HealthyNCT05174624
The Healthy Human Global Project - Hong Kong (HHGP-Hong Kong)
An observational study of Healthy and Immune System and Related Disorders, run by Centre for Immunology & Infection at 1 site in China.
Trial summary
The Healthy Human Global Project-Hong Kong aims to elucidate the heritable and non-heritable factors that drive immunological variance within a healthy population in Hong Kong. By gaining a deeper understanding of these parameters, a path can be paved for personalised and precision medicine, tailored for an Asian… Read more about this study
- Who is it for?
- Ages 20 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Immune System and Related Disorders
- How many people
- 1,026 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 14 Sep 2023
- Phase
- Observational
- 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 20 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The HHGP- Hong Kong will recruit 1,000 healthy participants, drawn from the FAMILY Cohort, its affiliates, or Hong Kong residents, to better understand the immunological variance within the Hong Kong population. This Cohort was part of a prospective population-based study in 2007, consisting of 46,001 participants in Hong Kong. It was the first large-scale programme to understand the determinants of physical, mental, and social wellbeing in Hong Kong. The Cohort has an excellent (99.8%) coverage of the neighbourhoods in Hong Kong and represents roughly 1% of all households, which enables detailed studies linking the social environment to physical and mental health.
Who may be able to join
- Subjects considered as healthy by the investigator based on medical history, clinical examination, laboratory results and ECG (blood sampling for laboratory assessments and ECG should be done at V0 and only after signed informed consent)
- Subjects who, according to the investigator, can and will comply with the requirements of the protocol and are available for all scheduled visits at the investigational site.
- Healthy male or female aged between 20 and 79 (included) years
- Self-declared Han ethnicity for 3 generations
- Body mass index (BMI) of ≥ 18.5 and ≤ 27.0 kg/m²
- Ability to give their informed consent in writing
- Must understand spoken Cantonese and written Chinese
- Current participants enrolled in the FAMILY Cohort or their affiliates (i.e. any individuals referred by a FAMILY Cohort participant), or Hong Kong residents.
Who cannot join
- Participation in the last 3 months or concurrent participation in another clinical study in which the subject has been exposed to a medical intervention including but not limited to pharmaceutical product or placebo or medical device
- First-degree relative to previously recruited individuals in the study cohort
- For women: pregnant or breastfeeding or intending to become pregnant or peri-menopausal
- 3.1 Peri-menopausal women as defined by menstrual irregularity: either a change in the menstrual cycle length of more than seven days (early perimenopause) or two or more missed periods with an interval of 60 days or more between periods (late perimenopause)
- Any physical exercise within the last 4 hours before inclusion (V1)
- Subjects following a special diet for medical reasons as prescribed by a general practitioner or dietician (e.g. calorie-restricted or weight-loss diet for significant overweight, cholesterol-lowering diet or subjects suffering from any clinically diagnosed food allergy or intolerance)
Show all 39Show fewer
- Binge drinking (drinking at least 5 cans of beer, 5 glasses of table wines or 5 pegs of spirits on a single occasion), >2 episodes within 3 months before inclusion
- Illicit drug use or substance abuse within 3 months before inclusion
- Presence of evidence of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to participate in the study satisfactorily.
- Severe/chronic/recurrent pathological conditions, among them:
- 9.1. Past or present diagnosed cancer, lymphoma, leukaemia
- 9.2. Personal history of organ transplant
- 9.3. Congenital or acquired immune deficiency (any confirmed or suspected immunosuppressive or immunodeficient condition, including a history of HIV infection)
- 9.4. Personal history of auto-immune diseases requiring or having previously required treatment (e.g. Rheumatoid Arthritis, Systemic Lupus Erythematosus, Sarcoidosis, Ankylosing Spondylitis, Autoimmune Haemolytic Anaemia, Autoimmune Thrombocytopenic Purpura, Crohn's Disease, Psoriasis, Scleroderma, Wegener's Granulomatosis, Type I Diabetes, Thyroiditis etc.)
- 9.5. Splenectomy
- 9.6. Acute or chronic, clinically significant, as determined by the investigator, pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests
- 9.7. History of clinically significant, as determined by the investigator, neurological disorder of seizures
- 9.8. Infectious diseases
- 9.8.1. Chronic/ latent infection (e.g. HIV, hepatitis B virus, hepatitis C virus, HTLV, except herpes viruses such as CMV and VZV) or current acute infection or past acute infection based on investigator's judgment within the last 3 months,
- 9.8.2. Presence of a rectal temperature ≥38.4°C, or axillary temperature ≥37.5°C, or intra-auricular temperature ≥38.4 °C, or buccal temperature ≥38°C on the scheduled date of inclusion,
- 9.8.3. Subject receiving (currently or in the last 3 months) antibiotics, intestinal, nasal or respiratory antiseptics.
- 9.9. Severe High Blood Pressure, defined as systolic BP≥160 mmHg and/or diastolic BP≥100 mmHg (2020 International Society of Hypertension Global Hypertension Practice Guidelines, grade 2 hypertension). Treated and controlled high blood pressure or documented white coat hypertension is allowed.
- 9.10. Type II diabetes mellitus requiring treatment with any medication. Diabetes mellitus treated by exercise and diet control only is permitted.
- 9.11. Chronic renal impairment as defined by Renal Insufficiency: glomerular filtration rate (GFR) <60 mL/min/1.73 m²16
- 9.12. Chronic bone disease as treated by bisphosphonates
- 9.13. Any significant disorder of coagulation or treatment with direct oral anticoagulants (DOACs) or warfarin derivatives or heparin or antiplatelet medications within 2 months preceding inclusion.
- 9.14. Dermatologic conditions: any current dermatological disorder that is severe enough to prevent skin biopsy (e.g. eczema, psoriasis, acute or chronic dermatitis)
- 9.15. Severe acute and chronic allergy
- 9.15.1. Severe Asthma defined as asthma that is uncontrolled despite adherence with optimized high dose inhaled corticosteroid- long-acting beta2-agonist (ICS-LABA) therapy and treatment of contributory factors, or that worsens when high dose treatment is decreased,
- 9.15.2. Severe food allergy, as defined by a history of giant urticaria, Quincke oedema or anaphylactic shock,
- 9.15.3. Severe insect bite allergy with a history of giant urticaria, Quincke oedema or anaphylactic shock,
- 9.15.4. Atopic dermatitis treated with medication.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within the 6 months before the inclusion. For corticosteroids, this will mean a dose equivalent to 20 mg/day of prednisone or equivalent for > 2 weeks (inhaled and topical steroids allowed)
- Chronic administration of NSAIDs, including aspirin: prolonged intake (> 2 weeks) within 6 months before the study or any intake [exception for low dose aspirin: maximum 250mg/daily]
- Receipt of any vaccination 6 weeks before the inclusion or planning to receive any vaccination during the study
- Receipt of blood products or immunoglobulins within 3 months before the inclusion or planning to receive blood products or immunoglobulins during the study
- Haemoglobin measurement less than 10.0 g/dL for women and less than 11.5 g/dL for men
- Platelet count less than 120.000/mm3
- Alanine aminotransferase (ALAT) and/or aspartate transaminase (ASAT) > 3 times the upper limit of the norm (ULN)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Healthy Human Global Project - Hong Kong: A Community-based Cross-sectional Study on Genetic and Environmental Determinants of Immune Phenotype Variance in a Healthy Asian Population - Establishing a Path Towards Personalized Medicine
The Healthy Human Global Project-Hong Kong aims to elucidate the heritable and non-heritable factors that drive immunological variance within a healthy population in Hong Kong. By gaining a deeper understanding of these parameters, a path can be paved for personalised and precision medicine, tailored for an Asian population.
Read the detailed description
The Healthy Human Global Project-Hong Kong (HHGP-Hong Kong) is built upon the Milieu Intérieur Consortium, a population-based study coordinated by the Institut Pasteur in Paris since 2011 (ClinicalTrials.gov study numbers NCT01699893 and NCT03905993). The Milieu Intérieur comprised of 1,000 healthy participants that are unrelated, and of Western European ancestry, to investigate inter-individual immunological variances by integrating intrinsic, environmental and genetic factors in innate immunity and adaptive immunity. Through the quantification of white blood cells by utilising standardised flow cytometry and correlating with sociodemographic variables, the Institut Pasteur team found that smoking, age, sex, and latent infection with cytomegalovirus, were the main non-genetic factors that affected variation in parameters of human immune cells.
The HHGP-Hong Kong will, therefore, replicate and adapt from the study design of Milieu Intérieur recruiting 1,000 healthy participants, drawn from the FAMILY Cohort, to better understand the immunological variance within the Hong Kong population. This Cohort was part of a prospective population-based study in 2007, consisting of 46,001 participants in Hong Kong. It was the first large-scale programme to understand the determinants of physical, mental, and social wellbeing in Hong Kong.
A technological platform will be developed to provide a personalized patient management strategy that takes into account individual genetics, previous infection history, resident microbiota, as well as personal lifestyle and environmental factors to define immune health.
- Conditions
- Healthy, Immune System and Related Disorders
- Being tested
- No intervention
- Keywords
- Community based cross-sectional study, Observational cohort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| FAMILY Cohort | This Cohort was part of a prospective population-based study in 2007, consisting of 46,001 participants in Hong Kong. It was the first large-scale programme to understand the determinants of physical, mental, and social wellbeing in Hong Kong. The Cohort has an excellent (99.8%) coverage of the neighbourhoods in Hong Kong and represents roughly 1% of all households, which enables detailed studies linking the social environment to physical and mental health. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors underlying immunological variance within the general healthy population
To identify factors (genetic, immunology and environmental) that contributes to the observed heterogeneity in immune responses (individual and population levels)
Measured: Through study completion, an average of 1 year
Naturally occurring variability of human response
To characterise the naturally occurring variability of human response using whole genome sequencing and single nucleotide polymorphisms (SNPs) haplotyping
Measured: Through study completion, an average of 1 year
Stimulated cytokine/chemokine measurement
To determine and measure cytokine/chemokine stimulated by 16 pattern-recognition receptors agonists (PRR agonists) or immune stimulators
Measured: Through study completion, an average of 1 year
Characterisation of commensal airway and gut microbiota
To characterise commensal microbiota (nasopharyngeal swab and stool samples) in the study population
Measured: Through study completion, an average of 1 year
Metagenomic architecture of faecal and nasal samples
To evaluate the metagenomic architecture of the population based on sequence analysis of bacterial, fungal and viral populations in faecal and nasal samples
Measured: Through study completion, an average of 1 year
Immune response and nutrition association
To associate immune response with nutrition data
Measured: Through study completion, an average of 1 year
Immune phenotype variance association with genetic polymorphisms and enterotype
To associate immune phenotype variance with genetic polymorphisms and enterotype
Measured: Through study completion, an average of 1 year
Heart rate variability with clinical and epidemiological data association
To associate heart rate variability with clinical and epidemiological data
Measured: Through study completion, an average of 1 year
Inflammation with physical and mental health outcome association
To associate inflammation with physical and mental health outcomes
Measured: Through study completion, an average of 1 year
Secondary outcomes (3)
Genotype-to-phenotype associations at a mechanistic level
To determine genotype-to-phenotype associations at a mechanistic level
Measured: Through study completion, an average of 1 year
Retrospective and prospective clinical and epidemiological data correlation with FAMILY Cohort
To correlate retrospective and prospective clinical data with and epidemiological data from the FAMILY Cohort
Measured: Through study completion, an average of 1 year
Immune variation comparison between healthy European (Milieu Intérieur) and Asian (HHGP- Hong Kong) populations
To compare immune variation between healthy European (Milieu Intérieur) and Asian (HHGP- Hong Kong) populations
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2022
- Study start1 Jul 2022
- Primary completion14 Sep 2023
- Study completion14 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,026 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Immunology & Infection
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong, Institut Pasteur
- Responsible party
- Sponsor
- Investigators
- James Di Santo, Principal investigator, Centre for Immunology & InfectionDarragh Duffy, Principal investigator, Centre for Immunology & InfectionMichael Ni, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05174624
- Sponsor's protocol ID
- UW21-549
- Other IDs
- HKUCTR-2959
- Status last verified
- Oct 2023
- First submitted
- 1 Dec 2021
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All personal information obtained in the research project will remain strictly confidential and will not be disclosed to or seen by any person other than the authorised researchers involved. All information obtained about the participants will be stored in a locked cabinet in a security-accessible area, and also in a password-protected database at The School of Public Health, The University of Hong Kong. All personal data will be anonymised for data analysis. Data and information may be inspected by regulatory authorities of academic research, such as the Institutional Review Board of the University of Hong Kong / Hospital Authority Hong Kong West Cluster, with the accompany of research staff. Any data and sample access request from local/international researchers or collaborators must comply with regulations as elaborated by international bodies/agreements including Declaration of Helsinki.
Publications
Delhalle S, Bode SFN, Balling R, Ollert M, He FQ. A roadmap towards personalized immunology. NPJ Syst Biol Appl. 2018 Feb 6;4:9. doi: 10.1038/s41540-017-0045-9. eCollection 2018.
PubMed 29423275Tsang JS, Schwartzberg PL, Kotliarov Y, Biancotto A, Xie Z, Germain RN, Wang E, Olnes MJ, Narayanan M, Golding H, Moir S, Dickler HB, Perl S, Cheung F; Baylor HIPC Center; CHI Consortium. Global analyses of human immune variation reveal baseline predictors of postvaccination responses. Cell. 2014 Apr 10;157(2):499-513. doi: 10.1016/j.cell.2014.03.031.
PubMed 24725414Carr EJ, Dooley J, Garcia-Perez JE, Lagou V, Lee JC, Wouters C, Meyts I, Goris A, Boeckxstaens G, Linterman MA, Liston A. The cellular composition of the human immune system is shaped by age and cohabitation. Nat Immunol. 2016 Apr;17(4):461-468. doi: 10.1038/ni.3371. Epub 2016 Feb 15.
PubMed 26878114Aziz N, Detels R, Quint JJ, Gjertson D, Ryner T, Butch AW. Biological variation of immunological blood biomarkers in healthy individuals and quality goals for biomarker tests. BMC Immunol. 2019 Sep 14;20(1):33. doi: 10.1186/s12865-019-0313-0.
PubMed 31521107Brodin P, Davis MM. Human immune system variation. Nat Rev Immunol. 2017 Jan;17(1):21-29. doi: 10.1038/nri.2016.125. Epub 2016 Dec 5.
PubMed 27916977Whitacre CC. Sex differences in autoimmune disease. Nat Immunol. 2001 Sep;2(9):777-80. doi: 10.1038/ni0901-777. No abstract available.
PubMed 11526384Thomas S, Rouilly V, Patin E, Alanio C, Dubois A, Delval C, Marquier LG, Fauchoux N, Sayegrih S, Vray M, Duffy D, Quintana-Murci L, Albert ML; Milieu Interieur Consortium. The Milieu Interieur study - an integrative approach for study of human immunological variance. Clin Immunol. 2015 Apr;157(2):277-93. doi: 10.1016/j.clim.2014.12.004. Epub 2015 Jan 3.
PubMed 25562703Patin E, Hasan M, Bergstedt J, Rouilly V, Libri V, Urrutia A, Alanio C, Scepanovic P, Hammer C, Jonsson F, Beitz B, Quach H, Lim YW, Hunkapiller J, Zepeda M, Green C, Piasecka B, Leloup C, Rogge L, Huetz F, Peguillet I, Lantz O, Fontes M, Di Santo JP, Thomas S, Fellay J, Duffy D, Quintana-Murci L, Albert ML; Milieu Interieur Consortium. Natural variation in the parameters of innate immune cells is preferentially driven by genetic factors. Nat Immunol. 2018 Mar;19(3):302-314. doi: 10.1038/s41590-018-0049-7. Epub 2018 Feb 23.
PubMed 29476184
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Healthy Human Global Project - Hong Kong: A Community-based Cross-sectional Study on Genetic and Environmental Determinants of Immune Phenotype Variance in a Healthy Asian Population - Establishing a Path Towards Personalized Medicine
- ClinicalTrials.gov ID
- NCT05174624
- Acronym / sponsor ID
- UW21-549
- Conditions
- Healthy, Immune System and Related Disorders
- Keywords
- Community based cross-sectional study, Observational cohort
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,026 participants (actual)
- Lead sponsor
- Centre for Immunology & InfectionUniversity, hospital or other
- Collaborators
- The University of Hong Kong, Institut Pasteur
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 14 Sep 2023 (actual)
- Study completion
- 14 Sep 2023 (actual)
- First posted
- 3 Jan 2022 (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 Healthy Human Global Project-Hong Kong aims to elucidate the heritable and non-heritable factors that drive immunological variance within a healthy population in Hong Kong. By gaining a deeper understanding of these parameters, a path can be paved for personalised and precision medicine, tailored for an Asian population.
Detailed description
The Healthy Human Global Project-Hong Kong (HHGP-Hong Kong) is built upon the Milieu Intérieur Consortium, a population-based study coordinated by the Institut Pasteur in Paris since 2011 (ClinicalTrials.gov study numbers NCT01699893 and NCT03905993). The Milieu Intérieur comprised of 1,000 healthy participants that are unrelated, and of Western European ancestry, to investigate inter-individual immunological variances by integrating intrinsic, environmental and genetic factors in innate immunity and adaptive immunity. Through the quantification of white blood cells by utilising standardised flow cytometry and correlating with sociodemographic variables, the Institut Pasteur team found that smoking, age, sex, and latent infection with cytomegalovirus, were the main non-genetic factors that affected variation in parameters of human immune cells.
The HHGP-Hong Kong will, therefore, replicate and adapt from the study design of Milieu Intérieur recruiting 1,000 healthy participants, drawn from the FAMILY Cohort, to better understand the immunological variance within the Hong Kong population. This Cohort was part of a prospective population-based study in 2007, consisting of 46,001 participants in Hong Kong. It was the first large-scale programme to understand the determinants of physical, mental, and social wellbeing in Hong Kong.
A technological platform will be developed to provide a personalized patient management strategy that takes into account individual genetics, previous infection history, resident microbiota, as well as personal lifestyle and environmental factors to define immune health.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FAMILY Cohort | – | Other: No interventionThis Cohort was part of a prospective population-based study in 2007, consisting of 46,001 participants in Hong Kong. It was the first large-scale programme to understand the determinants of physical, mental, and social wellbeing in Hong Kong. The Cohort has an excellent (99.8%) coverage of the neighbourhoods in Hong Kong and represents roughly 1% of all households, which enables detailed studies linking the social environment to physical and mental health. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The HHGP- Hong Kong will recruit 1,000 healthy participants, drawn from the FAMILY Cohort, its affiliates, or Hong Kong residents, to better understand the immunological variance within the Hong Kong population. This Cohort was part of a prospective population-based study in 2007, consisting of 46,001 participants in Hong Kong. It was the first large-scale programme to understand the determinants of physical, mental, and social wellbeing in Hong Kong. The Cohort has an excellent (99.8%) coverage of the neighbourhoods in Hong Kong and represents roughly 1% of all households, which enables detailed studies linking the social environment to physical and mental health.
Key inclusion criteria (8 listed)
- Subjects considered as healthy by the investigator based on medical history, clinical examination, laboratory results and ECG (blood sampling for laboratory assessments and ECG should be done at V0 and only after signed informed consent)
- Subjects who, according to the investigator, can and will comply with the requirements of the protocol and are available for all scheduled visits at the investigational site.
- Healthy male or female aged between 20 and 79 (included) years
- Self-declared Han ethnicity for 3 generations
- Body mass index (BMI) of ≥ 18.5 and ≤ 27.0 kg/m²
Key exclusion criteria (39 listed)
- Participation in the last 3 months or concurrent participation in another clinical study in which the subject has been exposed to a medical intervention including but not limited to pharmaceutical product or placebo or medical device
- First-degree relative to previously recruited individuals in the study cohort
- For women: pregnant or breastfeeding or intending to become pregnant or peri-menopausal
- 3.1 Peri-menopausal women as defined by menstrual irregularity: either a change in the menstrual cycle length of more than seven days (early perimenopause) or two or more missed periods with an interval of 60 days or more between periods (late perimenopause)
- Any physical exercise within the last 4 hours before inclusion (V1)
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 |
|---|---|---|
| No interventionNo intervention | Other | FAMILY Cohort |
Primary outcome
Factors underlying immunological variance within the general healthy population
Time frame: Through study completion, an average of 1 year
To identify factors (genetic, immunology and environmental) that contributes to the observed heterogeneity in immune responses (individual and population levels)
Naturally occurring variability of human response
Time frame: Through study completion, an average of 1 year
To characterise the naturally occurring variability of human response using whole genome sequencing and single nucleotide polymorphisms (SNPs) haplotyping
Stimulated cytokine/chemokine measurement
Time frame: Through study completion, an average of 1 year
To determine and measure cytokine/chemokine stimulated by 16 pattern-recognition receptors agonists (PRR agonists) or immune stimulators
Characterisation of commensal airway and gut microbiota
Time frame: Through study completion, an average of 1 year
To characterise commensal microbiota (nasopharyngeal swab and stool samples) in the study population
Metagenomic architecture of faecal and nasal samples
Time frame: Through study completion, an average of 1 year
To evaluate the metagenomic architecture of the population based on sequence analysis of bacterial, fungal and viral populations in faecal and nasal samples
Immune response and nutrition association
Time frame: Through study completion, an average of 1 year
To associate immune response with nutrition data
Immune phenotype variance association with genetic polymorphisms and enterotype
Time frame: Through study completion, an average of 1 year
To associate immune phenotype variance with genetic polymorphisms and enterotype
Heart rate variability with clinical and epidemiological data association
Time frame: Through study completion, an average of 1 year
To associate heart rate variability with clinical and epidemiological data
Inflammation with physical and mental health outcome association
Time frame: Through study completion, an average of 1 year
To associate inflammation with physical and mental health outcomes
3 secondary outcomes
Genotype-to-phenotype associations at a mechanistic level
Time frame: Through study completion, an average of 1 year
Retrospective and prospective clinical and epidemiological data correlation with FAMILY Cohort
Time frame: Through study completion, an average of 1 year
Immune variation comparison between healthy European (Milieu Intérieur) and Asian (HHGP- Hong Kong) populations
Time frame: Through study completion, an average of 1 year
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 4 Oct 2023.
- Background: PubMed 29423275Delhalle S, Bode SFN, Balling R, Ollert M, He FQ. A roadmap towards personalized immunology. NPJ Syst Biol Appl. 2018 Feb 6;4:9. doi: 10.1038/s41540-017-0045-9. eCollection 2018.
- Background: PubMed 24725414Tsang JS, Schwartzberg PL, Kotliarov Y, Biancotto A, Xie Z, Germain RN, Wang E, Olnes MJ, Narayanan M, Golding H, Moir S, Dickler HB, Perl S, Cheung F; Baylor HIPC Center; CHI Consortium. Global analyses of human immune variation reveal baseline predictors of postvaccination responses. Cell. 2014 Apr 10;157(2):499-513. doi: 10.1016/j.cell.2014.03.031.
- Background: PubMed 26878114Carr EJ, Dooley J, Garcia-Perez JE, Lagou V, Lee JC, Wouters C, Meyts I, Goris A, Boeckxstaens G, Linterman MA, Liston A. The cellular composition of the human immune system is shaped by age and cohabitation. Nat Immunol. 2016 Apr;17(4):461-468. doi: 10.1038/ni.3371. Epub 2016 Feb 15.
- Background: PubMed 31521107Aziz N, Detels R, Quint JJ, Gjertson D, Ryner T, Butch AW. Biological variation of immunological blood biomarkers in healthy individuals and quality goals for biomarker tests. BMC Immunol. 2019 Sep 14;20(1):33. doi: 10.1186/s12865-019-0313-0.
- Background: PubMed 27916977Brodin P, Davis MM. Human immune system variation. Nat Rev Immunol. 2017 Jan;17(1):21-29. doi: 10.1038/nri.2016.125. Epub 2016 Dec 5.
- Background: PubMed 11526384Whitacre CC. Sex differences in autoimmune disease. Nat Immunol. 2001 Sep;2(9):777-80. doi: 10.1038/ni0901-777. No abstract available.
- Background: PubMed 25562703Thomas S, Rouilly V, Patin E, Alanio C, Dubois A, Delval C, Marquier LG, Fauchoux N, Sayegrih S, Vray M, Duffy D, Quintana-Murci L, Albert ML; Milieu Interieur Consortium. The Milieu Interieur study - an integrative approach for study of human immunological variance. Clin Immunol. 2015 Apr;157(2):277-93. doi: 10.1016/j.clim.2014.12.004. Epub 2015 Jan 3.
- Background: PubMed 29476184Patin E, Hasan M, Bergstedt J, Rouilly V, Libri V, Urrutia A, Alanio C, Scepanovic P, Hammer C, Jonsson F, Beitz B, Quach H, Lim YW, Hunkapiller J, Zepeda M, Green C, Piasecka B, Leloup C, Rogge L, Huetz F, Peguillet I, Lantz O, Fontes M, Di Santo JP, Thomas S, Fellay J, Duffy D, Quintana-Murci L, Albert ML; Milieu Interieur Consortium. Natural variation in the parameters of innate immune cells is preferentially driven by genetic factors. Nat Immunol. 2018 Mar;19(3):302-314. doi: 10.1038/s41590-018-0049-7. Epub 2018 Feb 23.
- HKU Clinical Trials Registry websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. All personal information obtained in the research project will remain strictly confidential and will not be disclosed to or seen by any person other than the authorised researchers involved. All information obtained about the participants will be stored in a locked cabinet in a security-accessible area, and also in a password-protected database at The School of Public Health, The University of Hong Kong. All personal data will be anonymised for data analysis. Data and information may be inspected by regulatory authorities of academic research, such as the Institutional Review Board of the University of Hong Kong / Hospital Authority Hong Kong West Cluster, with the accompany of research staff. Any data and sample access request from local/international researchers or collaborators must comply with regulations as elaborated by international bodies/agreements including Declaration of Helsinki.
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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 Di Santo principal investigator
Centre for Immunology & Infection
Darragh Duffy principal investigator
Centre for Immunology & Infection
Michael Ni principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Immune System and Related Disorders, run by Centre for Immunology & Infection at 1 site in China.
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 39 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 4 Oct 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 China. 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?
Factors underlying immunological variance within the general healthy population (time frame: Through study completion, an average of 1 year). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05174624, which also lists 8 linked publications.
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 4 Oct 2023.