The Healthy Human Global Project - Hong Kong (HHGP-Hong Kong)

NCT05174624 | Completed

• 2 other identifiers: UW21-549HKUCTR-2959
• Study Type: observational
• Target: 1,026
• Locations: 1 country
• Sites: 1

Brief 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 population.

Conditions

Healthy; Immune System and Related Disorders

Keywords

Community based cross-sectional study; Observational cohort

Outcome Measures

Primary Outcomes (9)

• 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)

  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

  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

  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

  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

  Through study completion, an average of 1 year

• Immune response and nutrition association

  To associate immune response with nutrition data

  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

  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

  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

  Through study completion, an average of 1 year

Secondary Outcomes (3)

• Genotype-to-phenotype associations at a mechanistic level

  Through study completion, an average of 1 year

• Retrospective and prospective clinical and epidemiological data correlation with FAMILY Cohort

  Through study completion, an average of 1 year

• Immune variation comparison between healthy European (Milieu Intérieur) and Asian (HHGP- Hong Kong) populations

  Through study completion, an average of 1 year

Study Arms (1)

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.

Other: No intervention

Interventions

No intervention OTHER

No intervention

FAMILY Cohort

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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)
• 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)
• 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:
• Past or present diagnosed cancer, lymphoma, leukaemia
• Personal history of organ transplant
• Congenital or acquired immune deficiency (any confirmed or suspected immunosuppressive or immunodeficient condition, including a history of HIV infection)
• 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.)
• Splenectomy
• 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
• History of clinically significant, as determined by the investigator, neurological disorder of seizures
• Infectious diseases

Sponsors & Collaborators

• Centre for Immunology & Infection: lead
• The University of Hong Kong: collaborator
• Institut Pasteur: collaborator

Study Sites (1)

HKU Centre for Immunology & Infection Research Clinic

Hong Kong, China

Location

Related Publications (8)

• 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.

  PMID: 29423275 BACKGROUND

• Tsang 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.

  PMID: 24725414 BACKGROUND

• Carr 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.

  PMID: 26878114 BACKGROUND

• Aziz 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.

  PMID: 31521107 BACKGROUND

• Brodin 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.

  PMID: 27916977 BACKGROUND

• Whitacre CC. Sex differences in autoimmune disease. Nat Immunol. 2001 Sep;2(9):777-80. doi: 10.1038/ni0901-777. No abstract available.

  PMID: 11526384 BACKGROUND

• Thomas 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.

  PMID: 25562703 BACKGROUND

• Patin 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.

  PMID: 29476184 BACKGROUND

Related Links

• HKU Clinical Trials Registry website

Biospecimen

Retention: SAMPLES WITH DNA

Blood, nasopharyngeal, stool, and hair samples from healthy adult donors

Study Officials

• James Di Santo

  Centre for Immunology & Infection

  PRINCIPAL INVESTIGATOR

• Darragh Duffy

  Centre for Immunology & Infection

  PRINCIPAL INVESTIGATOR

• Michael Ni

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: January 3, 2022
• Study Start: July 1, 2022
• Primary Completion: September 14, 2023
• Study Completion: September 14, 2023
• Last Updated: October 4, 2023

Record last verified: 2023-10

Locations

CN (1)