Healthy VolunteersPhase 4CoviCompare_JNCT05037266
Cohort Assessing the Immunogenicity and the Safety of the COVID-19 Vaccine Janssen in Healthy Volunteers Based on 2 Age Groups: 65 Years or Older - 55 to 65 Years. Covicompare-Janssen
A Phase 4 study testing COVID-19 Vaccine Janssen (Ad26.COV2-S) in people with Healthy Volunteers, run by Centre Hospitalier Universitaire de Saint Etienne at 10 sites in France.
Trial summary
In response to the COVID-19 pandemic, several vaccines (Pfizer, Moderna, Astrazeneca, Janssen) have been developed and are being administered to millions of people in France and billions around the world through massive vaccination programs. The Janssen vaccine is the fourth COVID-19 vaccine to be licensed in Europe. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- COVID-19 Vaccine Janssen (Ad26.COV2-S)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 10 sitesFrance
- Study dates
- 20 Sep 2021to 29 Jan 2024
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults, or stable medical condition for adults with pre-existing medical conditions. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrolment, nor expected to require any significant change in therapy or hospitalization for worsening disease in foreseeable future.
- Understands and agrees to comply with the study procedures (visits, phone calls) and provides written free informed consent.
- Able to comply with study procedures based on Investigator judgement.
- Affiliated to a social security system, (except state medical aid)
Who cannot join
- Subject is ill or febrile (body temperature ≥ 38.0°C) within 72 prior hours or and/or symptoms suggestive of COVID-19 within the past 14 days at enrolment visit (ill or febrile participants may be re-scheduled within the inclusion period when no longer presenting symptoms)
- History of documented COVID-19 (PCR+, antigenic test+ or chest CT Scan + or serology SARS-CoV- 2+) prior to the vaccine administration
- Subjects with positive serology to SARS-CoV-2 at the enrolment visit.
- Subjects who already received another anti-SARS-CoV-2-vaccine
- Subjects who received BCG (Bacille Calmette and Guérin vaccine) given within the last year.
- An immediate family member or household member of study staff.
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- Use of immunosuppressive drugs like e.g. corticosteroids at a dosage > 10mg/day (excluding topical preparations and inhalers) within 3 months prior to enrolment or 6 months for chemotherapies
- Received immunoglobulin or other blood product within 3 months prior to enrolment or planned receipt of immunoglobulin or a blood product through study completion.
- Received any vaccination within 4 weeks prior to first injection or plan to receive a licensed vaccine 4 weeks after the last injection (exception for flu vaccine within 2 weeks).
- History of severe adverse reactions to vaccine administration, including anaphylaxis and related symptoms, such as rash, respiratory difficulty, angioedema and abdominal pain to vaccines, or history of allergic reaction likely to be exacerbated by any component of the anti-SARS-CoV-2- vaccine.
- History of severe allergic event
- Participation in another investigational clinical study within 4 weeks before the enrolment visits or planned before the study completion.
- Known HIV (human immunodeficiency virus), active HCV (Hepatitis C virus) or HBV (Hepatitis B virus) infection
- Any pathological condition, such as cancer, which may be susceptible of reducing immunity response
- History of heparin-induced thrombocytopenia (HIT)
- Any bleeding disorder considered as contraindication to intramuscular injection or phlebotomy
- The use of investigational Ig, investigational monoclonal antibodies or convalescent serum are not allowed during the study
- Any condition which in the opinion of the investigator may interfere with the aim of the study
- Pregnant or breastfeeding or positive pregnancy urine test at enrolment visit.
- Woman in childbearing without efficacious contraception (in the opinion of the investigator) for 31 days after treatment
- People under legal protection measure (tutorship, curatorship or safeguard measures)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Chu de Dijon
Dijon, 21000
Centre Hospitalier Regional Lille
Lille, 59000
APHM
Marseille, 13000
Centre Hospitalier Universitaire Nantes
Nantes, 44000
Hopital Bichat
Paris, 75000
Hopital Cochin
Paris, 75000
Centre Hospitalier Universitaire Rennes
Rennes, 35033
Chu de Rouen
Rouen, 76000
Centre Hospitalier de Saint-Etienne
Saint-Etienne, 42055
Centre Hospitalier Tours
Tours, 37000
About this study
In response to the COVID-19 pandemic, several vaccines (Pfizer, Moderna, Astrazeneca, Janssen) have been developed and are being administered to millions of people in France and billions around the world through massive vaccination programs.
The Janssen vaccine is the fourth COVID-19 vaccine to be licensed in Europe. It received a European marketing authorization for all adults, without age limit, on March 11, 2021. Janssen's vaccine is a viral non replicating vector (adenovirus) vaccine targeting the Spike protein of the SARS-CoV-2 virus. It differs from currently available vaccines in that it is a single-dose regimen with significant protection at 28 days post-injection. Monitoring of the durability of the immune response is essential to assess the need for a booster vaccination. Insufficient data are available in the adult population regarding the evolution of the immune response. This point seems to be even more important in the elderly. Indeed, their immune system declines with age, leading to a greater susceptibility to infectious diseases and a weaker response to vaccination. This is called immunosenescence. Vaccination in this population is essential to avoid severe COVID-19 cases, since older people are particularly at risk.
Read more
Two CoviCompare studies with two licensed vaccines messenger RNA vaccines (Pfizer, Moderna) are underway to evaluate the immune response to each vaccine according to age.
We propose to conduct a study to evaluate the immunogenicity of the Janssen vaccine in different age groups with long-term follow-up. This will allow determining the need of a booster.
A common battery of in vitro and ex vivo immuno-monitoring tests has been set up to systematically assess the acquisition of humoral and cellular immunity over time over a period of 24 months following vaccination in the CoviCompare project. This trial, part of the CoviCompare project will use the same immunomonitoring set. This will also allow comparison of the immune response to different vaccines in subjects of different age in order to determine in this at risk population the better vaccination schedules.
The only difference between this trial and the other 2 trials of the CoviCompare project is that adults aged 18-45 will not be concerned here, because the adenovirus vaccine is not recommended for this age group in France
Read the detailed description
In this trial of the Covicompare project, we will therefore evaluate the immune response after Janssen vaccine in subjects aged more than 65 years and 55 to 65 years without a prior COVID-19, following the same immunomonitoring analyses as for the other CoviCompare project trials.
- Conditions
- Healthy Volunteers
- Being tested
- COVID-19 Vaccine Janssen (Ad26.COV2-S)
- Keywords
- vaccine, immunity, immunogenicity, Janssen vaccine, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19 Vaccine Janssen (Ad26.COV2-S)Biological
one dose (0.5mL) at D1 and one dose (0.5mL) at D57
| Study group | Role | What they receive |
|---|---|---|
| 55 - 64 years old (50 volunteers) | Experimental | 1 injection of vaccine Janssen (Ad26.COV2-S) at Day 1 and boost vaccine at Day 57 Receives: Biological: COVID-19 Vaccine Janssen (Ad26.COV2-S) |
| At least 65 years old (50 volunteers) | Experimental | 1 injection of vaccine Janssen (Ad26.COV2-S) at Day 1 and boost vaccine at Day 57 Receives: Biological: COVID-19 Vaccine Janssen (Ad26.COV2-S) |
What is being measured
The primary outcome is the main question the study is designed to answer.
IgG humoral response to vaccine
Anti SARS-CoV-2 Spike IgG as measured by ELISA
Measured: Day 29
Secondary outcomes (7)
IgG humoral response to vaccine
Anti SARS-CoV-2 Spike IgG (total and subclasses IgG 1-4) as measured by ELISA
Measured: Day 1, Day 29, Day 57, Month 6, Month 12, Month 24
IgA humoral response to vaccine
Anti SARS-CoV-2 Spike IgA as measured by Elisa
Measured: Day 1, day 29, Day 57, Month 6, Month 12, Month 24
IgM humoral response to vaccine
Anti SARS-CoV-2 Spike IgM as measured by Elisa
Measured: Day 1, day 29, Day 57, Month 6, Month 12, Month 24
neutralizing antibody humoral response to vaccine
Anti-SARS-CoV-2 neutralizing antibody (pseudo-neutralization test using lentiviral models expressing SARS-Cov-2 proteins)
Measured: Day 1, day 29, Day 57, Month 6, Month 12, Month 24
T cells response to vaccine
Fluorospot assays (TH1, TH2, TH17, Cytotoxicity). Phenotyping of SARS-CoV-2 specific T cells by mass cytometry
Measured: Day 1, Day 57, Month 6
Mucosal response to vaccine
Mucosal SARS-CoV-2 -specific antibody via measure of sIgA, sIgM and IgG in saliva by specific home-made and commercially available ELISA assays.
Measured: Day 1, day 29, Day 57, Month 6, Month 12, Month 24
B cell response to vaccine
Determination of the epitope profiling and B cell repertoire (stereotype clonotype) of the humoral response
Measured: Day 1, Day 57, Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start20 Sep 2021
- Primary completion14 Feb 2022
- Study completion29 Jan 2024
Why it stopped: The study was stopped due to lack of inclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ELISABETH BOTELHO-NEVERS, MDPHD, Principal investigator, CENTRE HOSPITALIER DE SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05037266
- Sponsor's protocol ID
- 21CH135
- Other IDs
- 2021-003191-14
- Acronym
- CoviCompare_J
- Status last verified
- Feb 2025
- First submitted
- 6 Sep 2021
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Assessing the Immunogenicity and the Safety of the COVID-19 Vaccine Janssen in Healthy Volunteers Based on 2 Age Groups: 65 Years or Older - 55 to 65 Years. Covicompare-Janssen
- ClinicalTrials.gov ID
- NCT05037266
- Acronym / sponsor ID
- CoviCompare_J / 21CH135
- Conditions
- Healthy Volunteers
- Keywords
- vaccine, immunity, immunogenicity, Janssen vaccine, COVID-19
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped due to lack of inclusions
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 14 Feb 2022 (actual)
- Study completion
- 29 Jan 2024 (actual)
- First posted
- 8 Sep 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.
In response to the COVID-19 pandemic, several vaccines (Pfizer, Moderna, Astrazeneca, Janssen) have been developed and are being administered to millions of people in France and billions around the world through massive vaccination programs.
The Janssen vaccine is the fourth COVID-19 vaccine to be licensed in Europe. It received a European marketing authorization for all adults, without age limit, on March 11, 2021. Janssen's vaccine is a viral non replicating vector (adenovirus) vaccine targeting the Spike protein of the SARS-CoV-2 virus. It differs from currently available vaccines in that it is a single-dose regimen with significant protection at 28 days post-injection. Monitoring of the durability of the immune response is essential to assess the need for a booster vaccination. Insufficient data are available in the adult population regarding the evolution of the immune response. This point seems to be even more important in the elderly. Indeed, their immune system declines with age, leading to a greater susceptibility to infectious diseases and a weaker response to vaccination. This is called immunosenescence. Vaccination in this population is essential to avoid severe COVID-19 cases, since older people are particularly at risk.
Two CoviCompare studies with two licensed vaccines messenger RNA vaccines (Pfizer, Moderna) are underway to evaluate the immune response to each vaccine according to age.
We propose to conduct a study to evaluate the immunogenicity of the Janssen vaccine in different age groups with long-term follow-up. This will allow determining the need of a booster.
A common battery of in vitro and ex vivo immuno-monitoring tests has been set up to systematically assess the acquisition of humoral and cellular immunity over time over a period of 24 months following vaccination in the CoviCompare project. This trial, part of the CoviCompare project will use the same immunomonitoring set. This will also allow comparison of the immune response to different vaccines in subjects of different age in order to determine in this at risk population the better vaccination schedules.
The only difference between this trial and the other 2 trials of the CoviCompare project is that adults aged 18-45 will not be concerned here, because the adenovirus vaccine is not recommended for this age group in France
Detailed description
In this trial of the Covicompare project, we will therefore evaluate the immune response after Janssen vaccine in subjects aged more than 65 years and 55 to 65 years without a prior COVID-19, following the same immunomonitoring analyses as for the other CoviCompare project trials.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 55 - 64 years old (50 volunteers) | Experimental | Biological: COVID-19 Vaccine Janssen (Ad26.COV2-S)1 injection of vaccine Janssen (Ad26.COV2-S) at Day 1 and boost vaccine at Day 57 |
| At least 65 years old (50 volunteers) | Experimental | Biological: COVID-19 Vaccine Janssen (Ad26.COV2-S)1 injection of vaccine Janssen (Ad26.COV2-S) at Day 1 and boost vaccine at Day 57 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy adults, or stable medical condition for adults with pre-existing medical conditions. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during 3 months before enrolment, nor expected to require any significant change in therapy or hospitalization for worsening disease in foreseeable future.
- Understands and agrees to comply with the study procedures (visits, phone calls) and provides written free informed consent.
- Able to comply with study procedures based on Investigator judgement.
- Affiliated to a social security system, (except state medical aid)
Key exclusion criteria (21 listed)
- Subject is ill or febrile (body temperature ≥ 38.0°C) within 72 prior hours or and/or symptoms suggestive of COVID-19 within the past 14 days at enrolment visit (ill or febrile participants may be re-scheduled within the inclusion period when no longer presenting symptoms)
- History of documented COVID-19 (PCR+, antigenic test+ or chest CT Scan + or serology SARS-CoV- 2+) prior to the vaccine administration
- Subjects with positive serology to SARS-CoV-2 at the enrolment visit.
- Subjects who already received another anti-SARS-CoV-2-vaccine
- Subjects who received BCG (Bacille Calmette and Guérin vaccine) given within the last year.
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 |
|---|---|---|
| COVID-19 Vaccine Janssen (Ad26.COV2-S)one dose (0.5mL) at D1 and one dose (0.5mL) at D57 | Biological | 55 - 64 years old (50 volunteers), At least 65 years old (50 volunteers) |
Primary outcome
IgG humoral response to vaccine
Time frame: Day 29
Anti SARS-CoV-2 Spike IgG as measured by ELISA
7 secondary outcomes
IgG humoral response to vaccine
Time frame: Day 1, Day 29, Day 57, Month 6, Month 12, Month 24
IgA humoral response to vaccine
Time frame: Day 1, day 29, Day 57, Month 6, Month 12, Month 24
IgM humoral response to vaccine
Time frame: Day 1, day 29, Day 57, Month 6, Month 12, Month 24
neutralizing antibody humoral response to vaccine
Time frame: Day 1, day 29, Day 57, Month 6, Month 12, Month 24
T cells response to vaccine
Time frame: Day 1, Day 57, Month 6
Mucosal response to vaccine
Time frame: Day 1, day 29, Day 57, Month 6, Month 12, Month 24
B cell response to vaccine
Time frame: Day 1, Day 57, Month 6
Results and safety
The study was stopped early (reason given: The study was stopped due to lack of inclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
ELISABETH BOTELHO-NEVERS, MDPHD principal investigator
CENTRE HOSPITALIER DE SAINT-ETIENNE
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing COVID-19 Vaccine Janssen (Ad26.COV2-S) in people with Healthy Volunteers, run by Centre Hospitalier Universitaire de Saint Etienne at 10 sites in France.
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 4 inclusion and 21 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: stopped early, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was stopped due to lack of inclusions). Results are not available in the source record.
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?
IgG humoral response to vaccine (time frame: Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2025.