Influenza Virus Vaccine Plus Vitamin A and D Supplements for Prevention of Respiratory Virus Infections in Children
Condition: Healthy Participants
MeSH terms: Influenza, Human
Intervention: Influenza virus vaccine; Vitamins A and D; Placebo
Intervention description: Children will have the first influenza virus vaccine dose (dose 1) administered on day 0 of the trial, and the second dose (dose 2) administered 28 days later.; The chewable gummy contains either Vitamin A (20,000 International Units) and Vitamin D3 (2,000 International Units), which should be fully chewed under supervision of study staff with documentation in the participant's research record and eMAR (electronic medical administration record). The chewable gummy should be administered prior to receiving influenza virus vaccination.; The chewable gummy matched placebo will be formulated with gelatin base and tangerine oil and match the Vitamin A and D in shape, taste, texture, and appearance. Gummies should be fully chewed under supervision of study staff with documentation in the participant's research record and eMAR (electronic medical administration record). The chewable gummy should be administered prior to receiving influenza virus vaccination.
Intervention MeSH terms: Vitamin D; Vitamin A
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 87.0
Sex: All
Minimum age: 2 Years
Maximum age: 8 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Children; Vitamin Supplements; Influenza virus vaccine

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