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AzTrials

Healthy ParticipantsPhase 1NCT03859687

Trial of Antibody Responses by Vitamin Supplementation

A Phase 1 study testing Vitamin A supplementation and No vitamin A supplementation in people with Healthy Participants, run by St. Jude Children's Research Hospital at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 1 year to 4 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants
What is being tested?
Vitamin A supplementation and No vitamin A supplementation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited States
Study dates
19 Aug 2019to 10 Jul 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 4 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105

Other trials in United States

About this study

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

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

Read more

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.
Read the 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.

Being tested
Vitamin A supplementation, No vitamin A supplementation
Keywords
Children, Vitamin Supplements, PCV13, Hepatitis A vaccine
Medical subject headings
Hepatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin A supplementationBiological

    liquid oral vitamin A supplementation

  • No vitamin A supplementationBiological

    No vitamin A supplementation

Study groups in NCT03859687
Study groupRoleWhat they receive
Intervention groupExperimentalPCV (Prevnar-13 Vaccine) and the hepatitis A vaccine (Havrix Vaccine) plus a liquid oral vitamin A supplementation
Receives: Biological: Vitamin A supplementation
Control groupExperimentalPCV (Prevnar-13 Vaccine) and the hepatitis A vaccine (Havrix Vaccine) only, 'No vitamin A supplementation'
Receives: Biological: No vitamin A supplementation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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: Measured at Day 21

  2. 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: Measured at Day 21

Secondary outcomes (14)

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

    Spearman's correlation coefficient.

    Measured: Measured at Day 21

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

    Spearman's correlation coefficient.

    Measured: Measured at Day 21

  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.

    The proportion difference with 95% confidence interval will be reported via Chi-square test or Fisher's test.

    Measured: Measured at Day 21

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

    Correlation will be expressed as Spearman's correlation coefficient.

    Measured: Measured at Day 21

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

    Correlation will be expressed as Spearman's correlation coefficient.

    Measured: Measured at Day 21

  6. Correlation of immunoglobulin G subclass 2 (IgG2) antibody (measured by Luminex assay

    Correlation will be expressed as Spearman's correlation coefficient.

    Measured: Measured at Day 21

  7. Correlation of immunoglobulin G subclass 3 (IgG3) antibody(measured by Luminex assay)

    Correlation will be expressed as Spearman's correlation coefficient.

    Measured: Measured at Day 21

  8. Correlation of immunoglobulin G subclass 4 (IgG4)antibody(measured by Luminex assay)

    Correlation will be expressed as Spearman's correlation coefficient.

    Measured: Measured at Day 21

  9. Correlation of immunoglobulin A (IgA) antibody(measured by Luminex assay)

    Correlation will be expressed as Spearman's correlation coefficient

    Measured: Measured at Day 21

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

    Correlation will be expressed as Spearman's correlation coefficient.

    Measured: Measured at Day 21

  11. Correlation of immunoglobulin G subclass 2 (IgG2) antibody(measured by Luminex assay)

    Correlation will be expressed as Spearman's correlation coefficient.

    Measured: Measured at Day 21

  12. Correlation of immunoglobulin G subclass 3 (IgG3) antibody (measured by Luminex assay)

    Correlation will be expressed as Spearman's correlation coefficient.

    Measured: Measured at Day 21

  13. Correlation of immunoglobulin G subclass 4 (IgG4) antibody(measured by Luminex assay)

    Correlation will be expressed as Spearman's correlation coefficient.

    Measured: Measured at Day 21

  14. Correlation of immunoglobulin A (IgA) antibody(measured by Luminex assay)

    Correlation will be expressed as Spearman's correlation coefficient.

    Measured: Measured at Day 21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2019
  2. Study start19 Aug 2019
  3. Primary completion10 Jul 2025
  4. Study completion10 Jul 2025

Why it stopped: Difficulty in starting recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03859687
Sponsor's protocol ID
PCVIT
Status last verified
Aug 2025
First submitted
22 Feb 2019
Last updated
5 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vitamin A supplementation and No vitamin A supplementation in people with Healthy Participants, run by St. Jude Children's Research Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Difficulty in starting recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Seroconversion rate in two arms (time frame: Measured at Day 21). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03859687.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.

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