CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 160 enrolled
Drug / intervention
ALVAC-HIV (vCP2438) +3 morebiological
Likely dose
ALVAC-HIV (vCP2438) 1 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03122223
NCT03122223Phase 2Completed
CompareCT.gov

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

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted Apr 20, 2017·Updated Mar 14, 2023

In Brief

A Phase 2 clinical trial evaluating ALVAC-HIV (vCP2438), Bivalent subtype C gp120/MF59, and 2 other interventions for HIV Infections. Completed, enrolled 160 participants across 12 sites in 4 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesTanzania, United States, Zambia, Zimbabwe
CollaboratorsGlaxoSmithKline, Sanofi Pasteur, a Sanofi Company

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedApr 20, 2017
Enrollment StartJan 16, 2018
Primary CompletionJul 30, 2020
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 9.2 years ago

Interventions

ALVAC-HIV (vCP2438)biological

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.

Bivalent subtype C gp120/MF59biological

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.

Bivalent subtype C gp120/AS01(B)biological

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.

Placebobiological

Sodium Chloride for Injection, 0.9%, administered IM.