nasvac clinical trial results

[Ashi2010]

NASVAC is a novel therapeutic vaccine
candidate developed at CIGB, Cuba, for chronic
hepatitis B that utilizes both surface (HBsAg)
and nucleocapsid (HBcAg) antigens of the HBV
administered in a unique immunization schedule
up to ten administrations. Immunogenicity studies
conducted in mice evidenced of the capacity of
the intranasal route to induce an effective immune
response against both antigens at mucosal as
well as systemic immune compartments. Five
toxicology studies later evidenced the safety of the
vaccine formulation and allowed the continuation of
research at the clinical level, in addition, a group
of studies conducted in transgenic mice evidenced
the capacity of NASVAC formulation to overcome
tolerance and induce humoral and cellular immune
response in tolerogenized systems. Furthermore, no
tissue damage was related to the active induction
of immunity or after transfer of cells from actively
immunized non transgenic donors or transgenic
donors.
Clinical results evidenced the safety of NASVAC
therapeutic immunization; no serious or severe
adverse events were detected after more than 100
patients have been immunized by systemic and/or
nasal routes. In terms of efficacy, phase III results
NASVAC is a novel therapeutic vaccine
candidate developed at CIGB, Cuba, for chronic
hepatitis B that utilizes both surface (HBsAg)
and nucleocapsid (HBcAg) antigens of the HBV
administered in a unique immunization schedule
up to ten administrations. Immunogenicity studies
conducted in mice evidenced of the capacity of
the intranasal route to induce an effective immune
response against both antigens at mucosal as
well as systemic immune compartments. Five
toxicology studies later evidenced the safety of the
vaccine formulation and allowed the continuation of
research at the clinical level, in addition, a group
of studies conducted in transgenic mice evidenced
the capacity of NASVAC formulation to overcome
tolerance and induce humoral and cellular immune
response in tolerogenized systems. Furthermore, no
tissue damage was related to the active induction
of immunity or after transfer of cells from actively
immunized non transgenic donors or transgenic
donors.
Clinical results evidenced the safety of NASVAC
therapeutic immunization; no serious or severe
adverse events were detected after more than 100
patients
In summary, a therapeutic vaccine therapy
containing HBsAg/HBcAg represents a safe and
efficacious therapeutic approach for CHB. This study
inspired optimism that ongoing protocols of immune
therapy against CHB may be improved by combined
strategies using novel routes of administration and
a reinforced administration schedule with a rational
selection of the antigens.

http://journal.blood.am/publish/download/16/blood_journal_16_03.pdf

[Jatashankar]

But this ain't a cure

[Paderla Anitha, DNB]

Hi and thanks for sharing. NASVAC is a therapeutic vaccine with potentialities to improve the quality of life of chronic hepatitis B patients. NASVAC is in the Phase-III Trial in Chronic Hepatitis B (CHB) Patients. Hopefully this will provide good results. Regards.