AIDS vaccine trial in Chennai (and 52 questions about the trial)

[Guest guest]

[Moderators note: 52 questions about this trial follows the main text. Will IAVI

or any of the sponsores of the trial answer this questions?]

AIDS vaccine trial

R. Prasad

CHENNAI: The Phase I clinical trial of the AIDS test vaccine was

initiated last week at the Tuberculosis Research Centre (TRC) here.

This is the second such trial being conducted in India — jointly by

the International AIDS Vaccine Initiative (IAVI) and the Government

of India. The first trial was started last February in Pune.

Enrolment of volunteers for the Chennai vaccine trial — TBC-M4 — has

started. The vaccine uses a recombinant Modified Vaccinia Ankara

(MVA) as a vector to carry six HIV-1 subtype C genes. It is a live

vector derived from vaccinia virus and is not known to replicate in

humans, as it is a highly weakened form.

The test vaccine was administered on a volunteer at TRC, Chennai, on

February 3.

" The most important point is that the vaccine trail has been started

and the recruitment [of volunteers] is an on going process, " said

Jean-Louis Excler, Director, Medical Affairs, IAVI, New Delhi.

The Chennai vaccine trial would enrol 32 volunteers and would be

conducted over 18 months. " It will take 18 months for each

volunteer, " Dr. Excler said. This is important as the enrolling

procedure is an on going process.

The results of the Chennai Phase I trial are expected to become

available by mid 2008.

The Y.R. Gaitonde Centre for AIDS Research and Education (YRG CARE),

a non-profit organisation, in close collaboration with TRC, would be

involved in the community mobilisation and recruitment of

volunteers, said Suniti , Director, YRG CARE.

YRG CARE is sensitising the community by going to banks, colleges,

factories and to other communities and talking about the vaccine.

Those interested would then come to the organisation to get the

details.

The test vaccine candidate for the Chennai trial has been developed

by Therion Biologics based in Cambridge, Massachusetts, U.S., with

the assistance of Sekhar Chakrabarti of the National Institute of

Cholera and Enteric Diseases, Kolkata.

The AIDS test vaccine trial at the National AIDS Research Institute,

Pune, was initiated on February 7 last year.

http://www.hindu.com/2006/02/07/stories/2006020705191300.htm

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52 questions about the proposed AIDS vaccine trial

1. What is the exact title of the vaccine research project?

2. Who are the responsible investigators in India and globally. Name and address

of all the key staff and their affiliation (and in other countries)

3. Address and location of the project

4. Who are the sponsors of the vaccine research project and the total budget of

the project

5. A copy of the project proposal (Purpose, methods and procedures)

6. What are the specific risks of the project (as identified by the researchers?

What method they have used to identify the risk)

7. What steps have been taken to reduce the risk?

8. What are the direct benefits to the participants (list all the benefits)

9. What are the toxicological/ pharmacological data available on the drugs to be

used in this project?

10. Is this a priority area of research (for eg research on locally appropriate

treatment options?)

11. What is the inclusion and exclusion criteria for this project and its

justifications

12. How the participants of this study will be recruited?

13. Are these criteria sensitive to (i) gender; (ii) age; (iii) vulnerable group

considerations?

14. Details of the pacebo arm of the study

15. Does the design include appropriate criteria for project

discontinuation, by the investigator or sponsor, of (a) individual participants;

and ( the project as a whole?

16. Are the project staff sufficiently qualified (on basis of education,

experience, reputation) to carry out this project ? (CVs of the key

investigators)

17. Details of the process of " community consensus-building " prior to initiating

the project, i.e. consultation/discussion of impact of

project and its relevance to (a) potential beneficiaries, ( participants'

communities?

18. To what degree possible, are (a) potential participants; (b)beneficiaries;

© other community members; (d) local clinicians, researchers, involved in: (i)

the design; (ii) evaluation; (iii) analysis; (iv) publication and/or

dissemination of the proposal, (v) implementation results?

19. Specific plan for the implementation of the result of the project in India

20. How does this project contribute to local capacity building, e.g. local

researchers, local clinicians?

21. Are the communities from which participants are drawn likely to benefit from

the project ?

22. Will the product (if any), if successful, be reasonably available to

participants and the communities from which they are drawn?

23. What specific steps are taken to ensure that the potential products would be

available to the community at the earliest?

24. Have adequate arrangements been made to ensure that the results findings of

the project are made available to (a) participants; (b)relevant communities,

within a reasonable time frame?

25. Who all will be the authors of the result of this study

26. Who will hold the patents of the potential product of this study?

27. Details of reviews carried out by any other relevant national or

institutional ethical review committee(s)?

28. Details of procedures to ensure that the project is

appropriately monitored as it progresses

29. Does the recruitment process include adequate protections for the privacy

and psychosocial needs of potential participants?

30. Is voluntary, non-coercive recruitment/participation ensured by informing

participants that hey may refuse to participate

31. Does the participation ensures that the participant may withdraw from the

project at any time without penalty or adverse consequences?

32. Has voluntariness of consent been adequately ensured for vulnerable/

hierarchical groups/individuals?

33. A copy of the informed consent form

34. Does the informed consent form/information sheet provide sufficient

information regarding: (i) purpose of the project (ii) procedures to be carried

out; (iii) risks (including possible discrimination); (iv) discomforts; (v)

inconveniences, including the time required for participation; (vi) benefits to

participants and others; (vii) alternatives to participation; (viii) additional

costs, if any, to participants and whether those costs will be reimbursed?

35. Is the informed consent form/information sheet written or presented (a) in

lay language; ( at an appropriate level of simplicity to ensure that

participants can understand, and © specify contact person/s to discuss and

explain details of the study?

36. Details of the procedures of acquiring informed consent?

37. Does research protocol and consent form/information sheet (a) describe steps

taken to protect confidentiality; and ( ensure that participants are informed

of the extent to which confidentiality can be maintained and possible protective

steps to be taken, if breached?

38. Are inducements provided for participation?

39. Do the inducements constitute an undue inducement or influence for

participation?

40. Are there adequate provisions to deal with adverse consequences (medical,

psychological, social) arising from the project, including compensation for

injury/loss?

41. Details of the proposed compensation for injury or loss

42. Is it likely that the participants could be infected with HIV during the

project lifecycle?

43. What percentage of participants are likely to be infected?

44. Do they belong to any particular groups?

45. What specific steps will be taken to reduce/eliminate such chances?

46. What are the potential adverse incidents anticipated in this project?

47. Are participants (and if appropriate, their families) given adequate support

(medical/psycho-social, e.g. provision of or referral to counselling) during and

after the conduct of project? (Spell out the details of these support)

48. What steps will be taken to register these adverse events and who will have

access to this registry?

49. Details of the ethics review committee (s) reviewing the project proposals

(List of members of the ERC)

50. Recommendations and suggestions of the ethic review committee (S)

51. Conflict of interest of the investigators

52. Conflict of interest of the ERC members

Moderator

AIDS INDIA e FORUM

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