A Phase I, Randomized, Double-Blind, Placebo-Controlled Safety, Tolerability and Immunogenicity S… (NCT05208125) | Clinical Trial Compass
CompletedPhase 1
A Phase I, Randomized, Double-Blind, Placebo-Controlled Safety, Tolerability and Immunogenicity Study of Candidate HIV-1 Vaccines ChAdOx1.HTI and MVA.HTI With Recombinant HIV-1 Envelope Protein ConM SOSIP.v7 gp140 Vaccine, Adjuvanted With MPLA Liposomes in ART-Suppressed HIV-1 Positive Individuals
Spain30 participantsStarted 2022-03-30
Plain-language summary
BCN03 is a Single-site, randomized, double-blind, placebo-controlled, phase I study to evaluate the safety, tolerability, immunogenicity, and efficacy of a vaccine regimen that includes a sequence of the T- and B-cell immunogens ChAdOx1.HTI and MVA.HTI and ConM SOSIP.v7 gp140 adjuvanted with MPLA liposomes in 30 virologically-suppressed ART-treated HIV-1 positive individuals.
Who can participate
Age range
18 Years – 60 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
. Males and females aged at least 18 years on the day of screening and no greater than 60 years on the day of the first IMP administration.
. Confirmed HIV-1 infection.
. Optimal virological suppression for at least 2 years prior to the screening visit, defined as maintained pVL \<50 cop/ml allowing for isolated blips (non-consecutive 50-200 copies/mL)
. Being on the same ART regimen within at least 4 weeks prior to screening visit.
. CD4 count ≥ 500 cells/mm3 at the screening visit.
. Nadir CD4 count ≥ 350 cells/mm3. Lower counts at the moment of acute HIV-1 infection will be allowed only if appropriate immune recovery was followed after ART initiation and ART was not initiated within first 6 months after estimated time of HIV-1 acquisition.
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
Local IMP-related AEs of Grade 3 and 4
Timeframe: From first administration up to week 30 (i.e., start of ATI, 2 weeks after last administration).
2
Systemic IMP-related AEs of Grade 3 and 4
Timeframe: From first administration up to week 30 (i.e., start of ATI, 2 weeks after last administration).
3
Descriptive of AEs
Timeframe: From first administration up to week 30 (i.e., start of ATI, 2 weeks after last administration)
. Willing and able to be adherent to their ART regimen for the duration of the study.
. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
Exclusion criteria
. If female, pregnant or planning a pregnancy during the study and until at least four months after the last IMP administration or until her pVL is \<50 copies/mL in two-consecutive determinations after ART resumption, whichever is later; or lactating.
. ART initiated within 6 months from the estimated time of HIV-1 acquisition documented by immediate ART initation after a) an HIV-1 documented seroconversion (\<180 days), b) an HIV-1 diagnose with negative or indeterminate western blot test or positive p24 antigenemia and/or c) presenting with symptoms suggestive of acute retroviral syndrome.
. When available, pre-ART genotypic data that demonstrates the presence of clinically significant drug resistance mutations that could prevent the construction of a viable ART regimen post-treatment interruption.
. Reported periods of suboptimal adherence to ART or suboptimal ART regimens (dual therapy allowed as switch-regimens if sustained viral uppression pVL\<50 copies/ml is documented).
. History of past ART interruptions longer than 2 weeks.
. Participation in another clinical trial that involves a treatment intervention (active arm) within 12 weeks of study entry (at screening visit).
. Any AIDS-defining disease or progression of HIV-related disease.