Status:
COMPLETED
Modelling the Interaction Between Rationally-designed Synthetic Model Viral Protein Immunogens
Lead Sponsor:
Imperial College London
Conditions:
HIV-1-infection
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The objective of this experimental medicine study is to determine the extent to which different prime-boost combinations influence serum neutralising antibody breadth and associated B and T cells resp...
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 of childbearing potential willing to use a highly effective method of contraception for the duration of the study until a minimum of 12 weeks after the final injection. 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.
- Any history of angioedema.
- History of urticaria deemed significant by the Chief Investigator.
- 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 :
March 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT03816137
Start Date
March 19 2019
End Date
December 31 2022
Last Update
November 5 2024
Active Locations (1)
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1
NIHR Imperial Clinical Resarch Facility
London, United Kingdom, W12 0HS