A Single-Blind randomized trial of High-Dose versus Standard-Dose Inactivated Influenza Vaccine in Adult Patients Treated for an Hematological Cancer (Flu-Hemato-Rando study)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

CHU De Liege

Participant type

Patients, Healthy volunteers

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Hemic and Lymphatic Diseases [C15], Diseases [C] - Immune System Diseases [C20]

Trial duration

18 Sep 2023 → ongoing

Decision date (initial)

2023-08-23

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

The two main aims of the study are :

- 1) A phase III, single center, randomized trial of QIIV-HD versus QIIV-SD vaccine in patients treated with an hematological cancer. A total of 140 patients will be recruited. Patients will be blinded for the vaccine received. The primary endpoint will be seroconversion to a least one of the four vaccine antigens. The hypothesis is that the seroconversion rate will increase from 40% in QIIV-SD patients to 65% in QIVV-HD patients. Randomization will be stratified for disease group (we aim at recruiting approximately 80 myeloma patients, 40 other B-cell malignancy patients and 20 patients treated for a myeloid malignancy).

- 2) A systems biology study aimed at defining a baseline signature predicting response to the vaccine as well as comparing activation of the immune system in patients included in the randomized study as well as in 40 healthy control subjects.

Conditions and MedDRA coding

Hematological cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Patients under treatment for: a multiple myeloma, or a B-cell malignancy (including patients given rituximab in the 6 months prior to vaccine even if no additional treatment given)., or a myeloid malignancy (hydroxyurea or tyrosine kinase inhibitors are not be considered as a “treatment” for the current study in contrast to JAK inhibitors or azacitidine) or standard chemotherapy
2. Age > or = 18 years at inclusion
3. Written informed consent

Exclusion criteria 6

1. HIV seropositivity
2. Pregnancy
3. Egg allergy or allergy to previous influenza vaccine
4. IVIg in the past 30 days or planning to receive IVIg in the 4 weeks after vaccination
5. Prior post-transplant IIV vaccination in the same season
6. Severe Heart failure (ejection fraction < 35%) at the last examination

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. First co-primary endpoint : the primary endpoint will be to compare seroconversion to a least one of the four vaccine antigens at 28 days after vaccination in patients randomized in the QIIV-HD versus QIIV-SD vaccine (see 6.3 for the definition of response)
2. Second co-primary endpoint : to define a baseline signature predicting response to the vaccine

Secondary endpoints 1

1. To compare response to QIIV-HD versus QIIV-SD vaccine for : • Seroconversion rate for the 4 vaccine antigens, • Partial and complete seroprotection rates, • Systemic and local adverse events occurring in the 6 months following vaccination, • Seroconversion to at least one of the four antigens in the 3 groups (multiple myeloma, other B-cell malignancy and myeloid malignancy), • Factors associated with response to the vaccine

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

CHU De Liege

Sponsor organisation

CHU De Liege

Address

Avenue De L'hopital 1

City

Liege

Postcode

4000

Country

Belgium

Scientific contact point

Organisation

CHU De Liege

Contact name

Prof Frédéric Baron

Public contact point

Organisation

CHU De Liege

Contact name

Prof Frédéric Baron

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

1 submissions — initial application plus substantial / non-substantial modifications