Status:
WITHDRAWN
Modelling the Interaction Between Synthetic Model Immunogens and the Induced B and T Cell Repertoires.
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
European Commission
Conditions:
Virus Diseases
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
MOSAIC is a single-blind experimental medicine study to determine the extent to which different prime-boost combinations of model immunogens based on HIV-1 envelope proteins influence the diversity of...
Detailed Description
One of the most effective arms of the human immune system is the ability of very low concentrations of antibody proteins to bind to viruses, bacteria and toxins and "neutralise" their activity or abil...
Eligibility Criteria
Inclusion
- Healthy male and female volunteers aged between 18 and 55 years.
- Available for ALL follow-up visits for the duration of the study.
- Entered and clearance obtained from The Over volunteering Prevention System (TOPS) database (to avoid impact of any co-administered investigational products or treatments on our outcomes).
- Women capable of becoming pregnant willing to take hormonal contraception or use an intrauterine device, or agree to complete abstinence (when in line with their preferred and usual lifestyle) for the duration of the study. Periodic abstinence (calendar, symptothermal and post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- Willing and able to give written informed consent.
Exclusion
- History of any medical, psychological or other condition, clinically significant laboratory result at screening, or use of any medications which, in the opinion of the investigators, would interfere with the study objectives or volunteers safety.
- HIV-1 or HIV-2 antibody positive or indeterminate upon screening, or history of receipt of Env-based HIV immunogens (which would render the volunteers non-naive to the model immunogens).
- Unable to read and/or speak English to a fluency level adequate for the full comprehension of study procedures and consent.
Key Trial Info
Start Date :
December 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04046978
Start Date
December 11 2019
End Date
December 31 2022
Last Update
August 22 2023
Active Locations (1)
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1
NIHR Imperial Clinical Research Facility
London, Please Select..., United Kingdom, W12 0HS