Validating the optimal dose of normal immunoglobulin for protection against hepatitis A

Phase 4

• Conditions: hepatitis A; Public Health - Other public health; Infection - Other infectious diseases; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12617001567314
• Lead Sponsor: Griffith University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-21
• Study Completion: 2019-11-06
• Last Update Posted: 5 July 2021

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantitative hepatitis A antibody concentration in serum measured according to manufacturer's instructions using Beckmann Coulter Access HAV Ab kit.[Days from IM injection of NHIG: 0, 1, 3, 7, 28, 50 (primary timepoint).]

Secondary Outcome Measures

Name	Time	Method
Adverse events: local tenderness, erythema, muscle stiffness, pyrexia, malaise, drowsiness, urticaria, local swelling, headache, nausea, dizziness, any other events volunteered or observed. <br>Participants will remain under observation for 20 minutes after NHIG administration. Participants will be questioned about any adverse events potentially related to NHIG administration when they return for blood sampling on days 1, 3 and 7.[Days after IM injection of NHIG: 0, 1, 3, 7.]