Impact of a Fourth Hexavalent Vaccine After Hematopoietic Stem Cell Transplantation

Phase 3

• Conditions: Haemopoietic Stem Cell Transplantation; Allograft
• Interventions: Drug: 4th dose of hexavalent vaccine 1 month after the 3rd dose

• Registration Number: NCT03402776
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2018-01-10
• Study First Submitted QC: 2018-01-10
• Study First Posted: 2018-01-18
• Study Start: 2018-05-01
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-01
• Last Update Posted: 2018-06-06
• Primary Completion: 2020-05-31
• Study Completion: 2021-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bad resp. after 3 vacc. inj., 4th inj	4th dose of hexavalent vaccine 1 month after the 3rd dose	After randomization, these patients will receive a 4th dose one month after the 3rd dose.

Primary Outcome Measures

Name	Time	Method
antibody response 1 month after the one year booster dose	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

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Grenoble, France