Global experts recommend that people with HIV should be vaccinated against meningococcal disease

• New global recommendation from the world’s leading experts in meningococcal disease
• Recent evidence shows that people who are HIV positive are at significantly higher risk of meningococcal meningitis
• In a new paper, experts recommend that countries introduce meningitis vaccination programmes for people living with HIV

The Global Meningococcal Initiative (GMI) – an international group of expert scientists, doctors and public health officials – has recommended that people who are human immunodeficiency virus (HIV)-positive should be vaccinated against meningococcal disease (MD).

This global recommendation has been published in the Journal of Infection.

The recommendation is based on recent studies showing an increased risk of MD in individuals who are HIV positive. Results of surveillance data analysis from 2003–2007 in patients of all ages in South Africa, showed that HIV was associated with a higher incidence of MD and higher rates of death from MD.

Other recent studies, including two from the United States from the 2000s, have found a 13-fold and 10-fold greater risk of MD for those with HIV. Patients in these studies were receiving antiretroviral therapy for HIV and a good standard of healthcare.

Immunogenicity studies have shown that two doses of vaccine to protect against MD are required for people who are HIV positive. Individuals with HIV who have been previously vaccinated with one dose of MenACWY should receive a second dose at the earliest opportunity, and continue to receive boosters at the appropriate interval.

Some countries already have recommendations for vaccination with the MenACWY conjugate vaccine, for example the United States. An important issue with such recommendations is, however, the cost of the conjugate vaccine, particularly in low-/middle-income countries with high rates of HIV.

Vinny Smith, co-author of the paper and Chief Executive of Meningitis Research Foundation (MRF) said, “Vaccinating the groups of people who are at the highest risk of meningitis and septicaemia will help us to defeat meningitis. We welcome the GMI’s recommendation to vaccinate people living with HIV to help save lives. Prevention of meningitis and septicaemia through vaccination is the best way to defeat the disease around the world. It is also vital that high-risk groups are particularly aware of symptoms so they can act quickly and get medical help as soon as meningococcal disease is suspected.”

Chris Head, President of the Confederation of Meningitis Organisations (CoMO) commented, “All our members want to see protection against all forms of meningococcal disease made as widely available as possible, and this is an important recommendation which will help to save lives.”

Another recommendation considered by the GMI related to vaccinating people attending planned mass gathering events. This was considered following MD outbreaks related to the World Scout Jamboree in Japan in 2015 and the World Youth Day Catholic Gathering in Poland in 2016. However, further work is needed to characterise the aspects of mass gatherings that pose significant risks for transmission of MD.

This is a press release from the Meningitis Research Foundation.  For more information on Meningitis, visit the Meningitis Research Foundation or you can visit them on social media (Twitter   |   Facebook   |   YouTube)

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Something to #Celebrate: Good news in #HIV #Vaccine Research!

Scientists may have discovered a way to spur the human body to create antibodies capable of blocking the HIV virus. Researchers at institutions around the United States said in five studies published Thursday in the journals Cell, Immunity and Science that they had made an important early step toward developing a vaccine for the disease.

“It’s early work, but we’re trying to rewrite some rules of vaccine development to overcome the extraordinary challenges of HIV,” William Schief, director of vaccine design for the Neutralizing Antibody Center at the Scripps Research Institute’s International AIDs Vaccine Initiative, said. “In a collaborative effort we have reached critical milestones, including the first proof ever that immunization with designer proteins can produce broadly neutralizing antibodies against HIV. The new results strongly support further developing these approaches toward testing in clinical studies.”

There are still some major challenges before clinical studies on humans can begin. To put it simply, HIV is difficult to combat because it attacks the very immune cells sent out to fight it. When the body is successful in fighting it (usually with the help of drugs) the virus is really good at hiding dormant until the next opportunity to stage a comeback. Traditional vaccines haven’t worked to fight HIV but this new research shows that so-called “broadly neutralizing antibodies” are capable of controlling or preventing infection from a range of HIV strains and researchers think these special antibodies are the key to formulating a vaccine.

But for it to be effective the vaccine would have to be much better than nature. Only about 10 to 20 percent of people infected with HIV develop the antibodies on their own and it can take years for them to develop. This new vaccine would have to coax the human immune system to act differently. The researchers were able to spur this kind of reaction in mice whose immune systems mimicked components of the human immune system.

Vaccines aren’t the only way scientists hope to address the HIV problem around the world. Other approaches — including one that resulted in the only known case of HIV being cured, stem cell transplants — are being looked at.

Want more?

Here’s another link on the same story: New vaccination strategies coach immune system to make HIV-neutralizing antibodies

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HIV scientists launch 23 million euro project to develop vaccine

A new 23 million euro initiative to accelerate the search for an effective HIV vaccine begins today.

Financed by the European Commission, the European AIDS Vaccine Initiative (EAVI2020) brings together leading HIV researchers from public organisations and biotech companies from across Europe, Australia, Canada and the USA in a focused effort to develop protective and therapeutic HIV vaccines.

Story via

According to the World Health Organisation, around 35 million people were living with HIV at the end of 2013. Over two million people are newly infected every year, and it is estimated that around 22 billion US dollars is spent yearly on HIV treatment and care. An effective vaccine remains the best hope of ending the epidemic.

Although researchers have been working on developing a vaccine for 30 years, recent advances are helping to speed up their quest. Scientists have isolated antibodies that are able to block HIV infection in preclinical models, and there have been new developments in using synthetic biology to design better vaccines.

The EAVI2020 consortium, which is led by Imperial College London, unites scientists from 22 institutions, pooling their knowledge and expertise to develop novel candidate vaccines that can be taken through to human trials within five years. EAVI2020 is funded with an EU grant under the health program of Horizon 2020 for research and innovation.

Professor Robin Shattock, Coordinator of EAVI2020, from the Department of Medicine at Imperial College London, said: “Creating an effective vaccine against HIV represents one of the greatest biological challenges of a generation. This project creates a unique opportunity for us to build on the enormous scientific progress gleaned over the last few years, providing an unprecedented insight into the nature of protective antibodies and anti-viral cellular response that will be needed for an effective vaccine. We now understand much more about how humans make protective immune responses and how to structure vaccine candidates. We have a level of understanding at a molecular level that was not previously available.

“But it is impossible for one group or institution to create an HIV vaccine on its own. This new project should enable us to move much more quickly. It brings together a multidisciplinary team of molecular biologists, immunologists, virologists, biotechnologists and clinicians, providing the breadth of expertise needed to take the latest discoveries in the lab and rapidly advance them through preclinical testing and manufacture, into early human trials.”

At Imperial, researchers will be looking at how healthy human volunteers’ immune systems respond to potential vaccines, studying the antibodies that the volunteers produce. The researchers will explore the pathways in the body that make these antibodies, in order to fine-tune candidate vaccines.

Dr Ruxandra Draghia-Akli, Director of the Health Directorate at the Directorate General for Research and Innovation of the European Commission said” In its dual role of policy maker and research funder, the European Commission has played an essential part for over thirty years in supporting HIV vaccine research. Despite major global investments in the field and the promising progress, several scientific obstacles have to be overcome to develop novel promising HIV vaccine candidates. It is with this in mind that the European Commission is providing an almost 23 million Euro grant to the EAVI2020 consortium from which we have high hopes for success. This will allow European scientists to work together and in collaboration with researchers from outside Europe to successfully develop predictive tools and better vaccine candidates to be tested at an early stage of the process”.

The project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 681137.

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HIV vaccine that transforms cell DNA brings fresh hope

A radical new approach to vaccination seems to completely protect monkeys from HIV, US scientists report.

Vaccines normally train the immune system to fight an infection.

Instead, researchers at the Scripps Research Institute in California have altered the DNA of monkeys to give their cells HIV-fighting properties.

The team describe it as “a big deal” and want to start human trials soon. Independent experts say the idea is worth “strong consideration”.

This technique uses gene therapy to introduce a new section of DNA inside healthy muscle cells.

That strip of DNA contains the instructions for manufacturing the tools to neutralise HIV, which are then constantly pumped out into the bloodstream.

Experiments, reported in the journal Nature, showed the monkeys were protected from all types of HIV for at least 34 weeks.

As there was also protection against very high doses, equivalent to the amount of new virus that would be produced in a chronically infected patient, the researchers believe the approach may be useful in people who already have HIV.

Lead researcher Prof Michael Farzan told the BBC: “We are closer than any other approach to universal protection, but we still have hurdles, primarily with safety for giving it to many, many people.

Shifting target

“We’re very proud of it and we think it’s a big deal, but we are biased.”

HIV vaccines have struggled because the virus mutates so rapidly it is a constantly shifting target.

This one targets areas that HIV struggles to change.

“The real strength of this thing is that it is more potent than any antibody,” Prof Farzan said.

However, there are safety questions.

After conventional vaccination, the immune system responds only after it is presented with a threat.

The gene therapy approach turns cells into factories that constantly spew out the artificial HIV-killers, and the long-term implications of that are unknown.

‘Important step’

The team want to begin trials in patients who have HIV but are unable to take conventional drug therapies within the next year.

Prof Nancy Haigwood, of Oregon Health & Science University, commented: “In the absence of a vaccine that can elicit broadly protective immunity and prevent infection, and given the lack of major breakthroughs on the horizon to provide one, the idea of conferring potent, sustained vaccine-like protection against HIV infection through gene therapy is certainly worth strong consideration.”

Dr Anthony Fauci, of the US National Institutes of Health, said: “It would be advantageous to curb HIV infection without daily antiretroviral drugs because of their cost, the potential for negative side-effects from lifelong therapy, and the difficulties some patients have adhering to daily drug regimens and tolerating certain drugs.

“This innovative research marks an important step toward our goal of putting HIV into sustained remission in chronically infected people.”

via BBC

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Bill Gates predicts HIV vaccine by 2030

Bill and Melinda Gates speak at Davos. Photograph: Ruben Sprich/Reuters

Bill Gates believes that a vaccine and new intensive drugs to combat HIV should be available by 2030 and end most new cases of the virus that has killed millions in the past three decades.

The Microsoft founder, whose philanthropic foundation spends tens of millions of dollars on medical research, told the World Economic Forum in Davos that the two “miracles” were within reach.

“We’re pretty optimistic in this 15-year period we will get those two new tools,” he said.

A vaccine was seen as being pivotal in preventing infections among susceptible populations, while new kinds of intense drug treatments should do away with the need for life-long treatment, he added.

The billionaire founded the Bill & Melinda Gates Foundation in 2000. The couple said in their annual letter about the foundation’s work that, along with progress toward a vaccine or a cure, the number of people getting treatment for HIV in sub-Saharan Africa would finally outstrip the number of new infections.

“When we reach that point in the region with the most dense HIV transmission in the world, cases will start going down everywhere around the globe for the first time since the disease was discovered more than 30 years ago,” they wrote.

Gates was also optimistic about the battle against malaria, where work on a vaccine is more advanced than for HIV.

GlaxoSmithKline filed the world’s first malaria vaccine for approval in July 2014.

“We won’t see the end of Aids,” Gates told the Davos forum last Friday. “But both for malaria and Aids we’re seeing the tools that will let us do 95-100% reduction. Those tools will be invented during this 15-year period.”

Bill and Melinda Gates also predicted in their annual letter that the lives of people in developing countries would improve faster in the next 15 years than at any other time in history.

In the UK there are an estimated 100,000 people living with HIV infection – both diagnosed and undiagnosed – of whom about 40% are gay men.

A drug called Truvada has been found in trials – when used as a pre-exposure prophylaxis (PrEP) in HIV negative people at risk of getting the virus – to reduce the transmission of HIV, but has not yet been approved or funded by the NHS for this. The drug may also be used in people who have been exposed to HIV, in combination with another drug, such as raltegravir. This is known as post-exposure prophylaxis (PEP).

There have been growing calls to make Truvada more widely available as a preventative measure in Britain, particularly to gay men.

via Guardian

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The quest for a HIV vaccine

Credit: UNAIDS

There is broad scientific consensus that getting to zero new HIV infections will require an HIV vaccine. Modelling shows that even a partially effective HIV vaccine can save many lives and dollars over time.

Although a vaccine to prevent HIV could be the tool to quicken the pace to reach the end of AIDS, the quest for an effective vaccine has until now proved elusive. The very nature and variety of the human immunodeficiency virus has meant that it has resisted most attempts to quell its spread and scientists and vaccinologists the world over are focusing efforts on finding solutions.

Exciting recent developments in HIV vaccine research are instilling hope around finding an effective vaccine. In 2009, results from a trial in Thailand—RV144—showed a 31.2% vaccine efficacy in preventing HIV infections. Although only modestly protective, the results instilled new hope that an HIV vaccine could be found and made available for populations around the world most in need of a vaccine.

The results represented a significant scientific advance, and were the first demonstration that a vaccine can prevent HIV infection in a general adult population. It was a discovery of great importance and has been followed by more encouraging data in the last couple of years.

Data presented in the past year has been presented on the protective immune responses that were stimulated by the Thai vaccine trial.  Trials are now planned to see if an RV144-like regimen will protect against a strain of HIV infection found in South Africa and against HIV acquisition by people at higher risk of exposure, specifically men who have sex with men.

UNAIDS and the US Centers for Disease Control worked closely with modelling teams to estimate the impact of the RV144 regimen in different countries and with different populations and found that 10% of infections could be prevented if the same 31% efficacy was found in people who receive the vaccine. This shows that a modestly effective HIV vaccine could add to the prevention toolbox of partially effective methods, hastening the decline of the HIV epidemic.

These and other advances in HIV vaccine development—including the design of new tools and technologies for vaccine delivery—have boosted optimism in the field about the prospects for the development of a safe and effective AIDS vaccine.

However, early data from the HIV Vaccines and Microbicides Resource Tracking Working Group is showing that a downturn in HIV vaccine funding that began in 2008 continued through 2011. The quest for effective HIV vaccines is a long-term investment in both the product (vaccines) and in the people who will develop, produce, market and support them. Investments in research and trials are essential and can bring benefits far beyond the AIDS field.

The need for a vaccine to prevent HIV is clear.  There are in excess of 34 million people living with HIV, and every day more than 7000 people are becoming newly infected with the virus. Although a vaccine may not provide the magic bullet to end the AIDS epidemic, it would provide an additional tool to add to the robust package of HIV prevention options which are now available.

UNAIDS will continue to work with multiple partners––scientific communities, national and international AIDS research agencies, the pharmaceutical industry, private foundations, member states, and affected communities––to push the HIV vaccine agenda forward and ensure that the quest for a safe and effective HIV vaccine continues.

Original Article via UNAids

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Cuba Will Start Clinical Human Trials of a Vaccine Against HIV This Year.

The announcement was confirmed by the director of clinical research of Cuba’s genetic engineering and biotechnology centre, Dr Verena Muizo, at the International Biotech Conference-Havana 2012.

“In terms of the vaccine against the human immunodeficiency virus (HIV), it should start soon,” he said.

“We hope in the second quarter of this year, or in the third. It is a clinical study of individuals infected with the human immunodeficiency virus, but it is a phase one study, for safety, and to start to try this possible vaccine.

Dr Muizo said the vaccine, known as TERAVAC-VIH-1, would start as a small study in just a few patients.  “The clinical study that we are going to do is going to be done with a small number of patients, 30.

“These are individuals that have not reached the Aids stage but are instead in the seropositive stage without reaching the clinical Aids stage.”
A seropositive patient tests positive for HIV antibodies, but still has an immune system strong enough to fight off opportunistic infections that can cause complications with patients with full-blown Aids. (sic)

The researchers working on the HIV vaccine, though hopeful, were quick to point out that the investigation is still in the early phases and they will not know for many years whether the vaccine is effective or not.

“The vaccine is starting its clinical evaluation and we hope it works.
“But really, we need a lot more time to really be able to show its effectiveness as a product,” Dr Muizo added.

In December last year a group of Canadian scientists won approval to start testing an experimental vaccine on humans. Developed by researchers from the University of Western Ontario, it received a green light from the US Food and Drug Administration.

Original article via Sky News

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This 90 Percent Successful Vaccine May Be Our Best Chance to Eradicate HIV/AIDS

Dr Esteban

Spanish researchers have completed the first human trial of a new vaccine against HIV. It has been successful in 90% of the HIV-free volunteers during phase I testing. This vaccine brings great hope to eradicate HIV forever.

The team lead by Dr Mariano Esteban, a researcher at the Spanish National Research Council‘s Biotechnology National Centre, has been working on this method since 1999. They are using an attenuated virus called the MVA-B, a variation of the Modified Ankara Vaccinia, which was previously used to eradicate smallpox. The Modified Ankara Vaccinia also forms the base of other vaccines. The B refers to the HIV-B, the most common HIV subtype in Europe.

Dr Esteban’s team inserted the HIV genes Gag, Pol, Nef and Env in MVA’s genetic sequence. In 2008, they tried the resulting HIV nuke on mice and monkeys. It was a complete success.

SUCCESSFUL HUMAN TEST

The first human test results were published in Vaccine and Journal of Virology. In the experiment, scientists injected the vaccine in 24 of 30 HIV-free volunteers. Six volunteers were treated with a placebo vaccine—they didn’t experience any effect. But 90% of the treated subjects developed a very strong immunological response against the HIV virus. 85% kept the immunological reaction for at least one year, which is really good news.

According to their results, there were no significant secondary effects in any of the patients, which was one of the major objectives of to be tested in this clinical trial.

Despite the success, Dr Esteban is cautious:

“The treatment has only been tested on 30 volunteers and, while the vaccine provokes a powerful response in most of the cases, it’s still to soon if the resulting defense would be effective against an actual HIV infection”.

The team will now start another phase I trial, injecting the vaccine in HIV-infected people. The objective of this trial is to test the therapeutical effect of the vaccine in these patients.

According to Dr Esteban, “in principle, the immunological profile of MVA-B satisfies the requirements for a promising vaccine against the HIV, like the creation of antibodies and the activation of key cells in the defense against the virus.” Sadly, it is still far away from commercialization: they need to test this on phase II and III trials, injecting vaccinated volunteers with the actual HIV virus on a larger scale.

Hopefully, one day, this vaccine will nail the HIV nemesis down.

Original Article by Jesus Diaz at Gizmodo

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SEEK concludes HIV-v vaccine Phase Ib/II trial

UK based biopharmaceutical firm SEEK has concluded a Phase Ib/II trial evaluating the safety, efficacy and tolerability of HIV-v vaccine.

The vaccine showed almost 90% difference in viral count in HIV-infected patients in comparison to placebo group, following a single vaccine injection.

SEEK claims its HIV-v vaccine targets only the conserved regions in the internal proteins of the HIV virus which remain constant across all HIV strains.

The company expects to investigate partnerships to undertake complete human trials during 2012-13.

SEEK CEO Gregory Stoloff said the next step will be to progress this to final human trials and determine the optimum dose and dosing regime to further enhance the vaccine’s efficacy.

SEEK chief scientific officer Wilson Caparros Wanderley said the results demonstrate that after a single immunizationthe HIV-v vaccine produces a response from both the antibody and T cell immune systems to the conserved regions only.

Original article written by Pharmaceutical Business Review

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Simian Immunodeficiency Vaccine Update

A post we made last week suggested a new vaccine can protect macaques against the monkey equivalent of HIV, however the vaccine using the common virus cytomegalovirus (CMV) as the vector or container of proteins from the simian immunodeficiency virus (SIV) protected none of a group of 24 rhesus macaques from infection. But in 13 of the monkeys vaccinated, it did produce infections characterised by an undetectable viral load.

This profound viral suppression led to an apparent decline in the number of SIV-infected cells over a period of two years after infection to the point that SIV-infected cells were undetectable in 72% of monkeys with controlled viremia. Despite this, there was no apparent waning of immune responses to SIV in the all-important effector-memory CD8 and CD4 lymphocytes over this time in twelve of the 13 monkeys.

The researchers comment that their vaccine seems to have produced “an unprecedented level of SIV control and even the possibility of progressive clearance of SIV infection over time.”

The question now is how to make a safe analogue of this vaccine for use in humans.