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

Phase 1

Completed

• Conditions: HIV Infections
• Interventions: Biological: SeV-G(NP) (0.2mL, 2x10^7 CIU); Biological: SeV-G(NP) (0.2mL, 2x10^8 CIU); Biological: Ad35-GRIN (0.5mL)

• Registration Number: NCT01705990
• Lead Sponsor: International AIDS Vaccine Initiative

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.

Study Timeline

• Study First Submitted: 2012-10-10
• Study First Submitted QC: 2012-10-12
• Study First Posted: 2012-10-15
• Study Start: 2013-03
• Primary Completion: 2015-03
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-25
• Last Update Posted: 2015-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: SeV-G(NP) followed by Ad35-GRIN	SeV-G(NP) (0.2mL, 2x10^7 CIU)	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 A: SeV-G(NP) followed by Ad35-GRIN	Ad35-GRIN (0.5mL)	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 C: Ad35-GRIN followed by SeV-G(NP)	SeV-G(NP) (0.2mL, 2x10^8 CIU)	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 C: Ad35-GRIN followed by SeV-G(NP)	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)
Group B: SeV-G(NP) followed by Ad35-GRIN	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)
Group D: SeV-G(NP) only	SeV-G(NP) (0.2mL, 2x10^8 CIU)	SeV-G(NP) (IN) at 2x10\^8 CIU at Month 0 and 4. (Vaccine/Placebo = 12/4)
Group B: SeV-G(NP) followed by Ad35-GRIN	SeV-G(NP) (0.2mL, 2x10^8 CIU)	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)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Immunogenicity	16 months	To assess (qualitative and quantitative) immune responses elicited by the different prime-boost regimens.
Shedding	16 months	To assess the presence and persistence of the SeV-G(NP) vector and the in vivo genetic integrity of the insert

Trial Locations

Locations (3)

Project San Francisco; 🇷🇼 Kigali, Rwanda

Kenya AIDS Vaccine Initiative; 🇰🇪 Nairobi, Kenya

St. Stephen's Centre; 🇬🇧 London, United Kingdom