Trial of Antibody Responses by Vitamin Supplementation

NCT03859687 | Terminated Phase 1 FDA Drug

• 1 other identifier: PCVIT
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Keywords

Children; Vitamin Supplements; PCV13; Hepatitis A vaccine

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (14)

• Spearman's correlation coefficient of vaccine antibody responses at days 0 with baseline vitamin levels for each arm.

  Measured at Day 21

• Spearman's correlation coefficient of vaccine antibody responses at days 21 with baseline vitamin levels for each arm.

  Measured at Day 21

• 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.

  Measured at Day 21

• Correlation of immunoglobulin M (IgM) antibody (measured by Luminex assay)

  Measured at Day 21

• Correlation of immunoglobulin G subclass 1 (IgG1) antibody (measured by Luminex assay)

  Measured at Day 21

Study Arms (2)

Intervention group

EXPERIMENTAL

PCV (Prevnar-13 Vaccine) and the hepatitis A vaccine (Havrix Vaccine) plus a liquid oral vitamin A supplementation

Biological: Vitamin A supplementation

Control group

EXPERIMENTAL

PCV (Prevnar-13 Vaccine) and the hepatitis A vaccine (Havrix Vaccine) only, 'No vitamin A supplementation'

Biological: No vitamin A supplementation

Interventions

Vitamin A supplementation BIOLOGICAL

liquid oral vitamin A supplementation

Intervention group

No vitamin A supplementation BIOLOGICAL

No vitamin A supplementation

Control group

Eligibility Criteria

• Age: 1 Year - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• The Gerber Foundation: collaborator

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

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

MeSH Terms

Conditions

Hepatitis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Nehali Patel, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: March 1, 2019
• Study Start: August 19, 2019
• Primary Completion: July 10, 2025
• Study Completion: July 10, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-08

Locations

US (1)