A Phase 1, randomized, blinded, dose-escalation study of rAAV1-PG9DP recombinant AAV vector coding for PG9 antibody in healthy male adults

• Research type

  Research Study

• Full title

  A Phase 1, randomized, blinded, dose-escalation study of rAAV1-PG9DP recombinant AAV vector coding for PG9 antibody in healthy male adults

• IRAS ID

  134950

• Contact name

  David Lewis

• Contact email

  D.J.Lewis@surrey.ac.uk

• Sponsor organisation

  International AIDS Vaccine Initiative

• Eudract number

  2013-002268-14

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The main objectives are to test the safety and tolerability of intramuscular injection at a single time point of a weakened and modified non-pathogenic virus rAAV1, that contains a gene for a human antibody PG9 against the HIV virus. We will measure the blood levels of PG9 produced by the muscles over time, determine how long the production of the PG9 persists after injection, and whether any reaction to the rAAV1 virus or PG9 antibody occurs.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  13/SC/0421

• Date of REC Opinion

  6 Jan 2014

• REC opinion

  Further Information Favourable Opinion