1. A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC- HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX® B/E) Boosting in HIV-Uninfected Thai Adults 1 Community Engagement in Prime-Boost HIV Vaccine Phase III Trial Punnee Pitisuttithum MBBS,DTM&H,FRCPT Faculty of Tropical Medicine Mahidol University FOR MOPH-TAVEG

2. A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC- HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX® B/E) Boosting in HIV-Uninfected Thai Adults Ministry of Public Health, Thailand Faculty of Tropical Medicine, Mahidol University Royal Thai Army US HIV Military Research Program Supported by NIH, Henry Jackson Foundation MOPH-Thai AIDS Vaccine Evaluation Group

3. A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC- HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX® B/E) Boosting in HIV-Uninfected Thai Adults Randomized, double-blind placebo controlled trial 16,402 community health volunteer were enrolled Vaccine ALVAC-HIV~0,1,3,6 M AIDSVAX B/E 3,6M Started in Sept 2003 Duration 3.5 years Primary end point : HIV infection, Lowering viral set point (Reuk- Gnam., et al.) MOPH, TM, RTA, WRAIR, NIH

4. A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC- HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX® B/E) Boosting in HIV-Uninfected Thai Adults Screening all sites (N = 26,658) Male 15,973 (60%) Female 10,685 (40%) Enrollment all sites (N = 16,402) Male 10,068 (61%) Female 6,334 (39%) Participants with age under 20 yrs (N =2,540) Male 1,658 (65%) Female 882 (35%) 13,977 volunteers received all 4 vaccinations 90% follow up at three years

5. A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC- HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX® B/E) Boosting in HIV-Uninfected Thai Adults Community Engagement Activities Pre screening and Screening period Follow up phase Pre and post announcement of the interim analysis Pre and post announcement of the final results 5

6. A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC- HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX® B/E) Boosting in HIV-Uninfected Thai Adults Community Education & Engagement Prior to enrollment Raising AIDS awareness Raising project awareness Understanding of the vaccine and the project Importance of follow up and solving of Participants impact events (PIEs) Creating sense of ownership Understanding of trial results Various activities involving participants and communities were implemented with the objectives of

7. A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC- HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX® B/E) Boosting in HIV-Uninfected Thai Adults Announcement of Result

8. A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC- HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX® B/E) Boosting in HIV-Uninfected Thai Adults Community health forum for disseminating trial information and the understanding of HIV vaccine, update the status of the trial, need to follow up Community engagement implements in routine health campaigns – Health fairs – Mobile unit health check up Community Advisory Board (CAB) - meeting bimonthly Community Activities

9. A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC- HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX® B/E) Boosting in HIV-Uninfected Thai Adults Community Health Forums: The forum activities are being conducted to reach volunteers’ families and neighbors as well as the community at large for better understanding of the trial process, particularly the importance of the follow-up phase since 2005. Nearly 400 CHF were conducted in both provinces

10. A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC- HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX® B/E) Boosting in HIV-Uninfected Thai Adults Community Advisory Board: A group of voluntary community members, who are actively involved with HIV/AIDS issues in the community, facilitated by investigators and NGOs To facilitate horizontal and vertical communication channels about HIV/AIDS & the vaccine trial for the community The CAB meets every 2 months; the major issues are empowerment, updating trial information and potential trial results. CAB and their members are actively involved in the community activities as well as volunteers’ relation activities, including information sharing with other CABs.

11. A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC- HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX® B/E) Boosting in HIV-Uninfected Thai Adults The chair of the CAB with some members together with the community representatives participated in the World AIDS Vaccine Awareness Day (2008)and expressed their enthusiasm in supporting trial participation and extended well wishes to the trial.

12. A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC- HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX® B/E) Boosting in HIV-Uninfected Thai Adults Involving NGO of the local community in every activites and later on they took the lead in the community activities. 12

13. A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC- HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX® B/E) Boosting in HIV-Uninfected Thai Adults 95% interval Retention 16,402 volunteers Enrolled Extend Service Hours on Sunday and one evening clinic per week Provider based system Mailing and phone reminders 24-hour phone access Edutainment campaigns/ interactive games Quarterly exhibition with educational boards Cultural activities Volunteer Relation, Club activities Tracking activities (Home visit) Mobile unit activities RETENTION ACTIVITIES at the sites ( started from 2005)

14. A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC- HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX® B/E) Boosting in HIV-Uninfected Thai Adults Volunteer Clubs Activities Volunteer Clubs Activities to create sense of ownership of the trial among the volunteers to establish communication channels and closer relationships among the volunteers and trial staff to strengthen the relationship among the trial volunteers from different sites and link them together

15. A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC- HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX® B/E) Boosting in HIV-Uninfected Thai Adults Volunteer clubs are now being encouraged to integrate their activities into other community social activities by involving community networks and CAB member in their areas. In 2006, 38 volunteer clubs were established They were facilitated by the district health office, MOPH,CRC, and NGOs

16. A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC- HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX® B/E) Boosting in HIV-Uninfected Thai Adults 16 Base on 4 potential results Sc1. Vaccines Success; Efficacy ≥ 50% Sc2. Modest vaccine success; LB>0,Efficacy<50% Sc3. Reduction in viral load (VL) with no preventive effect No vaccine effect Community engagement for final analysis

17. A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC- HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX® B/E) Boosting in HIV-Uninfected Thai Adults 17 The trial is scheduled to have final analysis and the result announcement by late September 2009 Communication with volunteers and community the trial result is crucial Assessing the community, volunteers and field staff on the understanding of each scenario prior the announcement is and important clues to prepare educational messages.

18. A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC- HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX® B/E) Boosting in HIV-Uninfected Thai Adults The communication plan for the final analysis of the trial includes  Pre-Result Announcement (Jan-Aug 2009)  Trial Result Announcement (Sep 2009)  Post Trial Result Announcement (Oct 2009- Mar 2010) 18

19. A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC- HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX® B/E) Boosting in HIV-Uninfected Thai Adults Sept’ 09  Simultaneous result announcement both USA and Thailand via VDO conference  Press conference  Result communication training workshops for field trial staff  Volunteers  Scientific community  Community at large/Thought leaders Oct’ 09 – Mar’ 10 Introduction of the potential results in target audience High level public health executives Field trial staff Participants Community at large/leaders in the community Scientific community Jan - Aug’ 09

20. A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC- HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX® B/E) Boosting in HIV-Uninfected Thai Adults 20 Pre-Result Announcement (Jan-Aug 09) Introduction of the potential results in target audience :  High Level Public Health Executives  Field trial staff ( Local communication coordinator, clinical site) Series of training workshop  Participants Face to face/ focus group discussion during follow up visits Volunteer’s club activities

21. A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC- HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX® B/E) Boosting in HIV-Uninfected Thai Adults Examples of questions raised by the participants from in depth discussion How can they be sure that the result is correct? Any long term side effects? Continuing treatment of HIV infected participants? If efficacious of >50%, then What next? What benefits the community and participants will have?,when? (vaccine),what’s the cost? Patent issue? 21

22. A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC- HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX® B/E) Boosting in HIV-Uninfected Thai Adults Scenario2: Efficacy of around 30% What next? Can they participate in the future AIDS vaccine trial? Any follow up care? Scenario 3: Effects on Viral load Any additive effects? Can it be used as therapeutic? 22 All these Q with A have been prepared as a manual to all staff and are use for training

23. A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC- HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX® B/E) Boosting in HIV-Uninfected Thai Adults 23 Trial Result Announcement (Sep 09) Activities include: Simultaneous Result Announcement both USA and Thailand via VDO Conference Press conference  at MOPH right after the result announcement, relevant to communication dossiers.  Press conference at both provinces, Chon Buri and Rayong in the afternoon

24. A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC- HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX® B/E) Boosting in HIV-Uninfected Thai Adults 24 Result Communication Training Workshops for field trial staff  (Chief Provincial Medical Officers, Hospital Directors, Chief District Health Officers, Local Communication coordinators, Clinical site)

25. A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC- HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX® B/E) Boosting in HIV-Uninfected Thai Adults 25 Post Trial Result Announcement (Oct 2009- Mar 2010) For volunteers –Schedule individual Appointment (30 volunteers/working day/clinical site) –VDO trial result briefing –Clinic appointment for education, un-blinding and counseling –Update Contact Information for future communication

26. A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC- HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX® B/E) Boosting in HIV-Uninfected Thai Adults Frequently asked questions of VE +31.2%: Long term side effects? Why no effect on viral load? 26

27. A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC- HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX® B/E) Boosting in HIV-Uninfected Thai Adults Community at large / Thought Leaders –Community Health Forum at least once after the trial announcement –CAB meeting Scientific community –Trial Result Seminar for National KOLs and technocrat- Dec 4,09 at The Joint International Meeting of Tropical Medicine and Malaria –International Meeting –AIDSVACCINE 2009,JAN2010 27

28. A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC- HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX® B/E) Boosting in HIV-Uninfected Thai Adults 28 Media materials Production Plan All Media Materials base on 4 scenarios will be prepared VDO CD Fact sheet/FAQ Brochure Flyers Posters Banner Radio spots TV program/scoop Advertorial advertisement Moving advertisement Website Newsletter

29. A Phase III Trial of Aventis Pasteur Live Recombinant ALVAC- HIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX® B/E) Boosting in HIV-Uninfected Thai Adults 29 Acknowledgement: Volunteers including their families & community members Ministry of Public Health, Thailand Faculty of Tropical Medicine, Mahidol University Royal Thai Army WRAIR/Henry M. Jackson Foundation DAIDS/NIAID/NIH sanofi pasteur GSID (VaxGen Inc.) WHO/UNAIDS