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Safety and Immune Response to a Clade C DNA HIV Vaccine

NCT02997969 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2019-06-21

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and immune response to an HIV clade C DNA vaccine and to an MF59-adjuvanted clade C Env protein in healthy, HIV-uninfected adults.

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

DNA-HIV-PT123 vaccine

Contains a mixture of 3 DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C ZM96 gag, 2) clade C ZM96 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose 4 mg administered as 1 mL intramuscularly (IM)

BIOLOGICAL

Protein/MF59 vaccine

clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered as 0.5 mL IM

BIOLOGICAL

Placebo

Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products

Sponsors & Collaborators

  • HIV Vaccine Trials Network

    collaborator NETWORK

  • IPPOX Foundation

    collaborator OTHER

  • Novartis Vaccines

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Mina Hosseinipour · UNC Project- Lilongwe

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-06-21
Primary Completion
2018-07-11
Completion
2018-07-11

Countries

  • South Africa
  • Tanzania
  • Zambia

Study Locations

More Related Trials

Entities

Drugs

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 NCT02997969 on ClinicalTrials.gov