Table 1.
Clinical trials with recombinant B cell epitope-based peptide carrier vaccines.
| Name of the study | Designation in the ClinicalTrials.gov database of privately and publicly funded clinical studies conducted around the world | No of patients | Design | Major findings | References |
|---|---|---|---|---|---|
| Skin test study of BM32 | NCT01350635 | 60 | Interventional, non-randomized, open-label | BM32 does not induce immediate or late-phase allergic skin inflammation and may be safe for vaccination | (76) |
| Phase II: Safety and dose finding trial of BM32 in subjects suffering from grass pollen allergy | NCT01445002 | 70 | Prospective, randomized, double-blind, placebo-controlled, single center. Pollen exposure chamber | BM32 is well-tolerated; reduced allergic symptoms upon provocation with grass pollen by inducing allergen-specific IgG blocking antibodies. BM32 does not boost allergen-specific IgE production | (77) |
| Phase II field study of grass pollen allergy vaccine BM32 | NCT01538979 | 181 | Prospective, randomized, double-blind, placebo-controlled, parallel-group field study. One baseline year followed by 2 years of treatment | Injections of BM32 induced allergen-specific IgG, improved clinical symptoms of grass pollen allergy over two seasons and were well-tolerated. The optimal dose for BM32 was determined to be 20 μg per BM32 component/injection | (78) |
| Effect of different pre-seasonal BM32 dosings on the induction of a protective allergen-specific IgG response | NCT02643641 | 130 | Prospective, randomized, double-blind, placebo-controlled, mono-centric, combination of pollen chamber and field study | Five injections of a mix of 20 μg of each BM32 component induced the best blocking IgG antibody response compared to three and four injections | |
| Study to evaluate induction of HBV virus neutralizing antibodies using VVX001 (i.e., BM325) | NCT03625934 | 84 | Double-blind, randomized, placebo-controlled, multicenter study. Evaluation of the effects of VVX001 (i.e., BM325) to elicit a protective IgG immune response in vaccine naive subjects, in subjects who failed to demonstrate seroconversion after treatment with a licensed hepatitis B vaccine and in patients chronically infected with HBV | Ongoing Besides HBV-related endpoints, the study will provide information about safety in non-allergic subjects, induction of allergen-specific IgG responses and IgE sensitization capacity |