1,200 pregnant women (600 HIV+ mothers and 600 HIV-controls) in their third trimester were enrolled from January 2016 to June 2019. Participants are being followed as mother-baby pairs at birth, within 10 days of life 6, 10, 14 24, 48, 72 and 96 weeks of age. At each visit clinical examinations are being used to assess health and the impact of environmental factors. In addition, questionnaires are administered and bio-samples for laboratory tests. The design of the study is non-interventional cohort but participants are being offered advice regarding health and hygiene.

maternal urine, stool, plasma, milk, cord blood, amniotic fluid, placenta, infant serum/plasma, dried blood spots and stool

HIV Infections

Immune Activation

Cormobidities

The University of Zimbabwe College of Health Science (UZ-CHS) BIRTH COHORT Study

HIV Exposure, Disease Acquisition and Progression Among Children: Role of Maternal Immunogenetics, Viral Genetic Diversity, HAART Exposure, Co-morbidities and Psycho-Social Status: (UZ-CHS Birth Cohort)

Comparison of morbidity of HEU vs. HUU infants, defined as impaired growth, immune- and neuro-development and/ or frequent clinically relevant infections

To determine any association of maternal HIV infection, HAART exposure.

To determine any association with maternal HIV and HAART exposure.

To determine any association of HAART exposure in utero and during breast feeding with pregnancy outcome, infant (HUU, HEU, HEI) growth and immune- and neuro-development.

To determine vertical transmission rates for HIV at birth and within the first 2 years of life and assess risk factors for transmission

HIV incidence rate among mother sero-negative at enrollment

To determine the association between maternal baseline and delivery HAART levels in different compartments and the relation of those to infant HIV transmission, mortality and morbidity.

To determine the association between antenatal immune dysregulation and infant death, growth and immune responses to vaccines.

To determine HIV drug resistance profiles in mother and infants unresponsive to HAART

To determine how CMV DNA is influenced by HIV infection, HAART use and as single infection or combined infections in HIV+ and HIV- women and determine the impact on pregnancy outcome and infant cmv vertical transmission

To determine how HBV infection infections in HIV+ and HIV- women and determine the impact on pregnancy outcome, infant vertical transmission

To determine HCV infections proportion in HIV positives and negatives and HIV+ and HIV- women and determine the impact on pregnancy outcome, infant incidence of congenital cmv infection

To determine syphilis infections proportion in HIV positives and negatives and the impact on pregnancy outcome, infant incidence of congenital syphilis infection

To determine the prevalence of helminthes infection using 18s sequencing and correlate with infant development of atopic dermatitis.

To determine the prevalence of maternal under and overnutrition using BMI and MUAC impact on pregnancy outcomes, infant mortality and morbidity.

To assess abnormalities in HIV + and HIV- including lipid profiles, bone, haematological (anemia) and hepatic toxicities associated with exposure to HAART among mothers and infants.

To determine infant non-infectious comorbidities (e.g. anaemia, atopic dermatitis, congenital infections and other conditions) and their impact on mortality and morbidity.

To assess delayed neuro-cognitive development using the Denver II tool in HUU, HEU and HEI infants and correlated with socio economic status and infectious diseases.

To determine humoural immune responses to EPI vaccines including antibody levels against measles, tetanus, diphtheria, pertussis, polio and rotavirus) in HUU, HEU and HEI infants.

To determine immune activation and systemic inflammatory biomarkers in HUU, HEU and HEI infants

To determine biomarkers for endothelial dysfunction including microbial translocation in HUU, HEU and HEI infants and association with household hygiene at delivery, 6, 48 and 96 weeks of age.

To determine antenatal reference ranges for MUAC, haemoglobin from FBC analyses, and biochemistry (kidney function, liver function tests, bone, lipid profiles) in mothers with a favourable outcome of pregnancy

To determine maternal- infant microbiota16S sequencing in pregnancy and relate it to infant immune development and atopy (anti-inflammatory (IL-4, -5, -13) and regulatory cytokines (IL-10, TGF-β) at delivery, 6 weeks 48 and 96 weeks of age.

Bacterial full genome metagenomics shotgun sequencing to identify the microbiota metabolic potential (i.e. bacterial genes present will be done) and mass spectrometry will be performed for analysis of small intestinal content (metabolome).

Wide range of nutritional profiles and HAART levels spectrometry will be performed for analysis of at least 700 metabolites including amino acids and lipids will be performed in plasma, breast milk and stool samples

To characterize pathogen genetic diversity including HIV, HBV, HCV, CMV subtypes, prevalent in our study population at time of infection

To determine host genetic markers for infectious disease susceptibility including human leukocyte antigen (HLA) and killer immunoglobulin like receptor (KIR) gene variants and their association with infection rates of HIV and co-infections in mothers and their infants.

Only anonymous data will be stored at local sites and transferred between sites for collaborative research efforts. All original data will be stored locally at the UZ-CHS for at least 10 years on suitable electronic devices. Data transfer with collaborating partners will be encrypted. using EGAcryptor. With our European partners we will follow the current European General Data Protection Regulation effective May 25, 2018.

Kerina Duri

Associate Professor

University of Zimbabwe

University Hospital Inselspital, Berne

University of Hamburg

University of Oxford

Wellcome Trust

University of Yaounde

University of Cape Town

Midlands State University, Zimbabwe

National Institute of Health Research, Zimbabwe

Healthy

drug for emergency prevention of Ebola based on recombinant monoclonal antibodies

GamEMab

Research Institute of Influenza

An Open Study of the Safety and Pharmacokinetics of a Medicinal Product for Emergency Prevention of Ebola

An Open, Dose Escalation Safety and Pharmacokinetics Study of the Medicine for Ebola Fever Emergency Prevention Based on Monoclonal Recombinant Antibodies With a Single Application in 3 Groups of Healthy Volunteers

Determination of Number of Participants With Adverse Events

Determination of Number of Participants With Serious Adverse Events

Determination of Number of Participants with Solicited Local and Systemic Adverse Events

Immunological methods will be used to study the level of specific antibodies and the duration of their circulation in the human body (ELISA)

Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation

Research Institute of Influenza, Sankt-Peterburg, Russian Federation

The treatment group will have faecal microbiota transplantation performed using stool from a healthy human donor

The placebo group will have autologous faecal microbiota transplantation performed.

Irritable Bowel Syndrome

Faecal microbiota transplantation

Alimentary Pharmabiotic Centre, University College Cork

Faecal Microbiota Transplantation in Irritable Bowel Syndrome

Randomised Placebo Controlled Trial of Faecal Microbiota Transplantation in Irritable Bowel Syndrome

This assessment will be obtained by defining the response (Yes or No) to the following question.
"Please consider how you felt in the past week in regard to your IBS, in particular your overall well-being, and symptoms of abdominal discomfort or pain, bloating or distension and altered bowel habit .Compared to the way you usually felt before the beginning of the trial, have you had adequate relief of your IBS-symptoms?"

The primary symptoms of IBS will be scored on a six point Likert scale at baseline, week 4 and at end of study. The following symptoms will be assessed and recorded: abdominal pain/discomfort, bloating/distension, sense of incomplete evacuation, straining at stool, urgency of bowel movement, passage of gas and mucus, bowel habit satisfaction. Each symptom will be assessed using a 6-point scale, where 0 = none to 5 = very severe. Bowel habit satisfaction will be assessed using a 6-point scale where 0 = very satisfied and 5 = very dissatisfied. Overall assessment of IBS symptoms will be also be scored on a 6 - point scale. An IBS composite score(15 point score) representing the sum of individual scores for abdominal pain/discomfort, bloating/distension, and bowel movement difficulty (straining at stool or urgency of bowel movement) will be calculated.

At baseline and at the end of the study each subject will complete an IBS-specific quality of life questionnaire (IBS-QOL)

At baseline and at the end of the study each subject will complete the Hospital Anxiety and Depression (HAD) Scale.

Patients will be monitored throughout the study period and they will be recorded as per the The Consolidated Standards of Reporting Trials (CONSORT) criteria

We will characterise all participants' microbiota composition at baseline and at the end of study to determine if there is a subgroup of patient/donor combinations, based on their microbiota composition, in whom a positive response to FMT was obtained. This would be very valuable for future optimization of a positive primary outcome.

Professor Fergus Shanahan

Professor and Chair Department of Medicine and Director Alimentary Pharmabiotic Centre, University College Cork

University College Cork

Amputation, Traumatic

This program is the primary site for a novel immune modulation protocol for hand and/or forearm transplantation using donor bone marrow stem cells. This protocol, otherwise called the "Pittsburgh Protocol" has been published and implemented in 8 hand/forearm transplantations. The Pittsburgh hand transplant program is the only center that has experience with the "Pittsburgh Protocol" to reduce the number and dosing of immunosuppressive drugs used to prevent rejection of hand/forearm transplants.

syphilis/potasio

The University of Zimbabwe College of Health Science (UZ-CHS) BIRTH COHORT Study

An Open Study of the Safety and Pharmacokinetics of a Medicinal Product for Emergency Prevention of Ebola

Faecal Microbiota Transplantation in Irritable Bowel Syndrome

Human Upper Extremity (Hand and Forearm) Allotransplantation

La base de datos de hierbas medicinales más completa respaldada por la ciencia