Impact of a Fourth Hexavalent Vaccine After Hematopoietic Stem Cell Transplantation

Allograft Clinical Trial

— EVaxAll  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03402776
• Other study ID #: 38RC17.191
• Status: Recruiting
• Phase: Phase 3
• Start date: May 1, 2018
• Est. completion date: May 1, 2021

Study information

• Verified date: June 2018
• Source: University Hospital, Grenoble
• Contact: Olivier EPAULARD, MD, PhD
• Phone: 04 76 76 68 13
• Email: oepaulard[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 1, 2021
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Allograft
• Haemopoietic Stem Cell Transplantation

Intervention

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

Locations

Country	Name	City	State
France	University Hospital	Grenoble

Sponsors (5)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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