NCT01705990

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P75+ for phase_1 hiv-infections

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Last Updated

August 26, 2015

Status Verified

August 1, 2015

Enrollment Period

2 years

First QC Date

October 10, 2012

Last Update Submit

August 25, 2015

Conditions

HIV Infections

Keywords

HIVAIDSHIV vaccineHIV prevention

Outcome Measures

Primary Outcomes (1)

  • 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.

    16 months approximately

Secondary Outcomes (2)

  • Shedding

    16 months

  • Immunogenicity

    16 months

Study Arms (4)

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

EXPERIMENTAL

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)Biological: Ad35-GRIN (0.5mL)

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

EXPERIMENTAL

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: SeV-G(NP) (0.2mL, 2x10^8 CIU)Biological: Ad35-GRIN (0.5mL)

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

EXPERIMENTAL

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: SeV-G(NP) (0.2mL, 2x10^8 CIU)Biological: Ad35-GRIN (0.5mL)

Group D: SeV-G(NP) only

EXPERIMENTAL

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)

Interventions

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

Delivered intranasally by drops

Group A: SeV-G(NP) followed by Ad35-GRIN
SeV-G(NP) (0.2mL, 2x10^8 CIU)BIOLOGICAL

Delivered intranasally by drops

Group B: SeV-G(NP) followed by Ad35-GRINGroup C: Ad35-GRIN followed by SeV-G(NP)Group D: SeV-G(NP) only
Ad35-GRIN (0.5mL)BIOLOGICAL

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

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

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy male or female adults,
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kenya AIDS Vaccine Initiative

Nairobi, Kenya

Location

Project San Francisco

Kigali, Rwanda

Location

St. Stephen's Centre

London, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 28077588DERIVED

Related Links

MeSH Terms

Conditions

HIV InfectionsAcquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesSlow Virus Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2012

First Posted

October 15, 2012

Study Start

March 1, 2013

Primary Completion

March 1, 2015

Last Updated

August 26, 2015

Record last verified: 2015-08

Locations

KE(1)GB(1)RW(1)