NCT04753892

Completed

3Sm Challenge Model Protocol

Imperial College London Source

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Other study identifiers

Sponsor study identifier

21HH6540

Study Type

interventional

Actual enrollment (reported)

8

Locations

1 country

Sites

1

Timeline

Study Start

September 10, 2021

Actual (reported)

Primary Completion

July 20, 2022

Actual (reported)

Study Completion

July 20, 2022

Actual (reported)

Brief Summary

The 3Sm challenge study is a small clinical study in eight healthy volunteers who will be injected with a protein which includes a short portion ('3Sm peptide') which is derived from a part (the '3S region') of the coat protein of HIV. The researchers believe that the 3Sm peptide might trigger an immune response which includes rare antibodies able to neutralise a wide range of different strains of HIV. The results will be useful in guiding the development of future vaccines against HIV, and other diseases.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 8 participants
Study completion date: July 20, 2022
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
February 12, 2021
Actual (reported)
First Posted
February 15, 2021
Actual (reported)
Study Start
September 10, 2021
Actual (reported)
Primary Completion
July 20, 2022
Actual (reported)
Study Completion
July 20, 2022
Actual (reported)

Last Updated: July 27, 2022
Status Verified: July 2022
Last Update Submitted: July 25, 2022

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

Serum titres of 3Sm antibodies
ELISA read-outs
From Month 0 to Month 6
Frequency of 3Sm secreting B cells in peripheral blood
ELISpot read-outs
From Month 0 to Month 6

Study Arms (1)

Arm 1

EXPERIMENTAL

The 3Sm peptide is conjugated to a mutant diphtheria carrier protein (CRM197) and the resulting challenge agent (3SM2-G-CRM197) will be mixed with a squalene adjuvant before intramuscular administration at Months 0, 1, 2 and 4, at a dosage of 32 micrograms of 3SM2-G-CRM197 and 9.7 micrograms of adjuvant.

Other: 3SM2-G-CRM197 with squalene adjuvant

Interventions

3SM2-G-CRM197 with squalene adjuvantOther

Immune challenge agent

Arm 1

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy male and female participants aged between 18 and 55 years on the day of screening.
Willing and able to provide written informed consent.

Sponsors & Collaborators

Minka Therapeutics
Type not reportedcollaborator
ANRS, Emerging Infectious Diseases
Governmentcollaborator
Imperial College London

Study Sites (1)

NIHR Imperial Clinical Research Facility

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

Study Officials

Katrina Pollock, MD
Imperial College London
PRINCIPAL INVESTIGATOR

Enrollment

8 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: BASIC SCIENCE
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

February 12, 2021

First Posted

February 15, 2021

Study Start

September 10, 2021

Actual (reported)

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Available for all follow-up visits for the duration of the study.

Entered into and obtained clearance from The Over volunteering Prevention System (TOPS) database (to avoid impact of any co-administered investigational products or treatments on our outcomes).

If female and of childbearing potential, willing to use a highly effective method of contraception from screening until a minimum of 6 weeks after the last immunogen challenge. Periodic abstinence (calendar, symptothermal and post-ovulation methods) and withdrawal are not acceptable methods of contraception.

If male and not sterilised, willing to avoid impregnating female partners through the use of condoms or sexual abstinence from screening until a minimum of 6 weeks after the last immunogen challenge, unless female partners are using a highly effective method during the same time period.

Registered with a GP in the UK prior to enrolment into the study.

Willing to grant authorised persons access to his/her trial-related medical record and GP records either directly or indirectly

Willing to avoid all vaccines from within 4 weeks before the first immunogen challenge through to 4 weeks after the final challenge, with the exception of seasonal influenza vaccine which may be given more than 7 days before or after the experimental immunogen, and deployed COVID-19 vaccine which may be given 14 days before or after the experimental immunogen (and at least 28 days is encouraged). It is recommended that participants have an up to date vaccination status for any required immunisations.

You may not qualify if:

Pregnant or lactating
History of any physical, medical, psychological or other condition, clinically significant laboratory, vital sign or examination finding at screening, or use of any medications which, in the opinion of the investigators, would interfere with the study objectives or participant's safety. This includes where there is a history of active disease requiring a clinically significant recent or planned investigation or change in treatment, including cardiac, respiratory, endocrine, metabolic, autoimmune, liver, neurological, oncological, psychiatric, immunosuppresive/immunodeficient or other disorders. Individuals with mild/moderate, well-controlled co-morbidities, of those that are no longer deemed clinically active or clinically significant by the investigator are allowed.
History of anaphylaxis or angioedema.
History of severe or multiple allergies to drugs or pharmaceutical agents.
History of severe local or general reaction to vaccination defined as:
local: extensive, indurated redness and swelling involving most of the arm, not resolving within 72 hours
general: fever ≥39.5 °C within 48 hours; bronchospasm; laryngeal oedema; collapse; convulsions or encephalopathy within 72 hours
Previous receipt of an investigational vaccine or immunogen based on HIV envelope.
Detection of antibodies to HIV.
Detection of antibodies to Hepatitis C.
Unable to read and/or speak English to a fluency level adequate for the full comprehension of study procedures and consent.
Participation in another study, or treatment with an investigational drug within 28 days of screening, which in the opinion of the investigator would interfere with study objectives or compromise the participant's safety.

Contact the study team to confirm eligibility.

Otherlead

Primary Completion

July 20, 2022

Actual (reported)

Study Completion

July 20, 2022

Actual (reported)

Last Updated

July 27, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing: Will not share

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04753892
Data provider: ClinicalTrials.gov
Source updated: 2022-07-27
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:20:14 UTC

Locations

GB(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Arm 1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations