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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 (COVIBOOSTAnci1)

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ClinicalTrials.gov Identifier: NCT05405283
Recruitment Status : Active, not recruiting
First Posted : June 6, 2022
Last Update Posted : July 11, 2022
Sponsor:
Collaborator:
IREIVAC/COVIREIVAC Network
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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. 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.


Condition or disease Intervention/treatment Phase
COVID-19 Vaccines Biological: 2nd booster with Comirnaty® (Pfizer-BioNTech) Biological: CoV2 preS dTM adjuvanted vaccine (B.1.351), Sanofi/GSK Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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
Actual Study Start Date : June 8, 2022
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Comirnaty® (Pfizer-BioNTech) Biological: 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

Experimental: CoV2 preS dTM adjuvanted vaccine (B.1.351), Sanofi/GSK Biological: CoV2 preS dTM adjuvanted vaccine (B.1.351), Sanofi/GSK
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




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. Rate of neutralizing antibody titer against SARS-CoV-2 viral at 6 months [ Time Frame: Up to 6 months after second booster ]
    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.

  2. Number and intensity of local and systemic adverse events at 28 days [ Time Frame: Up to 28 days after second booster ]
    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

  3. Anti-Spike and anti-RBD IgG levels at 6 months [ Time Frame: Up to 6 months after second booster ]
    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;

  4. Difference in anti-Spike and anti-RBD B.1.351 IgG level at 6 months [ Time Frame: 6 months ]
    Difference in anti-Spike and anti-RBD B.1.351 IgG levels between M3 and M6

  5. Difference in anti-Spike and anti-RBD B.1.351 IgG level at D15 [ Time Frame: 15 days ]
    Difference in anti-Spike and anti-RBD B.1.351 IgG levels between D15 and D0

  6. ELISPOT IFN CD4 and CD8 response [ Time Frame: 15 days ]
    ELISPOT IFN CD4 and CD8 response at D15



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age ≥ 60 years.
  2. 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.
  3. 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
  4. 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
  5. Understands and agrees to comply with the study procedures.
  6. Written informed consent signed by the participant and the investigator.
  7. Person affiliated to a social security scheme.

Exclusion Criteria:

  1. 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.
  2. Virologically documented (PCR or serology) history of COVID 19.
  3. 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.
  4. 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.
  5. Known HIV, HCV or HBV infection.
  6. Any condition, such as cancer, that may reduce the immune response.
  7. Use of experimental Ig, experimental monoclonal antibodies or convalescent serum is not allowed during the study.
  8. 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.
  9. Participant having been vaccinated against BCG in the previous year.
  10. 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.
  11. Any bleeding disorder considered as a contraindication to an intramuscular injection, previous phlebotomy or receipt of anticoagulants.
  12. 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.
  13. Subject under legal protection (e.g. guardianship, tutorship).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05405283


Locations
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France
GH Broca-Cochin-Hôtel-Dieu CIC 1417 Cochin-Pasteur
Paris, France, 75004
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
IREIVAC/COVIREIVAC Network
Investigators
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Principal Investigator: Odile Launay Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT05405283    
Other Study ID Numbers: AP211184
2021-004550-33 ( EudraCT Number )
First Posted: June 6, 2022    Key Record Dates
Last Update Posted: July 11, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
COVID 19
mRNA vaccines
Immunology
Sub-unit vaccine
Second booster
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases