TABLE 1.

Clinical studies retested with the anti-HBs in-house assay

StudyPopulationVaccine groupaReference assayNo. of patients in group to be testedTime point(s)bRationale
A50-70 yr oldExperimental HepB formulationRIA72 (subset)PI, mo 1Verify concordance with AUSAB RIA in an elderly population which reaches lower seroprotection rate and GMT than in adults 18-40 yr old
Engerix-BPI, mo 1
PII, mo 6
PIII, mo 7
BAdult nonresponderscExperimental HepB formulationRIA58 (all)PreVerify concordance with AUSAB RIA in a difficult population and check specificity of anti-HBs in-house assay on prevaccination samples
Engerix-BPI, mo 1
PII, mo 2
PII, mo 6
PIII, mo 7
C11-18 yr oldEngerix-BRIA72 (subset)PI, mo 1Verify concordance with AUSAB RIA after vaccination with a vaccine from another manufacturer
RecombivaxdPII, mo 2
PII, mo 6
PIII, mo 7
D18-40 yr oldEngerix old 1EIA72 (subset)PII, mo 6Verify concordance with AUSAB EIA following different formulations of the same vaccine
Engerix old 2PIII, mo 7
Engerix
E12-15 yr oldAmbirix 720/20RIA, EIA140 (all)PIII, mo 7Verify concordance with AUSAB RIA and AUSAB EIA
Twinrix 360/10
FChildren <1 yr oldInfanrix hexaRIA50 (subset)PreVerify concordance with AUSAB RIA after vaccination with HBV in combined pediatric vaccines
Infanrix penta + HiberixPII, mo 6
PII, mo 8
PIII, mo 9
GChildren <1 yr oldInfanrix hexaEIA62 (all)Pre, mo 1.5Verify concordance with AUSAB EIA after vaccination with HBV in combined pediatric vaccines
Infanrix penta + HiberixPIII, mo 7
PIII, mo 15
PIV, mo 6
  • a Engerix old 1, previous formulation, containing thiomersal as a preservative; Engerix old 2, previous formulation, using thiomersal during the production process.

  • b Pre, sample taken prior to vaccination; PI to PIV, postdose months 1 to 4; mo 1, mo 2, etc., study month 1, study month 2, etc.

  • c Nonresponders are healthy adults with an anti-HBs antibody concentration of <10 mIU/ml 2 to 5 months after having received at least four doses of HBV.

  • d Recombivax is a trademark of Merck & Co.