COVID-19 VaccinesPhase 3COVIBOOSTAnci1NCT05405283
Randomized, Single-blinded, Multicenter Trial Comparing the Immune Response to a 2nd Booster Dose of COVID-19 mRNA Vaccine (Pfizer-BioNTech) or Sanofi /GSK B.1.351 Adjuvanted Vaccine in Adults
A Phase 3 study testing 2nd booster with Comirnaty® (Pfizer-BioNTech) and CoV2 preS dTM adjuvanted vaccine (B.1.351), Sanofi/GSK in people with COVID-19 Vaccines, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The effectiveness of COVID-19 vaccines in reducing the risk of severe COVID-19 is currently demonstrated. In France, since the beginning of the vaccination campaign, 54,266,859 people have received at least one injection (ie. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Vaccines
- What is being tested?
- 2nd booster with Comirnaty® (Pfizer-BioNTech) 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
- 189 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jun 2022to Jul 2023
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 60 years.
- Adult in good health 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 or hospitalisation for worsening in the 3 months prior to inclusion, and for which no significant change in treatment or hospitalisation for worsening of the disease is envisaged in the near future.
- For participants over 60 years of age who participated in Coviboost, to have received a booster dose of mRNA vaccine (Pfizer-BioNTech) administered at least 6 months before the 2nd booster dose
- Not included in Coviboost (new participants to be recruited) and having received 2 doses of mRNA vaccine (Pfizer-BioNTech) with an interval of 3 to 6 weeks and a 1st booster dose of mRNA vaccine (Pfizer-BioNTech) or Moderna administered at least 6 months before the 2nd booster dose
- Understands and agrees to comply with the study procedures.
- Written informed consent signed by the participant and the investigator.
- Person affiliated to a social security scheme.
Who cannot join
- Acute febrile infection (body Acute febrile infection (body temperature ≥ 38.0°C) within the previous 72 hours and/or had symptoms suggestive of COVID-19 within the last 28 days or had case contact within the last 10 days before the inclusion visit.
- Virologically documented (PCR or serology) history of COVID 19.
- Immunosuppressive drugs such as corticosteroids at a dosage > 10 mg prednisone equivalent/day (excluding topical preparations and inhalers) within 3 months prior to inclusion or within 6 months for chemotherapies.
- Treated with immunoglobulin or other blood product within 3 months prior to inclusion or scheduled for administration of immunoglobulin or blood product before the end of the study.
- Known HIV, HCV or HBV infection.
- Any condition, such as cancer, that may reduce the immune response.
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- Use of experimental Ig, experimental monoclonal antibodies or convalescent serum is not allowed during the study.
- History of severe adverse reactions after vaccine administration including anaphylactic reaction and associated symptoms such as rash, difficulty breathing, angioedema and abdominal pain, or a history of an allergic reaction that may be exacerbated by a component of the SARS-COV-2 vaccine during the first vaccine injection.
- Participant having been vaccinated against BCG in the previous year.
- Having received a vaccination within 2 weeks prior to the 2nd booster dose or scheduled to receive a licensed vaccine 2 weeks after the 2nd booster dose.
- 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 Jardé 1 or Jardé 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: Randomized, Single-blinded, Multicenter Trial Comparing the Immune Response to a 2nd Booster Dose of COVID-19 mRNA Vaccine (Pfizer-BioNTech) or Sanofi /GSK B.1.351 Adjuvanted Vaccine in Adults Who Received 2 Doses of Pfizer-BioNTech mRNA Vaccine and a Booster Dose of Pfizer-BioNTech or Moderna mRNA Vaccine
The effectiveness of COVID-19 vaccines in reducing the risk of severe COVID-19 is currently demonstrated. In France, since the beginning of the vaccination campaign, 54,266,859 people have received at least one injection (ie. 80.5% of the total population), 53,354,698 people now have a complete vaccination schedule (ie. 79.1% of the total population) and since the beginning of the booster campaign, 39,558,416 people have received a 1st booster dose.
However, the 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, suggest the need to administer booster doses at variable intervals depending on age and comorbidities. Real-life efficacy data from France and around the World confirm that people who have received a booster dose are better protected than those who have only received a primary vaccination schedule (HAS).
Read more
In this context, the Ministry of Health, has pronounced on the possibility of administering a second booster dose for people aged 60 and over. Moreover, the recommendations for the Haute Autorité de Santé for the 2nd booster dose in general population should be available in June 2022.
Three vaccines, mRNA BNT162b2 vaccine, Sanofi/GSK monovalent D614 and B.1.351 formulations were administered as 1st booster in the CoviBOOST trial. All three vaccines boosted antibodies and neutralizing response after a BNT162b2 initial course. Heterologous boosting with the Sanofi/GSK SARS-CoV-2 recombinant adjuvanted protein vaccine B.1.351 (Beta formulation) provided higher rates of neutralizing antibodies against variants, including Omicron BA.1, compared with the mRNA BNT162b2 vaccine. Due to the start of the study after the beginning of booster vaccination campaign in elderly, the enrollment of participants over 65 years of age was difficult so, only 8 subjects aged 60 years and over were enrolled. As vaccine immunogenicity is lower in older populations and is waning more rapidly, it is important to evaluate the adjuvanted vaccine in this population.
The objective of this ancillary study is to compare, in participants aged of 60 years and older and previously vaccinated with 3 doses of mRNA vaccine (2 doses of Pfizer BioNTech) and a 3rd dose of Pfizer BioNTech or Moderna, the immunogenicity of a second booster dose of the B.1.351 strain recombinant protein- based subunit vaccine to BNT162b2 (mRNA Pfizer BioNTech Vaccine).These results will provide important information for booster vaccination recommendations in this age group.
Read the detailed description
The 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, suggest the need to administer booster doses at variable intervals depending on age and comorbidities. Real-life efficacy data from France and around the World confirm that people who have received a booster dose are better protected than those who have only received a primary vaccination schedule (HAS).
Currently available data from the United States and the United Kingdom show that the protection conferred by the first booster dose diminishes after 3 months, particularly in persons 60 years of age and older, and justified the recommendation of a second booster dose.
Data from Israel show that a second booster dose (4th dose) reduces the rate of confirmed infections by a factor of 2 and the rate of severe disease by a factor of 4. The safety data, although limited, are reassuring.
In this context, the Ministry of Health, has pronounced on the possibility of administering a second booster dose for people aged 60 and over. Moreover, the recommendations for the Haute Autorité de Santé for the 2nd booster dose in general population should be available in June 2022.
The vaccines currently recommended in France, for booster vaccination are mRNA vaccines. However, some vaccines that were developed later in the clinic could present an interesting alternative in terms of reactogenicity, accessibility, cost and acceptability. Moreover, a heterologous vaccination scheme could be more immunogenic than a homologous scheme. Therefore, it is important to be able to evaluate these vaccines as a second booster dose.
The COVID 19 vaccines developed by Sanofi are based on a classical adjuvanted recombinant protein approach. Three candidate 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, and the third is a vaccine combining the two.
Three vaccines, mRNA BNT162b2 vaccine, Sanofi/GSK monovalent D614 and B.1.351 formulations were administered as 1st booster in the CoviBOOST trial. All three vaccines boosted antibodies and neutralizing response after a BNT162b2 initial course. Heterologous boosting with the Sanofi/GSK SARS-CoV-2 recombinant adjuvanted protein vaccine B.1.351 (Beta formulation) provided higher rates of neutralizing antibodies against variants, including Omicron BA.1, compared with the mRNA BNT162b2 vaccine.
Due to the start of the study after the beginning of booster vaccination campaign in elderly, the enrollment of participants over 65 years of age was difficult so, only 8 subjects aged 60 years and over were enrolled. As vaccine immunogenicity is lower in older populations and is waning more rapidly, it is important to evaluate the adjuvanted vaccine in this population.
The objective of this ancillary study is to compare, in participants aged of 60 years and older and previously vaccinated with 3 doses of mRNA vaccine (2 doses of Pfizer BioNTech) and a 3rd dose of Pfizer BioNTech or Moderna, the immunogenicity of a second booster dose of the B.1.351 strain recombinant protein- based subunit vaccine to BNT162b2 (mRNA Pfizer BioNTech Vaccine).These results will provide important information for booster vaccination recommendations in this age.
Participants enrolled will be healthy adults of 60 years old and over they will be recruited in 15 centers in mainland France, via the COVIREIVAC network.
The study will be a randomized, single-blinded, multicentre trial with two parallel arms:
ARM 1 receiving Pfizer-BioNTech vaccine
- Group 1.A: 1rst booster Pfizer
- Group 1.B: 1rst booster Moderna
ARM 2 receiving SP/GSK subunit B.1.351 vaccine
- Group 2.A: 1rst booster Pfizer
- Group 2.B: 1rst booster Moderna
Participants will undergo 4 visits :
- V1 (D0): inclusion, randomization, pregnancy test, PCR test, blood draw and administration of the booster dose
- V2 (D15): follow-up visit with a review of solicited and unsolicited local and systemic reactions that occurred since the last visit, and blood draw
- V3 (D28): follow-up visit with review of potential adverse events and blood draw
- V4 (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
Blood samples will be used to conduct immunological analyses, and cellular analyses for a sub-category of 25 participants per group.
- Conditions
- COVID-19 Vaccines
- Being tested
- 2nd booster with Comirnaty® (Pfizer-BioNTech), CoV2 preS dTM adjuvanted vaccine (B.1.351), Sanofi/GSK
- Keywords
- COVID 19, mRNA vaccines, Immunology, Sub-unit vaccine, Second 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.
2nd booster with Comirnaty® (Pfizer-BioNTech)Biological
In participants previously vaccinated with 3 doses of mRNA vaccine, he/she will receive one dose of Comirnaty® (Pfizer-BioNTech) vaccine as a second booster
CoV2 preS dTM adjuvanted vaccine (B.1.351), Sanofi/GSKBiological
In participants previously vaccinated with 3 doses of mRNA vaccine, he/she will receive one dose of CoV2 preS dTM adjuvanted vaccine (B.1.351), Sanofi/GSK vaccine as a second booster
| Study group | Role | What they receive |
|---|---|---|
| Comirnaty® (Pfizer-BioNTech) | Active comparator | Not described Receives: Biological: 2nd booster with Comirnaty® (Pfizer-BioNTech) |
| CoV2 preS dTM adjuvanted vaccine (B.1.351), Sanofi/GSK | Experimental | Not described 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.
Immunogenicity of a second booster 15 days after receiving the second booster
Proportion of patient with an increase of at least 10-fold between D0 and D15 after the 2nd booster dose in neutralizing antibody titers against SARS-CoV-2 D614,B.1.351, Delta and Omicron BA.1 and BA.2 viral strains, measured by a microneutralization technique.
A 10-fold increase implies that the second titer is at least 2 dilutions higher than the first, which represents an unambiguous increase according to the state of the art of serum neutralization.
Measured: 15 days after second booster
Secondary outcomes (7)
Rate of neutralizing antibody titer against SARS-CoV-2 viral at 6 and 12 months
The rate of neutralizing antibody titer against SARS-CoV-2 viral strains D614, Beta, Delta and Omicron BA.1 and BA.2, measured by microneutralization, until 6 months after the 2nd dose in each group.
Measured: Up to 12 months after second booster
Number and intensity of local and systemic adverse events at 28 days
Number and intensity of local and systemic adverse events of any degree occurring up to day 7 after administration of the 2nd booster dose (assessed from the list of solicited adverse events); number and intensity of unsolicited local and systemic clinical events up to 28 days
Measured: Up to 28 days after second booster
Anti-Spike and anti-RBD IgG levels at 6 and 12 months
Anti-Spike and anti-RBD IgG levels expressed as BAU/ml, according to WHO recommendations, at D15, D28, M3 and M6 after administration of the 2nd booster dose of mRNA vaccine vs. the 2nd dose of adjuvanted subunit B.1.351 vaccine;
Measured: Up to 12 months after second booster
Difference in anti-Spike and anti-RBD B.1.351 IgG level at 6 months and 12 months
Difference in anti-Spike and anti-RBD B.1.351 IgG levels between M3, M6 and M12
Measured: 6 months
Difference in anti-Spike and anti-RBD B.1.351 IgG level at D15
Difference in anti-Spike and anti-RBD B.1.351 IgG levels between D15 and D0
Measured: 15 days
ELISPOT IFN CD4 and CD8 response
ELISPOT IFN CD4 and CD8 response at D15
Measured: 15 days
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
Measured: Day 0, Day 7 and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start8 Jun 2022
- Primary completion15 Jul 2022
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 VaccinesStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 189 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
- Investigators
- Odile Launay, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405283
- Sponsor's protocol ID
- AP211184
- Other IDs
- 2021-004550-33
- Acronym
- COVIBOOSTAnci1
- Status last verified
- Jun 2023
- First submitted
- 3 Jun 2022
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Single-blinded, Multicenter Trial Comparing the Immune Response to a 2nd Booster Dose of COVID-19 mRNA Vaccine (Pfizer-BioNTech) or Sanofi /GSK B.1.351 Adjuvanted Vaccine in Adults Who Received 2 Doses of Pfizer-BioNTech mRNA Vaccine and a Booster Dose of Pfizer-BioNTech or Moderna mRNA Vaccine
- ClinicalTrials.gov ID
- NCT05405283
- Acronym / sponsor ID
- COVIBOOSTAnci1 / AP211184
- Conditions
- COVID-19 Vaccines
- Keywords
- COVID 19, mRNA vaccines, Immunology, Sub-unit vaccine, Second booster
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- IREIVAC/COVIREIVAC Network
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- Jul 2023 (estimated)
- First posted
- 6 Jun 2022 (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 effectiveness of COVID-19 vaccines in reducing the risk of severe COVID-19 is currently demonstrated. In France, since the beginning of the vaccination campaign, 54,266,859 people have received at least one injection (ie. 80.5% of the total population), 53,354,698 people now have a complete vaccination schedule (ie. 79.1% of the total population) and since the beginning of the booster campaign, 39,558,416 people have received a 1st booster dose.
However, the 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, suggest the need to administer booster doses at variable intervals depending on age and comorbidities. Real-life efficacy data from France and around the World confirm that people who have received a booster dose are better protected than those who have only received a primary vaccination schedule (HAS).
In this context, the Ministry of Health, has pronounced on the possibility of administering a second booster dose for people aged 60 and over. Moreover, the recommendations for the Haute Autorité de Santé for the 2nd booster dose in general population should be available in June 2022.
Three vaccines, mRNA BNT162b2 vaccine, Sanofi/GSK monovalent D614 and B.1.351 formulations were administered as 1st booster in the CoviBOOST trial. All three vaccines boosted antibodies and neutralizing response after a BNT162b2 initial course. Heterologous boosting with the Sanofi/GSK SARS-CoV-2 recombinant adjuvanted protein vaccine B.1.351 (Beta formulation) provided higher rates of neutralizing antibodies against variants, including Omicron BA.1, compared with the mRNA BNT162b2 vaccine. Due to the start of the study after the beginning of booster vaccination campaign in elderly, the enrollment of participants over 65 years of age was difficult so, only 8 subjects aged 60 years and over were enrolled. As vaccine immunogenicity is lower in older populations and is waning more rapidly, it is important to evaluate the adjuvanted vaccine in this population.
The objective of this ancillary study is to compare, in participants aged of 60 years and older and previously vaccinated with 3 doses of mRNA vaccine (2 doses of Pfizer BioNTech) and a 3rd dose of Pfizer BioNTech or Moderna, the immunogenicity of a second booster dose of the B.1.351 strain recombinant protein- based subunit vaccine to BNT162b2 (mRNA Pfizer BioNTech Vaccine).These results will provide important information for booster vaccination recommendations in this age group.
Detailed description
The 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, suggest the need to administer booster doses at variable intervals depending on age and comorbidities. Real-life efficacy data from France and around the World confirm that people who have received a booster dose are better protected than those who have only received a primary vaccination schedule (HAS).
Currently available data from the United States and the United Kingdom show that the protection conferred by the first booster dose diminishes after 3 months, particularly in persons 60 years of age and older, and justified the recommendation of a second booster dose.
Data from Israel show that a second booster dose (4th dose) reduces the rate of confirmed infections by a factor of 2 and the rate of severe disease by a factor of 4. The safety data, although limited, are reassuring.
In this context, the Ministry of Health, has pronounced on the possibility of administering a second booster dose for people aged 60 and over. Moreover, the recommendations for the Haute Autorité de Santé for the 2nd booster dose in general population should be available in June 2022.
The vaccines currently recommended in France, for booster vaccination are mRNA vaccines. However, some vaccines that were developed later in the clinic could present an interesting alternative in terms of reactogenicity, accessibility, cost and acceptability. Moreover, a heterologous vaccination scheme could be more immunogenic than a homologous scheme. Therefore, it is important to be able to evaluate these vaccines as a second booster dose.
The COVID 19 vaccines developed by Sanofi are based on a classical adjuvanted recombinant protein approach. Three candidate 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, and the third is a vaccine combining the two.
Three vaccines, mRNA BNT162b2 vaccine, Sanofi/GSK monovalent D614 and B.1.351 formulations were administered as 1st booster in the CoviBOOST trial. All three vaccines boosted antibodies and neutralizing response after a BNT162b2 initial course. Heterologous boosting with the Sanofi/GSK SARS-CoV-2 recombinant adjuvanted protein vaccine B.1.351 (Beta formulation) provided higher rates of neutralizing antibodies against variants, including Omicron BA.1, compared with the mRNA BNT162b2 vaccine.
Due to the start of the study after the beginning of booster vaccination campaign in elderly, the enrollment of participants over 65 years of age was difficult so, only 8 subjects aged 60 years and over were enrolled. As vaccine immunogenicity is lower in older populations and is waning more rapidly, it is important to evaluate the adjuvanted vaccine in this population.
The objective of this ancillary study is to compare, in participants aged of 60 years and older and previously vaccinated with 3 doses of mRNA vaccine (2 doses of Pfizer BioNTech) and a 3rd dose of Pfizer BioNTech or Moderna, the immunogenicity of a second booster dose of the B.1.351 strain recombinant protein- based subunit vaccine to BNT162b2 (mRNA Pfizer BioNTech Vaccine).These results will provide important information for booster vaccination recommendations in this age.
Participants enrolled will be healthy adults of 60 years old and over they will be recruited in 15 centers in mainland France, via the COVIREIVAC network.
The study will be a randomized, single-blinded, multicentre trial with two parallel arms:
ARM 1 receiving Pfizer-BioNTech vaccine
- Group 1.A: 1rst booster Pfizer
- Group 1.B: 1rst booster Moderna
ARM 2 receiving SP/GSK subunit B.1.351 vaccine
- Group 2.A: 1rst booster Pfizer
- Group 2.B: 1rst booster Moderna
Participants will undergo 4 visits :
- V1 (D0): inclusion, randomization, pregnancy test, PCR test, blood draw and administration of the booster dose
- V2 (D15): follow-up visit with a review of solicited and unsolicited local and systemic reactions that occurred since the last visit, and blood draw
- V3 (D28): follow-up visit with review of potential adverse events and blood draw
- V4 (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
Blood samples will be used to conduct immunological analyses, and cellular analyses for a sub-category of 25 participants per group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comirnaty® (Pfizer-BioNTech) | Active comparator | Biological: 2nd booster with Comirnaty® (Pfizer-BioNTech) |
| CoV2 preS dTM adjuvanted vaccine (B.1.351), Sanofi/GSK | Experimental | Biological: CoV2 preS dTM adjuvanted vaccine (B.1.351), Sanofi/GSK |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 60 years.
- Adult in good health 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 or hospitalisation for worsening in the 3 months prior to inclusion, and for which no significant change in treatment or hospitalisation for worsening of the disease is envisaged in the near future.
- For participants over 60 years of age who participated in Coviboost, to have received a booster dose of mRNA vaccine (Pfizer-BioNTech) administered at least 6 months before the 2nd booster dose
- Not included in Coviboost (new participants to be recruited) and having received 2 doses of mRNA vaccine (Pfizer-BioNTech) with an interval of 3 to 6 weeks and a 1st booster dose of mRNA vaccine (Pfizer-BioNTech) or Moderna administered at least 6 months before the 2nd booster dose
- Understands and agrees to comply with the study procedures.
Key exclusion criteria (13 listed)
- Acute febrile infection (body Acute febrile infection (body temperature ≥ 38.0°C) within the previous 72 hours and/or had symptoms suggestive of COVID-19 within the last 28 days or had case contact within the last 10 days before the inclusion visit.
- Virologically documented (PCR or serology) history of COVID 19.
- Immunosuppressive drugs such as corticosteroids at a dosage > 10 mg prednisone equivalent/day (excluding topical preparations and inhalers) within 3 months prior to inclusion or within 6 months for chemotherapies.
- Treated with immunoglobulin or other blood product within 3 months prior to inclusion or scheduled for administration of immunoglobulin or blood product 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 |
|---|---|---|
| 2nd booster with Comirnaty® (Pfizer-BioNTech)In participants previously vaccinated with 3 doses of mRNA vaccine, he/she will receive one dose of Comirnaty® (Pfizer-BioNTech) vaccine as a second booster | Biological | Comirnaty® (Pfizer-BioNTech) |
| CoV2 preS dTM adjuvanted vaccine (B.1.351), Sanofi/GSKIn participants previously vaccinated with 3 doses of mRNA vaccine, he/she will receive one dose of CoV2 preS dTM adjuvanted vaccine (B.1.351), Sanofi/GSK vaccine as a second booster | Biological | CoV2 preS dTM adjuvanted vaccine (B.1.351), Sanofi/GSK |
Primary outcome
Immunogenicity of a second booster 15 days after receiving the second booster
Time frame: 15 days after second booster
Proportion of patient with an increase of at least 10-fold between D0 and D15 after the 2nd booster dose in neutralizing antibody titers against SARS-CoV-2 D614,B.1.351, Delta and Omicron BA.1 and BA.2 viral strains, measured by a microneutralization technique. A 10-fold increase implies that the second titer is at least 2 dilutions higher than the first, which represents an unambiguous increase according to the state of the art of serum neutralization.
7 secondary outcomes
Rate of neutralizing antibody titer against SARS-CoV-2 viral at 6 and 12 months
Time frame: Up to 12 months after second booster
Number and intensity of local and systemic adverse events at 28 days
Time frame: Up to 28 days after second booster
Anti-Spike and anti-RBD IgG levels at 6 and 12 months
Time frame: Up to 12 months after second booster
Difference in anti-Spike and anti-RBD B.1.351 IgG level at 6 months and 12 months
Time frame: 6 months
Difference in anti-Spike and anti-RBD B.1.351 IgG level at D15
Time frame: 15 days
ELISPOT IFN CD4 and CD8 response
Time frame: 15 days
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 0, Day 7 and Month 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Individual participant dataSharing planned: Undecided
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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 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 2nd booster with Comirnaty® (Pfizer-BioNTech) and CoV2 preS dTM adjuvanted vaccine (B.1.351), Sanofi/GSK in people with COVID-19 Vaccines, 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 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 3 Jul 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?
Immunogenicity of a second booster 15 days after receiving the second booster (time frame: 15 days after second booster). 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 3 Jul 2023.