PACTR201403000794397Completed未知
A Phase I/IIa Clinical Trial of HIV-1 Vaccines pSG2.HIVconsv DNA, MVA.HIVconsv and Ad35-GRIN in Combined Regimens in Healthy HIV-1/2-negative Adults in Nairobi.
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- niversity of Oxford
- Enrollment
- 72
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 Year(s) to 50 Year(s) (—)
- Sex
- All
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
- •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
- •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
Investigators
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