Sunday, February 22, 2015

Zimbabwean scientists, in collaboration with a global consortium of researchers, are preparing to conduct the country's first-ever HIV vaccine trial as part of the global effort to find a lasting solution to the spread of HIV.

Zimbabwean scientists, in collaboration with a global consortium of researchers, are preparing to conduct the country's first-ever HIV vaccine trial as part of the global effort to find a lasting solution to the spread of HIV.
151. We shall cast terror into the hearts of those who disbelieve, because they joined others in worship with Allah, for which He had sent no authority; their abode will be the Fire and how evil is the abode of the Zalimun(polytheists and wrong-doers).
152. And Allah did indeed fulfil His Promise to you when you were killing them (your enemy) with His Permission; until (the moment) you lost your courage and fell to disputing about the order, and disobeyed after He showed you (of the booty) which you love. Among you are some that desire this world and some that desire the Hereafter. Then He made you flee from them (your enemy), that He might test you. But surely, He forgave you, and Allah is Most Gracious to the believers.
153. (And remember) when you ran away (dreadfully) without even casting a side glance at anyone, and the Messenger (Muhammad ) was in your rear calling you back. There did Allah give you one distress after another by way of requital to teach you not to grieve for that which had escaped you, nor for that which had befallen you. And Allah is Well-Aware of all that you do.
154. Then after the distress, He sent down security for you. Slumber overtook a party of you, while another party was thinking about themselves (as how to save their ownselves, ignoring the others and the Prophet ) and thought wrongly of Allah - the thought of ignorance. They said, "Have we any part in the affair?" Say you (O Muhammad ): "Indeed the affair belongs wholly to Allah." They hide within themselves what they dare not reveal to you, saying: "If we had anything to do with the affair, none of us would have been killed here." Say: "Even if you had remained in your homes, those for whom death was decreed would certainly have gone forth to the place of their death," but that Allah might test what is in your breasts; and to Mahis that which was in your hearts (sins), and Allah is All-Knower of what is in (your) breasts.
155. Those of you who turned back on the day the two hosts met (i.e. the battle of Uhud), it was Shaitan(Satan) who caused them to backslide (run away from the battlefield) because of some (sins) they had earned. But Allah, indeed, has forgiven them. Surely, Allah is Oft-Forgiving, Most Forbearing.
156. O you who believe! Be not like those who disbelieve (hypocrites) and who say to their brethren when they travel through the earth or go out to fight: "If they had stayed with us, they would not have died or been killed," so that Allah may make it a cause of regret in their hearts. It is Allah that gives life and causes death. And Allah is All-Seer of what you do.
157. And if you are killed or die in the Way of Allah, forgiveness and mercy from Allah are far better than all that they amass (of worldly wealths, etc.).
158. And whether you die, or are killed, verily, unto Allah you shall be gathered.
159. And by the Mercy of Allah, you dealt with them gently. And had you been severe and harsh-hearted, they would have broken away from about you; so pass over (their faults), and ask (Allah's) Forgiveness for them; and consult them in the affairs. Then when you have taken a decision, put your trust in Allah, certainly, Allah loves those who put their trust (in Him).
160. If Allah helps you, none can overcome you; and if He forsakes you, who is there after Him that can help you? And in Allah (Alone) let believers put their trust.3. Aal-'Imran

"The vaccine to be tested in Zimbabwe is a preventive vaccine that will be administered to HIV-negative people," clinical trials coordinator Dr. Portia Hunidzarira told The Anadolu Agency.
"Those already taking anti-retroviral treatments (ARTs) are not eligible," she explained, referring to the drug used to suppress the virus among people who already have HIV.
Hunidzarira said the trials aimed to determine whether the vaccine could prevent HIV-negative people from contracting the virus.
The trials will also gauge the safety of new vaccine products and regimens, while measuring the immune response among trial subjects. 
Dr. Lynda Stranix-Chibanda, a pediatrician at the University of Zimbabwe, is leading the initiative on behalf of the HIV Vaccine Trials Network (HVTN) in conjunction with the University of Zimbabwe and University of California San Francisco (UZ-UCSF) Collaborative Research Program.
The HVTN is a publicly-funded multi-disciplinary global consortium of scientists tasked with facilitating the development of HIV/AIDS vaccines.
Stranix-Chibanda said the trials would likely be conducted in June at the Seke South Clinic in the town of Chitungwiza, located nearly 30km south of capital Harare.
They are currently pursuing regulatory approval mechanisms with the relevant authorities in Zambia. These authorities include the Chitungwiza Ethics Committee, the Joint Research Ethics Committee, the Medical Research Council of Zimbabwe, the Research Council of Zimbabwe, the National Biotechnology Authority of Zimbabwe and the Medical Control Authority of Zimbabwe.
Stranix-Chibanda said the vaccine to be tested was based on one used in Thailand's RV144 trial, which was moderately successful at preventing new HIV infections among vaccinated adults.
She added that RV144 had been modified for a sub-strain of the virus called Clade CHIV, which is found in southern Africa.
She went on to note that the HVTN107 vaccine – which will be tested in Zimbabwe and other southern African countries – had seen the addition of another booster, including an adjuvant to test the response as compared to RV144.
RV144 had a six-month vaccination schedule, while HVTN107 will have a 12-month schedule.
The trials in Thailand, which were reportedly administered to 16,000 adults, were 60 percent effective at one year and 31 percent effective at three years.
"The next phase of the program will involve the selection of the best candidates, further research to assess the effectiveness of the drug, and – if successful – licensure for use," Stranix-Chibanda told AA.
According to Emilder Chihota, a community educator participating in the UZ-UCSF Collaborative Research Program, 26 people will take part in the first phase of the vaccine trials.
She said the trials were part of a global effort to find an effective means of preventing new infections.
Stranix-Chibanda said Zimbabwe had been selected to join the initiative because the country's research environment was conducive to intense clinical trials.
She noted that HVTN had 30 research sites on five continents and had carried out 50 clinical trials since 1999, testing various HIV vaccines for safety, immunogenicity and efficacy.
The HVTN is funded by the U.S. National Institute of Health, the South African Medical Research Council, and the Bill and Melinda Gates Foundation, among others.
-Alarming-
Stranix-Chibanda said she had been moved to take part in the project by the problems HIV had caused in Zimbabwe and the region.
"As a pediatrician, l have long worked in Zimbabwe with mothers and babies trying to stop the spread of HIV," she told AA.
"l have also joined the global effort to find a lasting solution to the spread of HIV by finding a vaccine," she added.
According to Dr. Nyaradzo Mgodi, co-principal investigator at the UZ-UCSF, the rate of new infections inZimbabwe remains alarming.
"A vaccine will benefit the population. We do not have a vaccine for HIV like we do for polio or measles," she told AA.
She said that other preventive measures – such as condoms or abstinence – were not very effective, although they helped reduce the spread of the disease.
"Due to human nature and behavioral changes, other preventive measures cannot be fully relied on. But a vaccine would be a stop-gap measure against new HIV infections," Mgodi asserted.
Hunidzarira, the clinical trials coordinator, agreed.
"We continue to put ourselves – and others – at risk of HIV infection," she said.
She noted that, due to poor logistical support in sub-Saharan Africa, only eight condoms were available each year for each sexually active person.
According to Hunidzarira, three out of five HIV-positive people in sub-Saharan Africa lack access to ARTs.
"Seventy-one percent of HIV-positive adults in sub-Saharan Africa could transmit the virus to others," she said.

Some of the most important breakthroughs of the past century involved the development of vaccines to protect against viruses: smallpox, polio, hepatitis, human papillomavirus (HPV), and even chickenpox. But one virus remains elusive to those seeking to create a vaccine to guard against it: HIV.
The HIV virus was first isolated in 1985, and it was announced at the time by HHS that, “We hope to have a vaccine ready for testing in about two years.”
Unfortunately, there have been many trials and many roads taken trying to develop a vaccine and there still isn’t a truly effective vaccine available. Why is it so difficult to conquer this disease?

Therapeutic vs. Prophylactic

An HIV/AIDS vaccine would theoretically have two goals. It could be administered to healthy individuals to protect them from being infected with the HIV virus. This is what is called a prophylactic vaccine. Most of the many vaccines developed have been for this public health purpose.
Lately, however, vaccines have also become therapeutic tools. Therapeutic vaccines can be used to increase the immune response to fight cancerous tumors, hepatitis B, tuberculosis, malaria, and even the bacteria that cause gastric ulcers.
HIV/AIDS is a good candidate for the use of a therapeutic vaccine. Researchers hope that a vaccine could reduce the viral load. Viral load is the amount of HIV virus in a patient, which often corresponds to the severity of the illness.

Types of Experimental Vaccines

Due to the difficulty in developing an HIV vaccine, there are many different strategies being tried:
  • Peptide vaccines use small proteins from HIV to trigger an immune response.
  • Recombinant subunit protein vaccines use larger pieces of proteins from HIV.
  • Live vector vaccines use non-HIV viruses to carry HIV genes into the body to trigger immune response. Smallpox is an example of this method.
  • Vaccine combinations use two vaccines, one after another to create a stronger immune response. This is referred to as a “prime-boost” combination.
  • Virus-like particle vaccine uses a non-infectious HIV look-alike that has some, but not all, HIV proteins.

Problems

It is very difficult to develop a vaccine for HIV, because HIV is a very different virus.
According to Dr. Anthony Fauci of the National Institute of Allergy and Infectious Diseases, there are several ways that HIV doesn’t fit normal vaccine paradigms:
  • The immune system of almost everyone is “blind” to HIV. Effective antibodies to the virus are rare.
  • Vaccines typically mimic the immune reaction of recovered patients – there are almost no patients who have recovered from HIV.
  • Vaccines protect against disease, not infection, and HIV has a long latent period before disease—AIDS—sets in.
  • Most vaccines are killed or weakened viruses: killed HIV is not effective at producing immune response, and any live form of the virus is too dangerous to use.
  • Vaccines are usually effective against diseases that are rarely encountered (diphtheria, hepatitis B). People in high-risk groups might be exposed to HIV daily.
  • A majority of vaccines protect from exposure through the respiratory or gastrointestinal system. HIV enters most often through genital surfaces or blood sharing.
  • Whereas most vaccines are tested thoroughly on animal models, there are no really good animal models for HIV/AIDS available.

The Latest Trials

In April 2013, one of the latest HIV vaccine studies, known as the HVTN-505 study, was ended. 2,500 people were recruited to be part of the study. A weakened cold virus called Ad5 was used to trigger the immune system to recognize HIV proteins.
The study was stopped when it was determined that the vaccine did not prevent HIV infection or reduce the viral load. In fact, 30 people on a placebo became infected with HIV, but 41 people on the vaccine became infected.
Although there’s no proof the vaccine made people more susceptible to HIV infection, earlier failure of Ad5 in the 2007 STEP study led some researchers to worry that anything that stimulated immune cells to attack HIV may increase the risk of HIV infection, due to the unique way HIV infection targets immune cells.

Hope from Thailand

One of the most successful clinical trials to date has been a US Military HIV Research trial in Thailand in 2009. Known as the RV144 trial, two vaccines were used together: a “prime” (the ALVAC vaccine) and a “boost” (the AIDSVAX B/E vaccine).
This combination vaccine was found to be safe and somewhat effective. The combination lowered the rate of infection by 31 percent compared to a placebo shot.
A 31 percent reduction is not sufficient for wide use of this vaccine combination. But, this success allows researchers to study why there was any protective effect at all. People who were protected had developed antibodies to a target on the HIV envelope protein, called the V1/V2 area. There is research underway that is investigating this development.

The Future of HIV Vaccines

July 2012 report suggests that $845 million was spent on AIDS vaccine research in 2011, and more is being allocated every year. Since 1985, more than 30 candidate vaccines have been tested in 80 clinical trials. There’s been only slow progress toward a workable vaccine. But with each failure, more is being learned that can be incorporated into new attempts.
The latest major vaccine trial involves the International AIDS Vaccine Initiative. Patients are being recruited in London, England and Kigali, Rwanda. This trial uses a live vector vaccine strategy, with the Sendai virus carrying HIV surface proteins. It also uses a combination strategy, with a second vaccine boosting immune response. This trial will take two years to complete and carries the hope of many
A cream used to treat the skin conditioneczema in children does not appear to increase the risk of cancer, according to a study funded by the maker of the cream.
Researchers looked at nearly 7,500 children in the United States who were given an average of 793 grams of pimecrolimus (Elidel) cream to treat eczema and were followed for 10 years.
As of May 2014, five cases of cancer were diagnosed among the children: two leukemias, two lymphomas and one bone cancer. There were no cases of skin cancer, the researchers said.
Based on the findings, "it seems unlikely" that pimecrolimus cream as used in the study to treat eczema is associated with an increased risk of cancer, lead researcher Dr. David Margolis, from the University of Pennsylvania in Philadelphia, and colleagues concluded.
The study was published online Feb. 18 in the journal JAMA Dermatologyand was funded by Montreal-based Valeant Pharmaceuticals International.
Eczema, which is common in children, causes patches of skin to become dry, inflamed and often intensely itchy. Pimecrolimus was approved by the U.S. Food and Drug Administration in 2001 to treat eczema in children who are at least 2 years old. The product carries a warning about the potential risk of cancer.
The study "will hopefully help to improve the management of [eczema], countering the concerns raised by FDA warnings," Dr. Jon Hanifin, of Oregon Health and Science University, wrote in an editorial that accompanied the study.
The findings "should help reduce the physician and pharmacist concerns that have restricted the use of these effective topical alternatives to corticosteroids. The interim results should help bring relief to a larger segment of the many young individuals with [eczema]," he concluded.

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