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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.
(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.
Thanks,
10 years seem like a long time after phase ||-|||, Iets hope it becomes available sooner than that. according to my doctors I am only a carrier (I hope they are right). I am being observed every 6 months via blood tests. I have my fibroscan booked next month. Docs have never given me any medication.
10 years seem like a long time after phase ||-|||, Iets hope it becomes available sooner than that. according to my doctors I am only a carrier (I hope they are right). I am being observed every 6 months via blood tests. I have my fibroscan booked next month. Docs have never given me any medication.
I dont know. 10 years? But you have more time then we have if you are still only the carrier..no? The carriers are not threated, just regulary observed..
Hi all,
Thank you all for posting this.
Roughly, how long will the remaining clinical trials take? when can we expect this vaccine to be registered for general use? 3 years, 5 years 10 years?
I know phase ||-||| is ending and there will be more trials in Brazil and Europe. but how long will all the trails take before it is available in hospitals for everyone?
Thanks
Thank you all for posting this.
Roughly, how long will the remaining clinical trials take? when can we expect this vaccine to be registered for general use? 3 years, 5 years 10 years?
I know phase ||-||| is ending and there will be more trials in Brazil and Europe. but how long will all the trails take before it is available in hospitals for everyone?
Thanks
without knowing the results of the Phase 2/3 clinical trials, it is difficult to say, especially since I am not an expert. China tested two therapeutic vaccines, both failed to do better than the placebo. Of course NASVAC has its own characteristics. I read an interview with Dr Julio Cesar Aguilar PhD, who is the scientific leader of the NASVAC vaccine project at the Vaccine Department, in the Center for Genetic Engineering and Biotechnology (CIGB) of Havana, Cuba:
If a new product like the therapeutic vaccine formulation NASVAC is registered, it would be a very valuable one. In the existing scenario, it has potentiality to be used as a first line therapy. NASVAC can be administered before starting more reactogenic therapies like IFN or before quasi-eternal treatments like taking nucleos(t)ide analogs for several years. The toxicological pattern of NASVAC will definitively be different and potentially safer according to preclinical and clinical results and also according to the experience with other products in CHB patients. For example, the induction of mutants won’t be an expectable risk.
The specific value of the product will be better appreciated after phase III controlled clinical trials. The results not necessarily need to be better, even in case of similar efficacy to conventional treatments; it will be a highly valuable product because the therapeutic effect will be obtained with minimum reactogenicity –as much as we know today. In case of superiority, the value will be much greater as it will be a finite treatment that could lead to relatively rapid and safe responses for patients. A potential benefit to further intervention could also be expected.
As for drinking, I am going to put my neck out and say an occasional drink is fine. I have a "silly" excuse - I think studyforhope may agree (LOL).
If a new product like the therapeutic vaccine formulation NASVAC is registered, it would be a very valuable one. In the existing scenario, it has potentiality to be used as a first line therapy. NASVAC can be administered before starting more reactogenic therapies like IFN or before quasi-eternal treatments like taking nucleos(t)ide analogs for several years. The toxicological pattern of NASVAC will definitively be different and potentially safer according to preclinical and clinical results and also according to the experience with other products in CHB patients. For example, the induction of mutants won’t be an expectable risk.
The specific value of the product will be better appreciated after phase III controlled clinical trials. The results not necessarily need to be better, even in case of similar efficacy to conventional treatments; it will be a highly valuable product because the therapeutic effect will be obtained with minimum reactogenicity –as much as we know today. In case of superiority, the value will be much greater as it will be a finite treatment that could lead to relatively rapid and safe responses for patients. A potential benefit to further intervention could also be expected.
As for drinking, I am going to put my neck out and say an occasional drink is fine. I have a "silly" excuse - I think studyforhope may agree (LOL).
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...
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...
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.
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.
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.
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.
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.
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.
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
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
Is it possible to send us a copy of the PDF files if I give you my email address?
I have asked the info directly via e-mail the Cuban institute, so they have sent me two huge PDF files..
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