ACTHIVE-001
Status:Ongoing
Phase:I
Principal Investigator(s):Godelieve de Bree
Objective:Amsterdam UMC Clinical Trial With a Native-like HIV-1 Envelope Vaccine (ACTHIVE-001)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.. As a part of the European AIDS Vaccine Initiative 2020 Consortium (EAVI2020), this study will aid with the objective to select and refine the best immunogens, adjuvants, prime-boost schedules and determine the impact of host factors such as gender and genetics, increasing the chance of discovery of a definitive vaccine, which most likely will be multi-component.Last updated September 16, 2022
Prevention Option(s):HIV Vaccine
Study Design:Open label, Randomized
Arms and Assigned Interventions
DescriptionBiological: 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.
Other Name: Recombinant HIV-1 trimeric gp140 Env protein: ConM SOSIP.v7.
Mode of DeliveryIntramuscular
ARMsActive Comparator
DescriptionBiological: 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.
Other Name: Recombinant HIV-1 trimeric gp140 Env protein: ConM SOSIP.v7.
Mode of DeliveryIntramuscular
ARMsActive Comparator
Official Code:
NCT03961438
Trial Sponsors:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Start Date
End Date
November 1, 2019
April 30, 2023
Enrollment:24
Age range:
18 Years ↔
50 Years
Population:Cisgender Men