NCT05405283: COVIBOOSTAnci1

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

Status unknown Phase 3 Last updated 28 June 2023

What this trial tests

Phase 3 trial testing 2nd booster with Comirnaty® (Pfizer-BioNTech) in COVID-19 Vaccines in 189 participants. Status unknown.

Timeline

8 June 2022

Primary endpoint
15 July 2022

1 July 2023

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	189
Start date	8 June 2022
Primary completion	15 July 2022
Estimated completion	1 July 2023
Sites	1 location across France

Drugs / interventions tested

• 2nd booster with Comirnaty® (Pfizer-BioNTech) — full drug profile →
• CoV2 preS dTM adjuvanted vaccine (B.1.351), Sanofi/GSK — full drug profile →

Conditions studied

• COVID-19 Vaccines — all drugs for COVID-19 Vaccines →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

60 and older, any sex, with COVID-19 Vaccines. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Understanding the challenges to COVID-19 vaccines and treatment options, herd immunity and probability of reinfection.
   Al-Hatamleh MAI, Abusalah MA, Hatmal MM, Alshaer W, et al · · 2023 · cited 7× · PMID 36570799 · DOI 10.1016/j.jtumed.2022.11.007