Immunitor at the 6th International Forum on Global Vaccinology

Immunitor at the 6th International Forum on Global Vaccinology 

An oral presentation - Phase II placebo-controlled study of
therapeutic AIDS vaccine, V-1 Immunitor - was delivered by Dr. Aldar
S. Bourinbaiar, the Scientific Director of Immunitor, at the plenary
session of the 6th International Forum on Global Vaccinology: Vaccines
and Immunization, 25 - 26 September 2003, Minsk, Belarus. The Forum
was organized by the Infections Control World Organization, Montreal,
Canada, and the Research Institute for Epidemiology and Microbiology,
Minsk, Belarus, under auspices of the Ministry of Public Health of the
Republic of Belarus and National Academy of Sciences of Belarus
(http://www.briem.ac.by/eng/konf.html).

The presented study was a result of collaboration with the clinical
team led by epidemiologist Dr. Orapun Metadilogkul of Rajavithi
General Hospital, the largest public medical institution of the Thai
Ministry of Public Health.

V-1 Immunitor (V1) is a polyvalent oral AIDS vaccine which was
licensed in Thailand as orally available dietary supplement. Except
for V-1 Immunitor no other oral killed vaccine against viruses is
available commercially. However, as noted by Dr. Bourinbaiar, there
are many killed bacterial oral vaccines on the market. Among these
are: a killed whole cell-cholera toxin recombinant B subunit vaccine
developed in Sweden (WC/rBS); a simpler version of cholera vaccine
without recombinant B subunit manufactured in Vietnam; Soviet tableted
cholera vaccine; E.coli oral vaccine against urinary tract infections
sold by OM Pharma (Geneva, Switzerland); Czech-made oral vaccines
Kanvakol, Alvakol, and Urvakol against several types of bacteria;
multibacterial vaccine Luivac against respiratory tract infection from
Sankyo (Tokyo, Japan); oral anti-bacterial vaccine, Imocur, to prevent
respiratory infections (Zambon, France); Broncho-Vaxom (Fournier,
France); tableted Buccaline preparation (Berna Biotech/Qualiphar); a
broad-spectrum antigenic preparation from Klebsiella pneumoniae
Biostim (Aventis Pharma); the Mexican/German anti-bacterial Paspat
made as an oral tablet (Altana Pharma); the French oral preparation,
Ribomunyl, containing ribosomal fractions of bacteria (Pierre Fabre);
Bulgarian polybacterial vaccine Respivax for bronchopulmonary
infections; the Polish propionibacterium acne vaccine; and several
Russian vaccines for a variety of microbial infections. These vaccine
preparations are used as therapeutic and prophylactic modalities. Most
clinical trials relating to these vaccines are either unpublished or
published in non-English language journals, which makes them virtually
unknown to Western vaccinologists. With the exception of, perhaps,
cholera vaccine almost all of these vaccines are marketed as
immunomodulators or food supplements. However, this misnomer in
regulatory terminology is semantic rather than scientific.

Placebo-controlled phase II study of V1 as a prophylactic vaccine in
healthy volunteers has been published in January 30, 2003 issue of
VACCINE journal (Vol. 21, pages 624-628;
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12531330&dopt=Abstract).
However, the clinical experience with V1 as a therapeutic modality was
primarily based on open-label studies which demonstrated body weight
gain, increase in CD4 and CD8 cells, decrease in viral load, and
improved survival of end-stage AIDS patients. In order to substantiate
prior non-controlled studies the placebo-controlled phase II clinical
trial has been undertaken in 45 asymptomatic volunteers who had over
350/mm3 CD4 T-cells at study entry. The results from 6-month follow-up
were as follows: HIV-positive volunteers who received V1 b.i.d. had
gained on average 85 CD4 T-cells (543 vs 628). This gain was
statistically significant (p=0.0062) while a small increase in T-cell
counts (530 vs 576) of patients on placebo failed to reach the
significance threshold (p=0.32). The clinical benefit of V1 was
further supported by steady increase in CD4/CD8 ratio among V1
recipients (0.4455 vs 0.5840, p=0.0011) and decline in CD4/CD8 ratio
among patients on placebo (0.5581 vs 0.5113, p=0.15). These results
suggest that V1 may reverse the disease progression without any
concurrent toxicity. Other immune and clinical improvements were
discussed during the presentation and results of this study will be
submitted for publication to a peer-reviewed AIDS journal in near
future.

Immunitor’s presentation was praised by the Honorary Chairman of
the Forum, Professor Veniamin  I. Votyakov, a member of Belarusian and
Russian Academy of Sciences, as an example of finding simple and
inexpensive solution to global health crisis especially in countries
that have no means to purchase often-expensive antiviral drugs or
vaccines.
 
‘This critical study enforces the value of our product and will
be further supported by results of ongoing and planned clinical trials
in Africa which is carried out by independent investigators,’
said Mr. Vichai Jirathitikal, who is a pharmacology graduate of
Mahidol University in Bangkok and the principal developer of the
vaccine. ‘V1 is now registered in Ghana and we have pending
licenses in several other African countries. We are currently
discussing plans to build a vaccine plant in two of these countries as
part of our long-term goal to provide affordable and safe therapy to
the developing world”.

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