HIV Infections
Conditions
Keywords
HIV, AIDS, HIV vaccine, HIV prevention
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALSeV-G(NP) (0.2mL, 2x10^7 CIU)
Delivered intranasally by drops
BIOLOGICALSeV-G(NP) (0.2mL, 2x10^8 CIU)
Delivered intranasally by drops
BIOLOGICALAd35-GRIN (0.5mL)
(1x10\^10 vp) Delivered intramuscularly by standard syringe and needle injection
Sponsors
International AIDS Vaccine Initiative
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy male or female adults, * 18 to 50 years of age (21 to 50 years of age for volunteers in Rwanda), * who do not report high-risk behaviour for HIV infection, * who are available for the duration of the trial, * who are willing to undergo HIV testing, * use an effective method of contraception, and * who, in the opinion of the principal investigator or designee, understand the study and who provide written informed consent.
Exclusion criteria
* confirmed HIV infection, * pregnancy and lactation, * significant acute or chronic disease, * clinically significant laboratory abnormalities, * recent vaccination or receipt of a blood product, * previous receipt of an HIV vaccine, and * previous severe local or systemic reactions to vaccination or history of severe allergic reactions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events as a measure of safety and tolerability | 16 months approximately | To evaluate the safety and tolerability of SeV-G(NP) and Ad35-GRIN administered in four prime-boost regimens. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shedding | 16 months | To assess the presence and persistence of the SeV-G(NP) vector and the in vivo genetic integrity of the insert |
| Immunogenicity | 16 months | To assess (qualitative and quantitative) immune responses elicited by the different prime-boost regimens. |
Countries
Kenya, Rwanda, United Kingdom
Outcome results
None listed