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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-A01949-32 | Other Identifier | ID-RCB |
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| Name | Class |
|---|---|
| Centre Hospitalier Spécialisé de Nouvelle-Calédonie | UNKNOWN |
| Direction de l'Action Sanitaire et Sociale | OTHER_GOV |
| Centre Hospitalier Territorial de Nouvelle-Calédonie | OTHER |
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The COVID-19 pandemic caused by SARS-CoV-2 since December 2019 has caused more than 210 million cases worldwide as of September 1, 2021. New Caledonia (NC) is an ultramarine French territory in the South Pacific so far relatively spared by this pandemic thanks to the establishment of a health lock. The vaccination campaign started locally on 20/01/2021 with the exclusive use of Pfizer's COMIRNATY mRNA vaccine. Vaccination is now offered to anyone over the age of 12. Vaccination against COVID-19 will be mandatory in New Caledonia as of October 31, 2021 for certain exposed populations and for the entire adult population as of December 31, 2021.
Clinical trials of COVID-19 vaccines, including those of mRNA vaccines, have taken care to maintain ethnic diversity within their samples. Efficacy studies have not shown a significant difference in the efficacy of Pfizer COMIRNATY vaccine in white, black American, or Hispanic populations. The response of non-European non-Asian Oceanian populations to Pfizer COMIRNATY vaccination has not been specifically studied at this time. According to the 2019 census in New Caledonia, 41.2% of the population identified themselves as Kanak (Melanesian), 24% as European, 8.3% as Wallisian-Futunian (Polynesian), 11% as mestizo, and 8% as belonging to other communities including Tahitian (Polynesian), Indonesian, Ni-Vanuatu (Melanesian), and Vietnamese communities (8). Some recent data are in favor of a significant variability of susceptibility to pathogens in Oceanian populations, stemming from a genetic inheritance from Neanderthal man and his cousin Denisova man. In a context of vaccine hesitancy, it is therefore important to ensure that the immune response of the New Caledonian population (Melanesian, Polynesian, European or other communities) to vaccination against COVID-19 is similar to that of populations studied in large clinical trials.
Observational equivalence study with prospective data collection. Vaccinated subjects to be included will be identified in the vaccination centers in the Southern Province during the injection of the second dose.
Information and consent collection. Completion of a questionnaire and collection of 4 mL of blood on a dry tube at M1 and M6 months.
Testing for the presence of anti-SARS-CoV-2 antibodies by ELISA (anti-Spike and anti-Nucleoprotein).
Return of the results of the serological analyses to the participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults vaccinated with a complete COVID-19 vaccine regimen | Other | Adults of Melanesian, Polynesian, European, and other communities vaccinated with a complete COVID-19 vaccine regimen, residing in New Caledonia. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample collection | Other | Blood sample collection at 1 month and 6 months after vaccination |
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| Measure | Description | Time Frame |
|---|---|---|
| Measurement by ELISA tests of the presence of antibodies at 1 month after the second dose of Pfizer COMIRNATY vaccine in the New Caledonian population | To assess in a standardized manner the humoral immune response to COVID-19 vaccination at 1 month after the second dose in vaccinated individuals of Polynesian, Melanesian, European and other communities in New Caledonia | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement by ELISA of the presence of antibodies at 6 months after the second dose of Pfizer COMIRNATY vaccine in the New Caledonian population | To evaluate and compare in a standardized manner the humoral immune response to COVID-19 vaccinationat 6 months after the second dose of Pfizer COMIRNATY vaccine in vaccinated individuals of Polynesian, Melanesian, European and other communities in New Caledonia |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Myrielle Dupont-Rouzeyrol, PhD | Institut Pasteur de Nouvelle-Calédonie | Study Director |
| Valérie Albert-Dunais, MD | Centre Hospitalier Spécialisé de Nouvelle-Calédonie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Territorial de Nouvelle-Calédonie | Dumbéa Sur Mer | New Caledonia | ||||
| Centre hospitalier spécialisé de Nouvelle-Calédonie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39325828 | Derived | Inizan C, Courtot A, Sturmach C, Griffon AF, Biron A, Bruel T, Enouf V, Demaneuf T, Munier S, Schwartz O, Gourinat AC, Medevielle G, Jouan M, van der Werf S, Madec Y, Albert-Dunais V, Dupont-Rouzeyrol M. Levels and functionality of Pacific Islanders' hybrid humoral immune response to BNT162b2 vaccination and delta/omicron infection: A cohort study in New Caledonia. PLoS Med. 2024 Sep 26;21(9):e1004397. doi: 10.1371/journal.pmed.1004397. eCollection 2024 Sep. |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Agence sanitaire et sociale de la Nouvelle Calédonie |
| UNKNOWN |
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| Questionnaires | Other | data collection (health data, vaccination data, etc.) |
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| 1 year |
| Serum neutralization analysis of the neutralizing capacity against different circulating SARS-CoV-2 variants of antibodies secreted at 1 and 6 months after the second dose of Pfizer COMIRNATY vaccine in the New Caledonian population | To study the functionality (neutralizing capacity) of antibodies secreted in response to COVID-19 vaccination by individuals of Melanesian, Polynesian, European and other community origin at 1 month and 6 months after the second dose of Pfizer COMIRNATY vaccine | 1 year |
| Post-hoc analysis of anti-Spike and anti-Nucleoprotein ELISA results at 1 month by age stratification (group over 70 years and control group 20-59 years) | To evaluate and compare in a standardized way the humoral immune response to the COVID-19 vaccination at 1 month after the second dose of Pfizer COMIRNATY vaccine in subjects aged over 70 years and a control group in the New Caledonian population | 1 year |
| Noumea |
| New Caledonia |
| Vaccination centers | Province Sud | New Caledonia |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |