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

November 8, 2022 updated by: Institut Pasteur

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

680

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Caledonia
      • Dumbéa Sur Mer, New Caledonia
        • Centre Hospitalier Territorial de Nouvelle-Calédonie
      • Nouméa, New Caledonia
        • Centre hospitalier spécialisé de Nouvelle-Calédonie
      • Province Sud, New Caledonia
        • Vaccination centers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults from Melanesian, Polynesian, European or other community origin
  • Adults vaccinated with 2 doses of Pfizer COMIRNATY vaccine, administered between 3 and 12 weeks apart
  • Adults planning to be present in the territory and to be available on both sampling dates (1 and 6 months)

Exclusion Criteria:

  • Persons who received the second dose of vaccine more than 12 weeks after the first dose
  • Persons vaccinated against COVID-19 with a vaccine other than Pfizer COMIRNATY
  • Women who report being pregnant or breastfeeding (where the immune response may be altered)
  • Immunocompromised persons (immunosuppressive treatment, immunomodulator, HIV positive, splenectomy, long term corticosteroid therapy, autoimmune diseases such as rheumatoid arthritis, lupus, spondyloarthritis, etc.)
  • People who are not intellectually capable of answering the questionnaire
  • Persons under guardianship, curatorship or any other legal incapacity
  • Persons with documented Covid-19 infection (known positive SARS-CoV-2 serology prior to inclusion, positive PCR or antigen test)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Adults vaccinated with a complete COVID-19 vaccine regimen
Adults of Melanesian, Polynesian, European, and other communities vaccinated with a complete COVID-19 vaccine regimen, residing in New Caledonia.
Other: Blood sample collection
Blood sample collection at 1 month and 6 months after vaccination
Other: Questionnaires
data collection (health data, vaccination data, etc.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: 6 months
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

Secondary Outcome Measures

Outcome Measure
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
Time Frame: 1 year
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
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
Time Frame: 1 year
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)
Time Frame: 1 year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Pasteur

Collaborators

Centre Hospitalier Territorial de Nouvelle-Calédonie
Centre Hospitalier Spécialisé de Nouvelle-Calédonie
Direction de l'Action Sanitaire et Sociale
Agence sanitaire et sociale de la Nouvelle Calédonie

Investigators

  • Study Director: Myrielle Dupont-Rouzeyrol, PhD, Institut Pasteur de Nouvelle-Calédonie
  • Principal Investigator: Valérie Albert-Dunais, MD, Centre hospitalier spécialisé de Nouvelle-Calédonie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2021

Primary Completion (ACTUAL)

September 17, 2022

Study Completion (ACTUAL)

September 17, 2022

Study Registration Dates

First Submitted

November 23, 2021

First Submitted That Met QC Criteria

November 24, 2021

First Posted (ACTUAL)

November 26, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 9, 2022

Last Update Submitted That Met QC Criteria

November 8, 2022

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-059
  • 2021-A01949-32 (OTHER: ID-RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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