New Cuban therapeutic nasal vaccine against chron. hepatitis B

[DavidEurope]

The clinical trial Phase II-III is ending. The vaccine is not registered yet for general use. Clinical trials are ongoing in Cuba and Bangladesh and new trials should start in Brazil and Europe next year.
(I just copy a part of the study document, it is quite big file)
The nasal vaccine candidate (NASVAC), comprising hepatitis B virus (HBV) surface
(HBsAg) and core antigens (HBcAg), has been shown to be highly immunogenic in animal models.
Methods: A phase I double-blinded, placebo-controlled randomized clinical trial was carried out in
19 healthy male adults with no serologic markers of immunity/infection to HBV. This study was
aimed at exploring the safety and immunogenic profile of nasal co-administration of both HBV
recombinant antigens. The trial was performed according to Good Clinical Practice guidelines.
Participants ranged in age from 18 to 45 years and were randomly allocated to receive a mixture
of 50 mg HBsAg and 50 mg HBcAg or 0.9% physiologic saline solution, as a placebo, via nasal spray
in a five-dose schedule at 0, 7, 15, 30, and 60 days. A total volume of 0.5 ml was administered in two dosages of 125 ml per nostril. Adverse events were actively recorded 1 h, 6 h, 12 h, 24 h,
48 h, 72 h, 7 days and 30 days after each dose. Anti-HBs and anti-HBc titers were evaluated
using corresponding ELISA kits at days 30 and 90.
Results: The vaccine candidate was safe and well tolerated. Adverse reactions included sneezing
(34.1%), rhinorrhea (12.2%), nasal stuffiness (9.8%), palate itching (9.8%), headache (9.8%), and
general malaise (7.3%). These reactions were all self-limiting and mild in intensity. No severe or
unexpected events were recorded during the trial. The vaccine elicited anti-HBc seroconversion in
100% of subjects as early as day 30 of the immunization schedule, while a seroprotective anti-HBs
titer (10 IU/l) was at a maximum at day 90 (75%). All subjects in the placebo group remained
seronegative during the trial.
Conclusion: The HBsAg—HBcAg vaccine candidate was safe, well tolerated and immunogenic in
this phase I study in healthy adults. To our knowledge, this is the first demonstration of safety and
immunogenicity for a nasal vaccine candidate comprising HBV antigens.

[StephenCastlecrag]

DavidEurope had very kindly sent us the files. However, the files did not contain any results from the Phase 2 clinical trials of NASVAC. It had the results of a Phase I trial that demonstrated NSAVAC is safe in healthy volunteers and is able to induce immune response against HBV through the production of antibodies.

The effect of NASVAC on patients with chronic Hepatitis B is yet to be announced. The second file is a paper that explains the scientific basis for investigation of therapeutic vaccine.

According to media reports, the results of the ongoing Phase 2 trials are promising.

[HepatitisBCarrier]

Hi All,

Sounds like a very good news.
I tried to google this too but I didn't find any answer. Can anyone tell me how long will it roughly take for this Vaccine to be available for general use? that is ofcourse of everything goes according to plan. If phase ||| trails are coming to an end doesn't this mean it will be available soon e.g. in 1 or 2 years?

Thanks in advance.

[ronny12]

Stephen & David i suppose you have read the article. Can you please inform us briefly about the results of nasvac(% hbsag loss, % hbvdna undetectable) when it will be available? thank you in advance.

[ono8ono]

could you send one to me too? thank you

ono8ono     gmail.com

[japonego]

hello david, could you also send it to me please?
pkmedinfo A gmail.com

[StephenCastlecrag]

Many thanks for the files. It is greatly appreciated.