A Phase II randomized trial of RSV vaccination in allogeneic hematopoietic stem cell transplant recipients (RSV-Allo study)

Conditions

allogeneic - Hematopoietic Stem Cell Transplantation

Brief summary

First co-primary endpoint : The primary endpoint will be to assess the efficacy of the each RSVpreF and RSVpreF3 OA vaccines in allo-HSCT recipients. We will use the surrogate marker of seroconversion (see section 7.3 for the definition of response) for assessing vaccine efficacy. Efficacy will be defined as a seroconversion rate > 80% with either one or two doses of the vaccine., Second co-primary endpoint : To define a baseline signature predicting response to RSVpreF and RSVpreF3 OA vaccines using systems vaccinology tools.

Related papers

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Interventions

DRUGArexvy powder and suspension for suspension for injection Respiratory Syncytial Virus (RSV) vaccine (recombinant

DRUGadjuvanted)

DRUGAbrysvo powder and solvent for solution for injection Respiratory syncytial virus vaccine (bivalent

DRUGrecombinant)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
First co-primary endpoint : The primary endpoint will be to assess the efficacy of the each RSVpreF and RSVpreF3 OA vaccines in allo-HSCT recipients. We will use the surrogate marker of seroconversion (see section 7.3 for the definition of response) for assessing vaccine efficacy. Efficacy will be defined as a seroconversion rate > 80% with either one or two doses of the vaccine., Second co-primary endpoint : To define a baseline signature predicting response to RSVpreF and RSVpreF3 OA vaccines using systems vaccinology tools.	—

Measure

Time frame

First co-primary endpoint : The primary endpoint will be to assess the efficacy of the each RSVpreF and RSVpreF3 OA vaccines in allo-HSCT recipients. We will use the surrogate marker of seroconversion (see section 7.3 for the definition of response) for assessing vaccine efficacy. Efficacy will be defined as a seroconversion rate > 80% with either one or two doses of the vaccine., Second co-primary endpoint : To define a baseline signature predicting response to RSVpreF and RSVpreF3 OA vaccines using systems vaccinology tools.

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Countries

Belgium

Outcome results

None listed