Trial of Antibody Responses by Vitamin Supplementation
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 1 - 4 |
| Updated: | 4/6/2019 |
| Start Date: | April 2019 |
| End Date: | February 12, 2024 |
| Contact: | Nehali Patel, MD |
| Email: | referralinfo@stjude.org |
| Phone: | 1-866-278-5833 |
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
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.
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.
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.
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.
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).
We found this trial at
1
site
262 Danny Thomas Pl
Memphis, Tennessee 38105
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Nehali Patel, MD
Phone: 866-278-5833
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