Influenza Virus Vaccine Plus Vitamin A and D Supplements for Prevention of Respiratory Virus Infections in Children

NCT02649192 | Completed Phase 2 Results FDA Drug

• 1 other identifier: FLUVIT
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Participants

Keywords

Children; Vitamin Supplements; Influenza virus vaccine

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Positive Responses in Virus-specific Antibody in Sera

  The percentage of 2X increases or conversion from undetectable to detectable response in virus-specific antibody toward any vaccine component after 2 immunizations in intervention and control groups will be reported.

  Day 56 after vaccination

• Isotype Ratios on Day 56

  Isotype ratios will be summarized with descriptive statistics.

  Day 56 after vaccination

Secondary Outcomes (4)

• Percentage of Participants With Seroconversion at Day 56 After Vaccination, Overall

  Day 56 after vaccination

• Percentage of Participants With Seroconversion at Day 56 After Vaccination, by Vitamin A Levels at Screening

  Day 56 after vaccination

• HAI Titers at Day 56 After Vaccination, Overall

  Day 56 after vaccination

• HAI Titers at Day 56 After Vaccination, by Vitamin A Levels at Screening

  Day 56 after vaccination

Study Arms (2)

Influenza Virus Vaccine Plus Vitamins A and D

ACTIVE COMPARATOR

Participants receive influenza virus vaccine and Vitamins A and D supplement on Day 0 and Day 28.

Biological: Influenza virus vaccine; Dietary Supplement: Vitamins A and D

Influenza Virus Vaccine Plus Placebo

PLACEBO COMPARATOR

Participants receive influenza virus vaccine and matched placebo on Day 0 and Day 28.

Biological: Influenza virus vaccine; Other: Placebo

Interventions

Influenza virus vaccine BIOLOGICAL

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.

Also known as: Fluzone®

Influenza Virus Vaccine Plus Placebo; Influenza Virus Vaccine Plus Vitamins A and D

Vitamins A and D DIETARY_SUPPLEMENT

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.

Also known as: Nutritional Supplement

Influenza Virus Vaccine Plus Vitamins A and D

Placebo OTHER

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.

Also known as: Look-alike Medication, Matched Placebo

Influenza Virus Vaccine Plus Placebo

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Resident of the Memphis area community.
• Parent or legal guardian willing and able to give informed consent and comply with study requirements.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

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

Influenza, Human

Interventions

Influenza Vaccines; Fumigant 93; Dietary Supplements; Medication Errors

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Drug Therapy; Therapeutics; Medical Errors; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Nehali Patel, MD
• Organization: St. Jude Children's Research Hospital

info@stjude.org

866-278-5833

Study Officials

• Nehali Patel, MD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: January 7, 2016
• Study Start: January 21, 2016
• Primary Completion: June 29, 2018
• Study Completion: June 29, 2018
• Last Updated: October 29, 2019
• Results First Posted: September 25, 2019

Record last verified: 2019-10

Locations

US (1)