The Immune Response to Influenza Vaccinations in Elderly Individuals

NCT03266237 | Completed Phase 4 DMC

• 1 other identifier: 2012/01214
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 9

Brief Summary

The aim of this study is to characterize the immune profile of frail and healthy aged individuals and investigate their immune responsiveness including the response to influenza vaccine over an 18-month period. The project will include a longitudinal study to define immune signatures and multi-parameter profiles associated with frailty and may lead to the identification of predictive markers of evolution to frailty and Immunosenescence in the elderly.

Conditions

Influenza

Keywords

Influenza; Influenza Virus Vaccines; Vaxigrip; Respiratory Tract Infections; Orthomyxoviridae Infections; Frailty; Aging; Safety; Immunogenicity

Outcome Measures

Primary Outcomes (1)

• The Immune Responsiveness of Elderly Subjects when Administered Influenza Vaccination as Measured by HAI

  Hemagglutination Inhibition (HAI) titer

  18-month period

Secondary Outcomes (3)

• Cellular Immune Response and Inflammatory Profile of elderly subjects when administered influenza vaccination - Flu-Specific T cells

  18 months

• Flu-Specific B Cell Response

  18 months

• Inflammatory Markers

  18 months

Other Outcomes (4)

• Clinical Assessments of the elderly subjects - Weight

  18 months

• Clinical Assessments of the elderly subjects - Height

  18 months

• Clinical Assessments of the elderly subjects - BMI

  18 months

Study Arms (4)

Healthy Adult

EXPERIMENTAL

Healthy adult participants aged 21-40 years will be vaccinated with Vaxigrip® influenza vaccine

Drug: Vaxigrip®

Healthy Elderly

EXPERIMENTAL

Healthy Elderly participants aged 65-90 years will be vaccinated with Vaxigrip® influenza vaccine.

Drug: Vaxigrip®

Healthy Elderly Pre-Frail

EXPERIMENTAL

Healthy Elderly participants aged 65-90 years will be vaccinated with Vaxigrip® influenza vaccine.

Drug: Vaxigrip®

Healthy Elderly Frail

EXPERIMENTAL

Healthy Elderly participants aged 65-90 years will be vaccinated with Vaxigrip® influenza vaccine.

Drug: Vaxigrip®

Interventions

Vaxigrip® DRUG

To describe the humoral immune response to Vaxigrip (IM) vaccination at Day 0 (baseline) and Day 28 according to the age and frailty status at baseline (i.e. in each study group) for each Influenza strain.

Healthy Adult; Healthy Elderly; Healthy Elderly Frail; Healthy Elderly Pre-Frail

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent form has been signed and dated.
• Able to attend all scheduled visits and to comply with all trial procedures.
• Living at home.
• Able to walk without personal assistance and no other physical limitations that can limit participation.
• Recruited from the cohort in Singapore Longitudinal Ageing Study-II (SLAS-II), as well as from sites in West Jurong and from Outpatient clinics at National University Hospital (NUH).

You may not qualify if:

• Participation at the time of study enrollment (or in the 4 weeks preceding trial vaccination) or planned participation during the present trial period in another clinical trial investigating vaccine, drug, medical device, or medical procedure.
• Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following trial vaccination, including influenza vaccination. However, 23-valent pneumococcal vaccine and tetanus vaccine will be allowed during this time window.
• Receipt of an influenza vaccine within the 6 months preceding the trial vaccination or planned influenza vaccination during the trial.
• Known or suspected congenital or acquired immunodeficiency or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
• Systemic hypersensitivity to eggs, chicken proteins, or any of the vaccine components or a history of a life-threatening reaction to Vaxigrip® or to a vaccine containing any of the same substances.
• Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
• Current alcohol or drug addiction.
• Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion.
• Identified as an Investigator or employee of the Investigator or study centre with direct involvement in the proposed study, or identified as an immediate family member (i.e. parent, spouse) of the Investigator or employee with direct involvement in the proposed study.
• Severe audio-visual impairment.
• Dementia, severe cognitive impairment (MMSE \<18), major depression or other psychotic disorders.
• Progressive, degenerative neurologic disease: e.g. Alzheimer's disease.
• Rapidly progressive or terminal illness under palliative care with life expectancy less than 12 months.
• Primary severely muscle/joint disorders resulting in physical disability interfering with the physical performance tests needed for the study.
• Hospital admission in the past 6 weeks.

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• National University of Singapore: collaborator
• Agency for Science, Technology and Research: collaborator
• Sanofi Pasteur, a Sanofi Company: collaborator

Study Sites (9)

Moral Neighbourhood Link @ Telok Blangah

Singapore, 090003, Singapore

Location

National University Hospital

Singapore, 119228, Singapore

Location

THK Seniors Activity Centre @ Henderson (Satellite 93)

Singapore, 150093, Singapore

Location

Moral Neighbourhood Link (Bukit Merah View)

Singapore, 150118, Singapore

Location

THK Seniors Activity Centre @ Beo Crescent

Singapore, 160044, Singapore

Location

SARAH Senior Activity Centre

Singapore, 160105, Singapore

Location

THK Seniors Service @ Taman Jurong

Singapore, 610337, Singapore

Location

TaRa @ Jurong Point, Jurong West Central 2

Singapore, 648886, Singapore

Location

Outpatient Clinic, St Luke's Hospital

Singapore, 659674, Singapore

Location

Related Publications (1)

• Camous X, Visan L, Ying CTT, Abel B, Nyunt MSZ, Narang V, Poidinger M, Carre C, Sesay S, Bosco N, Burdin N, Tambyah PA, Pin NT, Larbi A. Healthy elderly Singaporeans show no age-related humoral hyporesponsiveness nor diminished plasmablast generation in response to influenza vaccine. Immun Ageing. 2018 Nov 12;15:28. doi: 10.1186/s12979-018-0137-4. eCollection 2018.

  PMID: 30455722 DERIVED

MeSH Terms

Conditions

Influenza, Human; Respiratory Tract Infections; Orthomyxoviridae Infections; Frailty

Interventions

vaxigrip

Condition Hierarchy (Ancestors)

Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Professor Paul Anantharajah Tambyah, MD

  National University of Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2016
• First Posted: August 30, 2017
• Study Start: December 1, 2013
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: August 30, 2017

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: five years approx
• Access Criteria: through a research agreement

Locations

SG (9)