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

International AIDS Vaccine Initiative65 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

HIV Infections

Interventions

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

Delivered intranasally by drops

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

Delivered intranasally by drops

Ad35-GRIN (0.5mL)BIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

Kenya AIDS Vaccine Initiative

Nairobi, Kenya

Project San Francisco

Kigali, Rwanda

St. Stephen's Centre

London, United Kingdom

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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