Reducing the Burden of Influenza After Solid-Organ Transplantation

Summary

Influenza is associated with significant morbidity and mortality in solid-organ transplant (SOT) recipients and it is mainly prevented by seasonal influenza vaccination. Unfortunately, the immunogenicity of standard influenza vaccine is suboptimal in this population. Vaccination with a high-dose (HD) influenza vaccine or an MF59-adjuvanted (MF59a) vaccine have significantly reduced the incidence of influenza and increased the immunogenicity of influenza vaccine in the elderly. The investigators will compare the immunogenicity and efficacy of two new vaccination strategies, consisting in vaccination with a HD influenza vaccine or an MF59a influenza vaccine, to the standard-dose non-adjuvanted vaccination (standard of care) in a population of SOT recipients.

Conditions

• Influenza
• Organ Transplantation

Interventions

BIOLOGICAL

High-dose influenza vaccine

The experimental intervention consists in an intramuscular injection of a MF59-adjuvanted trivalent inactivated influenza vaccine containing 15 µg of antigen per strain (Fluad®) or an intramuscular injection of trivalent inactivated influenza vaccine containing 60 µg of antigen per strain (Fluzone-HD®) and will be performed at day 0.

BIOLOGICAL

MF59-adjuvanted influenza vaccine

The experimental intervention consists in an intramuscular injection of a MF59-adjuvanted trivalent inactivated influenza vaccine containing 15 µg of antigen per strain (Fluad®) or an intramuscular injection of trivalent inactivated influenza vaccine containing 60 µg of antigen per strain (Fluzone-HD®) and will be performed at day 0.

BIOLOGICAL

Standard intramuscular influenza vaccine

The control intervention consists in an intramuscular injection of one dose of VaxigripTetra®, the standard non-adjuvanted intramuscular influenza vaccine (as routinely done).

Sponsors & Collaborators

• University Hospital, Basel, Switzerland

  collaborator OTHER

• University of Bern

  collaborator OTHER

• University Hospital, Geneva

  collaborator OTHER

• University of Zurich

  collaborator OTHER

• Cantonal Hospital of St. Gallen

  collaborator OTHER

• Fondazione Epatocentro Ticino

  collaborator OTHER

• Cantonal Hospital Chur

  collaborator UNKNOWN

• Hospitales Universitarios Virgen del Rocío

  collaborator OTHER

• Oriol Manuel

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-10-26

Primary Completion

2020-08-15

Completion

2020-08-15

FDA Drug

Yes

Countries

• Spain
• Switzerland

Study Locations