SARS-CoV-2 Acute Respiratory DiseaseCOVCALNCT05135585
Evaluation of the Post-vaccination Immune Response to COVID-19 in the New Caledonian Population
A study testing Blood sample collection and Questionnaires in people with SARS-CoV-2 Acute Respiratory Disease, run by Institut Pasteur at 3 sites in New Caledonia.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Acute Respiratory Disease
- What is being tested?
- Blood sample collection and Questionnaires
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 680 participants
- Where
- 3 sitesNew Caledonia
- Study dates
- 1 Dec 2021to 17 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
New Caledonia3 sites
Centre Hospitalier Territorial de Nouvelle-Calédonie
Dumbéa Sur Mer
Centre hospitalier spécialisé de Nouvelle-Calédonie
Noumea
Vaccination centers
Province Sud
About this study
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.
Read the 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.
- Conditions
- SARS-CoV-2 Acute Respiratory Disease
- Being tested
- Blood sample collection, Questionnaires
- Keywords
- Immune Response, Vaccination, Pacific, Population of New Caledonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionOther
Blood sample collection at 1 month and 6 months after vaccination
QuestionnairesOther
data collection (health data, vaccination data, etc.)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Blood sample collection; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start1 Dec 2021
- Primary completion17 Sep 2022
- Study completion17 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2 Acute Respiratory DiseaseStudies of the same condition, open and under way.
- More trials run by Institut PasteurThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 680 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Pasteur
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre Hospitalier Spécialisé de Nouvelle-Calédonie, Direction de l'Action Sanitaire et Sociale, Centre Hospitalier Territorial de Nouvelle-Calédonie, Agence sanitaire et sociale de la Nouvelle Calédonie
- Responsible party
- Sponsor
- Investigators
- Myrielle Dupont-Rouzeyrol, PhD, Study director, Institut Pasteur de Nouvelle-CalédonieValérie Albert-Dunais, MD, Principal investigator, Centre Hospitalier Spécialisé de Nouvelle-Calédonie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135585
- Sponsor's protocol ID
- 2021-059
- Other IDs
- 2021-A01949-32
- Acronym
- COVCAL
- Status last verified
- Oct 2021
- First submitted
- 23 Nov 2021
- Last updated
- 9 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39325828
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Post-vaccination Immune Response to COVID-19 in the New Caledonian Population
- ClinicalTrials.gov ID
- NCT05135585
- Acronym / sponsor ID
- COVCAL / 2021-059
- Conditions
- SARS-CoV-2 Acute Respiratory Disease
- Keywords
- Immune Response, Vaccination, Pacific, Population of New Caledonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 680 participants (actual)
- Lead sponsor
- Institut PasteurIndustry (pharma, biotech, devices)
- Collaborators
- Centre Hospitalier Spécialisé de Nouvelle-Calédonie, Direction de l'Action Sanitaire et Sociale, Centre Hospitalier Territorial de Nouvelle-Calédonie, Agence sanitaire et sociale de la Nouvelle Calédonie
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 17 Sep 2022 (actual)
- Study completion
- 17 Sep 2022 (actual)
- First posted
- 26 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults vaccinated with a complete COVID-19 vaccine regimen | Other | Other: Blood sample collection, Other: QuestionnairesAdults of Melanesian, Polynesian, European, and other communities vaccinated with a complete COVID-19 vaccine regimen, residing in New Caledonia. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample collectionBlood sample collection at 1 month and 6 months after vaccination | Other | Adults vaccinated with a complete COVID-19 vaccine regimen |
| Questionnairesdata collection (health data, vaccination data, etc.) | Other | Adults vaccinated with a complete COVID-19 vaccine regimen |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2022.
- Derived from this study: PubMed 39325828Inizan 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Myrielle Dupont-Rouzeyrol, PhD study director
Institut Pasteur de Nouvelle-Calédonie
Valérie Albert-Dunais, MD principal investigator
Centre Hospitalier Spécialisé de Nouvelle-Calédonie
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample collection and Questionnaires in people with SARS-CoV-2 Acute Respiratory Disease, run by Institut Pasteur at 3 sites in New Caledonia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in New Caledonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05135585, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2022.