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AIDS (Acquired Immune Deficiency Syndrome) is a set of symptoms and infections resulting from damage to the human immune system caused by the human immunodeficiency virus (HIV). This condition progressively reduces the effectiveness of the immune system and leaves individuals susceptible to opportunistic infections and tumors. Significant loss of bodyweight, chronic diarrhea with unknown causes, fever, and continuing dry cough are known symptoms of the initial AIDS infection. Most patients die from opportunistic infections or malignancies associated with the progressive failure of the immune system such as severe dermatitis, herpes zoster, pneumonia, and so on.

 
  Worldwide

The lengthy campaign and education to prevent HIV infection has steadily reduced the number of newly HIV infected population. However, by the 2008, the number of infected people reached around 33.4 million around the world, including the death toll, and is continuously increasing. This number of the infected people was more than 20% higher than the number in 2000 and was about 3 times greater than it was in 1990. In particular it is believed that about 430,000 new HIV infections took place during the course of stem transmission in uterus, child delivery, or the post-partum period as a result of breastfeeding.

In many regions of the world, new HIV infections are heavily concentrated among the younger generation, between ages 15 to 24, which from the case of 2006 accounted for 40% of the entire new infections. Sub-Saharan Africa area continues to bear the brunt of the global epidemic. Two thirds (63%) of the entire adult and child population with HIV reside in south sub-Saharan Africa and 32% in southern Africa. In 2006, 34% of all deaths resulted from AIDS occurred in southern Africa. In 2006, there was a 21% increase from 2004 in HIV infection in the Eastern Europe and Central Asia, and the same for the newly infected population.

  HIV in Korea

According to KCDCP (Korea Center for Disease Control and Prevention), 6,680 cases of HIV infection have been reported by 2009.09, among whom 1,183 died and 5,497 are still living. Male infected took 91.7%, which was 8 times higher than female of 8.3%. Most cases were associated with sexual contacts (99%), and there has been no report of infection related to blood transfusion or maternal transmission during pregnancy since 2007.

 
 

Since HIV was defined as the causative virus for AIDS in 1983, there has been no commercialized and USFDA approved HIV/AIDS vaccine even though many researchers conducted pre-clinical or clinical trials with HIV vaccine candidates. More recently, the failure of Merck, the leading pharmaceutical corporation in AIDS vaccine research, in the process of Phase II clinical trials, certainly held off other ongoing HIV vaccine projects, as well as the initiation of new projects.

According to the IAVI (International AIDS Vaccine Initiative), about 20 clinical trials are currently underway, but unfortunately most are sharing similar techniques and are based on the same strategy, which is deemed by most experts and critics not to have much hope.
 
Clinical phase Strategy (Prime / boost)

# Studies (Total volunteers)

A.  DNA +/- viral vector vaccines

I DNA / protein / pox vector
DNA / pox vector
DNA / adeno vector
DNA
Adeno(Ad35) / adeno(Ad5) or DNA

1(3)
3(184)
2(89)
2(160)
1(192)

Ib DNA / adeno vector(Ad5)

1(90)

II DNA / pox vector

4(295)

IIa DNA / pox vector

1(225)

 B.  Protein-based vaccines

I Protein

1(15)

III Pox vector / protein

1(16,403)

C.  Adenoviral vector alone vaccines

I Adeno(Ad26) vector
Adeno(Ad5) vector
Adeno(Ad35) / adeno(Ad35 vector
Adeno(Ad35) or Ad35 / Ad5 vector

1(48)
2(88)
1(42)
1(35)

D.  Pox virus vector alone vaccines

I

Viral vector - pox

4(172)

Source: Ongoing HIV Vaccine Human Clinical Trials, IAVI Report, June 11, 2009
 
 

Recently, an AIDS vaccine candidate failed during Phase III trials. The said candidate was developed with only parts of HIV antigens, gp120 and gp41, which once again implied with greater certainty that chances are slim with those HIV vaccine candidates that are based on certain parts of HIV antigens. The whole-killed virus technique, on the other hand, has been successful in other types of vaccine development for humans, thus considered ‘conventional wisdom’, and it has been generally adopted in animal vaccine development. Sumagen’s SAV 001 is in this context the first whole-killed virus based HIV vaccine, which makes Dr. Kang’s research unique.

 

Sumagen’s SAV 001 is unique and different from other vaccine candidates, as it uses genetically re-engineered whole virus genome and thereby eliminate its pathogenicity and then inactivates its virulence through chemical treatment and irradiation methods, finally arriving at the first ‘whole-killed virus’ based HIV vaccine.

 

 

What makes HIV vaccine’s clinical trials difficult is the fact that there is no cross-infection between human HIV and animal HIV. To overcome this barrier, Dr. Kang and University of California at Davis laboratories cooperated to make new viruses called SHIV (Simian-Human immunodeficiency Virus) having SIV (Simian Immunodeficiency Virus) to transmit into monkey bodies. This monkey immunogenicity test was completed in August 2005, and the result showed an effectively high immune responses, not only to cell mediated immune responses but also to human immune responses with SAV 001.

Subsequent immunogenicity tests were followed using rats and mice at Charles River Laboratories in Montreal Canada, which resulted in enhanced immune responses when SAV 001 was injected into animal bodies combined with adjuvant, IFA (Incomplete Freund’s Adjuvant). Following these tests, Sumagen determined the appropriate dosage and injection scheme to induce the maximum immune response.

 

The safety of SAV 001 with and without adjuvant was tested and proven through the non-clinical GLP (Good Laboratory Practice) toxicity study using monkey at renowned CRO (Contract Research Organization), Southern Research Institute, Birmingham United States. The study design was based on FDA and WHO guidelines. The result was that there were no severe toxicities with SAV 001 even with higher dosages and multiple injections than what would actually be anticipated in a real case.

The first clinical trials to test its toxicity safety on human is underway in the United States on HIV-1 infected patient. It has drawn so much of attentions from all around the world because it is the first case that whole HIV virus, though killed, is actually injected to human. Once SAV 001’s safety is confirmed through Phase I clinical trials, Sumagen will initiate a larger scale clinical trials on a global basis on higher risk HIV patients, Phase II trials, in order to test its effect and immunogenicity.

Sumagen has developed and established a manufacturing process for SAV 001 under the CGMP condition (Current Good Manufacturing Practice) to produce SAV 001 not only for the Phase I trials but also for the larger scale Phase II on a global basis. This mass production facility also must satisfy BSL3 conditions (Bio Safety Level 3). Since very few manufacturing facilities meet these rigorous standards, Sumagen closely cooperates with University of Western Ontario to host HIV/AIDS vaccine manufacturing facility that would satisfy all the rigorous conditions and standards.