Re: Phase I AIDS Vaccine Trial

[Guest guest]

Dear FORUM,

It is wonderful to see a congratulatory note from Dr. Ahmed. Considering his

close involvement with AIDS vaccine research in India (he is part of a NGO

network called National Group for Vaccine Initiative) sponsored by IAVI.

Sekhar Chakraborty was a co-developer of the vector. Many state that the biotech

company involved in making the viral vector did so to get a buy-in with the ICMR

and scientific community in India. Dr. PM Bhargava an initial supporter of AIDS

vaccine research has been critical of the means adopted by IAVI and others.

AIDS clinical research in India is a farce.

There is no primary research, development or even epi research a supported by

organisations like vaccine and microbicide research organisations.

To top it all, p[oliticians are part of their board and head these

organisations.

I wish Dr. Ahmed could provide the accomplishments of the vaccine research

programme in India apart from doing clinical trials.

Best wishes,

Ramesh

Dr. Ramesh Vaidya

e-mail: <dr.r.a.vaidya@...>

[Guest guest]

Dear Forum ,

Re: /message/9235

Phase I AIDS Vaccine Trial in India

While ensuring that all current HIV prevention efforts should go on

uninterrupted , we also strongly feel the need of an effective

preventive AIDS Vaccine in India.

My congratulatory remark about the two scientists who contributed in making

the Phase I AIDS Vaccine Trial in India a success has certain reasons .

Dr Ramesh Vaidya raised certain issues and critical issues should be discussed

.. We know this is not the time to be too enthusiastic about the success of the

Phase I trial as this is just the stepping stone & Phases II & III will be most

challenging & AIDS Vaccine development programme in the world have not shown

encouraging results .

But that should not deter Indian scientists from making all out effort .

Unless scientific efforts are made we will never have an AIDS Vaccine.

Scientists world over know it too well the challenges and still

they persists in their efforts learning every time from their

mistakes – all with a hope , understanding that uncertainties do

prevail , development process is time consuming & very expensive.

Inspite of all these constraints , the effort goes on . Whoever &

wherever in India , scientists contribute to the development of an

AIDS Vaccine , it needs to be supported . Any one having other

scientific idea or other designs should come forward and contribute

in a collaborative manner .

A sweeping statement like " AIDS clinical research in India is a

farce " which is not backed by facts somehow belittles all the work

done by Indian scientists who have been working against very heavy

odds.

All that I can say from reports about Prof Bhargava is that Dr

Ramanathan have presented the work done by TRC under Phase I Trial

in the National Advisory Board where he is a member and he has never

questioned the scientific or the ethical basis of the trial in any

meetings

Most of the research in India is carried out by Government agencies

and these naturally are headed ultimately by Ministers who are

Political leaders as these are part of either Health Ministry or the

Science & Technology Ministry. Political leaders are representatives

of people.

IAVI should be lauded for very effective advocacy with major political parties

and successfully including different

stakeholders on board . IAVI even took advice from President Kalam

while he was in office.

HIV/AIDS Research in India

Since the first HIV seropositive case reported in 1986, at Chennai,

Indian scientists comprising of basic, clinical, epidemiological as

well as social scientists came forward to tackle this problem.

One should see the developments of AIDS control program in India in the

different web site before arriving at a conclusion that there is no AIDS

research in India.

ICMR is one such organizations which is actively involved in HIV/AIDS research

through its different centers in India. The creation of NARI, Pune dedicated

fully to HIV/AIDS research is one such strong initiatives of ICMR.

It is extremely wrong to think that there is no research in India.

People should make the constructive criticism instead of negating the efforts by

Indian scientists.

In the basic science, extensive work is going on in different parts

of India which include CMC Vellore, JNCASR, Bangalore, AIIMS,

ICGEB,New Delhi, PGI, Chandigarh, NICED, Calcutta, RMRC, Dibrugarh,

NARI,Pune, NIV, Pune, NCCS, Pune etc.

The list of the achievement in basic science is a very long one and one can

easily have the access at the web sites of these institutes.

Basic Science Research is a key , which contributes in the development of the

AIDS Vaccine & its design.

That the Indian HIV-1 strain is different genetically from

the strains of other parts of the world is now internationally

accepted and this work is the result of the data generated in

different institutes of India.

One can log on to the Google.co.in and search for Indian HIV-1 strains and he

/she can see the list ofpublications in peer reviewed journals.

AIDS vaccine research work comprises of two major facets. While the

better recognized component is the development of HIV vaccines by

basic scientists, it is very important to note that there are other

equally important areas where vital contributions have been made.

HIV/AIDS Vaccine Research & Development in India The concepts to make the

appropriate vaccine for HIV/AIDS was generated & emerged in late 1990s by couple

of workers in the field and Dr Sekhar Chakrabarti was one of them.

It is worth to mention here that Dr Chakrabarti is involved in HIV/AIDS research

since the beginning of this epidemic during his stay at NIH, USA while working

with Dr Bernard Moss and Dr C Gallo. Dr Chakrabarti received several

award and patent for his HIV research.

Dr Chakrabarti initially discussed about the pox virus system as he developed

several vectors while at NIH, USA. It was in the year 2000 when MOU was signed

between ICMR, NACO, Ministry of Health, Govt of India and IAVI where it was

clearly mentioned that Indian strain would be used and Indian scientist would be

involved in the development of the vaccine.

With the support from IAVI, Dr Chakrabarti worked at Therion

Biologicals to construct the TBC-M4 vaccine that was used in phase I

trial at Chennai.

As is well known, the genes were isolated from Indian volunteers with help from

NARI. The strain of HIV used was isolated at NARI, Pune.

In Science, the work is always collaborative approach and Dr Chakrabarti with

the help from Therion scientists developed this candidate vaccine for India.

It will be also worthwhile to mention here that Dr Bhargava, an eminent Indian

scientist is very much aware of Dr Chakrabarti's work and achievements. Dr

Sekhar is a highly respected virologist of

international repute who has published papers on MVA in such journals

as Science.

Further, he has patents also for some of his innovations

in this regard.

Therefore, I find it unacceptable and inappropriate if it is said that just 'to

get a buy-in with ICMR' he was involved

in the development.

Dr Sekhar Chakrabarti has been in the forefront of the development of the MVA

based vaccine which was tested in the TRC Chennai trial.

Apart from this, many other basic researchers are working on development on

devising novel HIV vaccines using many

different approaches.

TRC is affiliated to the Indian Council of Medical Research (ICMR), which, along

with National AIDS Control Organisation (NACO) and the International AIDS

Vaccine Initiative (IAVI), has spearheaded the vaccine trial in India.

The initial success of the trial with the MVA (Modified Vacinia Anacara)- based

vaccine candidate (TBC-M4) comes in the wake of National AIDS Research Institute

(NARI) in Pune winding up research with another vaccine candidate AAV

(Adena-Associated Virus).

The Pune institute's trials ended in December 2007, after tests in two other

countries, Germany and Belgium, with the same vaccine candidate failed.

To date, there have been at least nine MVA vaccine candidates that have been

tested or are still currently in testing in labs around the world.

The Union government and the IAVI had signed an agreement to conduct

the HIV vaccine trials both in Chennai's TRC and Pune's NARI. But,

with the Pune trials being stopped, the Chennai project is India's

only hope for a HIV vaccine.

Dr Ramanathan, from TRC whose team has been tirelessly working on the vaccine,

which could provide a key preventive weapon in India's war against AIDS.

However, this is just beginning and the encouraging result only can stimulate

further development.

In phase II of the trial, the vaccine will be tested on a larger number of

volunteers, about 300 men and women.

The objective of the phase II trial is to double-check the safety of the

vaccine, its immune response and the dosage to be administered.

It will take about four years for this phase to be completed and another eight

years for phase III, during which about 3,000 volunteers, drawn from low and

high risk groups, would be tested.

There are approximately 30 AIDS vaccine candidates in the clinical pipeline in

various stages of testing today. One of these candidates is being tested in a

phase III trial in Thailand, the third AIDS vaccine candidate to reach efficacy

testing to date.

Testing vaccines in clinical trials Equally important is the research carried

out in conducting clinical trials of HIV vaccines. Apart from the skills needed

to do trials with the highest possible international standards, innovative ideas

were generated to tackle the problem of recruiting absolutely healthy

individuals who were at very low risk of getting HIV infection as volunteers.

This has been amply demonstrated in both the Pune and the

Chennai trials where the challenges of identifying, recruiting and

holding on to the trial volunteers for the entire duration of the

trial.

I am emphasizing this point very clearly here because the

trials have conformed to both scientific and ethical guidelines.

Under these circumstances, I would be very surprised if any one were

to say that Indian scientists have not contributed to HIV vaccine

research for the truth is otherwise.

Dr S I Ahmed

Email : siahmed60@...