1 GROUPWORK (2) Most impactful next steps for adolescent trials: HIV vaccines Consultation on ethical-legal complexities in adolescent HIV vaccine & microbicide trials: Durban, South Africa 6 September 2007

2 Most impactful next steps for vaccine trials in adolescents Science: We need a summary/fact sheet of anticipated differences in safety and efficacy of HIV vaccine candidates in adults versus adolescents that stakeholders can use to explain the scientific justification to their constituencies –E.g. No evidence for differences in vaccine safety between adolescents and adults –E.g. Certain vaccines may be effective at adolescents when given at lower doses or fewer doses compared to adults (ex. Hepatitis B) – reference NIAID White Paper –Mary Allen + Craig Wilson to develop – out to broader group

3 Most impactful next steps for vaccine trials in adolescents Community participation: We need better community involvement –Community education: Better materials for CABs + community representatives and media groups –Develop innovative approaches to sharing information (e.g., participatory, interactive methodologies for community participation and education) –Use and adapt existing resources Materials developed in Haiti—a booklet Training manuals for adults could be modified for adolescents AVAC, IAVI and Masikulisane CPP to assist with the development of materials for key stakeholder groups

4 Most impactful next steps for vaccine trials in adolescents Risks: We need to address the risk of vaccine-induced antibody response in adolescents –Devise ways to reassure communities and IRBs (e.g. data) –Compile + share best practices –Consider provision of long-term confirmatory testing? NIAID does this, but do other entities? IAVI does long-term follow-up, but it’s not mandatory SAAVI has a plan for life insurance issues Develop an in-country procedure/ plan for long-term issues, such as HIV testing that occurs in the context of: –Life insurance –Immigration purposes –Military –Employment –Need in-country, governmental support or WHO involvement or some central government office to ensure that after sites have been closed, people still have access to confirmatory testing

5 Most impactful next steps for vaccine trials in adolescents Risks cont’d: –We must address risk of social harms like stigma, impact on school attendance Get data E.g. VAXgen phase III study HVTN data on social impact  trends towards younger participants reporting more events But could be b/c adolescents share more information about their research participation, or they’re more sensitive to social stigma Mary Allen to take forward (Nicole has data on this) –We must address the potential risk of “disinhibition” Get data Clarify changes in individual behavior and group behavior Craig Wilson is going to create a memo + look for a position paper that may help Safety data and duration of protection in adolescents

6 Most impactful next steps for vaccine trials in adolescents Consent: We need to address key consent issues: –Better consent counselling to address adolescent-specific and cultural issues –Better assessment of understanding –See available resources: E.g. Standardized package of information + resources for assessment of understanding (HVTN 075—modified consent form to develop adolescent assent form that was much more adolescent-friendly); HPTN 035 open- ended assessment of understanding –HAVEG to co-ordinate We need to work further on disclosure and privacy –Is there a way to meet mandatory reporting requirements without sacrificing adolescents’ trust? –-Delineating what to report and what not to

7 Most impactful next steps for vaccine trials in adolescents Review: Better engagement between researchers and regulators

8 Some best practices Heightened response to vaccine-induced seropositivity or presence of antibodies –SAAVI’s approach to life insurance testing Greater community involvement/education Counseling re: risk reduction –Adolescent education to prevent behavioral change based on misunderstandings about protective effect of experimental vaccine