A Phase 1, Randomized, Blinded, Dose-escalation Study of rAAV1-PG9DP Recombinant AAV Vector Coding for PG9 Antibody in Healthy Male Adults.
|ClinicalTrials.gov Identifier: NCT01937455|
Recruitment Status : Active, not recruiting
First Posted : September 9, 2013
Last Update Posted : January 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV Infections||Biological: rAAV1-PG9DP||Phase 1|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Safety and Immunogenicity Study of rAAV1-PG9DP Recombinant AAV Vector Coding for PG9 Antibody in Healthy Male Adults.|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||February 2018|
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, v:p = 4:1 in Group D1)
1.2x10^14 vg administered intramuscularly
- Safety and Tolerability [ Time Frame: 12 months ]
- 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 ]To assess (qualitative and quantitative) immune responses elicited by the different dose levels.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01937455
|Surrey Clinical Research Centre|
|Guildford, United Kingdom, GU2 7XP|
|Southampton Centre for Biomedical Research|
|Southampton, United Kingdom, SO16 6YD|
|Principal Investigator:||David JM Lewis||Clinical Research Centre, Institute of Biosciences and Medicine, FHMS, University of Surrey|