T wenty years ago, Human Immunodeficiency Virus (HIV) and Acquired Immune Deficiency Syndrome (AIDS) were not foreseen as serious problems, at least in terms of scale.
Today, it is a wholly different picture. The small wave of HIV/AIDS has become a tide, infecting and killing swathes of the populations of developing countries, and with women and children particularly at risk.
Sub-Saharan Africa is blighted by HIV and AIDS. In a continent where poverty and disease are rife, famines regular occurrences and wars of many kinds despoil whole countries, controlling and treating the infection is extremely difficult.
In 2008, about two million people died of AIDS globally, 33.4 million were living with HIV and 2.7 million were newly infected with the virus.
The impact of HIV/AIDS on women and girls has been particularly devastating, and they now comprise 50 per cent of those aged 15 and older living with HIV.
The effect of HIV/AIDS on children and young people is a severe and growing problem.
In 2008, 430,000 children under age 15 were infected with HIV and 280,000 died of AIDS. And about 15 million children had lost one or both parents due to the disease.
Retroviral treatments have had some impact, prolonging the life expectancy of many sufferers. Unfortunately, those living at subsistence level simply cannot afford these drugs and neither can their governments.
Seek, formerly known as PepTcell, has just announced a breakthrough — a successful trial of a vaccine against HIV.
Based at the Cherwell Innovation Centre at Upper Heyford, the company specialises in immunology, researching the body’s immune cells and systems.
Chief Scientific Officer Dr Wilson Caparros-Wanderley is very encouraged by these early results but stressed that a product on the market is still some way off.
He said: “We conducted a small-scale trial on 55 patients, all of whom are HIV positive, but who have not developed full-blown AIDS and show no signs of any HIV or AIDS-related problems.
“Our tests were to check efficacy as a prophylactic, a disease preventer. Trials as a therapeutic, to cure patients already infected, would demand a minimum of 3,000 patients and cost £20,000 each. That is something for later and with a partner to share the costs.”
The trial was to test for efficacy and any side effects. Normally, such a trial would involve several doses, each dose weight adjusted for the individual, but weight adjustment is not possible with vaccines. Instead, the doses were estimated. Each patient received just a single dose.
Not everyone with HIV presents the same clinical picture, but Seek’s trial aimed at those with a CD4 count of 350 or higher and a higher than normal viral load. Simply put, CD4 is a key part of the HIV infection process and those with high CD4 counts are healthier than those with lower.
A CD4 count of 200, for example, would usually mean a patient with full blown AIDS. The greater the viral load, the less healthy the patient.
Trial subjects were divided into five groups — placebo, lower dose, higher dose, plus higher and lower dose, each with adjuvant.
An adjuvant is a technically inert compound added to the vaccine that gives the immune system a ‘kick’ and amplifies its response. Normally, the adjuvant is aluminium hydroxide, but Seek used an oil emulsion.
Using an adjuvant is key, because such compounds are cheap to buy and easy to obtain keeping the cost per dose low — vital in developing countries.
The trial results were most encouraging and there were no significantly adverse reactions. Trial volunteers were monitored for six months and even after just the single injection, viral loads were substantially reduced and CD4 counts increased.
HIV/AIDS is a master of disguise and changes its building blocks every 90 days.
Each block has a different function, with some more important than others. Hit the key blocks and the therapy will take effect.
What HIV/AIDS does is to redirect functionality from one block to another, making an unimportant block look attractive to a vaccine, which then misses an important one.
The core functions of the virus carry on multiplying, unaffected by the therapy, while the virus also creates new forms of itself.
Seek identified all the sequences present in HIV and their vaccine is a cocktail designed to induce an immune response.
Now the company will continue its trials and research, joining with a suitable partner once this initial success is proven. Seek is rare, in that it has no venture capital funding, being financed entirely by high net worth individuals.
That allows flexibility and Seek is researching other avenues, such as an anti-tussive (a medicine designed to reduce coughing) and an H1N1 influenza vaccine for cases where there is no known treatment.
“Retrovirals are expensive, need lifelong dosage and have nasty side effects,” said Dr Caparros-Wanderley.
“In a few years, we plan to have a cheap and effective weapon to combat HIV and AIDS.”
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