Impact of a Fourth Hexavalent Vaccine After Hematopoietic Stem Cell Transplantation (EVaxAll)

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.

Study Overview

• Status: Unknown
• Conditions: Allograft; Haemopoietic Stem Cell Transplantation
• Intervention / Treatment: Drug: 4th dose of hexavalent vaccine 1 month after the 3rd 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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38000
    • Recruiting
    • University Hospital
    • Principal Investigator: Olivier Epaulard
    • Contact: Olivier Epaulard, MD, PhD; Phone Number: +33476765291; Email: oepaulard@chu-grenoble.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: good resp. after 3 vacc. inject.; no randomization for a 4th dose.
Experimental: bad resp. after 3 vacc. inj., 4th inj; 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; 4th dose of hexavalent vaccine 1 month after the 3rd dose
No Intervention: bad resp. after 3 vacc. inj., no 4th inj; After randomization, these patients will not receive a 4th dose one month after the 3rd dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: University Hospital, Clermont-Ferrand; Centre Hospitalier Universitaire de Nice; Centre Hospitalier Universitaire de Besançon; University Hospital of Saint-Etienne
• Investigators: Principal Investigator: olivier epaulard, MD, PhD, University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Anticipated): May 31, 2020
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: January 10, 2018
• First Posted (Actual): January 18, 2018

Study Record Updates

• Last Update Posted (Actual): June 6, 2018
• Last Update Submitted That Met QC Criteria: June 1, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: vaccine; poliomyelitis; tetanus; hepatitis B; haemopoietic stem cell transplantation; diphteria; haemophilus influenza
• Other Study ID Numbers: 38RC17.191

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No