Safety and Immunogenicity of MVA.HIVconsv in HIV-1 Seropositive Adults on HAART (NCT01024842) | Clinical Trial Compass
TerminatedPhase 1
Safety and Immunogenicity of MVA.HIVconsv in HIV-1 Seropositive Adults on HAART
Stopped: Slow recruitment therefore study was stopped after 95% volunteers were enrolled.
United Kingdom19 participantsStarted 2009-12
Plain-language summary
In this study, the novel vaccine candidate, MVA.HIVconsv, will be tested for safety, tolerability and immunogenicity in HIV-1-seropositive subjects receiving effective antiretroviral therapy.
MVA.HIVconsv will be tested as a single vaccine modality, as a prelude to testing in a heterologous viral vector boost regimen which will include a replication-defective simian adenovirus expressing the same immunogen.
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:
* Male or female, aged 18-60 years
* Confirmed HIV-1 seropositive
* Willing and able to give written informed consent for participation in the study
* Treated continuously with a combination of 3 or more antiretroviral agents for the preceding 12 months
* Willing and able to adhere to an effective ART regimen for the duration of the study (switching from current regimen is allowed if for reasons of tolerability or toxicity)
* CD4 cell count \> 350 cells/μl at screening and at the preceding clinic visit
* Plasma viral load \< 50 copies / ml at screening and at the preceding clinic visit
* No new AIDS-defining diagnosis or progression of HIV-related disease in the preceding 6/12 months
* Haematological and biochemical laboratory parameters as follows:
* Haemoglobin \> 10g/dl
* Platelets \> 100,000/μl
* ALT ≤ 2.5 x ULN
* Creatinine ≤ 1.3 x ULN
* Serology: negative for hepatitis B surface antigen OR HbsAg positive with HBV DNA \< 1000 copies/ml; negative for hepatitis C antibodies OR confirmed clearance of HCV infection (spontaneous or following treatment); negative syphilis serology or documented adequate treatment of syphilis if positive EIA IgG or TPHA
* Available for follow up for duration of study (screening + 38 weeks) and willing to comply with the protocol requirements
* Women of child-bearing age must not be pregnant, planning a pregnancy or breast-feeding. Sexually active women must be willing to use an approved method of contraception from…
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
The proportion of volunteers who develop a grade 3 or 4 local or systemic reactions
Timeframe: Actively collected data throughout the study until 6 months after the last vaccination