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Evaluating the Safety and Immunogenicity of ALVAC-HIV and MF59®- or AS01B-adjuvanted Bivalent Subtype C gp120 in Healthy, HIV-uninfected Adult Participants

NCT03122223 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2023-03-14

Study results available
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Summary

A phase 1/2a clinical trial to evaluate the safety and immunogenicity of ALVAC-HIV (vCP2438) and of MF59®- or AS01B-adjuvanted clade C Env protein, in healthy, HIV-uninfected adult participants

Conditions

  • HIV Infections

Interventions

BIOLOGICAL

ALVAC-HIV (vCP2438)

expresses the gene products 96ZM651 gp120 (clade C strain) linked to the sequences encoding the HIV-1 transmembrane anchor (TM) sequence of gp41 (28 amino acids clade B LAI strain) and Gag and Pro (clade B LAI strain). It is formulated as a lyophilized vaccine for injection at a viral titer greater than or equal to 1 × 10\^6 cell culture infectious dose (CCID)50 and less than 1 × 10\^8 CCID50 (nominal dose of 10\^7 CCID50) and is reconstituted with 1 mL of sterile sodium chloride solution (NaCl 0.4%), administered IM as a single 1 mL dose.

BIOLOGICAL

Bivalent subtype C gp120/MF59

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 IM as a single 0.5 mL dose.

BIOLOGICAL

Bivalent subtype C gp120/AS01(B)

clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 20 mcg or 100 mcg, mixed with AS01B adjuvant, administered IM as a single 0.75 mL dose.

BIOLOGICAL

Placebo

Sodium Chloride for Injection, 0.9%, administered IM.

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Sanofi Pasteur, a Sanofi Company

    collaborator INDUSTRY

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Z Mike Chirenje · UZ-UCSF Collaborative Research Program

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-01-16
Primary Completion
2020-07-30
Completion
2020-07-30
FDA Drug
Yes

Countries

  • United States
  • Tanzania
  • Zambia
  • Zimbabwe

Study Locations

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Entities

Drugs
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 NCT03122223 on ClinicalTrials.gov