Vaccine ReactionPhase 3CoviBOOST 2NCT05749926
Immunogenicity and Reactogenicity of the Beta-variant Recombinant Protein Booster Vaccine (VidPrevtyn Beta, Sanofi) Compared to a Bivalent mRNA Vaccine (Comirnaty Original/Omicron BA.4-5, BioNTech-Pfizer) in Adults Previously Vaccinated With at Least 3 Doses of COVID-19 mRNA Vaccine
A Phase 3 study testing Comirnaty® BNT162b2 /Omicron BA.4-5 vaccine (Pfizer-BioNTech) and VidPrevtyn® Beta vaccine (Sanofi/GSK) in people with Vaccine Reaction and COVID-19, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The objective of this trial is to compare the immunogenicity and the safety of the Beta-variant recombinant protein booster vaccine (VidPrevtyn® Beta, Sanofi) to a bivalent mRNA vaccine (Comirnaty Original/Omicron BA.4-5, BioNTech-Pfizer) in adults previously vaccinated with at least 3 doses of COVID-19 mRNA vaccine. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vaccine Reaction, COVID-19
- What is being tested?
- Comirnaty® BNT162b2 /Omicron BA.4-5 vaccine (Pfizer-BioNTech) and VidPrevtyn® Beta vaccine (Sanofi/GSK)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteFrance
- Study dates
- 16 May 2023to 12 Jul 2024
- 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
- Male or female aged 18 years and over
- Adult in a healthy condition or with a stable health status, determined by medical history, targeted physical examination and clinical judgement of the investigator to be in stable state of health. Participants with pre-existing stable chronic medical conditions defined as condition not requiring significant change in therapy or hospitalization for worsening disease within 4 weeks from enrollment can be included at the discretion of the investigator.
- For women of childbearing age: a negative highly sensitive pregnancy urinary test during the inclusion visit
- Confirmed receipt of at least three doses of COVID-19 mRNA vaccine the last dose at least 6 months prior to study vaccine
- 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
- Confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection < 3 months prior to the study vaccine dose.
- 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.
- 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.
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- 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:
- Any bleeding disorder considered as a contraindication to an intramuscular injection,
- Participation in other interventional research involving humans within 4 weeks prior to the inclusion visit, or participation in any other vaccine trial excepted for those with mid or long term follow up when vaccination was made at least 4 weeks before the injection in the study. In this case no delay is required after the end of the study participation".
- Subject under legal protection (e.g. guardianship)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunogenicity and Reactogenicity of the Beta-variant Recombinant Protein Booster Vaccine (VidPrevtyn Beta, Sanofi) Compared to a Bivalent mRNA Vaccine (Comirnaty Original/Omicron BA.4-5, BioNTech-Pfizer) in Adults Previously Vaccinated With at Least 3 Doses of COVID-19 mRNA Vaccine: A Non-inferiority Multicenter Single-blinded, Randomized Trial
The objective of this trial is to compare the immunogenicity and the safety of the Beta-variant recombinant protein booster vaccine (VidPrevtyn® Beta, Sanofi) to a bivalent mRNA vaccine (Comirnaty Original/Omicron BA.4-5, BioNTech-Pfizer) in adults previously vaccinated with at least 3 doses of COVID-19 mRNA vaccine. The results will provide important data for the future COVID 19 vaccine strategy.
A biobank will also be set up to evaluate the protection conferred by one or other of these vaccines as booster in the event of the emergence of new variants in the future.
Read the detailed description
The efficacy of COVID 19 vaccines for reducing the risk of severe COVID-19 infection is demonstrated in real life.
However, data currently available on the persistence of immunity after vaccination on the one hand and the emergence of viral variants with reduced sensibility to vaccine immunity on the other, raise the need to administer boosters to maintain the protection and to compare different strategies as bivalent mRNA vaccines but also others platforms.
The vaccines currently recommended as boosters in France are mRNA bivalent vaccines, adapted to better match the circulating variants of SARS-CoV-2 and expected to provide broader protection against Omicron sub variants (19). However, the rapid antigenic evolution of SARS-CoV-2 and the antigenic imprinting against the initial Hu-1 strain could reduce their effectiveness.
More recently, the Beta-variant recombinant protein booster vaccine (VidPrevtyn Beta, Sanofi) obtained European authorization and is recommended in France as booster as an alternative to the bivalent mRNA vaccines (21, 22). However, in the absence of comparative data with the bivalent mRNA vaccines, VidPrevtyn Beta is recommended as second line.
It has been shown with vectored vaccines that a heterologous vaccination scheme could be more immunogenic than a homologous scheme (23). Our group previously showed that VidPrevtyn Beta, administered as a third vaccine dose, induces higher immune response than the mRNA BNT162b2 vaccine (Comirnaty, BioNTech-Pfizer), against Beta variant but also others variants of concern (VOC) including Omicron BA1 (20) and Omicron BA4/5 (data submitted for publication). The data available at 3 and 6 months after the boost, show that VidPrevtyn Beta could be also of interest in term of durability of the response (data not published). The hypothesis is that a Beta variant protein recombinant vaccine could enlarge the protection against the variants by overpassing antigenic imprinting and the adjuvant improve the duration of immune response and protection. Moreover, the Beta-variant recombinant protein vaccine could bring an advantage in terms of reactogenicity, acceptability, cost and accessibility.
In this context, as recently pointed by the HAS, comparative data on immunogenicity and reactogenicity between a bivalent mRNA vaccine and the Beta-variant recombinant protein, both administered as boosters, are needed to better adapt the COVID 19 vaccine recommendations for the future.
This study is Comparative, non-inferiority, single-blinded, multicenter, randomized trial.
Randomization in a 1:1 ratio, will be stratified by age (18-60 years and ≥ 60 years of age) and history of SARS-CoV-2 infection
- Conditions
- Vaccine Reaction, COVID-19
- Being tested
- Comirnaty® BNT162b2 /Omicron BA.4-5 vaccine (Pfizer-BioNTech), VidPrevtyn® Beta vaccine (Sanofi/GSK)
- Keywords
- COVID 19, mRNA vaccines, Immunulogy, 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.
Comirnaty® BNT162b2 /Omicron BA.4-5 vaccine (Pfizer-BioNTech)Biological
A single administration of COVID-19 vaccine will be performed at D0, depending on randomization
VidPrevtyn® Beta vaccine (Sanofi/GSK)Biological
A single administration of COVID-19 vaccine will be performed at D0, depending on randomization
| Study group | Role | What they receive |
|---|---|---|
| Comirnaty® BNT162b2 /Omicron BA.4-5 vaccine (Pfizer-BioNTech) | Active comparator | Length of use : 1 day Receives: Biological: Comirnaty® BNT162b2 /Omicron BA.4-5 vaccine (Pfizer-BioNTech) |
| VidPrevtyn® Beta vaccine (Sanofi/GSK) | Experimental | Length of use : 1 day Receives: Biological: VidPrevtyn® Beta vaccine (Sanofi/GSK) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutralizing antibody titers against the SARS-CoV-2 variant of most prominent public health interest and against one of the variant targeted by the vaccines
Title : Neutralizing antibody titers against the SARS-CoV-2 variant of most prominent public health interest and against one of the variant targeted by the vaccines Time Frame : 28 Days
Description:
There will be a coprimary endpoint : Neutralizing antibody titers against the SARS-CoV-2 variant of most prominent public health interest according to pandemic evolution (among D614G, B.1.351, Omicron sub-variants BA.4-5, BQ1.1 and XBB or another recent variant) and against one of the variant targeted by the vaccines. The two variants will be specified in the statistical analysis plan before D28 data base lock.
Neutralizing antibody titers will be measured by a microneutralization technique 28 days after the booster dose.
Measured: 28 Days
Secondary outcomes (5)
Humoral immune response against SARS-CoV-2 variants
- Neutralizing antibody titers
- Neutralizing antibody titers against SARS-CoV-2 D614G, and variants B.1.351, Omicron sub-variants BA.4-5, BQ1.1 and XBB (or another recent variant of prominent public health interest according to pandemic evolution), measured by a microneutralization technique.
- Seroresponse rate in each group. Seroresponse is defined as a 10 fold or greater rise in serum neutralization titer at each follow-up time relative to D0.
- ELISA: Anti-Spike IgG levels expressed as BAU/mL, according to WHO recommendations.
- LUMINEX:
- Antibodies to CTD domain of the SARS-CoV-2 N protein to detect recent natural infections.
- Full length Spike protein expressed as BAU/mL)
- Antibodies to RBD of Wuhan, B.1.1.7, B.1.617.2, B.1.351, Omicron BA.1/2/5, BQ1.1, XBB and others variants according to pandemic evolution.
Measured: Day0, Day15, Day28, 3 Months, 6 Months and 12 Months
Number and intensity of local and systemic adverse
Number and intensity of local and systemic adverse events of any degree occurring up to day 7 after administration of the booster dose (assessed from the list of solicited adverse events); number and intensity of unsolicited clinical events up to 28 days
Measured: 7 and 28 days
Factors of interest
Factors of interest are age, gender, previous SARS-COV-2 infection, time interval between the last dose of vaccine and the booster dose, and vaccine boost type
Measured: Day 0
Cellular immune response
- ELISpot IFN-IL-2 CD4 and CD8 response at D0 and D15 (ancillary study) against B1.351, BA.5, BQ1.1, XBB.1 ;
- Repertoire analysis of Memory Spike specific B cells and early ASC response at D0, D7 and M3.
Measured: Day 0, Day 7, Day 15, Month 3
Number of Covid 19 cases
Number of Covid 19 cases (symptomatic with PCR or Ag positive tests, or asymptomatic with anti NP antibodies increase from D7 to M12)
Measured: Day 7 up to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2023
- Study start16 May 2023
- Primary completion12 Jul 2023 (estimated)
- Study completion12 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine ReactionStudies 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
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- IREIVAC/COVIREIVAC Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05749926
- Sponsor's protocol ID
- APHP220775
- Other IDs
- 2022-002715-38
- Acronym
- CoviBOOST 2
- Status last verified
- Jun 2023
- First submitted
- 28 Feb 2023
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD will not be share. The 2 vaccines used in this study are marketed vaccine and used in routine care.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Reactogenicity of the Beta-variant Recombinant Protein Booster Vaccine (VidPrevtyn Beta, Sanofi) Compared to a Bivalent mRNA Vaccine (Comirnaty Original/Omicron BA.4-5, BioNTech-Pfizer) in Adults Previously Vaccinated With at Least 3 Doses of COVID-19 mRNA Vaccine: A Non-inferiority Multicenter Single-blinded, Randomized Trial
- ClinicalTrials.gov ID
- NCT05749926
- Acronym / sponsor ID
- CoviBOOST 2 / APHP220775
- Conditions
- Vaccine Reaction, COVID-19
- Keywords
- COVID 19, mRNA vaccines, Immunulogy, Sub-unit vaccine, Booster
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- IREIVAC/COVIREIVAC Network
- Study start
- 16 May 2023 (actual)
- Primary completion
- 12 Jul 2023 (estimated)
- Study completion
- 12 Jul 2024 (estimated)
- First posted
- 1 Mar 2023 (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 objective of this trial is to compare the immunogenicity and the safety of the Beta-variant recombinant protein booster vaccine (VidPrevtyn® Beta, Sanofi) to a bivalent mRNA vaccine (Comirnaty Original/Omicron BA.4-5, BioNTech-Pfizer) in adults previously vaccinated with at least 3 doses of COVID-19 mRNA vaccine. The results will provide important data for the future COVID 19 vaccine strategy.
A biobank will also be set up to evaluate the protection conferred by one or other of these vaccines as booster in the event of the emergence of new variants in the future.
Detailed description
The efficacy of COVID 19 vaccines for reducing the risk of severe COVID-19 infection is demonstrated in real life.
However, data currently available on the persistence of immunity after vaccination on the one hand and the emergence of viral variants with reduced sensibility to vaccine immunity on the other, raise the need to administer boosters to maintain the protection and to compare different strategies as bivalent mRNA vaccines but also others platforms.
The vaccines currently recommended as boosters in France are mRNA bivalent vaccines, adapted to better match the circulating variants of SARS-CoV-2 and expected to provide broader protection against Omicron sub variants (19). However, the rapid antigenic evolution of SARS-CoV-2 and the antigenic imprinting against the initial Hu-1 strain could reduce their effectiveness.
More recently, the Beta-variant recombinant protein booster vaccine (VidPrevtyn Beta, Sanofi) obtained European authorization and is recommended in France as booster as an alternative to the bivalent mRNA vaccines (21, 22). However, in the absence of comparative data with the bivalent mRNA vaccines, VidPrevtyn Beta is recommended as second line.
It has been shown with vectored vaccines that a heterologous vaccination scheme could be more immunogenic than a homologous scheme (23). Our group previously showed that VidPrevtyn Beta, administered as a third vaccine dose, induces higher immune response than the mRNA BNT162b2 vaccine (Comirnaty, BioNTech-Pfizer), against Beta variant but also others variants of concern (VOC) including Omicron BA1 (20) and Omicron BA4/5 (data submitted for publication). The data available at 3 and 6 months after the boost, show that VidPrevtyn Beta could be also of interest in term of durability of the response (data not published). The hypothesis is that a Beta variant protein recombinant vaccine could enlarge the protection against the variants by overpassing antigenic imprinting and the adjuvant improve the duration of immune response and protection. Moreover, the Beta-variant recombinant protein vaccine could bring an advantage in terms of reactogenicity, acceptability, cost and accessibility.
In this context, as recently pointed by the HAS, comparative data on immunogenicity and reactogenicity between a bivalent mRNA vaccine and the Beta-variant recombinant protein, both administered as boosters, are needed to better adapt the COVID 19 vaccine recommendations for the future.
This study is Comparative, non-inferiority, single-blinded, multicenter, randomized trial.
Randomization in a 1:1 ratio, will be stratified by age (18-60 years and ≥ 60 years of age) and history of SARS-CoV-2 infection
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comirnaty® BNT162b2 /Omicron BA.4-5 vaccine (Pfizer-BioNTech) | Active comparator | Biological: Comirnaty® BNT162b2 /Omicron BA.4-5 vaccine (Pfizer-BioNTech)Length of use : 1 day |
| VidPrevtyn® Beta vaccine (Sanofi/GSK) | Experimental | Biological: VidPrevtyn® Beta vaccine (Sanofi/GSK)Length 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 (7 listed)
- Male or female aged 18 years and over
- Adult in a healthy condition or with a stable health status, determined by medical history, targeted physical examination and clinical judgement of the investigator to be in stable state of health. Participants with pre-existing stable chronic medical conditions defined as condition not requiring significant change in therapy or hospitalization for worsening disease within 4 weeks from enrollment can be included at the discretion of the investigator.
- For women of childbearing age: a negative highly sensitive pregnancy urinary test during the inclusion visit
- Confirmed receipt of at least three doses of COVID-19 mRNA vaccine the last dose at least 6 months prior to study vaccine
- Understands and agrees to comply with the study procedures
Key exclusion criteria (11 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
- Confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection < 3 months prior to the study vaccine dose.
- 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.
- Any medical condition, such as cancer, that might impair the immune response.
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 |
|---|---|---|
| Comirnaty® BNT162b2 /Omicron BA.4-5 vaccine (Pfizer-BioNTech)A single administration of COVID-19 vaccine will be performed at D0, depending on randomization | Biological | Comirnaty® BNT162b2 /Omicron BA.4-5 vaccine (Pfizer-BioNTech) |
| VidPrevtyn® Beta vaccine (Sanofi/GSK)A single administration of COVID-19 vaccine will be performed at D0, depending on randomization | Biological | VidPrevtyn® Beta vaccine (Sanofi/GSK) |
Primary outcome
Neutralizing antibody titers against the SARS-CoV-2 variant of most prominent public health interest and against one of the variant targeted by the vaccines
Time frame: 28 Days
Title : Neutralizing antibody titers against the SARS-CoV-2 variant of most prominent public health interest and against one of the variant targeted by the vaccines Time Frame : 28 Days Description: There will be a coprimary endpoint : Neutralizing antibody titers against the SARS-CoV-2 variant of most prominent public health interest according to pandemic evolution (among D614G, B.1.351, Omicron sub-variants BA.4-5, BQ1.1 and XBB or another recent variant) and against one of the variant targeted by the vaccines. The two variants will be specified in the statistical analysis plan before D28 data base lock. Neutralizing antibody titers will be measured by a microneutralization technique 28 days after the booster dose.
5 secondary outcomes
Humoral immune response against SARS-CoV-2 variants
Time frame: Day0, Day15, Day28, 3 Months, 6 Months and 12 Months
Number and intensity of local and systemic adverse
Time frame: 7 and 28 days
Factors of interest
Time frame: Day 0
Cellular immune response
Time frame: Day 0, Day 7, Day 15, Month 3
Number of Covid 19 cases
Time frame: Day 7 up to Month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Individual participant dataSharing planned: No. The IPD will not be share. The 2 vaccines used in this study are marketed vaccine and used in routine care.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Comirnaty® BNT162b2 /Omicron BA.4-5 vaccine (Pfizer-BioNTech) and VidPrevtyn® Beta vaccine (Sanofi/GSK) in people with Vaccine Reaction and COVID-19, 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 7 inclusion and 11 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 29 Jun 2023. 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?
Neutralizing antibody titers against the SARS-CoV-2 variant of most prominent public health interest and against one of the variant targeted by the vaccines (time frame: 28 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 29 Jun 2023.