Impact of a Fourth Hexavalent Vaccine Dose During Primary Vaccination After Haematopoietic Stem Cell Transplantation

Impact of a Fourth Hexavalent Vaccine After Hematopoietic Stem Cell Transplantation

Sponsors

Lead sponsor: University Hospital, Grenoble

Collaborator: Centre Hospitalier Universitaire de Nice
University Hospital, Clermont-Ferrand
University Hospital of Saint-Etienne
Centre Hospitalier Universitaire de Besancon

Source University Hospital, Grenoble
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.

Overall Status Recruiting
Start Date May 1, 2018
Completion Date May 1, 2021
Primary Completion Date May 31, 2020
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
antibody response 1 month after the one year booster dose 1 month after the one year booster dose
Enrollment 200
Condition
Intervention

Intervention type: Drug

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

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

Arm group label: bad resp. after 3 vacc. inj., 4th inj

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Olivier EPAULARD, MD, PhD Principal Investigator University Hospital, Grenoble
Overall Contact

Last name: Olivier EPAULARD, MD, PhD

Phone: 04 76 76 68 13

Email: [email protected]

Location
facility status contact investigator University Hospital olivier epaulard, MD, PhD +33476765291 [email protected] OLIVIER epaulard Principal Investigator
Location Countries

France

Verification Date

June 2018

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 3
Arm Group

Arm group label: good resp. after 3 vacc. inject.

Arm group type: No Intervention

Description: no randomization for a 4th dose.

Arm group label: bad resp. after 3 vacc. inj., 4th inj

Arm group type: Experimental

Description: After randomization, these patients will receive a 4th dose one month after the 3rd dose.

Arm group label: bad resp. after 3 vacc. inj., no 4th inj

Arm group type: No Intervention

Description: After randomization, these patients will not receive a 4th dose one month after the 3rd dose.

Acronym EVaxAll
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: randomized, open-label, prospective, multicenter study

Primary purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov