Immunogenicity and Safety of the Seasonal Flu Vaccine in Elderly and in SOT Recipients

NCT02746783 | Completed Phase 1 DMC

• 1 other identifier: Vaccinâge 2013-15
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the effect of a different dose of the seasonal flu vaccine 2013-2015 on the immune response to improve the investigators understanding of cellular and humoral immune responses induced. The scope of this study is to determine the profile of cellular activation and antibody production in the ageing immune system following flu immunization. This study will enroll 100 male or female subjects ≥65 year old and 90 transplant recipients. These persons will be deemed to be " at risk " in case of influenza infection and should be vaccinated according to Swiss Federal Office of Public Health. A medical doctor from the CHUV will inform the patients about the present study and ask them whether they would be willing to participate in the study. All subjects will be distributed between the two groups according to a computer-generated randomization sequence. The randomization will be done in blocks to ensure balance across groups. The participants and site staff will not be blinded due to the different administration assignments. Group 1 subjects will receive a single dose and group 2 subjects a double dose of MUTAGRIP® manufactured by Sanofi Pasteur containing A/California/7/2009 (H1N1); A/Texas/50/2012 (H3N2); B/Massachusetts/2/2012. Vaccine immunogenicity and safety will be assessed 1, 2, 4 and 24 weeks after vaccination. Study duration per volunteer is 6 months after vaccination.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Change from Baseline in Immunogenicity

  Humoral immune responses (antibodies directed against all three strains A/California/7/2009 (H1N1); A/Texas/50/2012 (H3N2); B/Massachusetts/2/2012).

  weeks 2, 4 and 24 after vaccination

• Change from Baseline in Immunogenicity

  Cellular immune responses directed against all three strains A/California/7/2009 (H1N1); A/Texas/50/2012 (H3N2); B/Massachusetts/2/2012.

  weeks 1, 2, 4 and 24 after vaccination

Secondary Outcomes (1)

• Number of Adverse Events as a Measure of Safety and Tolerability

  24 weeks after vaccination

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Single dose of MUTAGRIP® containing A/California/7/2009 (H1N1); A/Texas/50/2012 (H3N2); B/Massachusetts/2/2012.

Drug: Single dose MUTAGRIP® influenza vaccine

Group 2

EXPERIMENTAL

Double dose of MUTAGRIP® (one dose into the right deltoid area and the other one into the left deltoid area) containing A/California/7/2009 (H1N1); A/Texas/50/2012 (H3N2); B/Massachusetts/2/2012.

Drug: Double dose of MUTAGRIP® influenza vaccine

Interventions

Single dose MUTAGRIP® influenza vaccine DRUG

All subjects will receive either a single or double doses of MUTAGRIP® containing A/California/7/2009 (H1N1); A/Texas/50/2012 (H3N2); B/Massachusetts/2/2012. The double dose regimen will be administered at the same time.

Group 1

Double dose of MUTAGRIP® influenza vaccine DRUG

All subjects will receive either a single or double doses of MUTAGRIP® containing A/California/7/2009 (H1N1); A/Texas/50/2012 (H3N2); B/Massachusetts/2/2012. The double dose regimen will be administered at the same time.

Group 2

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥65 year old.
• Able to give informed consent.
• Necessity to receive influenza seasonal vaccination in 2013-2015.
• Availability for the duration of the study and willingness to attend all scheduled visits.
• Hemoglobin value ≥100 g/l , Leukocytes ≥3.5 G/L, Platelets count ≥100 G/l at the time of screening, or determined within 8 weeks before screening in the course of regular medical examination and validated by the medical doctor.

You may not qualify if:

• Contraindication against seasonal flu vaccination.
• Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of the study vaccine, or planned use during the study period and safety follow-up.
• Immunodeficiency or chronic administration (defined as more than 14 consecutive days) of immunosuppressive or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, ≥0.5 mg/kg/day. Inhaled and topical steroids are allowed).
• Hypersensitivity to the active substances, to any of the excipients, to eggs, chicken proteins, neomycin, formaldehyde and octoxinol 9.
• Acute disease at the time of enrollment \[Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., temperature \<38°C\].
• An unstable chronic condition (unstable chronic renal failure, unstable diabetes, unstable chronic cardiac condition, uncontrolled asthma, etc.).
• Receipt of blood-derived products (immunoglobulin; plasma) within 120 days prior to enrollment.

Sponsors & Collaborators

• University of Lausanne Hospitals: lead

Study Sites (1)

Vaccine and Immunotherapy Center (VIC) of the Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (1)

• Mombelli M, Rettby N, Perreau M, Pascual M, Pantaleo G, Manuel O. Immunogenicity and safety of double versus standard dose of the seasonal influenza vaccine in solid-organ transplant recipients: A randomized controlled trial. Vaccine. 2018 Oct 1;36(41):6163-6169. doi: 10.1016/j.vaccine.2018.08.057. Epub 2018 Sep 1.

  PMID: 30181045 DERIVED

Study Officials

• Giuseppe Pantaleo, Prof.

  Vaccine and Immunotherapy Center (VIC) of the Centre Hospitalier Universitaire Vaudois (CHUV), Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Giuseppe Pantaleo

Study Record Dates

• First Submitted: August 8, 2014
• First Posted: April 21, 2016
• Study Start: October 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: March 26, 2020

Record last verified: 2020-03

Locations

CH (1)