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Be Part of Research - Trial Details - Phase 2a Respiratory Syncytial Virus (RSV) Human Challenge Study of Clesrovimab (MK-1654) in Healthy Participants (MK-1654-005)
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Phase 2a Respiratory Syncytial Virus (RSV) Human Challenge Study of Clesrovimab (MK-1654) in Healthy Participants (MK-1654-005)

Completed

Open to: ALL

Age: 18.0 - 55.0

London

Medical Conditions

Virus Diseases

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The primary objective of this study is to determine if a single intravenous (IV) dose of clesrovimab when administered at 1 of 4 dose levels results in a reduction in viral load after intranasal inoculation (with RSV A Memphis 37b) compared to IV placebo. It is hypothesized that at least 1 of the 4 dose levels of clesrovimab given prior to inoculation will reduce the area under the viral load-time curve (VL-AUC) from Day 2 through Day 11 (inclusive) after viral inoculation (Study Day 31 through Day 40) compared to placebo.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Oct 2019 Mar 2020

Publications

"Maas BM, Lommerse J, Plock N, Railkar RA, Cheung SYA, Caro L, Chen J, Liu W, Zhang Y, Huang Q, Gao W, Qin L, Meng J, Witjes H, Schindler E, Guiastrennec B, Bellanti F, Spellman DS, Roadcap B, Kalinova M, Fok-Seang J, Catchpole AP, Espeseth AS, Stoch SA, Lai E, Vora KA, Aliprantis AO, Sachs JR. Forward and reverse translational approaches to predict efficacy of neutralizing respiratory syncytial virus (RSV) antibody prophylaxis. EBioMedicine. 2021 Nov;73:103651. doi: 10.1016/j.ebiom.2021.103651. Epub 2021 Nov 11."; "34775220"

INTERVENTIONAL

Intervention Type : BIOLOGICAL
Intervention Description : Single dose of clesrovimab administered via IV infusion.

Intervention Arm Group : Clesrovimab 100 mg;Clesrovimab 200 mg;Clesrovimab 300 mg;Clesrovimab 900 mg;

Intervention Type : OTHER
Intervention Description : Placebo (0.9% sodium chloride, USP sterile saline) administered via IV infusion.

Intervention Arm Group : Placebo;

Intervention Type : BIOLOGICAL
Intervention Description : Approximately 4Log10 plaque-forming units (PFU)/mL RSV-A virus inoculation strain Memphis 37b administered via intranasal inoculation.

Intervention Arm Group : Clesrovimab 100 mg;Clesrovimab 200 mg;Clesrovimab 300 mg;Clesrovimab 900 mg;Placebo;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • HVIVO Services Ltd ( Site 0001)
    London
    E1 2AX


The study is sponsored by Merck Sharp & Dohme LLC



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Read full details for Trial ID: NCT04086472
Last updated 29 August 2022

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