HIV-v vaccine, Phase I, two stage multicentre study

• Research type

  Research Study

• Full title

  A MULTICENTRE, TWO STAGE, RANDOMISED, DOUBLE BLIND STUDY OF THE SAFETY, TOLERABILITY AND IMMUNOGENICITY OF A HUMAN IMMUNODEFICIENCY VIRUS (HIV) VACCINE CANDIDATE, HIV-V

• IRAS ID

  22676

• Sponsor organisation

  Harrison Clinical Research Ltd

• Eudract number

  2009-010593-37

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The objectives of this study are to evaluate the safety, tolerability and immunogenicity of two different doses of HIV-v vaccine and the adjuvant (ISA-5) alone in adult male subjects infected with HIV-1 strain of the Human immunodeficiency virus (HIV and not currently receiving or requiring antiretroviral therapy. HIV is a lentivirus that can lead to acquired immunodeficiency syndrome (AIDS), a condition in humans in which the immune system begins to fail, leading to life-threatening opportunistic infections. Adjuvants are drugs that have few or no pharmacological effects by themselves, but may increase the efficacy or potency of other drugs when given at the same timeThis is a two stage study.IThis is a non-randomised, single blind study of five patients that will be vaccinated sequentially with at least 24 hours observation of each patient before vaccination of the next patient. The first patient will receive ISA-5 only, the second and third patients will receive low dose HIV-v with and without ISA-5 respectively and the fourth and fifth patients will receive high dose HIV-v with and without ISA-5 respectively.Following completion of the first five subjects and subject to confirmation of safety and tolerability, the remaining 50 patients will be recruited at stage II.IIThis is a double blind, group comparative study of two dose levels of HIV-v and control. 50 volunteers will be recruited and divided into 5 groups of 10 and treated as follows:1.-HIV-v 250ug in 1ml water 2.-HIV-v 250ug in 1ml ISA-53.-HIV-v 500ug in 1ml water for injection4.-HIV-v 500ug in 1ml ISA-5 5.-Control: 1ml ISA-5 or 1ml water 5 patients respectivelyThe study consists of a screening period of 3-21 days before vaccination. During screening, eligibility will be assessed and this will be followed by a double blind treatment follow up of 28 days with a follow up period of 5 months.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  09/H0801/68

• Date of REC Opinion

  28 Sep 2009

• REC opinion

  Further Information Favourable Opinion