HIV vaccine efficacy
The first HIV vaccine efficacy study to launch anywhere in seven years is now testing whether an experimental vaccine regimen safely prevents HIV infection among South African adults. The study, called HVTN 702, involves a new version of the only HIV vaccine candidate ever shown to provide some protection against the virus. HVTN 702 aims to enrol 5,400 men and women, making it the largest and most advanced HIV vaccine clinical trial to take place in South Africa, where more than 1,000 people become infected with HIV every day.
“If deployed alongside our current armoury of proven HIV prevention tools, a safe and effective vaccine could be the final nail in the coffin for HIV,” said Anthony S. Fauci, M.D., director of the US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health and a co-funder of the trial. “Even a moderately effective vaccine would significantly decrease the burden of HIV disease over time in countries and populations with high rates of HIV infection, such as South Africa.” The experimental vaccine regimen being tested in HVTN 702 is based on the one investigated in the RV144 clinical trial in Thailand led by the U.S. Military HIV Research Program and the Thai Ministry of Health. The Thai trial delivered landmark results in 2009 when it found for the first time that a vaccine could prevent HIV infection, albeit modestly. The new regimen aims to provide greater and more sustained protection than the RV144 regimen and has been adapted to the HIV subtype that predominates in southern Africa.
“The people of South Africa are making history by conducting and participating in the first HIV vaccine efficacy study to build on the results of the Thai trial,” said HVTN 702 Protocol Chair Glenda Gray, M.B.B.C.H., F.C.Paed. (SA). “HIV has taken a devastating toll in South Africa, but now we begin a scientific exploration that could hold great promise for our country. If an HIV vaccine were found to work in South Africa, it could dramatically alter the course of the pandemic.” Dr Gray is president and chief executive officer of the South African Medical Research Council; research professor of paediatrics at the University of the Witwatersrand, Johannesburg; and a founding director of the Perinatal HIV Research Unit at Chris Hani Baragwanath Hospital in Soweto, South Africa.
The experimental vaccine regimen tested in the Thai trial was found to be 31.2% effective at preventing HIV infection over the 3.5-year follow-up after vaccination. In the HVTN 702 study, the design, schedule and components of the RV144 vaccine regimen have been modified in an attempt to increase the magnitude and duration of vaccineelicited protective immune responses.
As the regulatory sponsor of HVTN 702, NIAID is responsible for all operational aspects of this pivotal Phase 2b/3 trial, which is enrolling HIV-uninfected, sexually active men and women aged 18 to 35 years. The NIAID-funded HIV Vaccine Trials Network (HVTN) is conducting the trial at 15 sites across South Africa. Results are expected in late 2020. HVTN 702 begins just months after interim results were reported for HVTN 100, its predecessor clinical trial, which found that the new vaccine regimen was safe for the 252 study participants and induced comparable immune responses to those reported in RV144.
HVTN 100 and HVTN 702 are part of a larger HIV vaccine research endeavour led by the Pox-Protein Public-Private Partnership, or P5 – a diverse group of public and private organizations committed to building on the success of the RV144 trial. The P5 aims to produce an HIV vaccine that could have a significant public health benefit in southern Africa and to advance scientists’ understanding of the immune responses associated with preventing HIV infection. P5 members include NIAID, the Bill & Melinda Gates Foundation, the South African Medical Research Council, HVTN, Sanofi Pasteur, GSK and the U.S. Military HIV Research Program.
The HVTN 702 vaccine regimen consists of two experimental vaccines: a canarypox vector-based vaccine called ALVAC-HIV and a two-component gp120 protein subunit vaccine with an adjuvant to enhance the body’s immune response to the vaccine. The vaccines do not contain HIV and therefore do not pose any danger of HIV infection to study participants. Both ALVAC-HIV (supplied by Sanofi Pasteur) and the protein vaccine (supplied by GSK) have been modified from the versions used in RV144 to be specific to HIV subtype C, the predominant HIV subtype in southern Africa. Additionally, the protein subunit vaccine in HVTN 702 is combined with MF59 (also supplied by GSK), a different adjuvant than the one used in RV144, in the hope of generating a more robust immune response. Finally, the HVTN 702 vaccine regimen includes booster shots at the one-year mark to prolong the early protective effect observed in RV144.
World AIDS Day 2016: “Dignity above all”
“Dignity above all” is the regional slogan of this year’s World AIDS Day, celebrated every year on 1 December. This year’s campaign in the Eastern Mediterranean Region calls on all stakeholders to work together to end stigma and discrimination against people living with HIV in health care settings.
The campaign is soliciting high-level political commitment and advocating active measures to end stigma and discrimination against people living with HIV in health care settings in which it is their right to receive adequate care and quality treatment.
In his message on World AIDS Day, Dr Ala Alwan, WHO Regional Director for the Eastern Mediterranean, said: “It is unacceptable that, over 35 years into the epidemic, stigma and discrimination against people living with HIV is still widespread among health care workers of all disciplines. Stigma and discrimination in health care settings seriously constrain our ability to end the HIV epidemic.”
He added, “Contrary to medical ethics, people living with HIV often endure rejection and denial of health care for general conditions that are related or unrelated to their HIV infection. Such negative experiences deter those in need from seeking care and eventually their health deteriorates.”
Globally, already 15 million people are accessing life-saving HIV treatment. New HIV infections have been reduced by 35% since 2000 and AIDS-related deaths have been reduced by 42% since the peak in 2004. However, in the Region, at the end of 2015, less than 20% of people living with HIV in the Region knew their HIV status and only 14% of them were receiving treatment.
While the world embarks on the “Fast-Track to End AIDS” strategy, ending the AIDS epidemic by 2030 as part of the Sustainable Development Goals will require greater investment, commitment and innovation.
The lack of policies and regulations to protect the rights of people living with HIV and to provide guidance and best practices in health care facilities worsen the situation. A generic policy for protecting people living with HIV in the Region from stigma and discrimination has been developed as a model by the WHO Regional Office. The policy identifies the forms of discrimination faced by people in health care settings. They include denial of access to services, counselling and testing, exclusion and isolation in specific wards and rooms, disclosure of HIV status without a patient’s consent, verbal abuse and lack of respect and extra unjustified infection control; measures that can mark a person as HIVpositive.
The policy also identifies reasons behind stigma and discrimination in health care settings among which are the lack of knowledge about modes of HIV transmission, fears around the incurability of the disease and judgmental attitudes towards behavioural practices of people living with HIV.
It clearly articulates the right of people living with HIV to health care and the ethical duties of health care providers both within and outside health care settings to provide adequate and equal care. The generic policy inspired country actions. Through close work with national AIDS programmes in Member States, 14 countries will denounce stigma and discrimination against people living with HIV in health care settings and will announce national policies to protect them against those breaches of medical ethics.
On the occasion of World AIDS Day, the WHO Regional Office is calling upon governments, civil society and patient groups to engage actively in ending HIV stigma and discrimination in health care settings and to put dignity above all.
Date of upload: 17th Jan 2017
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