Immunogenicity and Reactogenicity Following a Booster Dose of COVID-19 mRNA Vaccine (Pfizer-BioNtech) and Two Adjuvanted Sub-unit Vaccines (SP/GSK) Administered in Adults Who Received 2 Doses of Pfizer-BioNTech mRNA Vaccine as a Primary Vaccination
COVIBOOST
2 other identifiers
interventional
247
1 country
1
Brief Summary
The vaccination campaign in France began in early 2021 and was declared mandatory for all French people in July 2021. The efficacy of COVID-19 vaccines has since been widely demonstrated, as well as their safety, and now 60% of the adult population in France has received a first dose, most of them with Pfizer-BioNTech's mRNA vaccine. However, despite the increasing coverage, new data highlight the need for a booster dose for the most vulnerable people, including patients with immune deficiency. This makes it likely that a booster dose will also be needed in the general population, especially among healthcare workers, due to the active circulation of new variants since the beginning of summer 2021 and evidence of reduced protection against them. On the other hand, in addition to evaluating the potential benefit of a booster vaccination, it appears interesting to also evaluate a heterologous vaccination regimen, i.e. a booster with a different vaccine than the one used for the primary vaccination. Some studies have already evaluated a two-dose heterologous regimen and the results have shown stronger protection against SARS-CoV-2. In addition, this alternative could provide a real benefit in terms of accessibility, cost, and acceptability. The vaccine developed by Sanofi-Pasteur is based on a traditional recombinant protein approach using GSK's AS03 adjuvant. Two formulations of this vaccine are currently under development, the first targeting the S protein of the D614 strain (Wuhan strain), the second targeting the B.1.351 variant. Their value as a booster needs to be evaluated. The objective of this trial is therefore to evaluate the immunological response and safety induced by a homologous vaccine booster (Pfizer-BioNTech vaccine booster) and a heterologous vaccine booster (one of the two experimental Sanofi/GSK vaccines booster), on the D614 (Wuhan) strain and on the SARS-CoV-2 variants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 covid19
Started Dec 2021
Typical duration for phase_3 covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2021
CompletedFirst Posted
Study publicly available on registry
November 17, 2021
CompletedStudy Start
First participant enrolled
December 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedJuly 11, 2022
July 1, 2022
12 months
November 8, 2021
July 7, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
rate of neutralizing antibody titers against SARS-CoV-2 D614 and B.1.351 viral strains
Increased rate of at least 10 fold between D0 and D15 after the booster dose in neutralizing antibody titers against SARS-CoV-2 D614 and B.1.351 viral strains, measured by a microneutralisation technique in each group to assess the immunogenicity of a booster dose of an adjuvanted subunit vaccine (SP vaccine) as between D614 or B.1.351 and a mRNA vaccine (Pfizer BioNTech) in adults who were primarily vaccinated with 2 doses of mRNA vaccine (Pfizer BioNTech) with the 2nd dose of vaccine received at least 6 months +/- 1 month prior to the booster dose.
15 days
Secondary Outcomes (15)
Rate of increase in neutralizing antibody titers against SARS-CoV-2 D614 and B.1.351 viral strains
28 days
Quantity and intensity of unsolicited local and systemic events up to 7 days
7 days
Quantity and intensity of unsolicited local and systemic events up to 28 days
28 days
Anti-Spike (D614) and anti-RBD (D614 and B.1.351) IgG levels
between Month 3 and Day 0
Difference in anti-Spike (D614) and anti-RBD (D614 and B.1.351) IgG levels at 3 months
Between Month 6 and Day 0
- +10 more secondary outcomes
Study Arms (3)
Comirnaty® (Pfizer-BioNTech)
EXPERIMENTALLength of use : 1 day
CoV2 preS dTM adjuvanted vaccine (D614), Sanofi/GSK
EXPERIMENTALLength of use : 1 day
CoV2 preS dTM adjuvanted vaccine (B.1.351), Sanofi/GSK
EXPERIMENTALLength of use : 1 day
Interventions
ARM 1 receiving Pfizer-BioNTech vaccine * Group 1.A: 18-64 years old * Group 1.B: 65 years and older
ARM 2 receiving SP/GSK subunit D614 vaccine * Group 2.A: 18-64 years old * Group 2.B: 65 years and older
ARM 3 receiving SP/GSK subunit B.1.351 vaccine * Group 3.A: 18-64 years old * Group 3.B: 65 years and older
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Adult in a healthy condition or with a stable health status if pre-existing medical history. Stable health status is defined as an existing disease that has not required a significant change in treatment of hospitalization for worsening in the 3 months before enrollment, and for which neither a significant change in treatment or hospitalization for worsening is expected in the near future
- Who has received 2 doses of mRNA vaccine (Pfizer-BioNTech) with an interval of 3 to 6 weeks
- Second dose of mRNA vaccine (Pfizer-BioNTech) administered 6 months +/- 1 month before the booster dose
- Understands and agrees to comply with the study procedures
- Written informed consent signed by both the participant and the investigator
- Subject affiliated to the French Social Security System.
You may not qualify if:
- Virologically documented history of COVID-19 (PCR or serology);
- Known HIV, HCV or HBV infection;
- Any medical condition, such as cancer, that might impair the immune response;
- Use of experimental immunoglobulins, experimental monoclonal antibodies or convalescent plasma is not permitted during the study;
- Pregnancy or breastfeeding currently ongoing;
- History of severe adverse events following vaccine administration including anaphylactic reaction and associated symptoms such as rash, breathing problems, angioedema, and abdominal pain, or a history of allergic reaction that could be triggered by a component of the SARS-COV-2 vaccine at the time of the first vaccine injection;
- Participant who has received BCG (tuberculosis) vaccine within the previous year;
- Has received a vaccine within 4 weeks prior to the boost injection or is scheduled to receive a registered vaccine 4 weeks after the boost injection
- Any bleeding disorder considered as a contraindication to an intramuscular injection, previous phlebotomy, or receipt of anticoagulants
- Subject under legal protection (e.g. guardianship, tutorship)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assistance Publique - Hôpitaux de Parislead
- COVIREIVACcollaborator
Study Sites (1)
GH Broca-Cochin-Hôtel-Dieu CIC 1417 Cochin-Pasteur
Paris, 75004, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Odile LAUNAY, PU-PH
Assistance Publique - Hôpitaux de Paris
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2021
First Posted
November 17, 2021
Study Start
December 8, 2021
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
July 11, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share