Clinical trial NCT05135585: Evaluation of the Post-vaccination Immune Response to COVID-19 in the New Caledonian Population
Official title: Evaluation of the Post-vaccination Immune Response to COVID-19 in the New Caledonian Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SARS-CoV-2 Acute Respiratory Disease
Keywords: Immune Response
Vaccination
Pacific
Population of New Caledonia
Lead sponsor: Institut Pasteur
Sponsor class: INDUSTRY
Collaborators: name: Centre Hospitalier Spécialisé de Nouvelle-Calédonie
name: Direction de l'Action Sanitaire et Sociale
name: Centre Hospitalier Territorial de Nouvelle-Calédonie
name: Agence sanitaire et sociale de la Nouvelle Calédonie
First posted: 2021-11-26
Enrollment: 680
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: 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
timeFrame: 6 months
Secondary outcomes:
measure: Measurement by ELISA of the presence of antibodies at 6 months after the second dose of Pfizer COMIRNATY vaccine in the New Caledonian population
timeFrame: 1 year
measure: 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
timeFrame: 1 year
measure: 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)
timeFrame: 1 year
Other outcomes:
Locations:
city: Dumbéa Sur Mer
country: New Caledonia
facility: Centre Hospitalier Territorial de Nouvelle-Calédonie
city: Nouméa
country: New Caledonia
facility: Centre hospitalier spécialisé de Nouvelle-Calédonie
city: Province Sud
country: New Caledonia
facility: Vaccination centers
Study officials:
affiliation: Institut Pasteur de Nouvelle-Calédonie
name: Myrielle Dupont-Rouzeyrol, PhD
role: STUDY_DIRECTOR
affiliation: Centre Hospitalier Spécialisé de Nouvelle-Calédonie
name: Valérie Albert-Dunais, MD
role: PRINCIPAL_INVESTIGATOR
References: