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| Name | Class |
|---|---|
| Centre Hospitalier Universitaire de Nice | OTHER |
| University Hospital, Clermont-Ferrand | OTHER |
| University Hospital of Saint-Etienne | OTHER |
| Centre Hospitalier Universitaire de Besancon |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| good resp. after 3 vacc. inject. | No Intervention | no randomization for a 4th dose. | |
| bad resp. after 3 vacc. inj., 4th inj | Experimental | After randomization, these patients will receive a 4th dose one month after the 3rd dose. |
|
| bad resp. after 3 vacc. inj., no 4th inj | No Intervention | After randomization, these patients will not receive a 4th dose one month after the 3rd dose. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4th dose of hexavalent vaccine 1 month after the 3rd dose | Drug | 4th dose of hexavalent vaccine 1 month after the 3rd dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| antibody response 1 month after the one year booster dose | 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 | 1 month after the one year booster dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olivier EPAULARD, MD, PhD | Contact | 04 76 76 68 13 | oepaulard@chu-grenoble.fr | |
| Saber TOUATI | Contact | 04 76 76 58 05 | stouati1@chu-grenoble.fr |
| Name | Affiliation | Role |
|---|---|---|
| Olivier EPAULARD, MD, PhD | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Recruiting | Grenoble | 38000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41144397 | Derived | 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. |
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| ID | Term |
|---|---|
| D013742 | Tetanus |
| D011051 | Poliomyelitis |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| OTHER |
randomized, open-label, prospective, multicenter study
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| D007239 | Infections |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |