Modelling the Interaction Between Rationally-designed Synthetic Model Viral Protein Immunogens (NCT03816137) | Clinical Trial Compass
CompletedPhase 1
Modelling the Interaction Between Rationally-designed Synthetic Model Viral Protein Immunogens
United Kingdom117 participantsStarted 2019-03-19
Plain-language 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 responses.
The investigators hypothesise that the different prime-boost model immunogen combinations will have differential impact on: the magnitude and breadth of induced serum neutralising antibodies; and the induced B- and T-cell responses in peripheral blood.
The investigators will investigate this by challenging the immune system of healthy adults with various model immunogens based on HIV-1 Env (ConM and ConS, with and without EDC stabilisation; Mos3.1, Mos3.2 and Mos3.3, and AMC011 and 763 SOSIP) in different prime-boost combinations.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Neutralising antibodies to virus expressing ConM and ConS envelopes
Timeframe: 6 Months
2
Neutralising antibodies to virus expressing Mosaic envelopes
Timeframe: 12 Months
3
Neutralising antibodies to virus expressing AMC011 and 763 SOSIP envelopes
. 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.