Impact of a Fourth Hexavalent Vaccine After Hematopoietic Stem Cell Transplantation

• Status: Unknown status
• Trial end date: 2021-05-01
• Target enrollment: 0
• Participant gender: All

Summary

It is recommended for patients who underwent an hematopoietic stem cell transplantation to receive 6 months after the graft 3 injections of hexavalent vaccine (diphteria-tetanus- poliomyelitis-pertussis-Hib-HBV) within 2 months followed by a booster dose one month after. The patients included in the study will have a measure of their antibody level against 5 pathogens (diphteria toxin, tetanus toxin, Haemophilus influenza b, hepatitis B virus, poliomyelitis virus) one month after the 3rd injection of hexavalent vaccine. If the antibody response is not sufficient, they will be randomized for a 4th dose in the following month. The antibody response will be again measured one month after the 1 year booster dose.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Grenoble
• Collaborators: Centre Hospitalier Universitaire de Besancon; Centre Hospitalier Universitaire de Nice; University Hospital of Saint-Etienne; University Hospital, Clermont-Ferrand
• Treatments: Vaccines

Criteria

Inclusion Criteria:

• having received an HSTC 6 months before (not more than 2 years)

• not receiving immunosuppressive therapy at inclusion

Exclusion Criteria:

• having received an HSTC 6 months more than 2 years before

• receiving immunosuppressive therapy at inclusion