Table 2

Tertiary prevention trials of antigen-specific vaccines after diagnosis of diabetes

Study (ref.)Drug/phaseSponsor/contactAge (years)Time from diagnosis/eligibilityRouteDosingTreated:placeboFollow-up duration/primary end pointStatus/target size
rhGAD65 (45)rhGAD65-alum/phase IIDiamyd10–18≤18 months/C-peptide ≥0.1 pmol/ml, GAD autoantibody positives.c.20 μg twice in 30 days1:115 months/fasting C-peptide, change in fasting and MMTT C-peptidePublished/n = 70
rhGAD65 (83)rhGAD65-alum/phase II/IIINIH, NIDDK, TrialNet/diabetestrialnet.org3–45*≤12 weeks/C-peptide ≥0.2 pmol/ml, GAD autoantibody positives.c.20 μg at 0, 4, and 12 weeks vs. 20 μg at 0 and 4 weeks vs. alum2:12 + 2 years/MMTT C-peptide (4-h AUC)Enrolling/n = 126
rhGAD65 (84)rhGAD65-alum/phase IIIDiamyd Therapeutics/swolf@tklreserach.com10–20*≤12 weeks/C-peptide ≥0.1 pmol/ml, GAD autoantibody positives.c.20 μg at 1, 30, 90, and 270 days vs. 20 μg at 0 and 30 days vs. alum alone2:115 months/MMTT C-peptideEnrolling/n = 320
rhGAD65 (85)rhGAD65-alum/phase IIIDiamyd Therapeutics/ulf.parkhede@trialformsupport.com10–20≤12 weeks/C-peptide ≥0.1 pmol/ml, GAD autoantibody positives.c.20 μg at 1, 30, 90, and 270 days vs. 20 μg at 0 and 30 days vs. alum alone2:115 months/MMTT C-peptideEnrolling/n = 320
Proinsulin peptide (48)Proinsulin C19-A3/phase IDiabetes Vaccine Development Centre, JDRF, NHMRC Australia21–53>5 years/C-peptide <0.2 pmol/mli.d.Intradermal 30 or 300 μg in 3 monthly doses3:16 months/adverse eventsPublished/n = 48
IBC-VS01 (86)Insulin peptide + IFA/phase INIAID ITN/Tihamer Orban, MD18–35≤30 daysOne injection1:12 years/adverse events MMTT C-peptideEnrollment closed/n = 12
BHT-3021 (87)plasmid encoding proinsulin/phase IBayhill Therapeutics/kwoody@bayhilltx.com≥18≤5 years/diagnosed ≤40 years, C-peptide ≥0.066 pmol/mli.m.One of four dose levels (0.3, 1, 3, or 6 mg) weekly for 12 weeks2:125–37 months/crossover optional, adverse eventsEnrolling/n = 72
DIA-AID (88)DiaPep277/phase IIIAndromeda Biotech/merana@andromedabio.com16–45≤12 weeks/C-peptide ≥0.22 pmol/mls.c.1 mg nine times in 21 months1:12 years/MMTT C-peptideEnrolling/n = 500
  • *Staggered enrollment. AUC, area under the curve; IFA, incomplete Freund's adjuvant; MMTT, mixed-meal tolerance test; NIAID ITN, National Institute of Allergy and Infectious Diseases Immune Tolerance Network; NIDDK, National Institute of Diabetes and Digestive and Kidney Diseases; NHMRC, National Health and Medical Research Council; NIH, National Institutes of Health; JDRF, Juvenile Diabetes Research Foundation.