A Phase III Trial of Aventis Pasteur Live Recombinant ALVACHIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX® B/E) Boosting

in HIV-Uninfected Thai Adults

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

MOPH-Thai AIDS Vaccine Evaluation Group

‡ 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

A Phase III Trial of Aventis Pasteur Live Recombinant ALVACHIV (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

(ReukGnam., et

MOPH, TM, RTA, WRAIR, NIH

A Phase III Trial of Aventis Pasteur Live Recombinant ALVACHIV (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

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

Community Education & Engagement Prior to enrollment
Various activities involving participants and communities were implemented with the objectives of
‡ 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

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

Announcement of Result

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

Community Activities
‡ 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

A Phase III Trial of Aventis Pasteur Live Recombinant ALVACHIV (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

A Phase III Trial of Aventis Pasteur Live Recombinant ALVACHIV (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.

A Phase III Trial of Aventis Pasteur Live Recombinant ALVACHIV (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.

A Phase III Trial of Aventis Pasteur Live Recombinant ALVACHIV (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.

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

RETENTION ACTIVITIES at the sites ( started from 2005)
Provider based system 16,402 volunteers Enrolled 24-hour phone access Mailing and phone reminders Edutainment campaigns/ interactive games

Extend Service Hours on Sunday and one evening clinic per week

95% interval Retention

Mobile unit activities

Tracking activities (Home visit)

Volunteer Relation, Club activities

Cultural activities

Quarterly exhibition with educational boards

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

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

A Phase III Trial of Aventis Pasteur Live Recombinant ALVACHIV (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

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

Community engagement for final analysis 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
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A Phase III Trial of Aventis Pasteur Live Recombinant ALVACHIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX® B/E) Boosting in HIV-Uninfected Thai Adults

‡ 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.
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A Phase III Trial of Aventis Pasteur Live Recombinant ALVACHIV (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 2009Mar 2010)

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

Jan - Aug¶ 09

Sept¶ 09

Oct¶ 09 ± Mar¶ 10 
Volunteers  Scientific community  Community at large/Thought leaders

Introduction of  Simultaneous the potential result results in target announcement audience both USA and Thailand via ‡ High level VDO public health conference executives  Press ‡ Field trial staff conference ‡ Participants  Result ‡ Community at communication large/leaders in training the community workshops for ‡ Scientific field trial staff community

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

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
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A Phase III Trial of Aventis Pasteur Live Recombinant ALVACHIV (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

A Phase III Trial of Aventis Pasteur Live Recombinant ALVACHIV (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? All these Q with A have been prepared as a manual to all staff and are use for training
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A Phase III Trial of Aventis Pasteur Live Recombinant ALVACHIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX® B/E) Boosting in HIV-Uninfected Thai Adults

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

‡ Result Communication Training Workshops for field trial staff 

(Chief Provincial Medical Officers, Hospital Directors, Chief District Health Officers, Local Communication coordinators, Clinical site)

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

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
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A Phase III Trial of Aventis Pasteur Live Recombinant ALVACHIV (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?

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A Phase III Trial of Aventis Pasteur Live Recombinant ALVACHIV (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

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

Media materials Production Plan
‡ ‡ ‡ ‡ ‡ ‡ ‡ VDO CD Fact sheet/FAQ Brochure Flyers Posters Banner Radio spots ‡ TV program/scoop ‡ Advertorial advertisement ‡ Moving advertisement ‡ Website ‡ Newsletter

All Media Materials base on 4 scenarios will be prepared
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A Phase III Trial of Aventis Pasteur Live Recombinant ALVACHIV (vCP1521) Priming With VaxGen gp120 B/E (AIDSVAX® B/E) Boosting in HIV-Uninfected Thai Adults

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
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