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Amsterdam UMC Clinical Trial With a Native-like HIV-1 Envelope Vaccine

NCT03961438 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-04-21

No results posted yet for this study

Summary

ACTHIVE-001 is a randomised, open-label, uncontrolled phase 1 clinical trial to determine the safety profile of the native-like HIV-1 envelope vaccine, ConM SOSIP.v7, adjuvanted with monophosphoryl lipid A (MPLA) liposomes. The study will furthermore determine the extent to which the vaccine influences the breadth of viruses neutralised by induced antibodies and the associated diversity of B and T cell responses.

The research will also investigate the effect of a within-schedule successive dose level reduction (i.e. fractional dose boosting), aimed to induce higher levels of somatic hypermutation and broadly neutralising antibodies. The primary outcome will be measurement of adverse events. Secondary and exploratory outcomes will include specific viral neutralisation activity of serum antibodies and characterisation of antigen specific blood and lymph node B and T cell responses.

Conditions

Interventions

BIOLOGICAL

ConM SOSIP.v7 gp140, adjuvanted with MPLA liposomes

Vaccine administration will be done at months 0, 2 and 6 by intramuscular injection into the deltoid muscle of the non-dominant arm. The immunogen will be used at the dosage of 100 μg and will be admixed with 500 μg MPLA formulated in liposomes.

BIOLOGICAL

ConM SOSIP.v7 gp140, adjuvanted with MPLA liposomes

Vaccine administration will be done at months 0, 2 and 6 by intramuscular injection into the deltoid muscle of the non-dominant arm. The immunogen will be used at the dosage of 100 μg at months 0 and 2, and 20 μg at month 6. All immunogen dosages will be admixed with 500 μg MPLA formulated in liposomes.

Sponsors & Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • Godelieve de Bree, MD, PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-11-15
Primary Completion
2022-06-06
Completion
2023-04-17

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

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 NCT03961438 on ClinicalTrials.gov