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New Cuban therapeutic nasal vaccine against chron. hepatitis B

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.

28 Responses
Avatar universal
NASVAC is meant to be a therapeutic vaccine, so the results of the Phase II trials are keenly awaited as they should be testing on patients with chronic hepatitis B. A paper was presented at a recent conference in Cuba by the doctor in charge of the Bangladesh trial. The Cuban press hailed the vaccine. Despite numerous requests to the Conference organizer about publishing papers from the conference, no reply was ever received. A direct request to the doctor concerned elicited only the most general response. So, we still have no concrete figures about the results from any of these phase II/III trials. I hope you would have better luck.
Avatar universal
That´s what they say, the phase II/III is ending... If I understood well it is very promising..
Avatar universal
That is what they keep on saying, without publishing any data - very frustrating.
Avatar universal
...then of course all the producers of antivirals and interferon will be ungry because for them is much more lucrative keeping us sick...
Avatar universal
Just to clarify some things.can we say that the hbv theraupetic vaccines will increase the odds of becoming hbsag -ve.they will be used(if proven effective)mono or in combination with existing hbv therapies?do they act on hbvdna or on hbsag?thanks in advance.
Avatar universal
If I have read well, there was 100% seroconverted people in trial..
Avatar universal
this info was disclosed along with other information ?
Avatar universal
I have asked the info directly via e-mail the Cuban institute, so they have sent me two huge PDF files..
Avatar universal
Is it possible to send us a copy of the PDF files if I give you my email address?
Avatar universal
of course, but I am not sure you can put your e-mail address here..
Avatar universal
send me an e-mail to david.***@**** then I will send you those files back
Avatar universal
you see, I tried to put my e-mail and it deleted part of it..:-(
Avatar universal
you can use space:
name @ yahoo . com

or

nameATgmail.com

or you can put the files on google docs and put the link, so everybody can see the docuemnts
Avatar universal
Thanks, my email address is

swong888 at gmail.com
Avatar universal
if is possible I want to see this results also

st4est at gmail.com
Avatar universal
I have sent it, just tell me if when zou dont get it.
Avatar universal
Many thanks for the files. It is greatly appreciated.
Avatar universal
hello david, could you also send it to me please?
pkmedinfo A gmail.com
Avatar universal
could you send one to me too? thank you

ono8ono     gmail.com
Avatar universal
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.
Avatar universal
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.
Avatar universal
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.
Avatar universal
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.
Avatar universal
I think it is very promising. Cuba got a huge power in the production of pharmaceutics. There were a lot of doctors comming to the Cuban hepatitis conference this year, that means it is something very important.

I dont understand too much all that HBV mechanism but would the vaccine heal us 100% ? Would it mean no more virus? Could I drink good French wine again? And now, when Entecavir will make the virus undetectable..can I drink a little again? I am already fed up of telling my friends that I cant have a drink with them...
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