HIV/AIDS
Conditions
Interventions
Ad35-GRIN or saline placebo
MVA.HIVconsv or saline placebo
pSG2.HIVconsv, Ad35-GRIN, MVA.HIVconsv,
Electroporated pSG2.HIVconsv DNA, Ad35-GRIN, MVA.HIVconsv
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy adults aged 18-50 Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study. Written informed consent. Willing to undergo HIV-1 testing, counselling and receive test results. All female volunteers must be willing to undergo urine pregnancy tests If sexually active using an effective method of contraception until at least 4 months after the last vaccination. Willing to forgo donating blood during the study
Exclusion criteria
Exclusion criteria: Any relevant abnormality including history of immunodeficiency or autoimmune disease, or use of medication that is clinically significant, within the previous 6 months. (Use of inhaled steroids for asthma or topical steroids for localized skin conditions will not exclude a volunteer.) Any clinically significant medical condition that is considered progressive or would make the volunteer unsuitable for the study Any of the following: Haematology Haemoglobin 1.3 x upper limit of normal (ULN) Aspartate aminotransferase (AST) > 2.5 x ULN Alanine aminotransferase (ALT) > 2.5 x ULN Urinalysis Protein = 2+ or more Blood = 2+ or more (for women: before or after menses) Confirmed HIV-1 or HIV-2 infection, hepatitis B, hepatitis C or untreated syphilis If female, pregnant, planning a pregnancy up to 4 months after the last vaccination, or lactating Receipt of live attenuated vaccine within +/- 60 days of vaccination with Investigational Medicinal Product (IMP) Receipt of other vaccine within +/- 14 days of vaccination with the IMP Receipt of blood transfusion or blood products within the previous 6 months Participate in another IMP clinical trial within the previous 3 months or during this study Receipt of any investigational HIV-1 vaccine within the previous 6 years History of severe reactogenicity events after vaccination, or history of severe allergic reactions Smallpox vaccination 40 mm in either deltoid region Presence of an implantable device Current use of any electronic stimulation device Cardiac disease or a heart condition History of syncope or fainting episode within 1 year Seizure disorder or history of seizure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vaccine Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Vaccine immunogenicity;Vaccine Safety | — |
Countries
Kenya
Contacts
Public ContactAlison Crook
Project Manager, University of Oxford
Outcome results
None listed