Healthy ParticipantsPhase 2NCT02649192

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

A Phase 2 study testing Influenza virus vaccine and Vitamins A and D in people with Healthy Participants, run by St. Jude Children's Research Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 2 to 8 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Participants
What is being tested?: Influenza virus vaccine and Vitamins A and D
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 87 participants
Where: 1 siteUnited States
Study dates: 21 Jan 2016to 29 Jun 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 2 to 8 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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

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 Double-Blind, Randomized, Placebo-Controlled Study of Antibody Induction by Vitamin Supplementation at the Time of Influenza Virus Vaccinations in Children

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.

Read the detailed description

Participants will be randomized to receive either an influenza virus vaccine plus Vitamins A \& D or an influenza virus vaccine plus placebo. They will be stratified based on retinol binding protein (RBP) levels at screening, using a cut-off indicative of Vitamin A insufficiency (≤22,000 ng/ml). Co-enrolled sibling participants will be first stratified by RBP levels, then siblings within the same stratum will be equally assigned to different arms to provide greater assurance of balanced treatment assignment. 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 antibody immune response.

All participants will receive two doses of an influenza virus vaccination administered at least 28 days apart. Vitamin levels and antibody responses toward the vaccine will be measured on day 0 (baseline levels obtained where day 0 equals the first influenza virus vaccination administration), day 28, and day 56. Placebo or Vitamins A + D (at the levels of 20,000 IU and 2,000 IU, respectively) will be administered orally on the days of vaccination.

Blood serum samples will be collected from participants on Day 0, prior to receiving influenza virus vaccine on Day 28, and during their Day 56 follow-up visit.

Parents will be asked to fill out diary cards to indicate food intake for children during the study period along with an optional food frequency questionnaire given on day 56. Specific measurements on days 28, and 56 will include analyses of vaccine-specific and total IgA, IgG, and IgA/IgG plus IgA/IgM ratios in sera. Functional activities of antibodies toward influenza vaccine will also be measured.

Conditions: Healthy Participants
Being tested: Influenza virus vaccine, Vitamins A and D, Placebo
Keywords: Children, Vitamin Supplements, Influenza virus vaccine
Medical subject headings: Influenza, Human

What participants receive

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

Influenza virus vaccineBiological
Also called Fluzone®
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.
Vitamins A and DDietary supplement
Also called Nutritional 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.
PlaceboOther
Also called Look-alike Medication, Matched Placebo
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.

Study groups in NCT02649192
Study group	Role	What they receive
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. Receives: 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. Receives: Biological: Influenza virus vaccine; Other: Placebo

What is being measured

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

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.
Measured: Day 56 after vaccination
Isotype Ratios on Day 56
Isotype ratios will be summarized with descriptive statistics.
Measured: Day 56 after vaccination

Secondary outcomes (4)

Percentage of Participants With Seroconversion at Day 56 After Vaccination, Overall
Secondary analyses will examine sero-conversion based on antibody functions (HAI or neutralization) defined as antibody titers of <1:40 converting to ≥1:40, or a four-fold increase in titer for participants with a starting titer of ≥1:40. Sero-conversion rate (expressed as percentage) will be estimated with 95% confidence interval. The rate difference will be described with point estimate and 95% confidence interval.
Measured: Day 56 after vaccination
Percentage of Participants With Seroconversion at Day 56 After Vaccination, by Vitamin A Levels at Screening
Secondary analyses will examine sero-conversion based on antibody functions (HAI or neutralization) defined as antibody titers of <1:40 converting to ≥1:40, or a four-fold increase in titer for participants with a starting titer of ≥1:40. Sero-conversion rate (expressed as percentage) will be estimated with 95% confidence interval for participants sufficient and insufficient in vitamin A at screening.
Measured: Day 56 after vaccination
HAI Titers at Day 56 After Vaccination, Overall
Measured: Day 56 after vaccination
HAI Titers at Day 56 After Vaccination, by Vitamin A Levels at Screening
Measured: Day 56 after vaccination

Timeline

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

21 Jan 201629 Jun 2018

First posted7 Jan 2016 (estimated)
Study start21 Jan 2016
Primary completion29 Jun 2018
Study completion29 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 87 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02649192
Sponsor's protocol ID: FLUVIT
Status last verified: Oct 2019
First submitted: 6 Jan 2016
Last updated: 29 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Randomized, Placebo-Controlled Study of Antibody Induction by Vitamin Supplementation at the Time of Influenza Virus Vaccinations in Children
ClinicalTrials.gov ID: NCT02649192
Acronym / sponsor ID: FLUVIT
Conditions: Healthy Participants
Keywords: Children, Vitamin Supplements, Influenza virus vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 87 participants (actual)
Lead sponsor: St. Jude Children's Research HospitalUniversity, hospital or other
Study start: 21 Jan 2016 (actual)
Primary completion: 29 Jun 2018 (actual)
Study completion: 29 Jun 2018 (actual)
First posted: 7 Jan 2016 (estimated)
Results: Posted 25 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Blood serum samples will be collected from participants on Day 0, prior to receiving influenza virus vaccine on Day 28, and during their Day 56 follow-up visit.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Influenza Virus Vaccine Plus Vitamins A and D	Active comparator	Biological: Influenza virus vaccine, Dietary Supplement: Vitamins A and DParticipants receive influenza virus vaccine and Vitamins A and D supplement on Day 0 and Day 28.
Influenza Virus Vaccine Plus Placebo	Placebo comparator	Biological: Influenza virus vaccine, Other: PlaceboParticipants receive influenza virus vaccine and matched placebo on Day 0 and Day 28.

Who may qualify

Ages: 2 to 8 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (2 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Influenza virus vaccineAlso: Fluzone®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.	Biological	Influenza Virus Vaccine Plus Placebo, Influenza Virus Vaccine Plus Vitamins A and D
Vitamins A and DAlso: Nutritional SupplementThe 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.	Dietary supplement	Influenza Virus Vaccine Plus Vitamins A and D
PlaceboAlso: Look-alike Medication, Matched PlaceboThe 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.	Other	Influenza Virus Vaccine Plus Placebo

Primary outcome

Percentage of Participants With Positive Responses in Virus-specific Antibody in Sera
Time frame: Day 56 after vaccination
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.
Isotype Ratios on Day 56
Time frame: Day 56 after vaccination
Isotype ratios will be summarized with descriptive statistics.

4 secondary outcomes

Percentage of Participants With Seroconversion at Day 56 After Vaccination, Overall
Time frame: Day 56 after vaccination
Percentage of Participants With Seroconversion at Day 56 After Vaccination, by Vitamin A Levels at Screening
Time frame: Day 56 after vaccination
HAI Titers at Day 56 After Vaccination, Overall
Time frame: Day 56 after vaccination
HAI Titers at Day 56 After Vaccination, by Vitamin A Levels at Screening
Time frame: Day 56 after vaccination

Results and safety

Results posted to the registry on 25 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
A&D - S1	5	5
Placebo - S1	4	4
A&D - S2	22	21
Placebo - S2	22	20
A&D - S3	12	11
Placebo - S3	14	14

Primary outcome: Percentage of Participants With Positive Responses in Virus-specific Antibody in Sera

Time frame: Day 56 after vaccination. Number. Unit: percentage of participants

Measure	A&D - S1 n = 5	Placebo - S1 n = 4	A&D - S2 n = 22	Placebo - S2 n = 22	A&D - S3 n = 12	Placebo - S3 n = 14
Value	80	75	100	100	100	100

Population analysed: All enrolled subjects who satisfied the inclusion/exclusion criteria were included in the analysis. For the four participants who didn't complete the study, results after one immunization were used.

Primary outcome: Isotype Ratios on Day 56

Time frame: Day 56 after vaccination. Median (Full Range). Unit: ratio

Measure	A&D-S1 n = 5	Placebo - S1 n = 4	A&D - S2 n = 20	Placebo - S2 n = 20	A&D - S3 n = 11	Placebo - S3 n = 14
IgA/IgG1	0.4 (0.06 to 0.67)	0.3 (0.22 to 0.5)	0.3 (0.004 to 0.63)	0.27 (0.13 to 0.47)	0.21 (0.13 to 0.65)	0.28 (0.12 to 0.87)
IgA/IgG2	0.71 (0.24 to 0.85)	0.69 (0.49 to 1.93)	0.96 (0.004 to 6.3)	1.13 (0.58 to 4.45)	0.65 (0.19 to 2.03)	0.75 (0.22 to 2.39)
IgA/IgG3	2.73 (0.38 to 7.75)	3.03 (1.55 to 7.44)	1.44 (0.02 to 6.97)	1.68 (0.29 to 5.13)	2.4 (0.89 to 12.5)	3.02 (0.41 to 12.3)
IgA/IgM	2.48 (0.16 to 2.8)	1.37 (0.83 to 2.89)	1.21 (0.03 to 3.06)	1.21 (0.45 to 2.88)	0.86 (0.23 to 1.9)	1 (0.14 to 3.26)

A&D-S1 vs Placebo - S1: p = 0.90, Wilcoxon (Mann-Whitney)
A&D - S2 vs Placebo - S2: p = 0.49, Wilcoxon (Mann-Whitney)
A&D - S3 vs Placebo - S3: p = 0.50, Wilcoxon (Mann-Whitney)

Population analysed: Subjects with complete isotype data at day 56. Subjects with an undetermined assay result were not included in analyses. In some cases, the limit of detection (LOD) for the assay was reached and that LOD value was used in calculations.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 56 days after the final participant was dosed on Day 0.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
A&D-S1	0 of 5 (0%)	5 of 5 (100%)	0 of 5
Placebo - S1	0 of 4 (0%)	2 of 4 (50%)	0 of 4
A&D - S2	0 of 22 (0%)	6 of 22 (27.3%)	0 of 22
Placebo - S2	0 of 22 (0%)	6 of 22 (27.3%)	0 of 22
A&D - S3	0 of 12 (0%)	4 of 12 (33.3%)	0 of 12
Placebo - S3	0 of 14 (0%)	3 of 14 (21.4%)	0 of 14

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
St. Jude Children's Research HospitalLink provided by the sponsor.
Clinical Trials Open at St. JudeLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nehali Patel, MD principal investigator

St. Jude Children's Research Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Influenza virus vaccine and Vitamins A and D 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 2 inclusion and 12 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: finished, as of the sponsor's last update on 29 Oct 2019. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Positive Responses in Virus-specific Antibody in Sera (time frame: Day 56 after vaccination). 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 NCT02649192.

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 29 Oct 2019.