A Phase 1, Randomized, Blinded, Dose-escalation Study of rAAV1-PG9DP Recombinant AAV Vector Coding for PG9 Antibody in Healthy Male Adults.
The purpose of this study is to evaluate the safety, tolerability and immunogenicity of rAAV1-PG9DP when administered intramuscularly at different dose levels in healthy male adults.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Safety and Immunogenicity Study of rAAV1-PG9DP Recombinant AAV Vector Coding for PG9 Antibody in Healthy Male Adults.|
- Safety and Tolerability [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Proportion of volunteers with moderate or greater reactogenicity (i.e., solicited adverse events) during a 7 day follow-up period after the injection
- Proportion of volunteers with moderate or greater adverse events (i.e. unsolicited adverse events) including safety laboratory (biochemical, haematological) parameters, from the day of the injection up to 180 days post injection
- Proportion of volunteers with serious adverse events (SAEs) related to the IMP throughout the study period
- The proportion of volunteers in each group with Adverse Event of Special Interest, defined as adverse events potentially caused by antigen-antibody complexes or immune responses directed to cells producing the transgene
- Pharmacokinetics and Immunogenicity [ Time Frame: 12 months ] [ Designated as safety issue: No ]To assess (qualitative and quantitative) immune responses elicited by the different dose levels.
|Study Start Date:||September 2014|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
Experimental: Group A
rAAV1-PG9DP or placebo (v:p = 3:1)
4x10^12 vg administered intramuscularly
Experimental: Group B
rAAV1-PG9DP or placebo (v:p = 3:1)
4x10^13 vg administered intramuscularly
Experimental: Group C/C1
rAAV1-PG9DP or placebo (v:p = 3:1 in Group C, and v:p = 9:3 in Group C1)
8x10^13 vg administered intramuscularly
Experimental: Group D/D1
rAAV1-PG9DP or placebo (v:p = 3:1 in Group D and D1)
1.2x10^14 vg administered intramuscularly
This study is a phase 1, randomized, blinded, dose-escalation study to evaluate the safety and tolerability of rAAV1-PG9DP when administered intramuscularly at 4x10^12 vg, 4x10^13 vg, 8x10^13 vg and 1.2x10^14 vg in healthy male adults.
Volunteers will be screened up to 42 days before injection and will be followed for 12 months after the single administration. It is anticipated that it will take approximately 13 months to enroll the study.
Volunteers will be randomly assigned investigational product (IP) or placebo within each of the dose groups described in the study design table above depending on which group is enrolling. Study staff and volunteers will be blinded only with respect to the allocation of placebo or IP. Blinding will not apply to the assignment of dosage levels.
Volunteers will be offered enrollment into a follow-up study at the research center when they have finished participating in the trial
Please refer to this study by its ClinicalTrials.gov identifier: NCT01937455
|Surrey Clinical Research Centre||Recruiting|
|Guildford, United Kingdom, GU2 7XP|
|Contact: David JM Lewis +44 1483689797 D.J.Lewis@surrey.ac.uk|
|Principal Investigator: David JM Lewis|
|Southampton Centre for Biomedical Research||Not yet recruiting|
|Southampton, United Kingdom, SO16 6YD|
|Contact: Jess Rajaram 023 8120 4989 uhs.recruitmentCRF@nhs.net|
|Principal Investigator: Robert Read|
|Principal Investigator:||David JM Lewis||Clinical Research Centre, Institute of Biosciences and Medicine, FHMS, University of Surrey|