber Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroconversion rate in two arms	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.	Measured at Day 21
Primary	Sera titer ratio	Titer ratios will be summarized with descriptive statistics. Two-sample tests (t-test or Wilcoxon rank-sum test) will be applied whenever appropriate	Measured at Day 21
Secondary	Spearman's correlation coefficient of vaccine antibody responses at days 0 with baseline vitamin levels for each arm.	Spearman's correlation coefficient.	Measured at Day 21
Secondary	Spearman's correlation coefficient of vaccine antibody responses at days 21 with baseline vitamin levels for each arm.	Spearman's correlation coefficient.	Measured at Day 21
Secondary	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.	The proportion difference with 95% confidence interval will be reported via Chi-square test or Fisher's test.	Measured at Day 21
Secondary	Correlation of immunoglobulin M (IgM) antibody (measured by Luminex assay)	Correlation will be expressed as Spearman's correlation coefficient.	Measured at Day 21
Secondary	Correlation of immunoglobulin G subclass 1 (IgG1) antibody (measured by Luminex assay)	Correlation will be expressed as Spearman's correlation coefficient.	Measured at Day 21
Secondary	Correlation of immunoglobulin G subclass 2 (IgG2) antibody (measured by Luminex assay	Correlation will be expressed as Spearman's correlation coefficient.	Measured at Day 21
Secondary	Correlation of immunoglobulin G subclass 3 (IgG3) antibody(measured by Luminex assay)	Correlation will be expressed as Spearman's correlation coefficient.	Measured at Day 21
Secondary	Correlation of immunoglobulin G subclass 4 (IgG4)antibody(measured by Luminex assay)	Correlation will be expressed as Spearman's correlation coefficient.	Measured at Day 21
Secondary	Correlation of immunoglobulin A (IgA) antibody(measured by Luminex assay)	Correlation will be expressed as Spearman's correlation coefficient	Measured at Day 21
Secondary	Correlation of immunoglobulin M (IgM) antibody(measured by Luminex assay)	Correlation will be expressed as Spearman's correlation coefficient.	Measured at Day 21
Secondary	Correlation of immunoglobulin G subclass 2 (IgG2) antibody(measured by Luminex assay)	Correlation will be expressed as Spearman's correlation coefficient.	Measured at Day 21
Secondary	Correlation of immunoglobulin G subclass 3 (IgG3) antibody (measured by Luminex assay)	Correlation will be expressed as Spearman's correlation coefficient.	Measured at Day 21
Secondary	Correlation of immunoglobulin G subclass 4 (IgG4) antibody(measured by Luminex assay)	Correlation will be expressed as Spearman's correlation coefficient.	Measured at Day 21
Secondary	Correlation of immunoglobulin A (IgA) antibody(measured by Luminex assay)	Correlation will be expressed as Spearman's correlation coefficient.	Measured at Day 21

External Links

•   Clinical Trials Open at St. Jude
•   St. Jude Children's Research Hospital