Phase 2
N=79
Influenza Virus Vaccine Plus Vitamin A and D Supplements for Prevention of Respiratory Virus Infections in Children
Healthy Participants
Bottom Line
View on ClinicalTrials.gov: NCT02649192 ↗Enrolled (actual)
79
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Percentage of Participants With Positive Responses in Virus-specific Antibody in Sera — 80; 75; 100; 100 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Influenza virus vaccine (Biological); Vitamins A and D (Dietary_supplement); Placebo (Other)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- St. Jude Children's Research Hospital
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Positive Responses in Virus-specific Antibody in Sera |
80; 75; 100; 100; 100; 100 | — |
| PRIMARY Isotype Ratios on Day 56 |
0.4; 0.3; 0.3; 0.27; 0.21; 0.28 | 0.90 |
| SECONDARY Percentage of Participants With Seroconversion at Day 56 After Vaccination, Overall |
0; 0; 71.4; 95.0; 72.7; 85.7 | — |
| SECONDARY Percentage of Participants With Seroconversion at Day 56 After Vaccination, by Vitamin A Levels at Screening |
0; 0; 81.8; 100; 100; 87.5 | — |
| SECONDARY HAI Titers at Day 56 After Vaccination, Overall |
5; 5; 640; 640; 905; 1280 | — |
| SECONDARY HAI Titers at Day 56 After Vaccination, by Vitamin A Levels at Screening |
5; 5; 640; 640; 1280; 640 | — |
Summary
Children are particularly vulnerable to respiratory virus infections, especially influenza. Vitamin A & D deficiencies are associated with vulnerability to infectious diseases of the respiratory tract. The central hypothesis of this protocol is that vitamin supplements will enhance antibody responses toward the flu vaccine in children. Children, 2-8 years old, will be randomized to receive influenza virus vaccine with a vitamin A+D supplement or influenza virus vaccine with placebo. Children will be tested for vitamin levels and immune responses before and after influenza virus vaccinations to determine if vitamin supplementation improves the influenza virus vaccine-induced immune response.
PRIMARY OBJECTIVE:
* To assess the vaccine-induced and total antibody (including IgG and IgA) response after influenza virus vaccine administration and IgA/IgG plus IgA/IgM ratios at 28 and 56 days in sera
SECONDARY OBJECTIVE:
* To assess the neutralizing response toward influenza virus vaccine in the sera.
Eligibility Criteria
Inclusion Criteria
- Resident of the Memphis area community.
- Parent or legal guardian willing and able to give informed consent and comply with study requirements.
Exclusion Criteria
- Current use of investigational or immunosuppressive drugs (e.g., steroids) at the time of enrollment.
- Currently taking a daily (routine) vitamin A, D, or multivitamin. Note: participants who report occasional or sporadic vitamin use will be allowed to enroll.
- History of lung disease, asthma, immunodeficiency, sickle cell disease, or any other serious underlying condition or disease in the opinion of the principal investigator.
- Evidence of developmental delay or evolving neurological disorders at screening. Current use of antibiotics or antivirals at enrollment.
- History of having a severe allergy to eggs or to any inactive ingredient in the influenza virus vaccine
- History of a life-threatening reaction to influenza vaccinations
- Currently wheezing at the time of enrollment
- History of heart, kidney, or lung conditions
- History of diabetes
- Use of an anti-influenza medication (including amantadine, rimantadine, oseltamivir, and zanamivir) within 14 days prior to enrollment
- Acute febrile [>100.0°F (37.8°C) oral] illness or acute respiratory illness (e.g., cough or sore throat) within 3 days prior to enrollment
- Previous receipt of current seasonal influenza vaccine
Data sourced from ClinicalTrials.gov (NCT02649192). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.