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

NCT05037266 | Terminated Phase 4

• 2 other identifiers: 21CH1352021-003191-14
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 10

Brief 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. 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

Conditions

Healthy Volunteers

Keywords

vaccine; immunity; immunogenicity; Janssen vaccine; COVID-19

Outcome Measures

Primary Outcomes (1)

• IgG humoral response to vaccine

  Anti SARS-CoV-2 Spike IgG as measured by ELISA

  Day 29

Secondary Outcomes (7)

• IgG humoral response to vaccine

  Day 1, Day 29, Day 57, Month 6, Month 12, Month 24

• IgA humoral response to vaccine

  Day 1, day 29, Day 57, Month 6, Month 12, Month 24

• IgM humoral response to vaccine

  Day 1, day 29, Day 57, Month 6, Month 12, Month 24

• neutralizing antibody humoral response to vaccine

  Day 1, day 29, Day 57, Month 6, Month 12, Month 24

• T cells response to vaccine

  Day 1, Day 57, Month 6

Study Arms (2)

55 - 64 years old (50 volunteers)

EXPERIMENTAL

1 injection of vaccine Janssen (Ad26.COV2-S) at Day 1 and boost vaccine at Day 57

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

Biological: COVID-19 Vaccine Janssen (Ad26.COV2-S)

Interventions

COVID-19 Vaccine Janssen (Ad26.COV2-S) BIOLOGICAL

one dose (0.5mL) at D1 and one dose (0.5mL) at D57

55 - 64 years old (50 volunteers); At least 65 years old (50 volunteers)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (10)

Chu de Dijon

Dijon, 21000, France

Location

Centre Hospitalier Regional Lille

Lille, 59000, France

Location

APHM

Marseille, 13000, France

Location

Centre Hospitalier Universitaire Nantes

Nantes, 44000, France

Location

Hopital Bichat

Paris, 75000, France

Location

Hopital Cochin

Paris, 75000, France

Location

Centre Hospitalier Universitaire Rennes

Rennes, 35033, France

Location

Chu de Rouen

Rouen, 76000, France

Location

Centre Hospitalier de Saint-Etienne

Saint-Etienne, 42055, France

Location

Centre Hospitalier Tours

Tours, 37000, France

Location

MeSH Terms

Conditions

COVID-19

Interventions

Ad26COVS1

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

COVID-19 Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• ELISABETH BOTELHO-NEVERS, MDPHD

  CENTRE HOSPITALIER DE SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: September 8, 2021
• Study Start: September 20, 2021
• Primary Completion: February 14, 2022
• Study Completion: January 29, 2024
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (10)