ADITEC FLU 2 STUDY: Understanding the Genetics Basis for Immune Responses to Flu Vaccines in Children and Adults

NCT02529904 | Completed Phase 2 DMC

• 1 other identifier: OVG 2015/02
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Influenza infection is related to significant morbidity and mortality in children. The trivalent inactive vaccine (TIV) has been documented to have poor immunogenicity in children and the live attenuated influenza vaccine (ATIV) although proven to have more efficacy is unable to be administered to children under 2 years old. The MF59 adjuvanted influenza vaccine as proven efficacy on reducing the rates of laboratory confirmed influenza, including in children. The study aims to assess early gene transcriptional responses to priming and boosting with MF59-ATIV in children aged 13-24 months and adults aged 18 - 65 years, and to establish correlations with haemagglutination inhibition (HAI) titers. It will be an open label study with 90 healthy children allocated to 3 groups (groups 1, 2 and 3) and 30 healthy adults allocated to group 4.

Conditions

Influenza

Outcome Measures

Primary Outcomes (2)

• Early gene transcriptional responses to immunization with MF59-ATIV

  Differential gene expression following ATIV baseline and days 1 and 3 post initial immunisation (adults and children) and at the baseline and day 1 and 3 post boots immunization (children). Gene expression analysis will be done using pax gene tubes for isolation of RNA

  113 days

• Relationship between early gene transcriptional responses and haemagglutination inhibition (HAI) responses

  HAI titers and HAI geometric mean titers (GMT) and the mean geometric increase in HAI at baseline and day 28 (adults and childrens) and day 56 (childrens only). HAI titers thresholds defined as: influenza A H1N1 \>= 1:40; influenza A H3N2 \>=1:110; influenza b \>= 1:620.

  113 days

Secondary Outcomes (3)

• Relationship between innate immune and gene transcriptional responses to ATIV immunization

  113 days

• Immunogenicity of ATIV in terms of HAI responses to each of the 3 vaccine strains

  113 days

• Relationship between reactogenecity of ATIV (with particular focus on early inflammatory responses and early innate immune responses and gene transcriptional patterns

  113 days

Study Arms (1)

MF59 - ATIV

EXPERIMENTAL

All child participants will receive 2 doses of the MF59-ATIV, with the doses separated by 28 days. Adult participants will receive one dose of MF59-ATIV.

Biological: MF59 - ATIV

Interventions

MF59 - ATIV BIOLOGICAL

All child participants will receive 2 doses of the MF59-ATIV, with the doses separated by 28 days. Adult participants will receive one dose of MF59-ATIV.

Also known as: Fluad vaccine

MF59 - ATIV

Eligibility Criteria

• Age: 13 Months - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Children:
• The investigator believes that the parents/LAR(s) of the child can and will comply with requirements of the protocol (e.g. completion of electronic diary, understanding of study procedure, consent process, availability at visits) and have internet access for the duration of the study.
• Written informed consent obtained from parent/LAR(s) of the subject
• Age from 13 months up to 24 months (excluding 24 months + 0 days and older) at time of V1 (first immunisation visit)
• Born to two caucasian parents
• Participant is healthy as determined by medical history and clinical examination
• Have received all the vaccines specified in the UK immunisation schedule
• Adults:
• Written and informed consent obtained from participant
• Age from 18 years up to 65 years (excluding 65 yrs + 0 days and older)
• Caucasian
• Participant has internet access for the duration of the study
• Participant is healthy as determined by medical history and clinical examination

You may not qualify if:

• Children
• Child in care
• Use (or planned use) of any non-registered or investigational product in last 30 days
• Previous influenza vaccination
• Microbiologically proven influenza illness or treatment with antiviral medications
• Confirmed or suspected egg allergy
• Chronic serious medical conditions which may, in the opinion of the investigator, interfere with evaluation of study objectives e.g. chronic lung disease, chronic liver/renal disease, chronic renal failure chronic heart disease, congenital genetic syndromes (e.g. Trisomy 21).
• Recommended for influenza vaccine in UK (eg. Children in clinical risk groups as specified by Public Health England)
• Suspected or confirmed immunosuppressive or immunodeficiency conditions (including splenic dysfunction \& HIV)
• Autoimmune conditions e.g. Type 1/2 diabetes mellitus, thyroid disease, juvenile idiopathic arthritis etc
• Bleeding disorders
• Adults
• Use (or planned use) of any non-registered or investigational product in last 30 days
• Confirmed or suspected egg allergy
• Chronic serious medical conditions which may, in the opinion of the investigator, interfere with evaluation of study objectives e.g. chronic lung disease, chronic liver/renal disease, chronic renal failure chronic heart disease

Sponsors & Collaborators

• University of Oxford: lead
• Emory University: collaborator
• VisMederi srl: collaborator

Study Sites (1)

Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine

Oxford, United Kingdom

Location

Related Links

• Memory-like innate response to booster vaccination with MF-59 adjuvanted influenza vaccine in children

MeSH Terms

Conditions

Influenza, Human

Interventions

fluad vaccine

Condition Hierarchy (Ancestors)

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

Study Officials

• Andrew J Pollard, PhD

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2015
• First Posted: August 20, 2015
• Study Start: August 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: December 7, 2023

Record last verified: 2018-08

Locations

GB (1)