NCT03402776

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2018

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 18, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

June 6, 2018

Status Verified

June 1, 2018

Enrollment Period

2.1 years

First QC Date

January 10, 2018

Last Update Submit

June 1, 2018

Conditions

Haemopoietic Stem Cell TransplantationAllograft

Keywords

haemopoietic stem cell transplantationvaccinediphteriatetanushaemophilus influenzapoliomyelitishepatitis B

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

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.

Drug: 4th dose of hexavalent vaccine 1 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.

Interventions

4th dose of hexavalent vaccine 1 month after the 3rd doseDRUG

4th dose of hexavalent vaccine 1 month after the 3rd dose

bad resp. after 3 vacc. inj., 4th inj

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Grenoble, 38000, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 41144397DERIVED

MeSH Terms

Conditions

TetanusPoliomyelitisHepatitis B

Condition Hierarchy (Ancestors)

Clostridium InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsMyelitisCentral Nervous System InfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeuroinflammatory DiseasesNeuromuscular DiseasesBlood-Borne InfectionsCommunicable DiseasesHepadnaviridae InfectionsDNA Virus InfectionsHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Olivier EPAULARD, MD, PhD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier EPAULARD, MD, PhD

CONTACT

04 76 76 68 13oepaulard@chu-grenoble.fr

Saber TOUATI

CONTACT

04 76 76 58 05stouati1@chu-grenoble.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: randomized, open-label, prospective, multicenter study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2018

First Posted

January 18, 2018

Study Start

May 1, 2018

Primary Completion

May 31, 2020

Study Completion

May 1, 2021

Last Updated

June 6, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)