NCT04046978

Brief Summary

MOSAIC is a single-blind experimental medicine study to determine the extent to which different prime-boost combinations of model immunogens based on HIV-1 envelope proteins influence the diversity of B and T cell responses.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

December 11, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

3.1 years

First QC Date

August 5, 2019

Last Update Submit

August 18, 2023

Conditions

Virus Diseases

Keywords

Virus Diseases

Outcome Measures

Primary Outcomes (1)

  • Serum titres of neutralising antibodies

    Serum titres of neutralising antibodies to virus expressing ConM and ConS, and mosaic (Mos3.1, Mos3.2 and Mos3.3) envelopes

    9 months

Study Arms (4)

Group F

EXPERIMENTAL

Mos3.1 100 ug at Month 0 Mos3.2 100 ug at Month 2 Mos3.3 100 ug at Month 4 ConM SOSIP 50 ug and ConS UFO 50 ug at Month 6

Other: ConM SOSIP 50 ug and ConS UFO 50 ugOther: Mos3.1 100 ugOther: Mos3.2 100 ugOther: Mos3.3 100 ug

Group G

EXPERIMENTAL

Mos3.2 100 ug at Month 0 Mos3.1 100 ug at Month 2 Mos3.3 100 ug at Month 4 ConM SOSIP 50 ug and ConS UFO 50 ug at Month 6

Other: ConM SOSIP 50 ug and ConS UFO 50 ugOther: Mos3.1 100 ugOther: Mos3.2 100 ugOther: Mos3.3 100 ug

Group H

EXPERIMENTAL

Mos3.3 100 ug at Month 0 Mos3.2 100 ug at Month 2 Mos3.1 100 ug at Month 4 ConM SOSIP 50 ug and ConS UFO 50 ug at Month 6

Other: ConM SOSIP 50 ug and ConS UFO 50 ugOther: Mos3.1 100 ugOther: Mos3.2 100 ugOther: Mos3.3 100 ug

Group I

EXPERIMENTAL

Mos3.1 33 ug, Mos3.2 33 ug and Mos3.3 33 ug at Months 0, 2 and 4 ConM SOSIP 50 ug and ConS UFO 50 ug at Month 6

Other: ConM SOSIP 50 ug and ConS UFO 50 ugOther: Mos3.1 33 ug, Mos3.2 33 ug and Mos3.3 33 ug

Interventions

ConM SOSIP 50 ug and ConS UFO 50 ugOTHER

Intramuscular injection of synthetic viral immunogens ConM SOSIP and ConS UFO

Group FGroup GGroup HGroup I
Mos3.1 100 ugOTHER

Intramuscular injection of synthetic viral immunogen Mos3.1

Group FGroup GGroup H
Mos3.2 100 ugOTHER

Intramuscular injection of synthetic viral immunogen Mos3.2

Group FGroup GGroup H
Mos3.3 100 ugOTHER

Intramuscular injection of synthetic viral immunogen Mos3.3

Group FGroup GGroup H
Mos3.1 33 ug, Mos3.2 33 ug and Mos3.3 33 ugOTHER

Intramuscular injection of synthetic viral immunogens Mos3.1, Mos3.2 and Mos3.3

Group I

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and female volunteers aged between 18 and 55 years.
  • Available for ALL follow-up visits for the duration of the study.
  • Entered and clearance obtained from The Over volunteering Prevention System (TOPS) database (to avoid impact of any co-administered investigational products or treatments on our outcomes).
  • Women capable of becoming pregnant willing to take hormonal contraception or use an intrauterine device, or agree to complete abstinence (when in line with their preferred and usual lifestyle) for the duration of the study. Periodic abstinence (calendar, symptothermal and post-ovulation methods) and withdrawal are not acceptable methods of contraception.
  • Willing and able to give written informed consent.

You may not qualify if:

  • History of any medical, psychological or other condition, clinically significant laboratory result at screening, or use of any medications which, in the opinion of the investigators, would interfere with the study objectives or volunteers safety.
  • HIV-1 or HIV-2 antibody positive or indeterminate upon screening, or history of receipt of Env-based HIV immunogens (which would render the volunteers non-naive to the model immunogens).
  • Unable to read and/or speak English to a fluency level adequate for the full comprehension of study procedures and consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIHR Imperial Clinical Research Facility

London, Please Select..., W12 0HS, United Kingdom

Location

MeSH Terms

Conditions

Virus Diseases

Condition Hierarchy (Ancestors)

Infections

Study Officials

  • Katrina Pollock, MD

    Imperial College London

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2019

First Posted

August 6, 2019

Study Start

December 11, 2019

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

August 22, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)