NCT05124171: COVIBOOST

Immunogenicity and Reactogenicity Following a 3rd Dose of COVID-19 mRNA Vaccine (Pfizer-BioNtech) and Two Adjuvanted Sub-unit Vaccines (SP/GSK) Administered as a Booster in Adults Who Received 2 Doses of Pfizer-BioNTech mRNA Vaccine as a Primary Vaccination: A Randomized, Single-blinded Multicenter Clinical Trial

Status unknown Phase 3 Last updated 7 July 2022

What this trial tests

Phase 3 trial testing BNT162b2 in COVID-19 in 247 participants. Status unknown.

Timeline

8 December 2021

Primary endpoint
1 December 2022

1 December 2022

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	247
Start date	8 December 2021
Primary completion	1 December 2022
Estimated completion	1 December 2022
Sites	1 location across France

Drugs / interventions tested

• BNT162b2 (bnt162b2) — full drug profile →
• CoV2 preS dTM adjuvanted vaccine (D614), Sanofi/GSK — full drug profile →
• CoV2 preS dTM adjuvanted vaccine (B.1.351), Sanofi/GSK — full drug profile →

Conditions studied

• COVID-19 — all drugs for COVID-19 →
• Vaccine Reaction — all drugs for Vaccine Reaction →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with COVID-19 or Vaccine Reaction. Healthy volunteers can join.

What's being measured

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

• rate of neutralizing antibody titers against SARS-CoV-2 D614 and B.1.351 viral strains
  Time frame: 15 days
  Increased rate of at least 10 fold between D0 and D15 after the booster dose in neutralizing antibody titers against SARS-CoV-2 D614 and B.1.351 viral strains, measured by a microneutralisation technique in each group to assess the immunogenicity of a booster dose of an adjuvanted subunit vaccine (SP vaccine) as between D614 or B.1.351 and a mRNA vaccine (Pfizer BioNTech) in adults who were primar

Sponsor's own description

The vaccination campaign in France began in early 2021 and was declared mandatory for all French people in July 2021. The efficacy of COVID-19 vaccines has since been widely demonstrated, as well as their safety, and now 60% of the adult population in France has received a first dose, most of them with Pfizer-BioNTech's mRNA vaccine.

However, despite the increasing coverage, new data highlight the need for a booster dose for the most vulnerable people, including patients with immune deficiency. This makes it likely that a booster dose will also be needed in the general population, especially among healthcare workers, due to the active circulation of new variants since the beginning of summer 2021 and evidence of reduced protection against them.

On the other hand, in addition to evaluating the potential benefit of a booster vaccination, it appears interesting to also evaluate a heterologous vaccination regimen, i.e. a booster with a different vaccine than the one used for the primary vaccination. Some studies have already evaluated a two-dose heterologous regimen and the results have shown stronger protection against SARS-CoV-2. In addition, this alternative could provide a real benefit in terms of accessibility, cost, and acceptability.

The vaccine developed by Sanofi-Pasteur is based on a traditional recombinant protein approach using GSK's AS03 adjuvant. Two formulations of this vaccine are currently under development, the first targeting the S protein of the D614 strain (Wuhan strain), the second targeting the B.1.351 variant. Their value as a booster needs to be evaluated.

The objective of this trial is therefore to evaluate the immunological response and safety induced by a homologous vaccine booster (Pfizer-BioNTech vaccine booster) and a heterologous vaccine booster (one of the two experimental Sanofi/GSK vaccines booster), on the D614 (Wuhan) strain and on the SARS-CoV-2 variants.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. mRNA-based vaccines and therapeutics: an in-depth survey of current and upcoming clinical applications.
   Wang YS, Kumari M, Chen GH, Hong MH, et al · · 2023 · cited 93× · PMID 37805495 · DOI 10.1186/s12929-023-00977-5
2. Challenges and developments in universal vaccine design against SARS-CoV-2 variants.
   Zhao F, Zai X, Zhang Z, Xu J, et al · · 2022 · cited 55× · PMID 36535982 · DOI 10.1038/s41541-022-00597-4
3. Immunogenicity and Safety of Beta-Adjuvanted Recombinant Booster Vaccine.
   Launay O, Cachanado M, Luong Nguyen LB, Ninove L, et al · · 2022 · cited 54× · PMID 35767474 · DOI 10.1056/nejmc2206711
4. Navigating the intricate in-vivo journey of lipid nanoparticles tailored for the targeted delivery of RNA therapeutics: a quality-by-design approach.
   Haghighi E, Abolmaali SS, Dehshahri A, Mousavi Shaegh SA, et al · · 2024 · cited 28× · PMID 39543630 · DOI 10.1186/s12951-024-02972-w
5. Nanoparticles in clinical trials of COVID-19: An update.
   Rauf A, Abu-Izneid T, Khalil AA, Hafeez N, et al · · 2022 · cited 22× · PMID 35953020 · DOI 10.1016/j.ijsu.2022.106818
6. Beta variant COVID-19 protein booster vaccine elicits durable cross-neutralization against SARS-CoV-2 variants in non-human primates.
   Pavot V, Berry C, Kishko M, Anosova NG, et al · · 2023 · cited 12× · PMID 36894558 · DOI 10.1038/s41467-023-36908-z
7. Heterologous versus homologous COVID-19 booster vaccinations for adults: systematic review with meta-analysis and trial sequential analysis of randomised clinical trials.
   Asante MA, Michelsen ME, Balakumar MM, Kumburegama B, et al · · 2024 · cited 9× · PMID 38915011 · DOI 10.1186/s12916-024-03471-3
8. 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