HealthyNCT04753892
3Sm Challenge Model Protocol
A study testing 3SM2-G-CRM197 with squalene adjuvant in people with Healthy, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 3SM2-G-CRM197 with squalene adjuvant
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Sep 2021to 20 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female participants aged between 18 and 55 years on the day of screening.
- Willing and able to provide written informed consent.
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NIHR Imperial Clinical Research Facility
London, Please Select..., W12 0HS
About this study
Official title: An Immune Challenge Model Using gp41 3Sm Peptide in Healthy Human Adults to Characterise B Cell Responses to a Model Virus-neutralizing Antibody-inducing Motif in Health Versus Chronic Viral Infection
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.
- Conditions
- Healthy
- Being tested
- 3SM2-G-CRM197 with squalene adjuvant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3SM2-G-CRM197 with squalene adjuvantOther
Immune challenge agent
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: 3SM2-G-CRM197 with squalene adjuvant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum titres of 3Sm antibodies
ELISA read-outs
Measured: From Month 0 to Month 6
Frequency of 3Sm secreting B cells in peripheral blood
ELISpot read-outs
Measured: From Month 0 to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start10 Sep 2021
- Primary completion20 Jul 2022
- Study completion20 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Minka Therapeutics, ANRS, Emerging Infectious Diseases
- Responsible party
- Sponsor
- Investigators
- Katrina Pollock, MD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04753892
- Sponsor's protocol ID
- 21HH6540
- Status last verified
- Jul 2022
- First submitted
- 12 Feb 2021
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Immune Challenge Model Using gp41 3Sm Peptide in Healthy Human Adults to Characterise B Cell Responses to a Model Virus-neutralizing Antibody-inducing Motif in Health Versus Chronic Viral Infection
- ClinicalTrials.gov ID
- NCT04753892
- Acronym / sponsor ID
- 21HH6540
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Minka Therapeutics, ANRS, Emerging Infectious Diseases
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 20 Jul 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 15 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Other: 3SM2-G-CRM197 with squalene adjuvantThe 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy male and female participants aged between 18 and 55 years on the day of screening.
- Willing and able to provide written informed consent.
- 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.
Key exclusion criteria (12 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3SM2-G-CRM197 with squalene adjuvantImmune challenge agent | Other | Arm 1 |
Primary outcome
Serum titres of 3Sm antibodies
Time frame: From Month 0 to Month 6
ELISA read-outs
Frequency of 3Sm secreting B cells in peripheral blood
Time frame: From Month 0 to Month 6
ELISpot read-outs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katrina Pollock, MD principal investigator
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3SM2-G-CRM197 with squalene adjuvant in people with Healthy, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum titres of 3Sm antibodies (time frame: From Month 0 to Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.