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Safety & Immunogenicity of HIV Vaccines in Healthy Kenyan Adults

NCT02099994 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2016-05-30

No results posted yet for this study

Summary

The study is part of a long-term aim to develop an effective HIV-1 vaccine and will evaluate safety and immunogenicity of vaccines focusing T cell responses on the conserved region of the HIV-1 proteome. The vaccines used are pSG2.HIVconsv DNA (D), MVA.HIVconsv (M) and Ad35-GRIN (A), delivered in regimens AM, DDDAM and DeDeDeAM, where e indicates electroporation.

Conditions

  • AIDS

Interventions

BIOLOGICAL

Ad35-GRIN

intramuscular administration of Ad35-GRIN 5 x 10\^10 vp or saline placebo

BIOLOGICAL

MVA.HIVconsv

IM administration of MVA.HIVconsv 2 x 10\^8 pfu or saline placebo

BIOLOGICAL

pSG2.HIVconsv DNA

IM administration of pSG2.HIVconsv DNA 4 mg or saline placebo

BIOLOGICAL

Electroporated pSG2.HIVconsv

IM administration of electroporated pSG2.HIVconsv 4mg or saline placebo

Sponsors & Collaborators

  • European and Developing Countries Clinical Trials Partnership (EDCTP)

    collaborator OTHER_GOV

  • International AIDS Vaccine Initiative

    collaborator NETWORK

  • Karolinska Institutet

    collaborator OTHER

  • University of Nairobi

    collaborator OTHER

  • Ichor Medical Systems Incorporated

    collaborator INDUSTRY

  • University of Oxford

    lead OTHER

Principal Investigators

  • Walter Jaoko · University of Nairobi

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • Kenya

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02099994 on ClinicalTrials.gov