Immune ResponseNCT05876195
KLH Challenge to Explore the Human Immune Response
A study testing Keyhole-Limpet Hemocyanin, Saline and Montanide ISA 51 VG in people with Immune Response, run by University of Oxford at 1 site in United Kingdom.
Trial summary
One approach to improve the efficiency of the drug development process is the use of human 'immune challenge' studies. In these studies, healthy volunteers are given small amounts of substances which are foreign to their immune system to provoke a temporary response: the 'challenge'. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune Response
- What is being tested?
- Keyhole-Limpet Hemocyanin, Saline and Montanide ISA 51 VG
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2023to Feb 2024
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study and is able to comply with the study protocol.
- Male or female between 18 and 45 years of age inclusive, at the time of signing the informed consent.
- Healthy as determined by a physician, based on a detailed medical history and a complete physical examination including vital signs and laboratory measurements.
- Body weight >= 50 kg and body mass index (BMI) within the range 18 to 30 kilogram/meter squared (inclusive).
- Female participants of child bearing potential: Females of child bearing potential are eligible to enter if they are not pregnant (negative pregnancy test on the day of both screening and vaccination) and willing to use effective methods of contraception to prevent pregnancy from the time of first dose to 60 days afterwards.
- Male participants with female partners of child-bearing potential: must agree to use effective methods of contraception from the time of the first dose of challenge agent to 60 days afterwards.
- At least 2 previous doses of a registered SARS-CoV2 vaccination, at least 60 days previously
- Sufficient English language ability to enable appropriate informed consent procedures to be conducted in English
Who cannot join
- Antibiotics or antiviral therapy after a serious illness within 30 days of study entry.
- SARS CoV2 (COVID-19) infection within the previous 30 days, diagnosed using PCR test or lateral flow device
- Any use of immunosuppressant or immunomodulatory agents (systemic or topical) in 3 months prior to study entry.
- Chronic medical conditions with potential effect on immune responses including diabetes, significant history of atopy, or any condition that, in the opinion of the investigator, would interfere with the study
- Presence of tattoos, naevi or other skin abnormalities such as keloids (or history of keloids) that may, in the opinion of the investigator, interfere with study assessments.
- Fitzpatrick skin type V and VI (due to potential interference with assessment of DTH response)
Show all 16Show fewer
- Pregnancy or breastfeeding
- Allergy to KLH, aluminium hydroxide, Montanide ISA-51, related vaccine adjuvants, or components of the study challenge agents
- Allergy to shellfish
- Residency in or significant previous travel to areas endemic for schistosomiasis (due to potential cross-reactive immune responses to KLH)
- Previous exposure to Keyhole Limpet Haemocyanin, e.g. in the context of a previous study
- Participants participating, within 7 days of screening, in recreational sun-bathing, or use of sun-bed, on the area of the skin from wrist to shoulder inclusive.
- Phobia of needles or minor surgical procedures.
- Current smoker or using nicotine replacement therapy
- Participants receiving any vaccinations within 2 months prior to screening visit, or will require vaccination prior to the end of study follow-up.
- Any other significant disease, disorder, or finding, which, in the opinion of the investigator, may either put the participant at risk, affect their ability to participate in the study or impair interpretation of the study data
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
NIHR Oxford Experimental Medicine Clinical Research Facility
Oxford, OX37LE
OxCRF Operational Lead, 01865 737846, oxcrf@ndorms.ox.ac.uk
About this study
Official title: Varying Keyhole Limpet Haemocyanin-adjuvant Dose Combinations to Explore the Immune Response: a Human Challenge Study
One approach to improve the efficiency of the drug development process is the use of human 'immune challenge' studies. In these studies, healthy volunteers are given small amounts of substances which are foreign to their immune system to provoke a temporary response: the 'challenge'. Depending on the nature and dose of the challenge, the body's immune system will react in a different but predictable way, elements of which mimic those seen in disease, thereby 'modelling' them. These models can help safely bridge the gap between animal experiments and patient groups and, if sufficiently understood, test the effect of new drugs without exposing patients to risk. Sadly, whilst immune challenge models have been used in drug development for many years, this has been done in a largely non-standardised, ad hoc manner, which greatly limits the usefulness of the approach.
The purpose of this research is to better understand, improve, and standardise a common method of immune challenge which uses a protein called 'Keyhole Limpet Haemocyanin' (KLH). KLH is available as a highly-purified formulation, and because it is not usually encountered by the human immune system (it is derived from an inedible shellfish), it allows us to study the development of immune responses right from the time it is administered. We plan to give different groups of healthy volunteers different doses of KLH with or without an 'immune-boosting' agent (Alhydrogel™ or Montanide ISA™51, commonly referred to as adjuvants), before measuring and comparing their response. We will then re-challenge all the volunteers a month later by injecting different doses of KLH into the skin on their forearms, similar to an allergy test, taking images, blood samples and skin biopsies to understand the nature, time course, and variability of the immune response in each individual. No previous studies have directly explored the effects of KLH dose or adjuvants in a rigorous manner. The results will help us to determine both whether administering KLH with different adjuvants elicits qualitatively different immune response profiles (thus modelling different diseases) and the optimal doses of KLH to evaluate new drugs with. In turn, we hope this will help improve the percentage of drugs progressing from concept to clinical therapy, addressing unmet health needs.
Read the detailed description
This is a single blind, parallel group, two-phase challenge study to determine the relative immunogenicity of subunit KLH, with and without aluminium hydroxide adjuvant, in healthy UK volunteers aged 18-45. The prime dose of subunit KLH (+/- aluminium hydroxide or Montanide ISA-51) will be administered IM, and the re-challenge dose of subunit KLH for assessment of DTH will be administered ID.
This trial will be conducted at a Clinical Research Facility based at the University of Oxford supporting researchers from Oxford University Joint Research Office (JRO) approved research.
There will be 7 randomised study groups (plus one non-randomised 'blood sample only' group, group 8 - see section 8.6) and it is anticipated that a maximum of 39 volunteers will be enrolled (excluding dropouts). Eligible participants will be randomised into any of 7 study groups (section 7.1) according to study phase. Randomisation and enrolment will occur in two phases. Phase 1 will consist of group 1 (placebo prime dose) and the standard (1000mcg) KLH dose +/- adjuvant groups (2, 3, and 4). Following interim analysis of data from these 21 participants, recruitment into Phase 2 (the lower [10mcg] KLH dose groups: groups 5,6,7) will occur provided there is sufficient evidence of immunogenicity in the standard dose group.
Should participants withdraw or dropout of the study, replacement volunteers will be enrolled to ensure the target number of participants per group is achieved with all participants competing the full follow-up period. A maximum of 6 additional volunteers may be sought for this purpose.
- Conditions
- Immune Response
- Being tested
- Keyhole-Limpet Hemocyanin, Saline, Montanide ISA 51 VG, Alhydrogel
- Keywords
- Keyhole Limpet Hemocyanin, Keyhole Limpet Haemocyanin, KLH, Human immune challenge, Proof of mechanism, Experimental Medicine, Adjuvant, Montanide, Alhydrogel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Keyhole-Limpet HemocyaninBiological
Also called KLH, Immucothel
Sub-unit Keyhole Limpet Haemocyanin (KLH, Immucothel, Biosyn, Fellbach, Germany)
SalineDrug
Also called Normal saline, 0.9% Saline
Placebo intervention.
Montanide ISA 51 VGDrug
Also called Montanide ISA 51
Montanide ISA-51 (Seppic, France) is a water-in-oil vaccine adjuvant
AlhydrogelDrug
Also called Aluminum hydroxide adjuvant 2%
Alhydrogel is a vaccine adjuvant
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Saline 0.9% (placebo) primary dose | Placebo comparator | IM saline 0.9% (placebo) day 0, followed by multi-dose ID subunit KLH (0 mcg (saline), 1 mcg, 3 mcg, 10mcg, 30mcg, 100mcg) day 28 Receives: Drug: Saline |
| Group 2: subunit KLH 1000mcg primary dose | Active comparator | IM dose subunit KLH 1000 mcg day 0, followed by multi-dose ID subunit KLH (0 mcg (saline), 1 mcg, 3 mcg, 10mcg, 30mcg, 100mcg) day 28 Receives: Biological: Keyhole-Limpet Hemocyanin |
| Group 3: subunit KLH 1000mcg plus aluminium hydroxide adjuvant 900mcg primary dose | Active comparator | IM dose subunit KLH 1000 mcg plus aluminium hydroxide 900mcg day 0, followed by multi-dose ID subunit KLH (0 mcg (saline), 1 mcg, 3 mcg, 10mcg, 30mcg, 100mcg) day 28 Receives: Biological: Keyhole-Limpet Hemocyanin; Drug: Alhydrogel |
| Group 4: subunit KLH 1000mcg plus Montanide ISA-51 primary dose | Active comparator | IM dose subunit KLH 1000 mcg plus Montanide ISA-51 day 0, followed by multi-dose ID subunit KLH (0 mcg (saline), 1 mcg, 3 mcg, 10mcg, 30mcg, 100mcg) day 28 Receives: Biological: Keyhole-Limpet Hemocyanin; Drug: Montanide ISA 51 VG |
| Group 5: subunit KLH 10mcg primary dose | Active comparator | IM dose subunit KLH 10 mcg day 0, followed by multi-dose ID subunit KLH (0 mcg (saline), 1 mcg, 3 mcg, 10mcg, 30mcg, 100mcg) day 28 Receives: Biological: Keyhole-Limpet Hemocyanin |
| Group 6: subunit KLH 10mcg plus aluminium hydroxide adjuvant 900mcg primary dose | Active comparator | IM dose subunit KLH 10 mcg plus aluminium hydroxide 900mcg day 0, followed by multi-dose ID subunit KLH (0 mcg (saline), 1 mcg, 3 mcg, 10mcg, 30mcg, 100mcg) day 28 Receives: Biological: Keyhole-Limpet Hemocyanin; Drug: Alhydrogel |
| Group 7: subunit KLH 10mcg plus Montanide ISA-51 primary dose | Active comparator | IM dose subunit KLH 10 mcg plus Montanide ISA-51 day 0, followed by multi-dose ID subunit KLH (0 mcg (saline), 1 mcg, 3 mcg, 10mcg, 30mcg, 100mcg) day 28 Receives: Biological: Keyhole-Limpet Hemocyanin; Drug: Montanide ISA 51 VG |
| Group 8: Blood-sample only group (non-randomised) | No intervention | No challenge agent, blood sampling only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish the immunogenicity of subunit KLH at different doses, with and without aluminium hydroxide or Montanide ISA-51 adjuvants
Proportion of participants with >2-fold increase over baseline (D0) in anti-KLH IgG antibody titre by ELISA in each group
Measured: Day 28
Secondary outcomes (5)
Determine whether different doses of subunit KLH, with and without aluminium hydroxide or Montanide ISA-51 adjuvants, elicit predominantly TH1, TH2 or balanced responses
Ratio of TH1:TH2 antigen responsive cells based on number of IFN- γ (TH1) and IL-4 (TH2) producing PBMCs (cells per 10^6 PBMC) in response to KLH stimulation by ELISpot in each group.
Measured: Day 28
Within-participant dose-response to intradermal KLH on day Day 28: skin induration response (EC50)
Intradermal KLH dose required for 50 percent of maximal induration response (EC50, measured in mm)
Measured: Day 30 (48 hours after Day 28 KLH re-challenge)
Within-participant dose-response to intradermal KLH on day Day 28: skin induration response (Emax)
Maximal induration response to intradermal KLH dose (Emax, measured in mm)
Measured: Day 30 (48 hours after Day 28 KLH re-challenge)
Within-participant dose-response to intradermal KLH on day Day 28: skin erythema response (EC50)
Intradermal KLH dose required for 50 percent of maximal erythema response (EC50, measured in mm)
Measured: Day 30 (48 hours after Day 28 KLH re-challenge)
Within-participant dose-response to intradermal KLH on day Day 28: skin erythema response (Emax)
Maximal erythema response to intradermal KLH dose (Emax, measured in mm)
Measured: Day 30 (48 hours after Day 28 KLH re-challenge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start1 Mar 2023
- Primary completionOct 2023 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ResponseStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group randomised experimental medicine study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- James Fullerton, MBBS, Principal investigator, NDORMS, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876195
- Sponsor's protocol ID
- 16114
- Status last verified
- Mar 2023
- First submitted
- 17 Mar 2023
- Last updated
- 25 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only non-identifiable data anonymised to the ICO Anonymisation: managing data protection risk code of practice generated in this study will be suitable for sharing. We will adhere to the MRC's policy on data sharing. ORA-data offers a means for Oxford's researchers to openly share non-confidential research data, without the need for external data users to undergo authentication. Each deposit is accompanied by appropriate metadata and is assigned a unique Digital Object Identifier (DOI) via the DataCite scheme, allowing it to be cited in publications. Directions to key datasets will also be made available via the group's web page on the Institute's web site. Appropriate metadata will be published with research data to enable other researchers to identify whether the data could be suitable for their own research.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Varying Keyhole Limpet Haemocyanin-adjuvant Dose Combinations to Explore the Immune Response: a Human Challenge Study
- ClinicalTrials.gov ID
- NCT05876195
- Acronym / sponsor ID
- 16114
- Conditions
- Immune Response
- Keywords
- Keyhole Limpet Hemocyanin, Keyhole Limpet Haemocyanin, KLH, Human immune challenge, Proof of mechanism, Experimental Medicine, Adjuvant, Montanide
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 25 May 2023 (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.
One approach to improve the efficiency of the drug development process is the use of human 'immune challenge' studies. In these studies, healthy volunteers are given small amounts of substances which are foreign to their immune system to provoke a temporary response: the 'challenge'. Depending on the nature and dose of the challenge, the body's immune system will react in a different but predictable way, elements of which mimic those seen in disease, thereby 'modelling' them. These models can help safely bridge the gap between animal experiments and patient groups and, if sufficiently understood, test the effect of new drugs without exposing patients to risk. Sadly, whilst immune challenge models have been used in drug development for many years, this has been done in a largely non-standardised, ad hoc manner, which greatly limits the usefulness of the approach.
The purpose of this research is to better understand, improve, and standardise a common method of immune challenge which uses a protein called 'Keyhole Limpet Haemocyanin' (KLH). KLH is available as a highly-purified formulation, and because it is not usually encountered by the human immune system (it is derived from an inedible shellfish), it allows us to study the development of immune responses right from the time it is administered. We plan to give different groups of healthy volunteers different doses of KLH with or without an 'immune-boosting' agent (Alhydrogel™ or Montanide ISA™51, commonly referred to as adjuvants), before measuring and comparing their response. We will then re-challenge all the volunteers a month later by injecting different doses of KLH into the skin on their forearms, similar to an allergy test, taking images, blood samples and skin biopsies to understand the nature, time course, and variability of the immune response in each individual. No previous studies have directly explored the effects of KLH dose or adjuvants in a rigorous manner. The results will help us to determine both whether administering KLH with different adjuvants elicits qualitatively different immune response profiles (thus modelling different diseases) and the optimal doses of KLH to evaluate new drugs with. In turn, we hope this will help improve the percentage of drugs progressing from concept to clinical therapy, addressing unmet health needs.
Detailed description
This is a single blind, parallel group, two-phase challenge study to determine the relative immunogenicity of subunit KLH, with and without aluminium hydroxide adjuvant, in healthy UK volunteers aged 18-45. The prime dose of subunit KLH (+/- aluminium hydroxide or Montanide ISA-51) will be administered IM, and the re-challenge dose of subunit KLH for assessment of DTH will be administered ID.
This trial will be conducted at a Clinical Research Facility based at the University of Oxford supporting researchers from Oxford University Joint Research Office (JRO) approved research.
There will be 7 randomised study groups (plus one non-randomised 'blood sample only' group, group 8 - see section 8.6) and it is anticipated that a maximum of 39 volunteers will be enrolled (excluding dropouts). Eligible participants will be randomised into any of 7 study groups (section 7.1) according to study phase. Randomisation and enrolment will occur in two phases. Phase 1 will consist of group 1 (placebo prime dose) and the standard (1000mcg) KLH dose +/- adjuvant groups (2, 3, and 4). Following interim analysis of data from these 21 participants, recruitment into Phase 2 (the lower [10mcg] KLH dose groups: groups 5,6,7) will occur provided there is sufficient evidence of immunogenicity in the standard dose group.
Should participants withdraw or dropout of the study, replacement volunteers will be enrolled to ensure the target number of participants per group is achieved with all participants competing the full follow-up period. A maximum of 6 additional volunteers may be sought for this purpose.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 8
- Model description
- Parallel group randomised experimental medicine study
| Arm | Type | Receives |
|---|---|---|
| Group 1: Saline 0.9% (placebo) primary dose | Placebo comparator | Drug: SalineIM saline 0.9% (placebo) day 0, followed by multi-dose ID subunit KLH (0 mcg (saline), 1 mcg, 3 mcg, 10mcg, 30mcg, 100mcg) day 28 |
| Group 2: subunit KLH 1000mcg primary dose | Active comparator | Biological: Keyhole-Limpet HemocyaninIM dose subunit KLH 1000 mcg day 0, followed by multi-dose ID subunit KLH (0 mcg (saline), 1 mcg, 3 mcg, 10mcg, 30mcg, 100mcg) day 28 |
| Group 3: subunit KLH 1000mcg plus aluminium hydroxide adjuvant 900mcg primary dose | Active comparator | Biological: Keyhole-Limpet Hemocyanin, Drug: AlhydrogelIM dose subunit KLH 1000 mcg plus aluminium hydroxide 900mcg day 0, followed by multi-dose ID subunit KLH (0 mcg (saline), 1 mcg, 3 mcg, 10mcg, 30mcg, 100mcg) day 28 |
| Group 4: subunit KLH 1000mcg plus Montanide ISA-51 primary dose | Active comparator | Biological: Keyhole-Limpet Hemocyanin, Drug: Montanide ISA 51 VGIM dose subunit KLH 1000 mcg plus Montanide ISA-51 day 0, followed by multi-dose ID subunit KLH (0 mcg (saline), 1 mcg, 3 mcg, 10mcg, 30mcg, 100mcg) day 28 |
| Group 5: subunit KLH 10mcg primary dose | Active comparator | Biological: Keyhole-Limpet HemocyaninIM dose subunit KLH 10 mcg day 0, followed by multi-dose ID subunit KLH (0 mcg (saline), 1 mcg, 3 mcg, 10mcg, 30mcg, 100mcg) day 28 |
| Group 6: subunit KLH 10mcg plus aluminium hydroxide adjuvant 900mcg primary dose | Active comparator | Biological: Keyhole-Limpet Hemocyanin, Drug: AlhydrogelIM dose subunit KLH 10 mcg plus aluminium hydroxide 900mcg day 0, followed by multi-dose ID subunit KLH (0 mcg (saline), 1 mcg, 3 mcg, 10mcg, 30mcg, 100mcg) day 28 |
| Group 7: subunit KLH 10mcg plus Montanide ISA-51 primary dose | Active comparator | Biological: Keyhole-Limpet Hemocyanin, Drug: Montanide ISA 51 VGIM dose subunit KLH 10 mcg plus Montanide ISA-51 day 0, followed by multi-dose ID subunit KLH (0 mcg (saline), 1 mcg, 3 mcg, 10mcg, 30mcg, 100mcg) day 28 |
| Group 8: Blood-sample only group (non-randomised) | No intervention | –No challenge agent, blood sampling only. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Participant is willing and able to give informed consent for participation in the study and is able to comply with the study protocol.
- Male or female between 18 and 45 years of age inclusive, at the time of signing the informed consent.
- Healthy as determined by a physician, based on a detailed medical history and a complete physical examination including vital signs and laboratory measurements.
- Body weight >= 50 kg and body mass index (BMI) within the range 18 to 30 kilogram/meter squared (inclusive).
- Female participants of child bearing potential: Females of child bearing potential are eligible to enter if they are not pregnant (negative pregnancy test on the day of both screening and vaccination) and willing to use effective methods of contraception to prevent pregnancy from the time of first dose to 60 days afterwards.
Key exclusion criteria (16 listed)
- Antibiotics or antiviral therapy after a serious illness within 30 days of study entry.
- SARS CoV2 (COVID-19) infection within the previous 30 days, diagnosed using PCR test or lateral flow device
- Any use of immunosuppressant or immunomodulatory agents (systemic or topical) in 3 months prior to study entry.
- Chronic medical conditions with potential effect on immune responses including diabetes, significant history of atopy, or any condition that, in the opinion of the investigator, would interfere with the study
- Presence of tattoos, naevi or other skin abnormalities such as keloids (or history of keloids) that may, in the opinion of the investigator, interfere with study assessments.
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 |
|---|---|---|
| Keyhole-Limpet HemocyaninAlso: KLH, ImmucothelSub-unit Keyhole Limpet Haemocyanin (KLH, Immucothel, Biosyn, Fellbach, Germany) | Biological | Group 2: subunit KLH 1000mcg primary dose, Group 3: subunit KLH 1000mcg plus aluminium hydroxide adjuvant 900mcg primary dose, Group 4: subunit KLH 1000mcg plus Montanide ISA-51 primary dose, Group 5: subunit KLH 10mcg primary dose, Group 6: subunit KLH 10mcg plus aluminium hydroxide adjuvant 900mcg primary dose, Group 7: subunit KLH 10mcg plus Montanide ISA-51 primary dose |
| SalineAlso: Normal saline, 0.9% SalinePlacebo intervention. | Drug | Group 1: Saline 0.9% (placebo) primary dose |
| Montanide ISA 51 VGAlso: Montanide ISA 51Montanide ISA-51 (Seppic, France) is a water-in-oil vaccine adjuvant | Drug | Group 4: subunit KLH 1000mcg plus Montanide ISA-51 primary dose, Group 7: subunit KLH 10mcg plus Montanide ISA-51 primary dose |
| AlhydrogelAlso: Aluminum hydroxide adjuvant 2%Alhydrogel is a vaccine adjuvant | Drug | Group 3: subunit KLH 1000mcg plus aluminium hydroxide adjuvant 900mcg primary dose, Group 6: subunit KLH 10mcg plus aluminium hydroxide adjuvant 900mcg primary dose |
Primary outcome
To establish the immunogenicity of subunit KLH at different doses, with and without aluminium hydroxide or Montanide ISA-51 adjuvants
Time frame: Day 28
Proportion of participants with >2-fold increase over baseline (D0) in anti-KLH IgG antibody titre by ELISA in each group
5 secondary outcomes
Determine whether different doses of subunit KLH, with and without aluminium hydroxide or Montanide ISA-51 adjuvants, elicit predominantly TH1, TH2 or balanced responses
Time frame: Day 28
Within-participant dose-response to intradermal KLH on day Day 28: skin induration response (EC50)
Time frame: Day 30 (48 hours after Day 28 KLH re-challenge)
Within-participant dose-response to intradermal KLH on day Day 28: skin induration response (Emax)
Time frame: Day 30 (48 hours after Day 28 KLH re-challenge)
Within-participant dose-response to intradermal KLH on day Day 28: skin erythema response (EC50)
Time frame: Day 30 (48 hours after Day 28 KLH re-challenge)
Within-participant dose-response to intradermal KLH on day Day 28: skin erythema response (Emax)
Time frame: Day 30 (48 hours after Day 28 KLH re-challenge)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Individual participant dataSharing planned: Yes. Only non-identifiable data anonymised to the ICO Anonymisation: managing data protection risk code of practice generated in this study will be suitable for sharing. We will adhere to the MRC's policy on data sharing. ORA-data offers a means for Oxford's researchers to openly share non-confidential research data, without the need for external data users to undergo authentication. Each deposit is accompanied by appropriate metadata and is assigned a unique Digital Object Identifier (DOI) via the DataCite scheme, allowing it to be cited in publications. Directions to key datasets will also be made available via the group's web page on the Institute's web site. Appropriate metadata will be published with research data to enable other researchers to identify whether the data could be suitable for their own research.
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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.
James Fullerton, MBBS principal investigator
NDORMS, University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Keyhole-Limpet Hemocyanin, Saline and Montanide ISA 51 VG in people with Immune Response, run by University of Oxford 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 8 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 25 May 2023. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oxford University RGEA (01865 (6)16491, rgea.sponsor@admin.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To establish the immunogenicity of subunit KLH at different doses, with and without aluminium hydroxide or Montanide ISA-51 adjuvants (time frame: Day 28). 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 25 May 2023.