Safety and Immunogenicity Study of SeV-G(NP) HIV Vaccine Administered Intranasally and Ad35-GRIN HIV Vaccine Given Intramuscularly in Prime-Boost Regimens in HIV-Uninfected Volunteers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase I Double-Blind, Randomized, Placebo-Controlled, Dose-Escalation Trial to Evaluate the Safety and Immunogenicity of a Sendai HIV Vaccine SeV-G(NP) Given Intranasally and Ad35-GRIN Administered Intramuscularly in Prime-Boost Regimens in HIV-Uninfected, Healthy Adult Volunteers

Conditions
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HIV Infections

Intervention / Treatment
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* Biological: SeV-G(NP) (0.2mL, 2x10^7 CIU)
* Biological: SeV-G(NP) (0.2mL, 2x10^8 CIU)
* Biological: Ad35-GRIN (0.5mL)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A: SeV-G(NP) followed by Ad35-GRIN<br>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)<br>* Delivered intranasally by drops<br>Biological: Ad35-GRIN (0.5mL)<br>* (1x10^10 vp) Delivered intramuscularly by standard syringe and needle injection<br>|
| Experimental: Group B: SeV-G(NP) followed by Ad35-GRIN<br>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)<br>* Delivered intranasally by drops<br>Biological: Ad35-GRIN (0.5mL)<br>* (1x10^10 vp) Delivered intramuscularly by standard syringe and needle injection<br>|
| Experimental: Group C: Ad35-GRIN followed by SeV-G(NP)<br>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)<br>* Delivered intranasally by drops<br>Biological: Ad35-GRIN (0.5mL)<br>* (1x10^10 vp) Delivered intramuscularly by standard syringe and needle injection<br>|
| Experimental: Group D: SeV-G(NP) only<br>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)<br>* Delivered intranasally by drops<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 16 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, AIDS, HIV vaccine, HIV prevention