Status and phase
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About
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of an adjuvanted GSK investigational HIV vaccine and Ad35-GRIN in 4 different regimens at months 1, 2, 3, and 4.
Full description
Volunteers will be screened up to 42 days before vaccination (up to 90 days for Ad35 neutralizing antibody) and will be followed for 12 months after the last vaccination (16 months total participation).
It is estimated that it will take approximately 5 months to complete enrolment.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Confirmed HIV-1 or HIV-2 infection
Any clinically relevant abnormality on history or examination including history of immunodeficiency, malignancy or autoimmune disease; use of systemic corticosteroids (<2 weeks use of topical or inhaled steroids is permitted); immunosuppressive, anticancer, anti-tuberculosis or other medications considered significant by the investigator within the previous 6 months
Any clinically significant acute or chronic medical condition that is considered progressive, or in the opinion of the investigator, makes the volunteer unsuitable for participation in the study
Detection of Ad35-specific serum neutralizing antibody
Reported high-risk behaviour for HIV infection within 6 months prior to first vaccination, as defined by the protocol.
If female, pregnant or planning a pregnancy within 4 months after last vaccination; or lactating
Unstable asthma (e.g. sudden acute attacks occurring without an obvious trigger) or asthma requiring:
Bleeding disorder that was diagnosed by a physician e.g., factor deficiency, coagulopathy or platelet disorder that requires special precautions. (A volunteer who states that he or she has easy bruising or bleeding, but does not have a formal diagnosis and has intramuscular (IM) injections and blood draws without any adverse experience is eligible)
History of splenectomy
Any abnormal laboratory parameters as defined by the protocol;
Receipt of live-attenuated vaccine within the previous 60 days (live attenuated flu vaccine within 14 days) or planned receipt within 60 days after vaccination with Investigational Product; or receipt of other vaccine (e.g. pneumococcal), allergy treatment with antigen injections or tuberculin skin test within the previous 14 days or planned receipt within 14 days after vaccination with Investigational Product
Receipt of blood transfusion or blood-derived products within the previous 6 months
Participation in another clinical trial of an Investigational Product currently, within the previous 3 months or expected participation during this study
Prior receipt of another investigational HIV vaccine candidate (note: receipt of an HIV vaccine placebo will not exclude a volunteer from participation if documentation is available and the IAVI Medical Monitor gives approval)
History of severe local or systemic reactogenicity to vaccines (e.g. anaphylaxis, respiratory difficulty, angioedema)
History of severe allergic reactions to any substance requiring hospitalization or emergency medical care (e.g. Steven-Johnson syndrome, bronchospasm or hypotension)
Known sensitivity to sulphite, aspirin or aminoglycoside antibiotics (e.g. amikacin, arbekacin, gentamicin, kanamycin, neomycin, netilmicin, paromomycin, streptomycin, tobramycin, etc)
Confirmed diagnosis of active hepatitis B (HBsAg), hepatitis C (HCV antibodies), active syphilis or active tuberculosis
History of severe neurological disorder, seizure or psychiatric disorder (e.g schizophrenia, severe psychosis, bipolar disorder requiring therapy, suicidal attempt or ideation)
For those volunteers at clinical centres participating in ophthalmic examinations, any clinically significant abnormality found on baseline ophthalmic examination.
Primary purpose
Allocation
Interventional model
Masking
147 participants in 4 patient groups
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Data sourced from clinicaltrials.gov
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