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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

Primary Purpose

HIV Infections

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

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

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

Ad35-GRIN (0.5mL)

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring HIV, AIDS, HIV vaccine, HIV prevention

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Kenya AIDS Vaccine Initiative
Project San Francisco
St. Stephen's Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

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

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

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

Group D: SeV-G(NP) only

Arm Description

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)

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)

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)

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Shedding

To assess the presence and persistence of the SeV-G(NP) vector and the in vivo genetic integrity of the insert

Immunogenicity

To assess (qualitative and quantitative) immune responses elicited by the different prime-boost regimens.

Full Information

NCT ID

NCT01705990

First Posted

October 10, 2012

Last Updated

August 25, 2015

Sponsor

International AIDS Vaccine Initiative

1. Study Identification

Unique Protocol Identification Number

NCT01705990

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

March 2013 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

International AIDS Vaccine Initiative

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

HIV, AIDS, HIV vaccine, HIV prevention

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

65 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

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)

Arm Title

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

Arm Type

Experimental

Arm Description

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)

Arm Title

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

Arm Type

Experimental

Arm Description

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)

Arm Title

Group D: SeV-G(NP) only

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

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

Intervention Description

Delivered intranasally by drops

Intervention Type

Biological

Intervention Name(s)

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

Intervention Description

Delivered intranasally by drops

Intervention Type

Biological

Intervention Name(s)

Ad35-GRIN (0.5mL)

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of participants with adverse events as a measure of safety and tolerability

Description

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 Outcome Measure Information:

Title

Shedding

Description

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

Title

Immunogenicity

Description

To assess (qualitative and quantitative) immune responses elicited by the different prime-boost regimens.

Time Frame

16 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Kenya AIDS Vaccine Initiative

City

Nairobi

Country

Kenya

Facility Name

Project San Francisco

City

Kigali

Country

Rwanda

Facility Name

St. Stephen's Centre

City

London

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

28077588

Citation

Nyombayire J, Anzala O, Gazzard B, Karita E, Bergin P, Hayes P, Kopycinski J, Omosa-Manyonyi G, Jackson A, Bizimana J, Farah B, Sayeed E, Parks CL, Inoue M, Hironaka T, Hara H, Shu T, Matano T, Dally L, Barin B, Park H, Gilmour J, Lombardo A, Excler JL, Fast P, Laufer DS, Cox JH; S001 Study Team. First-in-Human Evaluation of the Safety and Immunogenicity of an Intranasally Administered Replication-Competent Sendai Virus-Vectored HIV Type 1 Gag Vaccine: Induction of Potent T-Cell or Antibody Responses in Prime-Boost Regimens. J Infect Dis. 2017 Jan 1;215(1):95-104. doi: 10.1093/infdis/jiw500. Epub 2016 Oct 17.

Results Reference

derived

Links:

URL

http://www.iavi.org

Description

International AIDS Vaccine Initiative

Learn more about this trial

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

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