. 2009 Oct;32(10):1769–1782. doi: 10.2337/dc09-0374

Table 2.

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

Study (ref.)	Drug/phase	Sponsor/contact	Age (years)	Time from diagnosis/eligibility	Route	Dosing	Treated:placebo	Follow-up duration/primary end point	Status/target size
rhGAD₆₅ (45)	rhGAD₆₅-alum/phase II	Diamyd	10–18	≤18 months/C-peptide ≥0.1 pmol/ml, GAD autoantibody positive	s.c.	20 μg twice in 30 days	1:1	15 months/fasting C-peptide, change in fasting and MMTT C-peptide	Published/n = 70
rhGAD₆₅ (83)	rhGAD₆₅-alum/phase II/III	NIH, NIDDK, TrialNet/diabetestrialnet.org	3–45^*	≤12 weeks/C-peptide ≥0.2 pmol/ml, GAD autoantibody positive	s.c.	20 μg at 0, 4, and 12 weeks vs. 20 μg at 0 and 4 weeks vs. alum	2:1	2 + 2 years/MMTT C-peptide (4-h AUC)	Enrolling/n = 126
rhGAD₆₅ (84)	rhGAD₆₅-alum/phase III	Diamyd Therapeutics/swolf@tklreserach.com	10–20^*	≤12 weeks/C-peptide ≥0.1 pmol/ml, GAD autoantibody positive	s.c.	20 μg at 1, 30, 90, and 270 days vs. 20 μg at 0 and 30 days vs. alum alone	2:1	15 months/MMTT C-peptide	Enrolling/n = 320
rhGAD₆₅ (85)	rhGAD₆₅-alum/phase III	Diamyd Therapeutics/ulf.parkhede@trialformsupport.com	10–20	≤12 weeks/C-peptide ≥0.1 pmol/ml, GAD autoantibody positive	s.c.	20 μg at 1, 30, 90, and 270 days vs. 20 μg at 0 and 30 days vs. alum alone	2:1	15 months/MMTT C-peptide	Enrolling/n = 320
Proinsulin peptide (48)	Proinsulin C19-A3/phase I	Diabetes Vaccine Development Centre, JDRF, NHMRC Australia	21–53	>5 years/C-peptide <0.2 pmol/ml	i.d.	Intradermal 30 or 300 μg in 3 monthly doses	3:1	6 months/adverse events	Published/n = 48
IBC-VS01 (86)	Insulin peptide + IFA/phase I	NIAID ITN/Tihamer Orban, MD	18–35	≤30 days		One injection	1:1	2 years/adverse events MMTT C-peptide	Enrollment closed/n = 12
BHT-3021 (87)	plasmid encoding proinsulin/phase I	Bayhill Therapeutics/kwoody@bayhilltx.com	≥18	≤5 years/diagnosed ≤40 years, C-peptide ≥0.066 pmol/ml	i.m.	One of four dose levels (0.3, 1, 3, or 6 mg) weekly for 12 weeks	2:1	25–37 months/crossover optional, adverse events	Enrolling/n = 72
DIA-AID (88)	DiaPep277/phase III	Andromeda Biotech/merana@andromedabio.com	16–45	≤12 weeks/C-peptide ≥0.22 pmol/ml	s.c.	1 mg nine times in 21 months	1:1	2 years/MMTT C-peptide	Enrolling/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.