Successful immunisation and safety shown in Vacc-4x/Endocine study
Bionor Pharma, Eurocine Vaccines and University of Oslo Hospital have revealed that vaccine-related immune responses are documented in patients given active vaccine in a nasal immunisation study, combining Bionor's Vacc-4x and Eurocine's adjuvant Endocine. Dose-related differences are currently under evaluation, and additional data including antibody production in mucosal secretions will be analysed and published at a later stage. The results also document safety by nasal administration of the vaccine. The clinical costs have been covered by a grant from the Research Council of Norway (RCN) of US$1.2 million (NKr 6.9 million), under the GLOBVAC programme.
Vacc-4x is a therapeutic HIV vaccine based on four, slightly modified peptides (building blocks of proteins) from conserved parts of the HIV virus. Endocine is an adjuvant shown to enhance the immune response to vaccine antigens delivered nasally. Researchers at University of Oslo Hospital studied the effect of nasal delivery of Vacc-4x in combination with Endocine, compared with the effect of Endocine alone.
The single-blinded, randomised, placebo-controlled, immunogenicity study included 24 patients, all receiving conventional HIV medicine (antiretroviral therapy, ART). A total of 18 patients received active, nasal vaccine (both Vacc-4x and the adjuvant Endocine) at either of three different dose levels of Vacc-4x, and six patients received Endocine only (control group). All patients were given weekly nasal drops for four weeks (one patient was withdrawn at week six, without reasons related to the study).
The final study visit was scheduled at week eight. Overall, the treatment was well tolerated, although some reported mild and transient sensations in the nose the same day. Only the patients given active nasal vaccine with Vacc-4x increased their vaccine related immune responses during the eight-week study period. This outcome was further confirmed by a skin test (DTH). These results support that immunisation of HIV-infected individuals by nasal co-administration of Vacc-4x and Endocine adjuvant is safe and is able to strengthen vaccine related immune responses.