Influenza Specific Immunity After Vaccination in Recipients of Haematopoietic Stem Cell Transplantation Compared to Healthy Controls

A Prospective Study to Evaluate the Immunogenicity and Efficacy of Inactivated Trivalent Influenza Vaccine in Children (> or = 6 months to < or =18 years of age) who have Undergone Allogeneic or Autologous Haematopoietic Stem Cell Transplant compared to Aged Matched Controls

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000240640

Acronym

Influenza Vaccine HSCT study

Enrollment

131

Registered

2014-03-06

Start date

2013-05-23

Completion date

2016-05-12

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is looking at whether children who have had a bone marrow transplant produce protective antibodies after the flu vaccine. We will compare this to healthy children, and also look at how many children get the flu despite being vaccinated. Who is it for? You or your child may be eligible to join this study if you/they are aged between 6 months to 18 years, and have undergone haematopoietic stem cell transplant 6 months to 2 years ago. Study details Bone marrow transplant (BMT) patients have significant problems with their immune system. The rate of problems caused by the flu (influenza) is particularly high in these patients. Vaccination is the main way to prevent the flu and the problems it causes. Vaccination of children and adolescents may not only protect the children themselves, but may also significantly decrease the rate of transmission and consequently, the knock-on effects in the general population. There are many studies in adults that have looked at the immune response of the flu vaccine in patients post transplant. Response rates are poor and whilst the response improves over time with recovery of their immune system, it rarely reaches that of healthy controls. The rates reported are between 9-40%. The studies that have been done are small. There are limitations to these studies and importantly, there is minimal amount of data for children. To our knowledge, there have been no studies conducted looking at the immune response to the flu vaccine in children alone. In this study all participants will receive the influenza vaccine as per immunisation guidelines. After each vaccine dose (1-2 doses may be administered), participants will undergo a blood test to evaluate influenza specific antibody levels. Participants will also be monitored from enrolment to the end of the influenza season (end of November of enrolment year) in order to identify frequency and severity of influenza infection.

Interventions

Trivalent Inactivated Influenza Vaccine 6 months to 2 years post transplant as per immunisation guidelines. Two doses of influenza vaccine at least 4 weeks apart are recommended for all HSCT recipients receiving influenza vaccine for the first time, with the 1st dose given as early as 6 months post transplant. This is given intramuscularly.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

6 Months to 18 Years

Healthy volunteers

Inclusion criteria

1.Age greater than or equal to 6 months to less than or equal to 18 years of age at time of vaccination and have undergone HSCT 2.HSCT recipients who are more than 6 months upto 2 years post transplant

Exclusion criteria

1.Known contraindication to influenza vaccine as defined in the National Health and Medical Research Council (NHMRC) Immunisation Handbook (10th ed.) 2.Receipt of an inappropriate dose of influenza vaccine for age of child during the current year

Outcome results