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

August 25, 2015 updated by: International AIDS Vaccine Initiative

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

65

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Nairobi, Kenya
        • Kenya AIDS Vaccine Initiative
  • Rwanda
      • Kigali, Rwanda
        • Project San Francisco
  • United Kingdom
      • London, United Kingdom
        • St. Stephen's Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)
Biological: SeV-G(NP) (0.2mL, 2x10^7 CIU)
Delivered intranasally by drops
Biological: Ad35-GRIN (0.5mL)
(1x10^10 vp) Delivered intramuscularly by standard syringe and needle injection
Experimental: 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)
Biological: Ad35-GRIN (0.5mL)
(1x10^10 vp) Delivered intramuscularly by standard syringe and needle injection
Biological: SeV-G(NP) (0.2mL, 2x10^8 CIU)
Delivered intranasally by drops
Experimental: 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)
Biological: Ad35-GRIN (0.5mL)
(1x10^10 vp) Delivered intramuscularly by standard syringe and needle injection
Biological: SeV-G(NP) (0.2mL, 2x10^8 CIU)
Delivered intranasally by drops
Experimental: Group D: SeV-G(NP) only
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)
Delivered intranasally by drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events as a measure of safety and tolerability
Time Frame: 16 months approximately
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
Time Frame: 16 months
To assess the presence and persistence of the SeV-G(NP) vector and the in vivo genetic integrity of the insert
16 months
Immunogenicity
Time Frame: 16 months
To assess (qualitative and quantitative) immune responses elicited by the different prime-boost regimens.
16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

International AIDS Vaccine Initiative

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

October 10, 2012

First Submitted That Met QC Criteria

October 12, 2012

First Posted (Estimate)

October 15, 2012

Study Record Updates

Last Update Posted (Estimate)

August 26, 2015

Last Update Submitted That Met QC Criteria

August 25, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IAVI S001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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