None listed
Conditions
Brief summary
Non-immune people exposed to hepatitis A are recommended to receive either hepatitis A vaccine or normal immunoglobulin (which contains hepatitis A antibodies), with the latter recommended for those in the most vulnerable groups. We have previously completed a pharmacokinetic modeling study using published data to estimate the minimum dose of hepatitis A antibodies that would be protective against hepatitis A up to day 50 after injection. This modeling study supported the hypothesis that the current national guideline provides insufficient antibodies for people who weigh over 85kg. The current study seeks to validate these modelling results in order to recommend the optimal dose of normal immunoglobulin for the prevention of hepatitis A. This study will compare the level of antibodies present in blood as a result of passive immunisation with the recommended dose of normal immunoglobulin to the level of antibodies in blood as a result of dosing by weight with the same product in healthy adults. To do this, we will conduct a randomised controlled trial where the usual care group will receive 2mL normal immunoglobulin irrespective of weight, and the test dose group will received 0.025mL/kg to a maximum of 5mL of normal immunoglobulin. Blood samples will be taken from both groups at days 0, 1, 3, 7, 28 and 50 and the groups mean hepatitis A antibody titres compared.
Interventions
2.5 IU/kg hepatitis A antibodies, which equates to 0.025mL/kg NHIG (Normal Human Immunoglobulin) as a single intramuscular (IM) dose
Sponsors
Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
17 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Healthy adult volunteers who provide informed consent, and meet the following criteria will be eligible: o are immune to measles and rubella according to commercial serology test o are not immune to hepatitis A according to commercial serology test o are not eligible for free hepatitis A vaccination and unlikely to require hepatitis A vaccination during the course of study (ie no planned overseas travel) o weigh at least 51kg Healthy 17 year olds who provide informed consent, meet the same criteria, and whose parent or guardian also consents will also be eligible.
Exclusion criteria
o have been in another clinical trial within the last 3 months prior to recruitment to this study o have history of hypersensitivity, allergy to blood products or haematological disorder o have received a blood product with the 3 months prior to recruitment to this study o have been / are to be administered a live virus vaccine within the three weeks prior to NHIG administration o are pregnant o have a low platelet count or abnormal results that have not been previously investigated on screening Full blood count.
Outcome results
None listed