This study is aimed at assessing the safety of candidate Hepatitis C (Hep C) vaccines AdCh3NSmut1 and MVA-NSmut when administered to Human Immunodeficiency Virus (HIV) seropositive individuals. This study also aims to assess the cellular immune response generated by these vaccines when administered as mentioned above.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion Criteria:
* HIV-1 seropositive adults must satisfy all the following inclusion criteria to be eligible for the study:
* Aged 18 to 60 years (inclusive)
* Resident in or near the trial sites for the duration of the vaccination study for the participant
* Able and willing (in the Investigator's opinion) to comply with all study requirements
* HIV Viral Load \<50 copies/mL at the last routine HIV follow-up visit within the last 9 months prior to inclusion whilst on treatment with an effective ART regimen
* Willingness to remain on ART for the study duration
* CD4 cell count above 350 cells/uL
* Negative HCV serology and negative HCV RNA polymerase chain reaction (PCR) testing
* For women of child bearing potential, willingness to practise continuous effective contraception during the study and a negative pregnancy test on the day(s) of vaccination. Effective contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly and, when applicable, in accordance with the product label. In subjects on ART, these are:
* Injectable progestogen
* Male partner sterilisation prior to the female subject's entry into the study, and this male is the sole partner for that subject
* Male condom combined with a vaginal spermicide (foam, gel, film, cream or suppository)
* Intrauterine device or intrauterine system
* In addition male partners should use condoms until 3 months after th…
What they're measuring
1
Safety of administering HCV prime-boost vaccinations to HIV seropositive individuals, as measured by the proportion of participants who develop a grade 3 or 4 local or systemic reaction
Timeframe: From Day 0 until 6 months after the last vaccination