Evaluation of the Post-vaccination Immune Response to COVID-19 in the New Caledonian Population

NCT05135585 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 680

Last updated 2022-11-09

No results posted yet for this study

Summary

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.

Conditions

  • SARS-CoV-2 Acute Respiratory Disease

Interventions

OTHER

Blood sample collection

Blood sample collection at 1 month and 6 months after vaccination

OTHER

Questionnaires

data collection (health data, vaccination data, etc.)

Sponsors & Collaborators

  • Centre Hospitalier Spécialisé de Nouvelle-Calédonie

    collaborator UNKNOWN
  • Direction de l'Action Sanitaire et Sociale

    collaborator OTHER_GOV
  • Centre Hospitalier Territorial de Nouvelle-Calédonie

    collaborator OTHER
  • Agence sanitaire et sociale de la Nouvelle Calédonie

    collaborator UNKNOWN
  • Institut Pasteur

    lead INDUSTRY

Principal Investigators

  • Myrielle Dupont-Rouzeyrol, PhD · Institut Pasteur de Nouvelle-Calédonie

  • Valérie Albert-Dunais, MD · Centre Hospitalier Spécialisé de Nouvelle-Calédonie

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2022-09-17
Completion
2022-09-17

Countries

  • New Caledonia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05135585 on ClinicalTrials.gov