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This is a pilot, cross-sectional, sample collection study to characterize the immune response and intestinal microorganisms in people with and without COVID-19 antibodies and helminth infection.
This is a pilot, cross-sectional, sample collection study to characterize the immune response and intestinal microbiota in people with and without SARS-CoV-1 antibodies and helminth infection.
A target sample size of 1500 participants aged 5 years or older will undergo a one-time blood and stool collection for SARS-CoV-2 antibody testing, diagnosis of parasitic infections, and experimental studies including transcriptomics (RNA) and microbiome (intestinal microorganisms) characterization. Participants willing to take part in the study will be selected from households in the Tiruvallur district, Tamil Nadu, India. Individual study participation involves a single study visit. Participants will be informed of the results of clinical testing and will be referred for medical care as appropriate.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with helminth infections | Measured by qPCR diagnostics of stool DNA extraction | Day 1 |
| Number of participants with SARS-CoV-2 antibodies | Measured by real-time qPCR (quantitative polymerase chain reaction) assay | Day 1 |
| Number of participants with positive malaria test | Measured by fingerprick blood samples | Day 1 |
| Average Differential blood count | Measured from venipuncture blood samples | Day 1 |
| Average Hematocrit levels | Measured from venipuncture blood samples | Day 1 |
| Number of participants with latent tuberculosis infection | Measured by IFN-γ release assay | Day 1 |
| Number of participants with Wuchereria bancrofti infection | Measured by enzyme-linked immunosorbent assay (ELISA) | Day 1 |
| Number of participants with Strongyloides stercoralis infection | Measured by enzyme-linked immunosorbent assay (ELISA) | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
Participants may be co-enrolled in other studies; however study staff should be notified of co-enrollment.
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Eligible participants will be enrolled from households in the Tiruvallur district, Tamil Nadu, India. Villages and towns in the Tiruvallur district will be selected in consultation with the Department of Public Health, Tamil Nadu. Areas that are known hotspots for COVID-19 will be selected.
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| Name | Affiliation | Role |
|---|---|---|
| Subash Babu, MBBS, PhD | National Institute for Research in Tuberculosis | Principal Investigator |
| P'ng Loke, PhD | National Institutes of Health (NIH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute for Research in Tuberculosis - International Centers for Excellence in Research (NIRT-ICER) | Chennai | Tamil Nadu | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38913614 | Background | Ferris BF, Balasubramanian S, Rajamanickam A, Munisankar S, Dasan B, Menon PA, Loke P, Babu S, Chami GF. Relative contribution of biomedical, demographic, and socioeconomic factors to COVID-19 vaccine receipt in rural India. PLoS One. 2024 Jun 24;19(6):e0305819. doi: 10.1371/journal.pone.0305819. eCollection 2024. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Coded PBMC, serum, stool RNA samples and data
| Number of participants with Ascaris infection | Stool sample analysis DNA extraction for qPCR and 16S sequencing | Day 1 |
| Number of participants with hookworm infection | Stool sample analysis DNA extraction for qPCR and 16S sequencing | Day 1 |
| Number of participants with Strongyloides infection | Stool sample analysis using Baermann technique, DNA extraction for qPCR and 16S sequencing | Day 1 |
| Number of participants with Trichuris infection | Stool sample analysis using DNA extraction for qPCR and 16S sequencing | Day 1 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |