Phase II Placebo-Controlled Study of V-1 Immunitor in VACCINE Journal

immunitor immunitor immunitor3 at hotmail.com
Fri Jan 31 05:33:29 EST 2003


Phase II Placebo-Controlled Study of V-1 Immunitor in VACCINE Journal

Researchers of Thailand-based Immunitor company announce the publication of 
results of placebo-controlled, Phase II clinical trial entitled ‘V-1 
Immunitor: oral therapeutic AIDS vaccine with prophylactic potential’ in 
January 30, 2003 issue of VACCINE – the top scientific journal in the field 
(Vol. 21(7-8): pages 624-628). The link to the abstract of the paper at the 
website of the National Library of Medicine of the NIH is as follows: 
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12531330&dopt=Abstract

This study is 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. In 
this trial V-1 Immunitor (V1) has been investigated as a preventive AIDS 
vaccine in 35 healthy, non-infected individuals. Twenty HIV-negative 
volunteers immunized with V1 gained 28.2% and 17.5% in absolute CD4 (825 
versus 1058; P=0.007) and CD8 (597 versus 702; P=0.013) cells, while 
lymphocytes in the placebo group did not increase, suggesting that a rise in 
CD4 and CD8 counts will be an easily measurable immune correlate of the 
efficacy of the AIDS vaccine. At the same time V1 did not induced 
HIV-specific antibodies as orally administered immunogens usually produce 
cell-mediated but not systemic humoral response. Currently, no other oral 
AIDS vaccine is available that has been tested in humans. The closest 
product, planned for clinical studies, is an IAVI-sponsored vaccine being 
developed by a research team of Dr. Robert Gallo – the co-discoverer of HIV.

V1 consists of a cocktail of fragments of HIV proteins derived from a large 
pool of specially processed blood from HIV carriers. These protein fragments 
or antigens are harmless since they are inactivated by heat and chemical 
means and are then formulated into an ordinary-appearing pill. When taken 
orally, V1 produces an immune response on mucosal surfaces as evidenced by 
rising T cell counts. Since HIV also enters the body through the mucosal 
surface of the vagina or rectum, a proper immunological response at the site 
of virus entry is the best chance to prevent infection in a rational manner. 
The vaccine as designed offers unique advantages: (1) it is safe; (2) has a 
broad-spectrum activity against any HIV species at any continent; (3) very 
large quantities can be manufactured at low cost; (4) it is extremely stable 
at ambient tropical temperature, thus eliminating the need for refrigerated 
storage and reducing the cost of transportation; (5) it is easy to 
administer (no syringes and no risk of being infected with contaminated 
needles); and (6) it does not require specially trained personnel for 
mass-distribution campaigns.

The vaccine, the first of its kind to originate from a developing country, 
is currently manufactured in Thailand. V1 is licensed by the Thai FDA as 
dietary food supplement for special purposes and also has a permit as an R&D 
drug. As of today, over 12 million units of V1 have been made and used by 
60,000 AIDS patients in Thailand and approximately 4,500 individuals in 50 
countries around the world. According to results of Phase I trial reported 
in the peer-reviewed journal HIV Clinical Trials in early 2001, in a study 
involving 40 HIV infected individuals, orally administered V1 boosted CD4 
and CD8 lymphocyte counts, decreased viral load, and reversed AIDS 
associated wasting (www.thomasland.com/_nonsearch/hct03104.pdf). In the 
subsequent study on 117 patients as reported in May 2002 in the same 
journal, administration of V1 to terminally ill, end-stage AIDS patients has 
resulted in prolonged survival and return to normal life, while all those 
who declined treatment were dead within two months 
(www.thomasland.com/_nonsearch/hct03310.pdf). V1 also appears to be 
beneficial to patients with viral hepatitis 
(www.dnavaccine.com/new.html?aid=610).

According to the United Nations Programme on HIV/AIDS (UNAIDS) about 14,000 
people worldwide are infected with HIV every day. In developing countries, 
where therapies are not readily available, HIV diagnosis is a death 
sentence. Of the 3 million deaths attributed to AIDS in 2001, 2.2 million 
occurred in Africa. Several large pharmaceutical firms, e.g., Aventis, 
Chiron, GlaxoSmithKline, Merck, Wyeth, and a dozen of smaller companies are 
working to advance their candidate HIV vaccines into human trials. However, 
only two AIDS vaccines, one by VaxGen and another by Immune Response 
Corporation, have reached late-stage trials involving several thousand 
volunteers.

‘This year we will start Phase III trial in Africa in accord with our 
strategy of going where there is a need,’ said Mr. Vichai Jirathitikal, who 
is a pharmacology graduate of Mahidol University in Bangkok and the 
principal developer of the vaccine. ‘We are currently running pilot 
therapeutic trials in eight African countries as part of the feasibility 
study. So far, the response from patients and clinicians has been 
enthusiastic; V1 appears to benefit even those who have HIV-2, a distant 
cousin of HIV. We are also discussing plans to build a plant in one of these 
countries as part of our long-term goal to provide self-reliance and 
independence to our allies. We want our technology to be affordable in third 
world countries. Our goal is to save lives; money is tangential. We have 
given V1 free-of-charge to 40,000 people in Thailand.’

‘The paper in VACCINE represents the culmination of many years of groundwork 
in basic science to understand how the virus spreads in the mucosa and a 
succession of preclinical and clinical studies in spite of the enormous 
hurdles of developing vaccine without adequate support,’ commented 
Immunitor’s Scientific Director, Dr. Aldar Bourinbaiar, who was involved in 
HIV research since 1983. ‘As opposed to start-up biotech companies, 
primarily depending on research grants and venture capital, we have a 
commercially viable line of proprietary products that sustain our activity, 
albeit at very modest level. This is and will be an uphill struggle but we 
are optimistic about seeing enrollment in a Phase III trial happening before 
end of this year. We hope that such a study will bring us one step closer to 
the ultimate goal of ending the AIDS pandemic.’ For further information 
please contact immunitor at aol.com.









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