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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

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.

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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.

Conditions

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HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group A: SeV-G(NP) followed by Ad35-GRIN

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 Type EXPERIMENTAL

SeV-G(NP) (0.2mL, 2x10^7 CIU)

Intervention Type BIOLOGICAL

Delivered intranasally by drops

Ad35-GRIN (0.5mL)

Intervention Type BIOLOGICAL

(1x10\^10 vp) Delivered intramuscularly by standard syringe and needle injection

Group B: SeV-G(NP) followed by Ad35-GRIN

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 Type EXPERIMENTAL

SeV-G(NP) (0.2mL, 2x10^8 CIU)

Intervention Type BIOLOGICAL

Delivered intranasally by drops

Ad35-GRIN (0.5mL)

Intervention Type BIOLOGICAL

(1x10\^10 vp) Delivered intramuscularly by standard syringe and needle injection

Group C: Ad35-GRIN followed by SeV-G(NP)

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 Type EXPERIMENTAL

SeV-G(NP) (0.2mL, 2x10^8 CIU)

Intervention Type BIOLOGICAL

Delivered intranasally by drops

Ad35-GRIN (0.5mL)

Intervention Type BIOLOGICAL

(1x10\^10 vp) Delivered intramuscularly by standard syringe and needle injection

Group D: SeV-G(NP) only

SeV-G(NP) (IN) at 2x10\^8 CIU at Month 0 and 4. (Vaccine/Placebo = 12/4)

Group Type EXPERIMENTAL

SeV-G(NP) (0.2mL, 2x10^8 CIU)

Intervention Type BIOLOGICAL

Delivered intranasally by drops

Interventions

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SeV-G(NP) (0.2mL, 2x10^7 CIU)

Delivered intranasally by drops

Intervention Type BIOLOGICAL

SeV-G(NP) (0.2mL, 2x10^8 CIU)

Delivered intranasally by drops

Intervention Type BIOLOGICAL

Ad35-GRIN (0.5mL)

(1x10\^10 vp) Delivered intramuscularly by standard syringe and needle injection

Intervention Type BIOLOGICAL

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes