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The purpose of this study is to evaluate the safety, tolerability and immunogenicity of Sendai HIV vaccine SeV-G(NP) given intranasally and Ad35-GRIN administered intramuscularly in prime-boost regimens in HIV-uninfected, healthy adult volunteers.
The study is a randomized, double-blind, placebo-controlled, dose-escalation trial assessing the safety, tolerability, and immunogenicity of SeV-G(NP) given intranasally by drops and Ad35-GRIN administered intramuscularly in each of four prime-boost regimens.
Volunteers will be screened up to 42 days before the 1st vaccination and will be followed for 12 months after the last vaccine administration (16 months after the first vaccination). It is anticipated that it will take approximately 6 months to enroll the study. Approximately 64 volunteers (48 vaccine and 16 placebo recipients) will be included in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: SeV-G(NP) followed by Ad35-GRIN | Experimental | SeV-G(NP) (IN) at 2x10^7 CIU at Month 0 followed by Ad35-GRIN (IM) at 1x10^10 vp at Month 4. (Vaccine/Placebo = 12/4) |
|
| Group B: SeV-G(NP) followed by Ad35-GRIN | Experimental | SeV-G(NP) (IN) at 2x10^8 CIU at Month 0 followed by Ad35-GRIN (IM) at 1x10^10 vp at Month 4. (Vaccine/Placebo = 12/4) |
|
| Group C: Ad35-GRIN followed by SeV-G(NP) | Experimental | Ad35-GRIN (IM) at 1x10^10 vp at Month 0 followed by SeV-G(NP) (IN) at 2x10^8 CIU at Month 4. (Vaccine/Placebo = 12/4) |
|
| Group D: SeV-G(NP) only | Experimental | SeV-G(NP) (IN) at 2x10^8 CIU at Month 0 and 4. (Vaccine/Placebo = 12/4) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SeV-G(NP) (0.2mL, 2x10^7 CIU) | Biological | Delivered intranasally by drops |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events as a measure of safety and tolerability | To evaluate the safety and tolerability of SeV-G(NP) and Ad35-GRIN administered in four prime-boost regimens. | 16 months approximately |
| Measure | Description | Time Frame |
|---|---|---|
| Shedding | To assess the presence and persistence of the SeV-G(NP) vector and the in vivo genetic integrity of the insert | 16 months |
| Immunogenicity | To assess (qualitative and quantitative) immune responses elicited by the different prime-boost regimens. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kenya AIDS Vaccine Initiative | Nairobi | Kenya | ||||
| Project San Francisco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28077588 | Derived | Nyombayire J, Anzala O, Gazzard B, Karita E, Bergin P, Hayes P, Kopycinski J, Omosa-Manyonyi G, Jackson A, Bizimana J, Farah B, Sayeed E, Parks CL, Inoue M, Hironaka T, Hara H, Shu T, Matano T, Dally L, Barin B, Park H, Gilmour J, Lombardo A, Excler JL, Fast P, Laufer DS, Cox JH; S001 Study Team. First-in-Human Evaluation of the Safety and Immunogenicity of an Intranasally Administered Replication-Competent Sendai Virus-Vectored HIV Type 1 Gag Vaccine: Induction of Potent T-Cell or Antibody Responses in Prime-Boost Regimens. J Infect Dis. 2017 Jan 1;215(1):95-104. doi: 10.1093/infdis/jiw500. Epub 2016 Oct 17. |
| Label | URL |
|---|---|
| International AIDS Vaccine Initiative | View source |
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| SeV-G(NP) (0.2mL, 2x10^8 CIU) | Biological | Delivered intranasally by drops |
|
| Ad35-GRIN (0.5mL) | Biological | (1x10^10 vp) Delivered intramuscularly by standard syringe and needle injection |
|
| 16 months |
| Kigali |
| Rwanda |
| St. Stephen's Centre | London | United Kingdom |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D012897 | Slow Virus Diseases |
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