Clinical trial NCT03402776: Impact of a Fourth Hexavalent Vaccine After Hematopoietic Stem Cell Transplantation
Official title: Impact of a Fourth Hexavalent Vaccine Dose During Primary Vaccination After Haematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Haemopoietic Stem Cell Transplantation
Allograft
Keywords: haemopoietic stem cell transplantation
vaccine
diphteria
tetanus
haemophilus influenza
poliomyelitis
hepatitis B
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Nice
name: University Hospital, Clermont-Ferrand
name: University Hospital of Saint-Etienne
name: Centre Hospitalier Universitaire de Besancon
First posted: 2018-01-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, open-label, prospective, multicenter study
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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 yrar after. However, this strategy do not constantly lead to efficient antibody levels.

the investigators aim to determine whether a 4th dose in the initial vaccine schedule (month 0, 1, 2, and 3) allows to obtain a better response.

After informed consent, the investigators will recruit 6 months after the graft 200 patients who had received an hematopoietic stem cell transplantation . The participants will have a measure of their antibody level against 5 pathogens (diphteria toxin, tetanus toxin, Haemophilus influenza b, hepatitis B virus, poliomyelitis virus) at month 0 (before the 1st hexavalent vaccine injection), and one month after the 3rd injection of this vaccine. If the antibody response is not sufficient, they will be randomized for a 4th dose in the following month.

The one year booster dose will be then injected to all participants, and the antibody response will be again measured one month after this dose. The primary endpoint is to compare the antibody levels at this date in patients who had an unsufficient immune response after the 3rd dose and who received or not a 4rth dose in the initial vaccine schedule.

Eligibility 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

Primary outcomes:
measure: antibody response 1 month after the one year booster dose
timeFrame: 1 month after the one year booster dose
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Grenoble
name: Olivier EPAULARD, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: