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COVID-19Phase 2CoviComMaliNCT05409261

Evaluation of the Immunogenicity and Safety of Ad26.COV2.S's COVID-19 Vaccine

A Phase 2 study testing Ad26.COV2.S in people with COVID-19 and Vaccine Reaction, run by ANRS, Emerging Infectious Diseases at 1 site in Mali.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Phase II, non-randomized, open-label, comparative, national, multicenter trial in Mali, aimed to assess the humoral vaccine immune response induced by Ad26.COV2.S vaccine in 200 adults one month after receiving the complete vaccination schedule of SARS-CoV-2 vaccine. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19, Vaccine Reaction, SARS CoV 2 Infection
What is being tested?
Ad26.COV2.S
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteMali
Study dates
2 Jun 2022to Mar 2025
Phase
Phase 2
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

  • Age between 18 and 45 years old or 55 years and older
  • Be eligible to receive one of the study vaccines as part of the trial
  • Understand and agree to comply with study procedures (visits, telephone calls)
  • Agree not to participate in any other vaccine study during the time of the study
  • Give written informed consent prior to any examination performed as part of the trial

Who cannot join

  • Positive SARS-CoV-2 antigenic test
  • Positive SARS-CoV-2 polymerase chain reaction (PCR) results less than 48 hours old
  • History of infection by SARS-CoV-2 confirmed by antigenic test or PCR within 3 months prior to inclusion
  • Symptoms compatible with infection to SARS-CoV-2: sick or febrile participants (body temperature ≥ 38.0°C)
  • Pregnant or breastfeeding woman
  • Known chronic disease impacting the participant's immune response (uncured cancer, human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection)
Show all 13Show fewer
  • Anti-coagulant treatment
  • Immunosuppressive treatment
  • Contraindication to the proposed vaccine (according to RCP)
  • Previously received at least one injection of a SARS-CoV-2 vaccine
  • Patient having received immunoglobulin or another blood product within 3 months prior to inclusion
  • A history of serious adverse vaccine reactions (anaphylaxis and associated symptoms such as rash, breathing difficulties, laryngeal edema, or a history of allergic reaction that may be exacerbated by a component of the SARS-CoV-2 vaccine)
  • Any condition that, in the opinion of the investigator, may adversely affect the well-being of the participant and interfere with the purpose of the study

Trial locations and contacts

1 site in 1 country.

Mali1 site

  • CVD-MALI

    Bamako, 251

Other trials in Mali

About this study

Official title: Phase II Trial Evaluating the Immunogenicity and Safety of Ad26.COV2.S Vaccine in Adult Participants in Mali

Phase II, non-randomized, open-label, comparative, national, multicenter trial in Mali, aimed to assess the humoral vaccine immune response induced by Ad26.COV2.S vaccine in 200 adults one month after receiving the complete vaccination schedule of SARS-CoV-2 vaccine.

Read the detailed description

The main objective of this phase II trial is to evaluate the humoral immune response induced by the Ad26.COV2.S vaccine in adults one month after complete vaccination regimen against SARS-CoV-2, compared younger (up to 45 years old) and elderly (55+ years old) populations.

200 participants will be included, 200 participants for each vacine. The age categories are 18 - 45 years, 55 - 64 years and 65+ years. The number of participants per age group will be distributed as follows 1:1:0,5. There will be no comparison between population on different vaccines.

Ad26.COV2 vaccine (200 participants) 18-45 years old, 80 participants 55-64 years old, 80 participants 65 years old or older, 40 participants

Participants in Ad26.COV2 arm receive intramuscularly as a single dose of 0.5mL.

Humoral vaccine immune responses, induced by Ad26.COV2.S vaccine, will be measured by ELISA at D0, M1, M2, M6, M12 and M24.

Being tested
Ad26.COV2.S
Keywords
Ad26.COV2.S
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ad26.COV2.SBiological

    Also called Janssen, Johnson&Johnson

    Recombinant vaccine, contains Adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein

Study groups in NCT05409261
Study groupRoleWhat they receive
Ad26.COV2.SExperimentalSingle dose (0.5mL) of SARS-CoV-2 vaccine Ad26.COV2.S.
Receives: Biological: Ad26.COV2.S

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Anti-SARS-CoV-2 Spike immunoglobulin G (IgG) level

    Anti-SARS-CoV-2 Spike IgG level is measured using ELISA test

    Measured: One month after complete vaccination schema

Secondary outcomes (10)

  1. Anti-SARS-CoV-2 Spike IgG level

    Anti-SARS-CoV-2 Spike IgG level is measured using ELISA test

    Measured: At inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion

  2. Anti-SARS-CoV-2 immunoglobulin M (IgM) level

    Anti-SARS-CoV-2 IgM level is measured using ELISA test

    Measured: At inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion

  3. Neutralizing antibody level for SARS-CoV-2

    Neutralizing antibody levels specific for SARS-CoV-2 and its variants (conventional in vitro neutralization and pseudo-neutralization assays)

    Measured: Inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion

  4. Fluorospot tests (type 1,2, and 17 helper T cell (TH1, TH2, TH17), Cytotoxicity)

    Fluorospot tests (TH1, TH2, TH17, Cytotoxicity) Phenotyping of antigen-specific T cells by mass cytometry at Day 0 and Month 6 selected from the results of the Fluorospot test.

    Measured: Inclusion (Day 0) and then 2 and 6 months after inclusion

  5. Mucosal SARS-CoV-2 specific antibody levels

    Mucosal SARS-CoV-2 specific antibody levels by measuring IgA, IgM and IgG in saliva using specific ELISAs

    Measured: Inclusion (Day 0) and then 1, 2, 6, 12, and 24 months after inclusion

  6. Determination of Epitope profile

    Determination of epitope profile

    Measured: Day 0 and Month 2

  7. B cell response to vaccine

    Determination of repertoire of B cells (stereotype clonotype)

    Measured: Day 0, Month 2, Month 6

  8. Measurement of ultrasensitive immunoglobulin A (IgA) and mucosal IgA and IgM functionality

    Measurement of ultrasensitive IgA in saliva by Photoring assay Measurement of mucosal IgA and IgM functionality by SARS-CoV-2 mucosal IgA- and IgM-specific antibody-dependent cell-mediated cytotoxicity (ADCC) test

    Measured: Day 0 and then 1, 2, 6, 12, and 24 months after inclusion

  9. Rate of adverse events

    Rate of adverse events of any grade attributable to the vaccine or vaccination occurring between Month 1 and Month 24

    Measured: Between month 1 and month 24 after inclusion

  10. SARS-CoV-2 infection

    Occurrence of confirmed COVID-19 cases during participant follow-up

    Measured: Date of inclusion until 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2022
  2. Study start2 Jun 2022
  3. Primary completion25 Sep 2022
  4. Study completionMar 2025 (estimated)

Resources

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 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05409261
Sponsor's protocol ID
ANRS0142S
Acronym
CoviComMali
Status last verified
Mar 2024
First submitted
1 Apr 2022
Last updated
27 Mar 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ad26.COV2.S in people with COVID-19 and Vaccine Reaction, run by ANRS, Emerging Infectious Diseases at 1 site in Mali.

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 5 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mali. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

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?

Anti-SARS-CoV-2 Spike immunoglobulin G (IgG) level (time frame: One month after complete vaccination schema). 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 NCT05409261.

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 27 Mar 2024.

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