Impact of a Fourth Hexavalent Vaccine After Hematopoietic Stem Cell Transplantation
NCT ID: NCT03402776
Last Updated: 2018-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
200 participants
INTERVENTIONAL
2018-05-01
2021-05-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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good resp. after 3 vacc. inject.
no randomization for a 4th dose.
No interventions assigned to this group
bad resp. after 3 vacc. inj., 4th inj
After randomization, these patients will receive a 4th dose one month after the 3rd dose.
4th dose of hexavalent vaccine 1 month after the 3rd dose
4th dose of hexavalent vaccine 1 month after the 3rd dose
bad resp. after 3 vacc. inj., no 4th inj
After randomization, these patients will not receive a 4th dose one month after the 3rd dose.
No interventions assigned to this group
Interventions
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4th dose of hexavalent vaccine 1 month after the 3rd dose
4th dose of hexavalent vaccine 1 month after the 3rd dose
Eligibility Criteria
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Inclusion Criteria
* not receiving immunosuppressive therapy at inclusion
Exclusion Criteria
* receiving immunosuppressive therapy at inclusion
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nice
OTHER
University Hospital, Clermont-Ferrand
OTHER
University Hospital of Saint-Etienne
OTHER
Centre Hospitalier Universitaire de Besancon
OTHER
University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Olivier EPAULARD, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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University Hospital
Grenoble, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Epaulard O, Carre M, Hermet E, Corbin V, Tavernier E, Botelho-Nevers E, Daguindau E, Brunel AS, Rohrlich PS, Risso K, Gallet S, Gonnet N, Touati S, Manceau M, Thiebault A. Antibody response to tetanus, diphtheria, poliomyelitis, hepatitis B, and H. influenzae b vaccines in allogeneic hematopoietic stem cell transplant adult recipients: A multicenter trial. PLoS One. 2025 Oct 27;20(10):e0335224. doi: 10.1371/journal.pone.0335224. eCollection 2025.
Other Identifiers
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38RC17.191
Identifier Type: -
Identifier Source: org_study_id
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