A Phase 1 interventional study of SeV-G(NP) (0.2mL, 2x10^7 CIU) and SeV-G(NP) (0.2mL, 2x10^8 CIU) in HIV Infections, sponsored by International AIDS Vaccine Initiative. Completed at 3 sites in 3 countries. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-26.
Sponsored by International AIDS Vaccine Initiative · Phase 1, Interventional, and Prevention
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.
4,258 studies on the registry are indexed under HIV Infections; 240 are open to participants now.
This study's enrollment of 65 is below the median of 83 across 3,251 interventional studies indexed under HIV Infections.
Browse HIV Infections studies →International AIDS Vaccine Initiative is the lead sponsor of 36 studies on the registry; 6 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
Biological: SeV-G(NP) (0.2mL, 2x10^7 CIU) · Biological: Ad35-GRIN (0.5mL)
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)
Biological: SeV-G(NP) (0.2mL, 2x10^8 CIU) · Biological: Ad35-GRIN (0.5mL)
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)
Biological: SeV-G(NP) (0.2mL, 2x10^8 CIU) · Biological: Ad35-GRIN (0.5mL)
SeV-G(NP) (IN) at 2x10\^8 CIU at Month 0 and 4. (Vaccine/Placebo = 12/4)
Biological: SeV-G(NP) (0.2mL, 2x10^8 CIU)
Delivered intranasally by drops
Delivered intranasally by drops
(1x10\^10 vp) Delivered intramuscularly by standard syringe and needle injection
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.
Time frame: 16 months approximately
Shedding
To assess the presence and persistence of the SeV-G(NP) vector and the in vivo genetic integrity of the insert
Time frame: 16 months
Immunogenicity
To assess (qualitative and quantitative) immune responses elicited by the different prime-boost regimens.
Time frame: 16 months
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
International AIDS Vaccine Initiative