COVID-19Phase 3COVIBOOSTNCT05124171
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
A Phase 3 study testing BNT162b2, CoV2 preS dTM adjuvanted vaccine (D614), Sanofi/GSK and CoV2 preS dTM adjuvanted vaccine (B.1.351), Sanofi/GSK in people with COVID-19 and Vaccine Reaction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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… 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
- What is being tested?
- BNT162b2, CoV2 preS dTM adjuvanted vaccine (D614), Sanofi/GSK and CoV2 preS dTM adjuvanted vaccine (B.1.351), Sanofi/GSK
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 1 siteFrance
- Study dates
- 8 Dec 2021to Dec 2022
- Phase
- Phase 3
- 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 ≥ 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
- For women of childbearing age: a negative highly sensitive pregnancy urinary test during the inclusion visit AND use of an effective contraceptive method prior to vaccination and until at least 12 weeks after the vaccination
- 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.
Who cannot join
- Acute febrile infection (body temperature ≥ 38.0°C) within the previous 72 hours and/or presenting symptoms suggestive of COVID-19 within the previous 28 days, or having been in contact with an infected individual for the last 10 days before the inclusion visit;
- Virologically documented history of COVID-19 (PCR or serology);
- Immunosuppressive therapy such as corticosteroids > 10 mg prednisone equivalent/day (excluding topical preparations and inhalers) within 3 months prior to inclusion or within 6 months for chemotherapies;
- Treatment with immunoglobulins or other blood derivatives within 3 months prior to inclusion or scheduled administration of immunoglobulins or blood derivatives before the end of the study;
- Known HIV, HCV or HBV infection;
- Any medical condition, such as cancer, that might impair the immune response;
Show all 14Show fewer
- 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
- Participation in other research involving humans (French classification Jarde 1 or Jarde 2) within 4 weeks prior to the inclusion visit, or participation in any other vaccine trial
- Subject under legal protection (e.g. guardianship, tutorship)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunogenicity and Reactogenicity Following a 3rd Dose of COVID-19 mRNA Vaccine (Pfizer-BioNtech) and Two Adjuvanted Sub-unit Vaccines (SP/GSK) Administered as a Booster in Adults Who Received 2 Doses of Pfizer-BioNTech mRNA Vaccine as a Primary Vaccination: A Randomized, Single-blinded Multicenter Clinical Trial
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.
Read more
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.
Read the detailed description
The efficacy of COVID 19 vaccines for reducing the risk of severe COVID-19 infection has now been demonstrated in real life. In France, the vaccination campaign started on December 27th, 2020 and was launched rapidly for healthcare professionals and for individuals at risk of severe COVID on January 2021. On August 5th 30th, 2021, approximately 60% of the population (> 12 years) had already received complete vaccination. Out of approximately 74,3 million doses of vaccine administered, 58 million doses are Pfizer BioNTech vaccine (78%).
Data currently available on the persistence of immunity on the one hand and the appearance of viral variants with reduced sensitivity to vaccine immunity on the other, raise the need to administer further additional dose at an interval from the primary vaccination that remains to be defined, possibly different according to age and co-existing diseases.
Currently, the only data published are related to the administration of a third dose (booster) of the same vaccine as the one used for primary vaccination. However, some vaccines developed more recently could be an interesting alternative for booster dose in terms of reactogenicity, availability, cost and acceptance. Moreover heterologous vaccination could be more immunogenic than homologous scheme.
The vaccine developed by Sanofi Pasteur is based on a conventional adjuvanted recombinant protein approach. Two prototype vaccines are under development, one based on the Spike protein of the SARS CoV-2 D614 strain, the other on the B.1.351 strain. Their interest as booster vaccines needs to be investigated.
The objective of this trial is to assess the response induced by a booster dose of either recombinant protein-based subunit vaccine (targeting D614 strain or B.1.351 strain) or by a booster dose of Pfizer-BioNTech mRNA vaccine (targeting Wuhan strain) in individuals previously vaccinated with 2 doses of Pfizer-BioNTech mRNA vaccine. These results will provide important information for booster vaccination recommendations.
Participants enrolled will be healthy adults with no medical history of COVID-19; they will be recruited in 10(15?) centers in mainland France, via the COVIREIVAC network.
The study will be a randomized, single-blinded, multicentre trial with three parallel arms:
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
Participants will undergo 5 visits :
- V1 (D0): inclusion, randomization, pregnancy test, PCR test, blood draw and administration of the booster dose
- V2 (D28): follow-up visit with a review of solicited and unsolicited local and systemic reactions that occurred since the last visit, and blood draw
- V3 (D90): follow-up visit with review of potential adverse events and blood draw
- V4 (D180): follow-up visit with review of potential adverse events and blood draw
- V5 (D365): follow-up visit with review of potential adverse events and blood draw
Blood samples will be used to conduct immunological analyses, and cellular analyses for a sub-category of 26 participants per group.
- Conditions
- COVID-19, Vaccine Reaction
- Being tested
- BNT162b2, CoV2 preS dTM adjuvanted vaccine (D614), Sanofi/GSK, CoV2 preS dTM adjuvanted vaccine (B.1.351), Sanofi/GSK
- Keywords
- COVID 19, mRNA vaccines, Immunology, Sub-unit vaccine, Booster
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNT162b2Biological
Also called pfzer/BioNTech, mARN vaccine,
ARM 1 receiving Pfizer-BioNTech vaccine
- Group 1.A: 18-64 years old
- Group 1.B: 65 years and older
CoV2 preS dTM adjuvanted vaccine (D614), Sanofi/GSKBiological
ARM 2 receiving SP/GSK subunit D614 vaccine
- Group 2.A: 18-64 years old
- Group 2.B: 65 years and older
CoV2 preS dTM adjuvanted vaccine (B.1.351), Sanofi/GSKBiological
ARM 3 receiving SP/GSK subunit B.1.351 vaccine
- Group 3.A: 18-64 years old
- Group 3.B: 65 years and older
| Study group | Role | What they receive |
|---|---|---|
| Comirnaty® (Pfizer-BioNTech) | Experimental | Length of use : 1 day Receives: Biological: BNT162b2 |
| CoV2 preS dTM adjuvanted vaccine (D614), Sanofi/GSK | Experimental | Length of use : 1 day Receives: Biological: CoV2 preS dTM adjuvanted vaccine (D614), Sanofi/GSK |
| CoV2 preS dTM adjuvanted vaccine (B.1.351), Sanofi/GSK | Experimental | Length of use : 1 day Receives: Biological: CoV2 preS dTM adjuvanted vaccine (B.1.351), Sanofi/GSK |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 days
Secondary outcomes (15)
Rate of increase in neutralizing antibody titers against SARS-CoV-2 D614 and B.1.351 viral strains
Rate of increase in neutralizing antibody titers against SARS-CoV-2 D614 and B.1.351 viral strains, measured by a microneutralisation technique between 0 and 28 days after the booster dose in each group
Measured: 28 days
Quantity and intensity of unsolicited local and systemic events up to 7 days
Quantity and intensity of local and systemic events of any grade occurring up to 7 days after boost injection (assessed from the list of solicited adverse events)
Measured: 7 days
Quantity and intensity of unsolicited local and systemic events up to 28 days
Quantity and intensity of local and systemic events of any grade occurring up to 28 days after boost injection (assessed from the list of solicited adverse events)
Measured: 28 days
Anti-Spike (D614) and anti-RBD (D614 and B.1.351) IgG levels
Anti-Spike (D614) and anti-RBD (D614 and B.1.351) IgG levels, expressed in BAU/ml, according to WHO recommendations D28 after the booster dose mRNA or adjuvanted subunit vaccine
Measured: between Month 3 and Day 0
Difference in anti-Spike (D614) and anti-RBD (D614 and B.1.351) IgG levels at 3 months
Difference in anti-Spike (D614) and anti-RBD (D614 and B.1.351) IgG levels between M3 and D0
Measured: Between Month 6 and Day 0
Difference in anti-Spike (D614) and anti-RBD (D614 and B.1.351) IgG levels at 12 months
Difference in anti-Spike (D614) and anti-RBD (D614 and B.1.351) IgG levels between M12 and D0
Measured: between Month 12 and Day 0
Neutralizing antibody titers against D614, alpha, gamma and delta variants at 3 months
Neutralizing antibody titers against D614, alpha, gamma and delta variants at 3 months
Measured: 3 months
Neutralizing antibody titers against D614, alpha, gamma and delta variants at 3 months
Neutralizing antibody titers against D614, alpha, gamma and delta variants at 3 months
Measured: 6 months
Neutralizing antibody titers against D614, alpha, gamma and delta variants at 12 months
Neutralizing antibody titers against D614, alpha, gamma and delta variants at 12 months
Measured: 12 months
ELISpot IFN CD4 and CD8 response at 28 days
ELISpot IFN CD4 and CD8 response at 28 days
Measured: 28 days
ELISpot IFN CD4 and CD8 response at 3 months
ELISpot IFN CD4 and CD8 response at 3 months
Measured: 3 months
ELISpot IFN CD4 and CD8 response at 12 months
ELISpot IFN CD4 and CD8 response at 12 months
Measured: 12 months
Anti-Spike (D614) and anti-RBD (D614 and B.1.351) IgG levels
Anti-Spike (D614) and anti-RBD (D614 and B.1.351) IgG levels, expressed in BAU/ml, according to WHO recommendations D3 after the booster dose mRNA or adjuvanted subunit vaccine (ancillary analysis) to assess the early humoral response by ELISA of a booster dose of mRNA vaccine or subunit adjuvanted vaccine
Measured: Day 3
ELISpot IFN CD4 and CD8 response
ELISpot IFN CD4 and CD8 response (ancillary analysis); to explore CD4 and CD8 cellular response induced by a booster dose of mRNA vaccine or adjuvanted subunit vaccine (ancillary analysis)
Measured: 28 days, 3 months and 12 months
Activated (CD71+) spike Beta specific B cells will also be sorted and cultured in single cells for further analysis of their BCR and their relationship with the early CSA response.
To explore B cells (CD71) functionality
Ancillary study endpoints:
Cf. Coviboost ancillary study protocol.
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start8 Dec 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- COVIREIVAC
- Responsible party
- Sponsor
- Investigators
- Odile LAUNAY, PU-PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124171
- Sponsor's protocol ID
- APHP211184
- Other IDs
- 2021-004550-33
- Acronym
- COVIBOOST
- Status last verified
- Jul 2022
- First submitted
- 8 Nov 2021
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Reactogenicity Following a 3rd Dose of COVID-19 mRNA Vaccine (Pfizer-BioNtech) and Two Adjuvanted Sub-unit Vaccines (SP/GSK) Administered as a Booster in Adults Who Received 2 Doses of Pfizer-BioNTech mRNA Vaccine as a Primary Vaccination: A Randomized, Single-blinded Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT05124171
- Acronym / sponsor ID
- COVIBOOST / APHP211184
- Conditions
- COVID-19, Vaccine Reaction
- Keywords
- COVID 19, mRNA vaccines, Immunology, Sub-unit vaccine, Booster
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- COVIREIVAC
- Study start
- 8 Dec 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 17 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 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.
Detailed description
The efficacy of COVID 19 vaccines for reducing the risk of severe COVID-19 infection has now been demonstrated in real life. In France, the vaccination campaign started on December 27th, 2020 and was launched rapidly for healthcare professionals and for individuals at risk of severe COVID on January 2021. On August 5th 30th, 2021, approximately 60% of the population (> 12 years) had already received complete vaccination. Out of approximately 74,3 million doses of vaccine administered, 58 million doses are Pfizer BioNTech vaccine (78%).
Data currently available on the persistence of immunity on the one hand and the appearance of viral variants with reduced sensitivity to vaccine immunity on the other, raise the need to administer further additional dose at an interval from the primary vaccination that remains to be defined, possibly different according to age and co-existing diseases.
Currently, the only data published are related to the administration of a third dose (booster) of the same vaccine as the one used for primary vaccination. However, some vaccines developed more recently could be an interesting alternative for booster dose in terms of reactogenicity, availability, cost and acceptance. Moreover heterologous vaccination could be more immunogenic than homologous scheme.
The vaccine developed by Sanofi Pasteur is based on a conventional adjuvanted recombinant protein approach. Two prototype vaccines are under development, one based on the Spike protein of the SARS CoV-2 D614 strain, the other on the B.1.351 strain. Their interest as booster vaccines needs to be investigated.
The objective of this trial is to assess the response induced by a booster dose of either recombinant protein-based subunit vaccine (targeting D614 strain or B.1.351 strain) or by a booster dose of Pfizer-BioNTech mRNA vaccine (targeting Wuhan strain) in individuals previously vaccinated with 2 doses of Pfizer-BioNTech mRNA vaccine. These results will provide important information for booster vaccination recommendations.
Participants enrolled will be healthy adults with no medical history of COVID-19; they will be recruited in 10(15?) centers in mainland France, via the COVIREIVAC network.
The study will be a randomized, single-blinded, multicentre trial with three parallel arms:
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
Participants will undergo 5 visits :
- V1 (D0): inclusion, randomization, pregnancy test, PCR test, blood draw and administration of the booster dose
- V2 (D28): follow-up visit with a review of solicited and unsolicited local and systemic reactions that occurred since the last visit, and blood draw
- V3 (D90): follow-up visit with review of potential adverse events and blood draw
- V4 (D180): follow-up visit with review of potential adverse events and blood draw
- V5 (D365): follow-up visit with review of potential adverse events and blood draw
Blood samples will be used to conduct immunological analyses, and cellular analyses for a sub-category of 26 participants per group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Comirnaty® (Pfizer-BioNTech) | Experimental | Biological: BNT162b2Length of use : 1 day |
| CoV2 preS dTM adjuvanted vaccine (D614), Sanofi/GSK | Experimental | Biological: CoV2 preS dTM adjuvanted vaccine (D614), Sanofi/GSKLength of use : 1 day |
| CoV2 preS dTM adjuvanted vaccine (B.1.351), Sanofi/GSK | Experimental | Biological: CoV2 preS dTM adjuvanted vaccine (B.1.351), Sanofi/GSKLength of use : 1 day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- For women of childbearing age: a negative highly sensitive pregnancy urinary test during the inclusion visit AND use of an effective contraceptive method prior to vaccination and until at least 12 weeks after the vaccination
- 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
Key exclusion criteria (14 listed)
- Acute febrile infection (body temperature ≥ 38.0°C) within the previous 72 hours and/or presenting symptoms suggestive of COVID-19 within the previous 28 days, or having been in contact with an infected individual for the last 10 days before the inclusion visit;
- Virologically documented history of COVID-19 (PCR or serology);
- Immunosuppressive therapy such as corticosteroids > 10 mg prednisone equivalent/day (excluding topical preparations and inhalers) within 3 months prior to inclusion or within 6 months for chemotherapies;
- Treatment with immunoglobulins or other blood derivatives within 3 months prior to inclusion or scheduled administration of immunoglobulins or blood derivatives before the end of the study;
- Known HIV, HCV or HBV infection;
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 |
|---|---|---|
| BNT162b2Also: pfzer/BioNTech, mARN vaccine,ARM 1 receiving Pfizer-BioNTech vaccine * Group 1.A: 18-64 years old * Group 1.B: 65 years and older | Biological | Comirnaty® (Pfizer-BioNTech) |
| CoV2 preS dTM adjuvanted vaccine (D614), Sanofi/GSKARM 2 receiving SP/GSK subunit D614 vaccine * Group 2.A: 18-64 years old * Group 2.B: 65 years and older | Biological | CoV2 preS dTM adjuvanted vaccine (D614), Sanofi/GSK |
| CoV2 preS dTM adjuvanted vaccine (B.1.351), Sanofi/GSKARM 3 receiving SP/GSK subunit B.1.351 vaccine * Group 3.A: 18-64 years old * Group 3.B: 65 years and older | Biological | CoV2 preS dTM adjuvanted vaccine (B.1.351), Sanofi/GSK |
Primary outcome
rate of neutralizing antibody titers against SARS-CoV-2 D614 and B.1.351 viral strains
Time frame: 15 days
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 secondary outcomes
Rate of increase in neutralizing antibody titers against SARS-CoV-2 D614 and B.1.351 viral strains
Time frame: 28 days
Quantity and intensity of unsolicited local and systemic events up to 7 days
Time frame: 7 days
Quantity and intensity of unsolicited local and systemic events up to 28 days
Time frame: 28 days
Anti-Spike (D614) and anti-RBD (D614 and B.1.351) IgG levels
Time frame: between Month 3 and Day 0
Difference in anti-Spike (D614) and anti-RBD (D614 and B.1.351) IgG levels at 3 months
Time frame: Between Month 6 and Day 0
Difference in anti-Spike (D614) and anti-RBD (D614 and B.1.351) IgG levels at 12 months
Time frame: between Month 12 and Day 0
Neutralizing antibody titers against D614, alpha, gamma and delta variants at 3 months
Time frame: 3 months
Neutralizing antibody titers against D614, alpha, gamma and delta variants at 3 months
Time frame: 6 months
Neutralizing antibody titers against D614, alpha, gamma and delta variants at 12 months
Time frame: 12 months
ELISpot IFN CD4 and CD8 response at 28 days
Time frame: 28 days
ELISpot IFN CD4 and CD8 response at 3 months
Time frame: 3 months
ELISpot IFN CD4 and CD8 response at 12 months
Time frame: 12 months
Anti-Spike (D614) and anti-RBD (D614 and B.1.351) IgG levels
Time frame: Day 3
ELISpot IFN CD4 and CD8 response
Time frame: 28 days, 3 months and 12 months
Activated (CD71+) spike Beta specific B cells will also be sorted and cultured in single cells for further analysis of their BCR and their relationship with the early CSA response.
Time frame: Day 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Odile LAUNAY, PU-PH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BNT162b2, CoV2 preS dTM adjuvanted vaccine (D614), Sanofi/GSK and CoV2 preS dTM adjuvanted vaccine (B.1.351), Sanofi/GSK in people with COVID-19 and Vaccine Reaction, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 8 inclusion and 14 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 11 Jul 2022. 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 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
rate of neutralizing antibody titers against SARS-CoV-2 D614 and B.1.351 viral strains (time frame: 15 days). 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 11 Jul 2022; AzTrials last refreshed its copy on 6 Nov 2026.