The Neo bnAb study is evaluating whether emerging ‘broadly neutralising antibody’ approaches can protect newborns against HIV infection.

Using antibodies to prevent HIV transmission to babies

Despite much progress in reducing mother-to-child transmission of HIV – more than 1.4 million infections have been averted since 2010 – 180,000 infants acquired HIV in 2017. With current approaches, global elimination goals are unlikely to be achieved.

Broadly neutralising antibodies are an exciting new option in HIV control. On very rare occasions, people generate antibodies to HIV that recognise multiple HIV strains. Mass production of these antibodies could provide a new weapon in the anti-HIV armoury.

The challenge

Most studies on broadly neutralising antibodies to date have focused on adults. The Neo bnAb will explore their potential use in newborns to prevent mother-to-child transmission.

The study is focused on one specific broadly neutralising antibody known as VRC01. Minor modifications have created a slightly different version, VRC01LS, that survives longer in the bloodstream, so could potentially provide protection for longer periods and require less frequent administration. Initial studies have shown that VRC01LS is safe to give to newborns.

The Neo bnAb trial will compare standard approaches used to prevent mother-to-child transmission with an enhanced programme in which babies also receive four doses of VRC01LS – at birth and at 12, 24 and 36 weeks. A total of 2,000 babies will be studied in two countries. As well as gathering data on efficacy, the study will also analyse cases of infection to determine how HIV evaded antibody protection, to inform the design of preventive antibody strategies.

The project

The Neo bnAb study will provide proof-of-concept evidence on the safety and efficacy of broadly neutralising antibody use for HIV prevention in newborns. It will also examine the operational feasibility and affordability of the intervention in the African context. Evidence of the effectiveness of broadly neutralising antibody could offer a novel way to prevent mother-to-child transmission of HIV and achieve global elimination targets.

Impact


crucial in

widening African

children’s access

to antiretrovirals

Bringing antiretroviral drugs to children

The CHAPAS trials have ensured that many more children with HIV have benefited
from life-saving antiretrovirals.

EDCTP portfolio: HIV & HIV-associated infections

The challenge

Despite much progress in reducing mother-to-child transmission of HIV – more than 1.4 million infections have been averted since 2010 – 180,000 infants acquired HIV in 2017. With current approaches, global elimination goals are unlikely to be achieved.

Broadly neutralising antibodies are an exciting new option in HIV control. On very rare occasions, people generate antibodies to HIV that recognise multiple HIV strains. Mass production of these antibodies could provide a new weapon in the anti-HIV armoury.

Most studies on broadly neutralising antibodies to date have focused on adults. The Neo bnAb will explore their potential use in newborns to prevent mother-to-child transmission.

The study is focused on one specific broadly neutralising antibody known as VRC01. Minor modifications have created a slightly different version, VRC01LS, that survives longer in the bloodstream, so could potentially provide protection for longer periods and require less frequent administration. Initial studies have shown that VRC01LS is safe to give to newborns.

The Neo bnAb trial will compare standard approaches used to prevent mother-to-child transmission with an enhanced programme in which babies also receive four doses of VRC01LS – at birth and at 12, 24 and 36 weeks. A total of 2,000 babies will be studied in two countries. As well as gathering data on efficacy, the study will also analyse cases of infection to determine how HIV evaded antibody protection, to inform the design of preventive antibody strategies.

The project

The later CHAPAS-3 trial compared the efficacy and safety of three fixed-dose combinations including two without stavudine (found to have some long-term side effects in adults, leading to a recommendation that its use be discontinued in children). The trial the first of its kind in Africa studied nearly 500 children at four sites in two African countries.

The Neo bnAb study will provide proof-of-concept evidence on the safety and efficacy of broadly neutralising antibody use for HIV prevention in newborns. It will also examine the operational feasibility and affordability of the intervention in the African context. Evidence of the effectiveness of broadly neutralising antibody could offer a novel way to prevent mother-to-child transmission of HIV and achieve global elimination targets.

ratios forfixed-dose combinations and on appropriatedosage according to weight. 

The CHAPAS-3 trial confirmed the effectiveness of fixed-dose combinations, providing further impetus to the rollout of antiretrovirals to children. Its evidence on abacavir informed the WHO recommendation of abacavir-containing combinations for first-line therapy in children. Trial data have also been used to support applications for regulatory approval for new scored efavirenz tablets.

Impact

Projects: CAPRISA 018 study

Project lead: Professor Salim Abdool Karim, Centre for the AIDS Programme of Research in South Africa, South Africa

Countries involvedFrance, The Netherlands, South Africa

Target population(s): Women

Year funded: 2017

EDCTP funding: €9.8 M

Total project funding: €11.4M plus donation of study drugs

About us

The European & Developing Countries Clinical Trials Partnership (EDCTP) is a public–public partnership between 14 European and 16 African countries, supported by the European Union. EDCTP’s vision is to reduce the individual, social and economic burden of poverty-related infectious diseases by affecting sub-Saharan Africa. EDCTP’s mission is to accelerate the development of new or improved medicinal products for the identification, treatment and prevention of infectious diseases, including emerging and re-emerging diseases, through pre- and postregistration clinical studies, with emphasis on phase II and III clinical trials. Our approach integrates conduct of research with development of African clinical research capacity and networking. The second EDCTP programme is implemented by the EDCTP Association supported under Horizon 2020, the European Union’s Framework Programme for Research and Innovation.

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