Vaccines

Speeches Shim

 HIV researchers from  KAVI-Institute of Clinical Research  examine serum samples
HIV researchers from KAVI-Institute of Clinical Research examine serum samples
Credit: Mark Muinde

Overview

HIV and AIDS continue to impose a global burden, especially in developing countries. Viral infectious diseases are most effectively controlled – some even eradicated – through prevention programs that include a vaccine. The U.S. Agency for International Development (USAID) recognizes that a vaccine is the ultimate tool to control the epidemic and has supported research and development (R&D) programming for a safe and globally-effective HIV vaccine for more than two decades.

Currently, USAID invests in new biomedical tools to control and ultimately end this pandemic, knowing it will require carefully combined behavioral and biomedical strategies to prevent HIV. USAID places special emphasis on the importance of supporting scientific capacity-strengthening efforts in countries and communities hardest hit by the ongoing epidemic. Therefore, at the core of USAID’s efforts is the intention to shift the scientific and programmatic direction into the hands of in-country scientists and clinicians who remain committed to alleviating the burdens of HIV in their own communities. Through two cooperative agreements, USAID investments support carefully combined behavioral and biomedical strategies that are needed to prevent HIV.

USAID Impact

First volunteer enrolled in Protocol W001 receives 1st vaccination
First volunteer enrolled in Protocol W001 receives 1st vaccination
Credit: KAVI-ICR, University of Nairobi

USAID currently funds vaccine R&D efforts through two complementary Cooperative Agreements under the HIV Vaccine and Biomedical Prevention Research Project (HVBP). The two agreements support unique activities that aim to accelerate vaccine R&D while enhancing the capacity of African scientists and engaging affected communities through strategic partnerships.

  • ADVANCE: Accelerate the Development of Vaccines and New Technologies to Combat the AIDS Epidemic is led by the International AIDS Vaccine Initiative (IAVI) and focuses on conducting preclinical and clinical HIV vaccine research and development. The program seeks to build the capacity of African and Indian scientific talent and institutions, implemented in partnership with clinical research centers in Kenya, Rwanda, South Africa, Uganda, Zambia and India, which are uniquely positioned to engage in local vaccine development and optimizing new partnerships.
  • CASPR: Coalition to Accelerate & Support Prevention Research is led by AVAC in collaboration with key partners and is focused on advocacy for HIV biomedical interventions in the pipeline from research to rollout. CASPR, an Africa-centered prevention research movement, is composed of experienced organizations that support advocacy, research literacy, policy, communications, community engagement, and regulatory activities for biomedical HIV prevention R&D globally.

Recent Contributions to Vaccine R&D through USAID Partnerships

  • Through ADVANCE, IAVI released and awarded a major Investigator Initiated Research (IIR) to fund early-career African and Indian scientists
    • In line with USAID’s focus on strengthening scientific capacity in Africa, the LDR program will position African and Indian scientists to take the lead in designing, driving, and supporting the scientific research enterprise. The new initiative offers opportunities for early and mid-career scientists to develop their expertise to become the next generation of scientific leaders in their respective fields. The kick-off seminar series featured lectures and interactive sessions by experts in social behavioral research, clinical trials, crafting meaningful research questions, community engagement, and scientific leadership. The first cohort comprises 30 participants from African and Indian Clinical Research Centers (CRCs), who range from laboratory scientists to clinical trials specialists.

  • Through ADVANCE, IAVI developed IAVI DataSpace, an accessible, fully-enabled platform
    • IAVI and its partners developed and implemented a cloud-based data warehouse, which is a secure, sustainable and scalable tool to support the work of the Africa-led research consortium, with clinical research centers in Zambia, South Africa, Kenya, Rwanda, Uganda, and India. The IAVI DataSpace currently provides access to data from Protocol C and Protocol G, with other protocol data currently in development. Created to promote Africa-based science and enable outcomes-driven research, the IAVI DataSpace can accommodate novel data while maximizing its impact. An effective vaccine must teach the immune system how to create a protective defense against HIV; using the data from these Acute HIV Infection (AHI) cohorts helps scientists understand how HIV evolves in the human host, providing critical information for vaccine design. Planned activities are underway to add the rich ADVANCE epidemiology, observational and clinical data and offer it to the broader field.
  • USAID supported IAVI and Scripps Research, to begin a Phase 1 study of eOD-GT8 60mer mRNA after confirming this novel HIV vaccine approach in the first in-human clinical trial
    • After seeing promising results in the IAVI G001 trial, USAID is providing support to IAVI G003, “A Phase 1 Study to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer mRNA V-human Vaccine (mRNA-1644) in HIV-1 Uninfected Adults in Good General Health.” The trial combines the germline targeting approach with an mRNA platform developed by the trial partner, Moderna. The mRNA technology allows for faster and more cost effective manufacturing than previous trials, which utilized protein-based immunogens that can be costly and time consuming to manufacture. The G003 trial will provide an opportunity to expand B-cell assay capacity at African partner CRCs. G003 trial outcomes will employ B-cell sorting and B-cell receptor (BCR) sequencing at multiple timepoints after vaccination, followed by surface plasmon resonance (SPR) testing of induced BCRs. Some of these techniques will be transferred to African partners to analyze trial samples and contribute to the data. G003 will form the basis of subsequent prime boost studies informed by results of subsequent parts of the IAVI G002 trial.
  • USAID provides a prominent South African partner with enhanced capacity to sequence emerging COVID-19 variants
    • In response to an inquiry from The National Institute for Communicable Disease to procure an instrument to enable rapid and accurate viral genomic surveillance to track and respond to the circulating variants of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), through PEPFAR, the USAID Office of HIV/AIDS and USAID’s regional South Africa office, co-funded a sequencing system. The instrument was procured to enable high-throughput, whole-genome sequencing for a broad range of pathogens, including SARS-CoV- 2, HIV, and Mycobacterium tuberculosis.
  • USAID’s HIV vaccine R&D informs COVID-19 vaccine efforts
    • Thanks to a global effort, unprecedented sharing of resources, and the benefit of decades of prior biomedical research in the HIV vaccine field, scientists were able to develop vaccines for COVID-19 in record time. Much of the technology and speed that enabled the rapid development of these life-saving vaccines against SARS-CoV-2 borrowed from the stalwart search for a safe and effective vaccine to prevent HIV/AIDS, which still annually infects over 1.7 million people worldwide and places a particular hardship on developing countries.
  • CASPR advocates help shape complex, next-generation prevention trials.
    • Global advocates came together in 2019 to review the technical concepts underlying next-generation prevention trials and the decision-points where advocates can and should weigh in. This group – known as the Trial Design Academy – has since participated in consultations with product developers around the design of upcoming trials. Advocates’ consultations led by CASPR partners helped to ensure advocate and community perspectives guide plans for the upcoming trials of islatravir, emtricitabine and tenofovir alafenamide (F/TAF), and lenacapavir.
  • CASPR expands its geographic footprint and training opportunities
    • As part of the coalition’s efforts to continue to shift leadership to Africa, CASPR expanded its geographic footprint and expertise by adding three new partner organizations to the consortium: UNASO in Uganda, TALC in Zambia, and PZAT in Zimbabwe. Along with growing the advocacy network, CASPR also expanded its offering of training opportunities, including IAVI’s budget advocacy trainings for civil society organizations s in Uganda and South Africa to increase domestic resource mobilization efforts, scale-up good participatory practice (GPP) online training to further institutionalized GPP within the PrEPVacctrial, and continue focus on women’s prevention issues through a variety of new workshops, trainings and webinars.
  • CASPR coalition engages in research translation efforts to help advocates understand the latest clinical trial results
    • USAID funded CASPR to play a critical role in ensuring the complex results of the clinical trials, HPTN083 and 084,were widely understood by advocates, and that the priorities of advocates informed the next steps. In the wake of the 083 results, CASPR advocated for comprehensive regulatory planning, and following the 084 results, have continued to push for accelerated introduction and equitable access as the coalition expands its work in this area. CASPR also ensured stakeholder engagement mechanisms were established, and disseminated valuable materials that explained the trial design and result data.

Additional Resources

Last updated: May 17, 2022

Share This Page