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

SARS-CoV-2 Acute Respiratory Disease Clinical Trial

— COVCAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05135585
• Other study ID #: 2021-059
• Secondary ID: 2021-A01949-32
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: September 17, 2022

Study information

• Verified date: October 2021
• Source: Institut Pasteur
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 680
• Est. completion date: September 17, 2022
• Est. primary completion date: September 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Respiration Disorders
• Respiratory Tract Diseases
• SARS-CoV-2 Acute Respiratory Disease

Intervention

Other:
• Blood sample collection
Blood sample collection at 1 month and 6 months after vaccination
• Questionnaires
data collection (health data, vaccination data, etc.)

Locations

Country	Name	City	State
New Caledonia	Centre Hospitalier Territorial de Nouvelle-Calédonie	Dumbéa Sur Mer
New Caledonia	Centre hospitalier spécialisé de Nouvelle-Calédonie	Nouméa
New Caledonia	Vaccination centers	Province Sud

Sponsors (5)

Lead Sponsor	Collaborator
Institut Pasteur	Agence sanitaire et sociale de la Nouvelle Calédonie, Centre Hospitalier Spécialisé de Nouvelle-Calédonie, Centre Hospitalier Territorial de Nouvelle-Calédonie, Direction de l'Action Sanitaire et Sociale

Country where clinical trial is conducted

New Caledonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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	1 year
Secondary	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
Secondary	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