The safety and immunogenicity of HIV vaccines (SeV-G(NP) and Ad35-GRIN

• Research type

  Research Study

• Full title

  A Phase I double-blind, randomized, placebo-controlled, dose-escalation trial to evaluate the safety and immunogenicity of a Sendai HIV vaccine SeV-G(NP) given intranasally and Ad35-GRIN administered intramuscularly in prime-boost regimens in HIV-uninfected, healthy adult volunteers

• IRAS ID

  116396

• Contact name

  Brian Gazzard

• Sponsor organisation

  International AIDS Vaccine Initative

• Eudract number

  2012-004431-23

• ISRCTN Number

  n/a

• Research summary

  This is a Phase 1 clinical trial of two experimental HIV vaccines in which the main goal is to test the safety of these vaccine products in HIV-negative, healthy adults who are at low risk of getting infected with HIV. It will also look at different types of immune responses that may be generated in the volunteers who receive the vaccines to assess if these might be effective vaccines to protect against HIV. Two experimental vaccines that will be used in this trial, SeV-G(NP) and Ad35-GRIN. The SeV-G(NP) is a replicating Sendai vector that contains the HIV-1 subtype A gag gene inserted in the NP position. The vaccine is made out of a virus called Sendai. In nature, Sendai virus is commonly found in mice and other small animals. It may grow in the human body but does not cause disease. The study vaccine SeV-G(NP) is made from a weakened and modified Sendai virus that contains artificially-made HIV genetic material that will be delivered to body cells. The Ad35-GRIN vaccine is a recombinant replication-defective adenovirus serotype 35 that has been modified so it cannot grow in the body and contains HIV-1 subtype A gag, reverse transcriptase, integrase, and nef genes (abbreviated as GRIN). Ad35-GRIN is made out of modified adenovirus serotype 35 (also known as Ad35) and has been tested in about 150 healthy volunteers. There were no safety concerns. In nature, adenoviruses are common and cause colds and respiratory infections worldwide. The modified virus, Ad35-GRIN, in this study will help carry artificially-made HIV genetic material (GRIN) to body cells. The SeV-G(NP) will be administered intranasally and the Ad35-GRIN will be administered intramuscularly by syringe and needle injection. The study vaccines do not contain the HIV virus. It is absolutely NOT POSSIBLE to get HIV infection from these vaccines.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  12/LO/1782

• Date of REC Opinion

  4 Dec 2012

• REC opinion

  Further Information Favourable Opinion