Haemopoietic Stem Cell TransplantationPhase 3EVaxAllNCT03402776
Impact of a Fourth Hexavalent Vaccine After Hematopoietic Stem Cell Transplantation
A Phase 3 study testing 4th dose of hexavalent vaccine 1 month after the 3rd dose in people with Haemopoietic Stem Cell Transplantation and Allograft, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haemopoietic Stem Cell Transplantation, Allograft
- What is being tested?
- 4th dose of hexavalent vaccine 1 month after the 3rd dose
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2018to 1 May 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- having received an HSTC 6 months before (not more than 2 years)
- not receiving immunosuppressive therapy at inclusion
Who cannot join
- having received an HSTC 6 months more than 2 years before
- receiving immunosuppressive therapy at inclusion
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital
Grenoble, 38000
olivier epaulard, MD, PhD, +33476765291, OEpaulard@chu-grenoble.fr
OLIVIER epaulard
About this study
Official title: Impact of a Fourth Hexavalent Vaccine Dose During Primary Vaccination After Haematopoietic Stem Cell Transplantation
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.
Read the 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.
- Conditions
- Haemopoietic Stem Cell Transplantation, Allograft
- Being tested
- 4th dose of hexavalent vaccine 1 month after the 3rd dose
- Keywords
- haemopoietic stem cell transplantation, vaccine, diphteria, tetanus, haemophilus influenza, poliomyelitis, hepatitis B
- Medical subject headings
- Tetanus, Poliomyelitis, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4th dose of hexavalent vaccine 1 month after the 3rd doseDrug
4th dose of hexavalent vaccine 1 month after the 3rd dose
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month after the one year booster dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study start1 May 2018
- Primary completion31 May 2020 (estimated)
- Study completion1 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Haemopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, open-label, prospective, multicenter study
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nice, University Hospital, Clermont-Ferrand, University Hospital of Saint-Etienne, Centre Hospitalier Universitaire de Besancon
- Responsible party
- Sponsor
- Investigators
- Olivier EPAULARD, MD, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402776
- Sponsor's protocol ID
- 38RC17.191
- Acronym
- EVaxAll
- Status last verified
- Jun 2018
- First submitted
- 10 Jan 2018
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41144397
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Fourth Hexavalent Vaccine Dose During Primary Vaccination After Haematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT03402776
- Acronym / sponsor ID
- EVaxAll / 38RC17.191
- Conditions
- Haemopoietic Stem Cell Transplantation, Allograft
- Keywords
- haemopoietic stem cell transplantation, vaccine, diphteria, tetanus, haemophilus influenza, poliomyelitis, hepatitis B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nice, University Hospital, Clermont-Ferrand, University Hospital of Saint-Etienne, Centre Hospitalier Universitaire de Besancon
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 May 2020 (estimated)
- Study completion
- 1 May 2021 (estimated)
- First posted
- 18 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- randomized, open-label, prospective, multicenter study
| Arm | Type | Receives |
|---|---|---|
| good resp. after 3 vacc. inject. | No intervention | –no randomization for a 4th dose. |
| bad resp. after 3 vacc. inj., 4th inj | Experimental | Drug: 4th dose of hexavalent vaccine 1 month after the 3rd doseAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- having received an HSTC 6 months before (not more than 2 years)
- not receiving immunosuppressive therapy at inclusion
Key exclusion criteria (2 listed)
- having received an HSTC 6 months more than 2 years before
- receiving immunosuppressive therapy at inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 4th dose of hexavalent vaccine 1 month after the 3rd dose4th dose of hexavalent vaccine 1 month after the 3rd dose | Drug | bad resp. after 3 vacc. inj., 4th inj |
Primary outcome
antibody response 1 month after the one year booster dose
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Derived from this study: PubMed 41144397Epaulard 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier EPAULARD, MD, PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 4th dose of hexavalent vaccine 1 month after the 3rd dose in people with Haemopoietic Stem Cell Transplantation and Allograft, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olivier EPAULARD, MD, PhD (04 76 76 68 13, oepaulard@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
antibody response 1 month after the one year booster dose (time frame: 1 month after the one year booster dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03402776, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.