Imperial College London
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DrSarahJoseph

Faculty of Medicine, Department of Infectious Disease

Clinical Immunologist
 
 
 
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Contact

 

s.joseph

 
 
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Location

 

457Medical SchoolSt Mary's Campus

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Summary

 

Publications

Citation

BibTex format

@article{Joseph:2019:10.1136/bmjgh-2019-edc.23,
author = {Joseph, S and Kaleebu, P and Ruzagira, E and Hansen, CH and Seeley, J and Basajja, V and Weber, J and Fox, J and Kingsley, C and Aboud, S and Lyamuya, E and Maganga, L and Pamba, D and Ramjee, G and Yssel, J and Viegas, E and Jani, I and Priddy, F and Nilsson, C and Kroidl, A and Pantaleo, G and Robb, M and Crook, A and Dunne, D and Mccormack, S},
doi = {10.1136/bmjgh-2019-edc.23},
journal = {BMJ Global Health},
pages = {A10.1--A10},
title = {OC 8491PREPVACC: A PHASE III, MAMS ADAPTIVE PROPHYLACTIC HIV VACCINE TRIAL WITH A SECOND RANDOMISATION TO COMPARE F/TAF WITH TDF/FTC PREP},
url = {http://dx.doi.org/10.1136/bmjgh-2019-edc.23},
volume = {4},
year = {2019}
}
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RIS format (EndNote, RefMan)

TY  - JOUR
AB  - <jats:sec><jats:title>Background</jats:title><jats:p>There remains an urgent need for a prophylactic HIV vaccine to control generalised epidemics. PrEP has demonstrated effectiveness of 86% and is recommended by WHO; uptake is generally high, but retention is disappointing in some settings. The EDCTP2 project PrEPVacc will assess the efficacy of two combination prophylactic vaccine regimens (DNA, MVA and Env protein/adjuvant) each compared to placebo and the proportion of infections averted by F/TAF in comparison to TDF/FTC. A Registration Cohort, recruiting HIV negative volunteers at risk of HIV will precede the trial.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>The PrEPVacc partnership agreed that 70% vaccine efficacy had public health relevance. The trial uses <jats:italic>nstage</jats:italic> software for multi-arm, multi-stage designs (MAMS) and the averted infections ratio (AIR) methodology with participants randomised (i) 1:1:1 to active product or placebo (ii) 1:1 to TDF/FTC : F/TAF until week 26 (presumed peak immunogenicity). Access to PrEP in the Registration Cohort and after week 26 will be standard of care. HIV seroconversions occurring between weeks 0–26 will inform the PrEP analysis, incorporating HIV incidence amongst those who do not take up PrEP locally in the Registration Cohort. Seroconversions after week 26 will inform vaccine analyses.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Up to 556 participants per group affords 92% power to detect vaccine efficacy of 70% at the final analysis, assuming incidence of 4/100-person years and 10% loss with 81% and 97% power to conclude that F/TAF can avert half or more of the infections prevented by TDF/FTC if effectiveness of TDF/FTC is 70% and 80%, respectively.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats
AU  - Joseph,S
AU  - Kaleebu,P
AU  - Ruzagira,E
AU  - Hansen,CH
AU  - Seeley,J
AU  - Basajja,V
AU  - Weber,J
AU  - Fox,J
AU  - Kingsley,C
AU  - Aboud,S
AU  - Lyamuya,E
AU  - Maganga,L
AU  - Pamba,D
AU  - Ramjee,G
AU  - Yssel,J
AU  - Viegas,E
AU  - Jani,I
AU  - Priddy,F
AU  - Nilsson,C
AU  - Kroidl,A
AU  - Pantaleo,G
AU  - Robb,M
AU  - Crook,A
AU  - Dunne,D
AU  - Mccormack,S
DO  - 10.1136/bmjgh-2019-edc.23
EP  - 1
PY  - 2019///
SP  - 10
TI  - OC 8491PREPVACC: A PHASE III, MAMS ADAPTIVE PROPHYLACTIC HIV VACCINE TRIAL WITH A SECOND RANDOMISATION TO COMPARE F/TAF WITH TDF/FTC PREP
T2  - BMJ Global Health
UR  - http://dx.doi.org/10.1136/bmjgh-2019-edc.23
VL  - 4
ER  -
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