Comments on: Future Directions for NIAID’s HIV Vaccine Clinical Research

By: Dr.Shabir Qureshi

Dr.Shabir Qureshi — Wed, 21 Sep 2011 19:37:53 +0000

Dear Dr.carl /Dr.johnson

First of all i find myself pleased to comment on the subject and let me start to say that it is very difficult and too hard to solve a problem when one aims to target with a blind eye.numerous funding and financial expenditure on HIV/AIDS vaccine development has gone waste and futile since 3 decades of its existance where millions of lives have been spoiled.The word impossible is written in the dictionary of fools ,after all scientists are closer to GOD.
Being a simple physician and researcher from INDIA i have been myself able to develop a nice alternative therapy for HIV/AIDS/HBV/HCV ,THOUGH WITHOUT facilities like research institute,laboratory,infrastructure finance and all.why could not scientists /doctors from NIH/USA and other countries find it out after expenditure of billions of dollars any cure or vaccine for the same.
i would like to suggest the authorities to make open call for proposals/invite for proposals for new ideas , from innovators /researchers /doctors or idea /thinkers throughtout globe so that if not billions/millions/but one idea from any part of the world may be able to solve this mystery by developing a foolproof effective vaccine once for all.

Thanks
yours sincerely
Dr.Shabir Qureshi
Srinagar INDIA

By: LB

LB — Wed, 22 Sep 2010 10:09:42 +0000

Will the slides from the ARAC meeting on the future of the clinical trials networks be posted to the blog?

By: Eddie

Eddie — Thu, 02 Sep 2010 00:19:07 +0000

I wonder why the NIAID has not approached a cocktail of at least 3 or 4 vaccines. We have seen it in HAART, and now we are seeing that it is giving encouraging results in Hepatitis C virus. Merck’s single vector vaccine failed along with other monoclonal vaccines in the past, until we had the thai trial last year as a conbination of 2 vaccines that showed a modest protection.So my question is: Why not enhance it to a 3 or 4 punch vaccine? Is it too complicated? I wish you all good hard work!

By: Nikolai Petrovsky

Nikolai Petrovsky — Mon, 26 Jul 2010 19:51:06 +0000

I would like to specifically comment on the question of other infectious diseases that the HIV clinical trial network system. Ideally, these should provide some similarities to HIV so that lessons can be learned and translated from the outcomes of these other vaccines to the HIV endeavors. Already, without questioning the rationale for their selection, TB and malaria are very different infections and present somewhat different vaccine challenges to HIV. That said, it would be possible to still use them to assist the HIV efforts, for example a concerted effort to use a well defined malaria or TB antigen as a platform to compare multiple different adjuvant formulations, not just to benefit malaria or TB vaccine efforts per se, but to help identify the best adjuvant for a future HIV vaccine. However, this presents challenges as people in the malaria or TB fields may resist potential dilution of their focused vaccine efforts in this way and, in any case, the correlate of vaccine protection in malaria may be very different to HIV and thereby the type of adjuvant required may also be very different. So with the current network disease focuses there appear to be limited opportunities for cross-fertilisation.
In selecting additional disease focuses for the network, I feel it would be rational to restrict these to viral infections as these will have the most similarities and utility to HIV. Therapeutic hepatitis B vaccines are the most obvious and worthy candidate. EBV, herpes simplex, and CMV, similarly present obvious similarities to HIV, can infect the same population groups and would be worth inclusion both for their own sakes but also because their success could inform successful HIV vaccine design.

By: Robert Reinhard

Robert Reinhard — Fri, 23 Jul 2010 11:13:46 +0000

Thank you for this post. The strategy for an organized set of adaptive trial designs is certainly a good direction to go forward as a way to test vaccines in the best experimental system currently available – i.e. human clinical trials. However, the articulation of the proposal by NIAID so far lacks sufficient detail to appreciate its potential for success or failure. This was underscored by the excellent vaccine session at the AIDS 2010 conference The Search for an HIV Vaccine: Where Are We, Where Are We Going, and How Can We Get There Faster?
http://globalhealth.kff.org/AIDS2010/July-18/The-Search-for-an-HIV-Vaccine.aspx
As Linda Gail Becker, Robin Shattock, Mark Feinberg and Alan Bernstein pointed out, a number of operational, product development, institutional and GCP issues must be integrated and publicly explained. These include:
1) Practical and meaningful use of behavioral and social science methods and design features as part of these experiments
2) Especially with the exciting results of the CAPRISA 004 study and preliminary data from CDC’s PrEP safety study, it is important to plan and articulate now how vaccine study designs will develop in a multi-intervention environment, also taking community perspectives into account
3) Although many potential adjuvants are available and likely necessary, especially supplied from industry, few have been targeted as a fully supported part of the research agenda or in ways that allow private sector involvement and sharing
4) Although NIAID itself and its US consortia have progressed much in data and materials sharing plans, those are not yet at the level for a full international effort considering the very large volume of data collected now and expected in the future.
The NIAID scheme would also benefit in the future from “blogs” or proposals that are authored and distributed from the whole range of global vaccine advocates. It would be helpful to produce ideas and systems that promote NIAID’s effort in relation to all HIV vaccine research even if NIH is the single largest funder. Efforts to bolster small company participation and others would also be welcome.

By: Seyed Mohsen Khatami

Seyed Mohsen Khatami — Mon, 19 Jul 2010 01:14:59 +0000

Dear Dr. Carl W.Diffenbach,
Director of NIAID’s Division of AIDS
Hello
The development of a safe and effective preventive vaccine for HIV remains as a prioritiy for scientific community and its development have presented significant challenges. Why it is so? Because the development of a safe and effective preventive vaccine for HIV does not obey and follow the principles of classic vaccinlogy. The experimental reason for my claim is the elusive result from the RV144 Thai trial. I believe that some rational empiric conclusions from the RV144 Thai trial can have leading effects in your future work for development of a safe and effective HIV vaccine. But according my view, the NIH researchers have at the present time long distance from the rational empiric conclusions that it must be intended in order to upgrade the RV144 Thai trial and its results. Sincerely, I pray for them that they can evaluate and reevaluate again and again the results of the RV144 Thai trial. The RV144 Thai was the first step in rational direction, but only the first step and nothing more. The developments and the improved results are depended to the continuation of this work based on the modification of experimental methodic and strategy by the help of criticism and self criticism.
The identification of two new broadly neutralizing human antibodies that can prevent more than 90 percent of known HIV strains is good news. Their broadly neutralizing functions and effects are certainly relative to laboratory strains of HIV and not relative to the wild type strains in vivo. At the best, these antibodies can be used directly in HIV-infected patient as antibody-based therapy.
In the end I will mention some words about the new vision for the national HIV/AIDS strategy in USA. According this vision, until 2016 the United States will become a place where new HIV infections are rare and … . The vision is good but is not realistic and pragmatistic. You cannot fight a war without resources. The great resources in order to fight and curb HIV are the scientific capacities. According my view a powerful country as the United States of America lacks at the present time the scientific capacity to promises such visionary utopia indicating a USA free from new HIV infection before 2016. The incidences of miracles do not associate with scientific endeavors.
Best wishes,
Seyed Mohsen Khatami