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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||189 participants|
|Intervention Model:||Parallel Assignment|
|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|
|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
- 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.
- 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.
- 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
- 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;
- 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
- 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
- ELISPOT IFN CD4 and CD8 response [ Time Frame: 15 days ]ELISPOT IFN CD4 and CD8 response at D15
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
|GH Broca-Cochin-Hôtel-Dieu CIC 1417 Cochin-Pasteur|
|Paris, France, 75004|
|Principal Investigator:||Odile Launay||Assistance Publique - Hôpitaux de Paris|