drugset / Trial / NCT01937455
A Phase 1, Randomized, Blinded, Dose-escalation Study of rAAV1-PG9DP Recombinant AAV Vector Coding for PG9 Antibody in Healthy Male Adults.
Phase 1
Unknown
21 enrolled
International AIDS Vaccine Initiative
Children's Hospital of Philadelphia · collabNational Institute of Allergy and Infectious Diseases (NIAID) · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
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.
Timeline
- Start
- 2014-09
- Primary completion
- 2018-02
- Completion
- 2018-02
Publications
- Libera M, Caputo V, Laterza G, Moudoud L, Soggiu A, Bonizzi L, Diotti RA. The Question of HIV Vaccine: Why Is a Solution Not Yet Available? J Immunol Res. 2024 Apr 8;2024:2147912. doi: 10.1155/2024/2147912. eCollection 2024.
- Priddy FH, Lewis DJM, Gelderblom HC, Hassanin H, Streatfield C, LaBranche C, Hare J, Cox JH, Dally L, Bendel D, Montefiori D, Sayeed E, Ackland J, Gilmour J, Schnepp BC, Wright JF, Johnson P. Adeno-associated virus vectored immunoprophylaxis to prevent HIV in healthy adults: a phase 1 randomised controlled trial. Lancet HIV. 2019 Apr;6(4):e230-e239. doi: 10.1016/S2352-3018(19)30003-7. Epub 2019 Mar 15.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rAAV1-PG9DP | Gene therapy (AAV / viral vector) | 4e+12 vg | Intramuscular |
| Subject | rAAV1-PG9DP | Gene therapy (AAV / viral vector) | 4e+13 vg | Intramuscular |
| Subject | rAAV1-PG9DP | Gene therapy (AAV / viral vector) | 8e+13 vg | Intramuscular |
| Subject | rAAV1-PG9DP | Gene therapy (AAV / viral vector) | 1.2e+14 vg | Intramuscular |