Global HIV Vaccine Enterprise

Date: 23 July 2023
Location: Brisbane Convention and Exhibition Centre

The satellite provides insights into the acceptability of various prevention products among specific vulnerable population groups across East Africa and India. It also highlights the need to bring together different stakeholders, in addition to the end-users, early on at the time of clinical development planning. The essence of technological advancements and health system delivery lessons in the post-COVID era, which may serve as useful leads for future product planning, will be discussed, which will help guide product developers in defining the unique value proposition for upcoming prevention interventions, account for specific importance to critical product attributes and identify effective communication channels and delivery strategies. It will also help funders to direct investments in areas where they are needed. Most importantly, the session re-emphasizes the need to have community voices and user choices at the heart of product development.

Chairs:

• Jean-Daniel Lelievre, IAS
• Ethel Makila, IAVI

Speakers and Panellists:

• Yvonne Wangui Machira, IAVI, Kenya
• Venkatesan Chakrapani, C-SHaRP, India
• Joyeeta Mukherjee, IAVI, India
• Saif ul Hadi, IAVI, India
• Francis Meyo, Busara Centre for Behavioral Economics, Kenya

Materials:

• Session recording

Date: 23 July 2023
Location: Brisbane Convention and Exhibition Centre

Antiretroviral therapy for pregnant and lactating people living with HIV and antiretroviral therapy (ARV) prophylaxis for their infants have together resulted in dramatic decreases in peri- and post-natal HIV transmission. Still, an estimated 160,000 HIV infections in infants and young children occurred in 2021. Gaps in prevention strategies, especially during the breastfeeding period when roughly 50% of perinatal transmission occurs, have left infants vulnerable. As a discreet, safe, and long-acting intervention, broadly neutralising antibodies (bNAbs) hold promise to contribute to closing the gaps in current strategies and reduce peri- and post-natal HIV transmission as an adjunct to, or in the place of, ARVs— supporting the elimination agenda. Importantly, because the doses required are significantly lower than adult doses, infant prophylaxis with bNAbs is likely cost-effective across a range of implementation scenarios in sub-Saharan Africa. In February 2023, 70 global experts convened in Cape Town, South Africa to reach a consensus and define an action plan for advancing bNAbs for peri- and post-natal prophylaxis. Join the IAS Global HIV Vaccine Enterprise and IAVI at this session to launch the takeaways from these proceedings.

Chair:

• Linda-Gail Bekker, Desmond Tutu Health Foundation, South Africa

Panel Chair:

• Shelly Malhotra, Executive Director, Global Access, IAVI, US

Speakers:

• Enele Mantombazane, Community Working Group, Chatsworth, South Africa
• Betsy McFarland, University of Colorado, USA
• Vincent Muturi-Kioi, IAVI, Kenya

Panellists:

• Glenda Gray, South African Medical Research Council (SAMRC), South Africa
• Paul Ndebele, George Washington University, USA
• Enele Mantombazane, Community Working Group, Chatsworth, South Africa
• Vincent Muturi-Kioi, IAVI, Kenya
• Priscilla Nyambayo, Zimbabwe Medicines Control Agency, Zimbabwe
• Betsy McFarland, University of Colorado, USA

Materials:

• Session recording

Date: 25 July 2023
Location: Brisbane Convention and Exhibition Centre

With recent HIV vaccine efficacy trials showing no efficacy, the difficulties in developing a vaccine have been highlighted, leading to an opportunity to rethink future trials and research directions. While different strategies are underway, an important point of reflection is the definition of target populations. Indeed, clinical trials of HIV vaccination are almost exclusively carried out in adult populations. However, data from other vaccine trials highlights that the effectiveness of vaccination could be much higher in younger populations. Monitoring data from populations of children living with HIV show that neutralization breadth and potency are higher in children living with HIV than in adults living with HIV. In children living with HIV in these studies, the functions mediated by the constant fragment (Fc) fraction of antibodies are also more effective than in adults. Furthermore, experiments performed in non-human primates (NHP) models indicate that younger animals respond better to vaccination suggesting that younger subjects may be the optimal target for future HIV vaccination. Join the IAS Global HIV Vaccine Enterprise (GHVE) in this satellite to describe i) recent data on HIV immune response in young children (cohort study) ii) results of vaccination strategies for young individuals in the NHP model iii) available data on ongoing HIV vaccination trials in children but also to discuss the ethical and regulatory challenges of including children in clinical trials with a focus on discovery medicine and the future acceptance of vaccination in children. This session is addressed at the pharmaceutical industry, academic researchers, community representatives, advocacy organizations, funders, policymakers, and regulatory authorities.

Chair:

• Glenda Gray, South African Medical Research Council (SAMRC), South Africa

Co-Chair:

• Jean-Daniel Lelièvre, Global HIV Vaccine Enterprise-IAS, Switzerland

Speakers:

• Sallie Permar, NY-Presbyterian/Weill Cornell Medical Center, USA
• Kristina De Paris, UNC School of Medicine, USA
• Ofer Levy, Harvard Medical School, USA
• Deirdre Josipovic, Perinatal HIV Research Unit (PHRU) University of the Witwatersrand, South Africa
• Ansuya Naidoo, IAVI, South Africa

Panellists

• Paul Ruff, South African Health Products Regulatory Authority Clinical Trials Committee, South Africa
• Ntando Yola, Desmond Tutu Health Foundation, HPTN, APHA, South Africa
• Laura Guay, Elizabeth Glaser Paediatric AIDS Foundation, Switzerland
• Ansuya Naidoo, IAVI, South Africa
• Deirdre Josipovic, Perinatal HIV Research Unit (PHRU) University of the Witwatersrand, South Africa

Materials:

• Session recording

Consistent with its strategic objectives, the Enterprise is convening HIV vaccine R&D stakeholders with the aim to build a consensus on efficient ways to prioritize and advance vaccine product development that encompasses design, clinical testing, and funding to accelerate the development of an HIV vaccine.

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A three-part event to engage scientists, clinicians, industry, funders and community representatives on experimental medicine to progress HIV vaccine development efforts.

• Webinar 01 - What is Experimental Medicine and what are the key challenges? (January 2022)

• Webinar 02 - Experimental Medicine trials for HIV vaccine research (February 2022)

• Webinar 03 - Building regulatory and ethics expertise for Experimental Medicine (September 2022)

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This two-part webinar series will highlight the key aspects related to the ethics of engaging adolescent girls and young women in HIV prevention research and sexual and reproductive health programming, and leverage insights from social and behavioural research to inform future design of engagement strategies for this group.

• Webinar 01 - Engaging Adolescent Girls and Young Women (AGYW) in HIV prevention research (August 2022)

• Webinar 02 - Better understanding the needs of adolescent women and young girls in HIV prevention research design (September 2022)

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This series of virtual workshops aims to continue from the first HIV Prevention Efficacy Trial Designs of the Future symposium, which was held in Seattle by the Fred Hutch and the NIAID in November 2018.

Participants will reflect on more recent advances and challenges within the HIV prevention field and on the rationale and lessons learnt for current HIV prevention designs. They will examine novel scientific approaches for establishing efficacy of new biologics in a future where all trial participants have access to effective prevention.

• Session 01 - Current efficacy trial design approaches – challenges and lessons learned (October 2020)

• Session 02 - Future efficacy trial design approaches (November 2020)

• Session 03 - Future efficacy trial design approaches (May 2021)

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This webinar organized in partnership with IAVI will discuss challenges and opportunities in access to future monoclonal antibodies for HIV prevention.

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