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A Phase 1, Randomized, Blinded, Dose-escalation Study of rAAV1-PG9DP Recombinant AAV Vector Coding for PG9 Antibody in Healthy Male Adults.

NCT01937455 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2018-01-11

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, tolerability and immunogenicity of rAAV1-PG9DP when administered intramuscularly at different dose levels in healthy male adults.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

rAAV1-PG9DP

4x10\^12 vg administered intramuscularly

BIOLOGICAL

rAAV1-PG9DP

4x10\^13 vg administered intramuscularly

BIOLOGICAL

rAAV1-PG9DP

8x10\^13 vg administered intramuscularly

BIOLOGICAL

rAAV1-PG9DP

1.2x10\^14 vg administered intramuscularly

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Children's Hospital of Philadelphia

    collaborator OTHER

  • International AIDS Vaccine Initiative

    lead NETWORK

Principal Investigators

  • David JM Lewis · Clinical Research Centre, Institute of Biosciences and Medicine, FHMS, University of Surrey

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • United Kingdom

Study Locations

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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 NCT01937455 on ClinicalTrials.gov