Introduction

Founded in 2001 and located within the Chelsea and Westminster Hospital, the IAVI Human Immunology Laboratory (HIL) serves as the clinical immunology hub for the International AIDS Vaccine Initiative’s vaccine development partnerships. Led by Professor Stephen Baker, the HIL holds an HTA licence allowing for the collection and storage of clinical samples using industry-standard Laboratory Information Management Systems (LIMS) to manage samples from collection to storage and use for immune-testing.

The HIL performs immunology testing using standardised validated assays across multiple clinical research centres in a GCLP environment to measure the capacity of different vaccine candidates to elicit immune responses aimed at protecting against infectious diseases. Work performed at the HIL is essential to ensuring the quality and consistency of data collected in clinical trials conducted with IAVI’s support, permitting the comparison of biologic candidates evaluated in different places and at different times. This capability is critical to making swift and scientifically informed decisions about whether or not to pursue the development of any biologic candidate.

Collaboration between the HIL and IAVI’s network of clinical research partners has led to the establishment of state-of-the-art research laboratories in Africa. All labs involved in clinical trial assays hold a Good Clinical Laboratory Practices accreditation, an internationally recognised badge of quality.

Current projects

The  ADVANCE programme, funded by the International AIDS Vaccine Initiative, is a five-year cooperative agreement to further the progress of HIV research in the region. ADVANCE’s goal is to cultivate a core group of researchers and scientists in Africa, enabling their centers and institutions to play a critical role in the global effort to identify, evaluate, and implement a vaccine for HIV. IAVI’s role in this process includes providing support for their research and technical assistance in the implementation of clinical trials; helping build capacity in new technology transfer; and ensuring engagement for new partners on the pathway to an efficacious HIV vaccine.

The PATH Malaria Vaccine Initiative (MVI) is an initiative of PATH whose mission is to accelerate the develoment of promising malaria vaccine candidates and ensure their availability and accessibility for the developing world. The role of the IAVI Human Immunology Laboratory is to develop and validate immunological assays and to serve as a reference laboratory for analysing cellular and humoral immune responses to malaria vaccine candidates.

European HIV Alliance (EHVA), a five year project funded by the European Union’s Horizon 2020 Research and Innovation Programme, is designed to foster the development of an effective vaccine. The EHVA encompasses 39 partners, each with the expertise to promote a comprehensive approach to the development of an effective HIV vaccine. The international alliance, which includes academic and industrial research partners from all over Europe, as well as sub-Saharan Africa and North America, will work to discover and progress novel vaccine candidates through the clinic. This program has as major goal to develop a Multidisciplinary Vaccine Platform (MVP) in the fields of prophylactic and therapeutic HIV vaccines. EHVA will also contribute to the field of HIV vaccines with a portfolio of highly-promising vaccine candidates that will be optimised and tested via the EHVA platform so as to be moved into larger clinical trials through EDCTP.

The European AIDS Vaccine Initiative (EAVI2020),  funded under H2020 by the EU, brings together leading HIV researchers from public organisations and biotech companies from across Europe, Australia, Canada and the USA in a focused effort to develop protective and therapeutic HIV vaccines. Led by Imperial College London, the EAVI2020 consortium unites scientists from 23 institutions, pooling their knowledge and expertise to develop novel candidate vaccines that can be taken through to human trials within five years.

Globally Relevant AIDS Vaccine Europe-Africa Trials Partnership (GREAT) is a research collaboration to develop an innovative AIDS vaccine that addresses the broad variability of HIV and would be suitable for use around the world. The core work of this proposal is to test the safety and immunogenicity of promising candidate preventive HIV-1 vaccines in a phase IIa clinical trial in vulnerable populations in Africa and to ensure that partner African Clinical Research Centres (CRCs) have the requisite capacity in place to advance these vaccines into phase IIb efficacy trials. GREAT is supported by the European and Developing Countries Clinical Trials Partnership (EDCTP), with co-funding from IAVI and Oxford University, and builds on extensive research expertise and infrastructure, as well as successful community engagement programs, at KAVI, KWTRP, UVRI and ZEHRP. In parallel to the trials, GREAT will support a range of projects at IAVI-partner CRCs to prepare them for participation in future large-scale vaccine efficacy trials.

PrEPVacc is a  combination HIV vaccine + pre-exposure prophylaxis (PrEP) phase IIb study using an innovative adaptive trial design. PrEPVacc is exploiting >20 years of European HIV research to demonstrate the efficacy of two regimens of experimental DNA, MVA and Env protein/adjuvant vaccines. All these PrEPVacc GMP vaccine products have already been studied in Europe and Africa in >600 volunteers, and are safe and immunogenic. This proposal is based on prior FP5, FP7, H2020 and EDCTP-1 programmes and will leverage substantial co-funding support from IAVI, CAVD, UK MRC, Wellcome Trust and Gilead. PrEPVacc represents a consortium of highly experienced African investigators, with access to high-risk populations and accredited laboratories in Uganda, Tanzania, Mozambique and South Africa, together with broad research capacity building. The adaptive trial design is novel in the HIV vaccine field and shall generate data on HIV vaccine efficacy and investigate correlates of protection, address adherence and attitudes to PrEP and its impact on HIV vaccine trials.