"hiv vaccine development: enabling the efforts through policy development" dr saladin...
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WHO/UNAIDS/UNSW Satellite Session "Access to care and treatment in the context of HIV vaccine and other prevention trials" IAS Conference, 22 July 2007, Sydney, Australia. "HIV Vaccine Development: Enabling the efforts through policy development" Dr Saladin Osmanov Coordinator - PowerPoint PPT PresentationTRANSCRIPT
WHO/UNAIDS/UNSW Satellite Session"Access to care and treatment in the context of
HIV vaccine and other prevention trials" IAS Conference, 22 July 2007, Sydney, Australia
"HIV Vaccine Development:
Enabling the efforts through policy development"
Dr Saladin Osmanov
Coordinator
WHO-UNAIDS HIV Vaccine Initiative
World Health Organization
Geneva, Switzerland
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An international landscape in the field ofHIV Vaccine R&D in 2007
An international landscape in the field ofHIV Vaccine R&D in 2007
The 2005-2007 G8 Summits re-affirmed the highest political level of support to global initiatives to accelerate the development of HIV vaccines, such as Global HIV Vaccine Enterprise
Multiple national and international programmes (e.g., NIH/HVTN, Walter Reed, IAVI, EU/EC, ANRS, Sweden, Italy and others) expand their efforts in the development and conducting clinical trials with promising HIV vaccine candidates based of multiple vaccine concepts
The Bill & Melinda Gates Foundation provides the first grants for the establishment of the Collaboration for AIDS Vaccine Discovery (CAVD), including 11 vaccine-discovery consortia and 5 centralized facilities
Growing number of low- and middle-income countries participating in preparation and conduct of HIV vaccine clinical trials
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Need to conduct multiple efficacy trials,especially in developing countries
Need to conduct multiple efficacy trials,especially in developing countries
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Continuum of the WHO-UNAIDS Efforts in the Area of HIV Vaccine R & D
Continuum of the WHO-UNAIDS Efforts in the Area of HIV Vaccine R & D
1989-2000: WHO HIV vaccine research activities initiated by the WHO Global Programme on AIDS (GPA) and continued with UNAIDS from 1995-2000
2000-2007: Establishment and functioning of a joint WHO-UANIDS HIV Vaccine Initiative (HVI)
Strategic and technical guidance provided by the WHO-UNAIDS HIV Vaccine Advisory Committee (VAC), Chaired by Prof David Cooper
Since October 2006: HVI has been tasked to coordinate its activities with Malaria and TB vaccine R&D, focusing on: Policy development, Regulatory research and Ethics
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WHO/UNAIDS priorities in the area of HIV vaccine R&D
WHO/UNAIDS priorities in the area of HIV vaccine R&D
Maintain high level of advocacy to facilitate the development of globally effective and accessible HIV vaccines in alignment with major international partners (e.g, Global HIV vaccine Enterprise)
Support comprehensive and sustainable capacity strengthening and networking of trial sites in developing countries integrated into overall vaccine R&D efforts for diseases of public health importance, such as HIV, malaria, TB and others
Facilitate the development and implementation of internationally agreed norms , standards and policies for the development, evaluation and future access to HIV vaccines
WHO-UNAIDS HIV Vaccine Initiative 6
Addressing ethical challenges in support of vaccine-related research and clinical trials Addressing ethical challenges in support of vaccine-related research and clinical trials
2000 Ethical Guidelines Guidance Point 16: “Care and treatment for HIV/AIDS… should be provided to participants…, with the ideal being to provide the best proven therapy, and the minimum to provide the highest level of care attainable in the host country in light of (circumstances specified)”
2004 WHO/UNAIDS Consultation“… there is broad, though not unanimous, agreement among sponsors of HIV vaccine trials that ART and a clinical care package should be provided to those who become infected during the conduct of a trial
WHO-UNAIDS HIV Vaccine Initiative 7
However, a number of outstanding questions remain unresolved
However, a number of outstanding questions remain unresolved
What level of care or standard, to whom, for how long, and who's obligation?
Disagreement on obligations to provide ART to those who are excluded during the screening process because they are HIV positive.
Disagreement on obligations to provide treatment of HIV in non-HIV vaccine trials: e.g. to participants who are screened and test positive for HIV during TB, malaria or cholera vaccine trial enrolment.
WHO-UNAIDS HIV Vaccine Initiative 8
Extensive WHO/UNAIDS Regional Consultations inAfrica, Latin America, Asia, Eastern Europe in
2005-2007
Extensive WHO/UNAIDS Regional Consultations inAfrica, Latin America, Asia, Eastern Europe in
2005-2007
To review ethical principles and guiding documents
To map out scenarios from practical field situations facing challenges in determining what care and treatment to provide
To develop a process for formulating care and treatment plans in vaccine trials
To identify potential solutions for improved care and treatment plans
Position paper has been published in Vaccines journal 2007
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Inclusion of Women and Adolescents in HIV Vaccine trials:
Reports published in AIDS journal in 2005 and 2007
Inclusion of Women and Adolescents in HIV Vaccine trials:
Reports published in AIDS journal in 2005 and 2007
More than 95% of cases in developing countries
More than 50% of cases among young people of 15-24 years
More than 40% of cases among women
Up to 10% of cases among children younger than 15 years
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WHO/AAVP Consultation on:“Inclusion of Adolescents in HIV Vaccine Trials”
16 - 18 March, 2006, Gaborone, Botswana
WHO/AAVP Consultation on:“Inclusion of Adolescents in HIV Vaccine Trials”
16 - 18 March, 2006, Gaborone, Botswana
Recommendations:
- Product development: safety, immunogenicity, duration of immunity, routes of administration, etc.
- Legal, Regulatory and Ethical: e.g., definition of age of consent, confidentiality, "statuary rape"
- Clinical trial design and trial endpoints: e.g., HIV infection in younger adolescents
- Community acceptance and participation
Report accepted for publication in AIDS journal 2007
WHO-UNAIDS HIV Vaccine Initiative 11
Regulatory Challenges and Related PoliciesRegulatory Challenges and Related Policies
- Production of candidate vaccines for clinical trials (GMP)
- Immunogenicity and potency measurement
- Safety monitoring
- Effective mechanisms for regulatory/ethical review, approval and oversight of clinical trials
- Understanding of novel efficacy trials concepts and their potential for licensing and the development of immunization strategies:
- Phase IIB-TOC trials (WHO/UNAIDS/IAVI Consensus meeting)
- Definition of HIV Vaccine Efficacy (WHO/UNAIDS/Enterprise Consultation is planned on 5-6 Sept.07 in Paris)
WHO-UNAIDS HIV Vaccine Initiative 12
UNAIDS/WHO/IAVI Consensus MeetingNew York, Jan 31-Feb 2, 2006
UNAIDS/WHO/IAVI Consensus MeetingNew York, Jan 31-Feb 2, 2006
Discuss issues related to the definition of intermediate phase of IIB-Test of Concept (IIB-TOC) trials and their position in the overall pathway of HIV vaccine R&D.
Make recommendations for: – situations where such trials could be of the greatest (or
the least) utility;– Issues related to preparation for, and conduct of IIB-TOC
trials, particularly with respect to conveying the correct messages to governments, national regulatory authorities, communities and participants;
– implications for product development, manufacturing, and potential licensing
Report has been published in AIDS journal Nov 2006
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Strategic elements to create favorable environment in support of HIV vaccines trials in developing countries
Strategic elements to create favorable environment in support of HIV vaccines trials in developing countries
Availability of cohorts Availability of cohorts Social behaviour expertiseSocial behaviour expertise
Government Government willingness willingness
& commitment & commitment
Epidemiology Epidemiology Virus MonitoringVirus Monitoring
Community Community involvementinvolvement
Public (media) attentionPublic (media) attention
Regulatory & Regulatory & Ethical Ethical
FrameworksFrameworksScientific Scientific
infrastructureinfrastructure
Clinical trial and Clinical trial and Laboratory expertiseLaboratory expertise
Data managementData management
National National CapacityCapacity Building Building
--
National National CapacityCapacity Building Building
--
InternationInternational al
collaboraticollaboration on
InternationInternational al
collaboraticollaboration on
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National AIDS Vaccine Plans and Strategies National AIDS Vaccine Plans and Strategies
Initiated in 1992 in Brazil, Thailand and Uganda.
Continued in several other countries.
Facilitate trials by describing policies, approval mechanisms, research priorities
A framework for coordinated plan of capacity building and site development
Brazil: Second generation (2000)
WHO-UNAIDS HIV Vaccine Initiative 15
New Generation of National AIDS Vaccine Plans/Strategies
TECHNICAL COMPONENTS
Virology EpidemiologySocio/
behaviouralClinical
trialsMedia/
PR Etc
NORMATIVE FRAMEWORKPolitical Legal Regulatory LogisticalEthical
SUPPORTING ENVIRONMENT Community
supportHIV/AIDSPrevention
Access to care, incl. ART
Infrastructure/human resources
Etc
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The African AIDS Vaccine Programme (AAVP) was launched in 2000
The African AIDS Vaccine Programme (AAVP) was launched in 2000
The AAVP is a network of African scientists and community, working together to promote and facilitate HIV vaccine research and evaluation in Africa, through capacity-building and regional and international collaboration (“the voice of Africa”).
Activities being developed and implemented through six thematic working groups:– Advocacy, information and resource mobilization.– Biomedical sciences (laboratory and clinical).– Population studies (Epidemiology and Socio-Behavioural issues).– Ethics, Law and Human Rights.– National Strategic Planning.– Community
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50 volunteers1 country
20002000
400 volunteers8 countries15 trial sites
> 4 000 volunteers? 12 countries
20062006
Increasing participation of African countries in Increasing participation of African countries in HIV vaccine trialsHIV vaccine trials
20082008
>10 000 volunteers
20120100
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Opportunities and Challenges for Global Networking and Policy Development in Support of HIV Vaccine R&D
Opportunities and Challenges for Global Networking and Policy Development in Support of HIV Vaccine R&D
Unity of Mission and Shared Vision:– Development of safe, globally effective and affordable for all
countries in the region– Balanced focus on all aspects vaccine R&D and clinical trials,
ensuring the highest scientific, ethical and regulatory standards
The Key Challenges:– Coordinate and promote regional and global collaboration in
alignment with the global HIV vaccine agenda (e.g., HIV Vaccine Enterprise)
– Optimize - capacity building & site development– Develop unified clinical trial platforms on global and regional basis– Careful assessment, development and harmonization of sensitive
policies based on extensive consultation with all stakeholders– Actively involve communities, create/maintain and support favourable
environment in support of vaccine trials