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  HIV-1 Tat:
    Scientific Background & Rationale
    HIV-1 Tat Protein
    Pre-clinical Studies
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    1st Gen.:Tat alone
    2d Gen.:Tat+Microparticles
    2d Gen.:Tat+Env
    Discovery Phase Leads
Dr. Barbara Ensoli was appointed as new member of the European Research Council (ERC)
January 10, 2013, 11:35AM
The European Commission has appointed Dr. Barbara Ensoli, Director of the National AIDS Center at ISS, as one of the eight new members for the Scientific Council, the governing body of the European Research Council (ERC).
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Unraveling the mechanisms required for HIV vaccine protection
November 14, 2012, 8:05AM
(ISS Press Release of November 14, 2012) As published today in PLoS ONE, by binding the Envelope protein present on virus particles, HIV Tat forms a new virus entry complex that favours the infection of cells present at the portals of virus entry (i.e. dendritic cells, macrophages). These cells represent also key HIV reservoirs that ensure the persistence of HIV in the host even under an “effective” antiretroviral treatment. By binding Env, Tat renders ineffective anti-Env antibodies at blocking virus entry in target cells. Thus, both anti-Tat and anti-Env antibodies are required for efficient HIV neutralization and should be both present to block HIV acquisition and spreading, but also the persistent infection and residual disease which is still present under antiretroviral therapy. “This finding offers an explanation for the marginal protection of preventative vaccines tested so far and suggest novel vaccine approaches for HIV infection and AIDS” – says Prof. Enrico Garaci, the President of the Istituto Superiore di Sanità (ISS). Based on this rationale, a phase I Tat/Env preventative vaccine trial is ongoing in Italy, while therapeutic immunization with Tat in HAART-treated patients (which already produce anti-Env antibodies) has been advanced to phase II clinical trials both in Italy (Ensoli et al., PLoS ONE 2010) and in South Africa ( The work has been conducted by the laboratory of Dr. B. Ensoli, National AIDS Center, ISS in cooperation with scientists from San Gallicano Hospital in Rome, University of Ferrara, Florence, Urbino and Novartis and stems out from funding of the Italian Ministry of Health and the EU Commission. PLoS ONE “HIV-1 Tat promotes integrin-mediated HIV transmission to dendritic cells by binding Env spikes and competes neutralization by anti-HIV antibodies”,
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June 15, 2011, 9:58AM
The National Center of the Istituto Superiore di Sanità launches the first phase of clinical testing of preventive HIV vaccine (study ISS P-002) based on a vaccine that combines the Tat protein, which is already advanced to therapeutic phase II trials in Italy and South Africa, and the Env protein, supplied by Novartis as part of a collaboration in the AVIP European project (

Tat and Env proteins have already been tested individually in clinical trials in humans and both were found to be safe and well tolerated, while to date the combination of the two products has been evaluated only in animal models where it has proved to be safe, well tolerated and capable of preventing HIV infection.

The new study ISS P-002, involves 3 prominent clinical centres in Italy (the Division of Infectious Diseases of the Policlinico of Modena; the Division of Infectious Diseases of the San Gerardo Hospital of Monza; the Infectious Dermatology of the IFO - San Gallicano of Rome), has been approved by the competent Regulatory Authorities and by the Ethical Committees of the clinical centres. The study will involve 50 adult subjects between 18 and 55 years of age and aims to evaluate the safety and immunogenicity of the new vaccine candidate.

Tat and Env proteins will be administered according to a prime-boost vaccine regimen, consisting of 3 priming doses given by intradermal injection, followed by 2 boosts administered intramuscularly. All persons willing to partecipate to the trial will have to contact directly the 3 clinical sites involved, where a multi-disciplinary medical team will monitor the volunteers for the all duration of the study.

The study will be supported by three independent committees, each with a specific function:
  • A Data Safety Monitoring Board (“DSMB”), formed by international experts of well-documented experience in the field of HIV/AIDS, will monitor the safety of the volunteers by periodically evaluating all clinical and laboratory data during the trial, to ensure the safety of the participants to the study.
  • An International Advisory Board (“IAB”), composed of international experts in the immunological, virological or vaccine field, will provide independent scientific and technical advices to the Sponsor.
  • A Community Advisory Board (“CAB”), constituted by exponents of non-governmental organisations (ONG) active in fighting and preventing HIV/AIDS, will assist the Sponsor since the very beginning of the study in supporting and protect the interests and well being of the volunteers.

The enrolment of the volunteers will be performed at each clinical centre.

Anyone interested in learning more about the trial may call the toll free AIDS telephone number, 800 861 061, from Monday to Friday between 13:00 and 18:00. Further details on the HIV-1 Tat vaccine are available on the ISS website at: and
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April 19, 2011, 8:00AM
The Istituto Superiore di Sanità and the South African National Department of Health announce today the launch of the phase II clinical trial ISS T-003 in South Africa based on the biologically active HIV-1 Tat protein, developed by the Italian research group coordinated by Barbara Ensoli at the National AIDS Centre of the Italian Istituto Superiore di Sanità chaired by Prof. Enrico Garaci.
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Published in PLoS ONE the results of the interim analysis of the Tat-based phase II therapeutic clinical trial (ISS T-002) on 87 HAART-treated patients.
November 12, 2010, 4:35AM
During the last 20 years the use of antibiotic drugs has changed the expectancy and quality of life of HIV-infected individuals. However, in spite of an effective viral-suppressing drug intervention, key signs of progression to AIDS such as the decline of CD4+ T cells and immune functions are only partially reverted by HAART, and are associated to a residual persistent immune activation. As a consequence, an increased risk of tumoral, cardiovascular, hepatic, renal and neurological diseases, as well as other clinical manifestations of accelerated aging, are now seen in HIV-treated disease. The 48-weeks interim data analysis of the Tat vaccine phase II trial (ISS T-002, NCT00751595), conducted in 87 patients under successful HAART has been published today in PLoS ONE ( . The results indicate that the Tat vaccine is not only safe and capable of inducing specific humoral (antibody) and cellular (T and B lymphocytes) immune responses, but it is also effective at significantly reducing the immunological alterations observed in HIV infection and still persisting during successful, viral-suppressing HAART. In particular, as compared to non-vaccinated HAART-treated individuals, vaccinated HAART-treated subjects show a significant increase of the number and percentage of CD4+ T cells, B lymphocytes (which normally does not occur under HAART), and regulatory T cells. These increments are accompanied by the reduction of immune activation markers that are the hallmark of the residual persistent immune activation observed under HAART. These findings suggest that the therapeutic vaccination with Tat may represent a novel and promising approach capable of reducing the immune dysregulation that persists even under successful HAART, with subsequent clinical benefit for the HAART-treated patients. Further, the more immune compromised patients appear to be the one benefiting the most from Tat vaccination. The phase II study is still ongoing in Italy in 10 (now 11) clinical sites. Thanks to these favorable results, the sample size has been increased from 128 to 160 subjects to include also more immune compromised individuals. Patients fulfilling the inclusion criteria will receive 3 or 5 intradermal administrations of the Tat protein given at monthly intervals in 2 different doses (7.5 μg or 30 μg). PLoS (Public Library of Science) ONE is a peer-reviewed open-access web journal, founded in 2006 by eminent scientists including the Nobel Laureate Harold E. Varmus. PLoS ONE is supported by an Advisory Board of the highest international caliber, and it works through a novel review process that, after a strict and accurate pre-review by the Editorial board and the subsequent review by qualified, external referees, offers a post-review process that is open to the whole scientific community to share opinions and considerations in a real time fashion by using an on-line forum.
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November 5, 2010, 4:15AM
According to Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases (NIAID), “a good therapeutic vaccine” could have a role in patients who have been treated early in their disease and whose blood levels of HIV are completely suppressed by drugs. Read more in the article published by Nature.
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November 5, 2010, 3:09AM
Milan, 3rd nov. (Adnkronos Health) - The discovery of an HIV/AIDS vaccine could not be far. There are clues to follow, and a useful lesson for scientists could arrive from a few patients, who are immune from the disease. These are the words of the Nobel Prize winner for the medicine. The French immunologist Françoise Barré-Sinoussi, who has obtained the award in 2008 for having discovered the HIV virus together with Luc Montagnier (they shared the prize with the German Harold zur Hausen, discoverer of the Papillomvavirus), says she is optimistic. Today, during a meeting organized by the Humanitas in Rozzano (Milan), she invited the investigators not to get discouraged. "The vaccine is the real great challenge of the research. The failure of the last clinical trial must be an incitement, for the scientists, to go back to the laboratory in order to better understand how the immune system works and to succeed in activating protecting responses also against insidious viruses like Hiv". Recent result, reminds the expert, "have identified some of the shelters where Hiv hides, suggesting new therapeutic targets. The challenge is translating these knowledges in a vaccine, which will likely not be preventative but therapeutic, and it will be part of the necessary integrated strategy for defeating Aids". Under observation must be those patients who are immune to the disease. "The solution – the Nobel continues - is maybe nearer than we believe: there is a small percentage of HIV infected patients who do not progress to AIDS, without the aid of drugs. The scientists must ‘learn’ from them, understand which mechanisms they have naturally developed, and repeat them with a vaccine". The expert has then reminded the last steps ahead made on prevention, starting from the local microbicide gel that has proved to be effective in reducing the risk of infection of 39% and that, "even if it does not solve the problem of the AIDS transmission because of sexual intercourses, strengthens the concept that we can prevent it". (Red-Lus/Adnkronos Health)

February 9, 2010, 12:46AM
The amendment approved by the ethical committees allows more patients to enter in the study (from 128 to 160). Moreover, people who had any CD4 cells nadir value before starting the therapy, who have been having a viral load <50 copies/mL for at least 6 months and have a CD4+ cells count >200 cells/l can be enrolled. Also people with HIV/HCV and HIV/HBV co-infection, not under concomitant immune modulator treatment, can be enrolled. HIV positive patients affected by active TB, concomitant neoplastic diseases, encephalopathy, neuropathy and central nervous system diseases, as well as those with an autoimmune disease history and not compensated systemic pathologies are excluded in the new criteria. Another important issue is the fact that patients who have been using CCR5 inhibitors and/or integrase inhibitors and/or fusion inhibitors for 6 months before the enrollment are excluded from the trial. For information please contact Telefono Verde AIDS at Istituto Superiore di Sanità, telephone number 800.861.061 from 13:00 to 18:00.

Can SIV infection be prevented?
May 24, 2009, 11:58PM
According to a study by the group led by Prof. Haase and recently published in Science (Vol. 323, p. 1726-1729), SIV (and, by extension, HIV-1) infections are controlled in animals mounting a fast and strong cytotoxic effector cell response. Infection could therefore be prevented if a vaccine confers to the host the capability to promptly mount upon infection a strong cytotoxic cellular immune response attacking and destroying the virus at the portal of entry.
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1985-2007: HIV seems to be more virulent nowadays
April 15, 2009, 2:25AM
After more than twenty years from the discovery of the HIV, a US study suggests that the virus has become more virulent than it was in the 80’s. The study, which has been conducted over six months on a group of antiretroviral-naive HIV seroconverters, has been published by Clinical Infectious Diseases in the May 1, 2009 issue.
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Kidney transplant in HIV-infected patients
March 31, 2009, 2:09AM
Survival after renal transplant is similar between HIV-infected and –uninfected individuals, although rates of graft loss may be higher among HIV-infected patients. Nevertheless, long-term graft survival comparable to that in HIV-negative patients can be achieved whether some precautions are taken.
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What can Europe do to accelerate AIDS vaccine research and development?
March 2, 2009, 1:01AM
Researchers’ passion is not enough to find a solution to the AIDS pandemic if it is not matched by all the funds needed to take up their work. This is the topic of a policy brief published by the International AIDS Vaccine Initiative (IAVI) aimed to the identification of the opportunities to stimulate AIDS vaccine research and development in both developed and developing countries.
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Why do we not yet have a HIV vaccine?
January 19, 2009, 4:07AM
A 2-day meeting to answer to this question was held in Princeton, NJ, on 29 and 30 May 2008. Read Dr. A.J. Levine’s point of view in this guest commentary published by Journal of Virology.
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IAVI’S AIDS Vaccine Blueprint 2008 resets expectations in the search for an AIDS vaccine
September 8, 2008, 2:22AM
The International AIDS Vaccine Initiative (IAVI) has released its “AIDS Vaccine Blueprint 2008” at the International AIDS Conference held in Mexico City on 3-8 August 2008. It offers a seriers of interim goals to bring the field closer to the ultimate goal, which is a safe, effective and accessible AIDS vaccine. In the words of Dr. Seth Berkley, President and CEO of IAVI “[...] Developing an AIDS vaccine may take more time and innovation than we might have once imagined, but we are confident that science will prevail. The necessary direction for the field is clear, and we must march forward.”
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Antibodies against gp120 may induce protection against HIV
August 29, 2008, 4:38AM
In the closing hours of the 17th International AIDS Conference in Mexico City (3-8 August 2008), researchers reported that catalytic antibodies against the HIV envelope protein gp120 may prevent HIV infection during sexual intercourse when used as a microbicide. Read more in the Washington Post editorial by David Brown.
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NIAID will not move forward with the PAVE 100 HIV vaccine trial
July 18, 2008, 1:57AM
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has determined that the HIV vaccine study known as PAVE 100 will not be conducted. However, NIAID will entertain a proposal for an alternative study about this vaccine candidate.
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NIAID creates HIV Vaccine Discovery Branch: it is time for sinergy
July 8, 2008, 2:06AM
The National Institute of Allergy and Infectious Diseases (NIAID) has created the “HIV Vaccine Discovery Branch” to promote sinergy between basic HIV researchers and vaccine designers. Read about its main duties and targets in the NIH News bullettin.
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PAVE’s trial rebirthing
June 30, 2008, 5:12AM
After the STEP trial failure, the Partnership for AIDS Vaccine Evaluation (PAVE) 100 decided to step behind for making the PAVE 100 trial move forward. The PAVE 100 trial was conceived as a phase 2b trial of about 8500 participants in 13 countries, using a DNA prime made up of 6 plasmid constructs (gag, pol, and nef, plus env from clade A, B, and C virus) followed by an adenovirus vector 5 (Ad5) booster). According to Scott Hammer, Principal Investigator, the PAVE 100 trial vaccine product and administration schedule would remain the same, but the study population would be greatly restricted, volunteers would be studied much more intensely, and emphasis will be shifted from product development toward basic research.
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HIV vaccine failures: wrong immune response
June 26, 2008, 2:38AM
The recent HIV vaccine failures have caused the need of designing novel vaccine approaches to HIV infection. This was the focus of a seminal meeting organized by The National Institute of Allergy and Infectious Disease (NIAID), which has been held in Bethesda, MD, USA on March 25, 2008. In a “Comment” published in the June issue of The Lancet, Dr. Boasso A., Dr. Shearer G.M. and Prof. Clerici. M. ask themselves why the traditional immunisation-memory-response paradigm seems not work in the case of an HIV vaccine.
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25 Years of HIV – the challenge
May 29, 2008, 3:39AM
“The HIV/AIDS catastrophe has been one of the defining features of the past quarter of a century. [...] Much remains to be accomplished in the global fight against HIV”. In the words of Anthony S. Fauci is the thought of many scientists, who are hardly committed in the challenge of an HIV/AIDS vaccine development.
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HIV/AIDS vaccines: a point of view over 25 years of failures
May 15, 2008, 2:49AM
In the quarter century since the discovery of HIV, Dr. Alan Bernstein, Executive Director of the Global HIV Vaccine Enterprise, tries to analyse the failure of HIV vaccine approaches according to another perspective. Read his editorial featured in May 9, 2008 edition of Science.
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Study by George Institute for International Health suggest that an AIDS vaccine is possible.
April 17, 2008, 3:28AM
IAVI has commissioned the George Institute for International Health to undertake a study. The views of over 30 stakeholders including public sector researchers, biotechnology firms, large pharmaceutical companies, and investors are due to be published later this year. Preliminary findings suggest that interviewees find scarce and fragmented funding of European academic research an important limitation for both the quality and quantity of innovative ideas. Results also suggests that collaborations between public research labs and biotech firms are a much needed model for mobilising biotech involvement in AIDS vaccine R&D, so long as the industry contribution is adequately funded and collaborations involve relatively small numbers of partners. For further information contact IAVI Secretariat.
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"Will there ever be an AIDS vaccine?"
January 21, 2008, 1:44AM
“Will there ever be an AIDS vaccine?” That is the question formulated by Dr. Robert Steinbrook in his editorial published by NEJM on December 2007 issue.
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AIDS Clinical Care published the Top HIV/AIDS stories of 2007
January 21, 2008, 1:43AM
Have a perspective on the 2007’s most important stories in HIV clinical care and research with the “Top HIV/AIDS Stories of the year” published by AIDS CLINICAL CARE
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An editorial by “Nature Medicine” tries to analyse in depth the situation and esorts researchers to learn from mistakes.
January 5, 2008, 2:06AM
It is a common belief among researchers that a vaccine is the only possible way to stop the AIDS pandemic in the world. Yet, the failure of some advanced (II, III) HIV vaccine clinical trials has renewed the skepticism about the possibility of developing an effective vaccine against HIV/AIDS. An editorial by “Nature Medicine” tries to analyse in depth the situation and esorts researchers to learn from mistakes.
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Report of the last Global HIV Vaccine Enterprise workshop held in May 2007, discusses new approaches to design vaccines that induce viral neutralizing antibody responses.
January 5, 2008, 2:05AM
At the last Global HIV Vaccine Enterprise workshop, which was held in May 2007, scientists discussed new approaches to design vaccines that induce viral neutralizing and other protective antibody responses, trying to identify key scientific issues, gaps, and opportunities that have emerged in the last few years, to make recommendations that Enterprise stakeholders should consider to plan new activities. The results of the workshop were published (PloS Medicine) in December 2007 in the summary report, entitled: “Antibody-Based HIV-1 Vaccine: Recent Developments and Future Directions”.
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Oct. 22-24, 2007: AVIP meeting in S.Africa
January 5, 2008, 2:04AM
On October 22-24 the AVIP consortium held its annual plenary meeting in Johannesburg, S.Africa, with participation of its Scientific Advisory Board and Monitoring Committee. During the two day meeting participants presented the results of research to the Advisory Board members for their recommendations. The meeting was also an occasion to further discussions and planning with S.African scientists for the Phase II clinical trials to be launched in the first half of 2008.
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