Safety & Immunogenicity of HIV Vaccines in Healthy Kenyan Adults (HIV-CORE 004)
- Conditions
- HIV/AIDS
- Registration Number
- PACTR201403000794397
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 72
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
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 < 9.0 g/dl for women and <11.0 g/dl for men
Absolute Neutrophil Count (ANC) ¿ 1000 /mm3
Absolute Lymphocyte Count (ALC) ¿ 600 /mm3
Platelets ¿100,000 /mm3, ¿ 550,000 /mm3
Biochemistry
Creatinine > 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 < 3 years ago
Major psychiatric illness < 3 years ago
Allergy or hypersensitivity to latex, chronic skin problems, or skin and subcutaneous tissue thickness > 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Vaccine Safety
- Secondary Outcome Measures
Name Time Method Vaccine immunogenicity;Vaccine Safety