COMIRNATY Original/Omicron BA.4-5 (tozinameran/famtozinameran) / Pfizer, BioNTech - LARVOL DELTA

LymphoBOOST: Lymph Node Aspiration to Decipher the Immune Response of Beta-variant Recombinant Protein Booster Vaccine (VidPrevtyn Beta, Sanofi) Compared to a Bivalent mRNA Vaccine (Comirnaty Original/Omicron BA.4-5, BioNTech-Pfizer) in Adults Previously Vaccinated With at Least 3 Doses of COVID-19 mRNA Vaccine. (clinicaltrials.gov) - P=N/A | N=12 | Completed | Sponsor: Assistance Publique - Hôpitaux de Paris | Recruiting ➔ Completed | Phase classification: P1 ➔ PN/A

Phase classification • Trial completion • Infectious Disease • Novel Coronavirus Disease

Assessing the Impact of Primary-Series Infection and Booster Vaccination on Protection against Omicron in Hong Kong: A Population-Based Observational Study. (PubMed, Vaccines (Basel)) - "The Comirnaty Original/Omicron BA.4/5 bivalent vaccine, introduced in December 2022, was associated with a lower risk of BA.4 infection when administered as a booster dose after three doses of CoronaVac...This study highlights the importance of promoting booster shot uptake and encouraging vaccination among those who have recovered from COVID-19 infections. The potential immune imprinting effect associated with the Comirnaty and CoronaVac vaccine underscores the need for continued surveillance and research to optimize vaccination strategies for emerging variants."

Journal • Observational data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Effectiveness of the Sanofi/GSK (VidPrevtyn Beta) and Pfizer-BioNTech (Comirnaty Original/Omicron BA.4-5) bivalent vaccines against hospitalisation in England. (PubMed, EClinicalMedicine) - "The finding that the adjuvanted vaccine targeting the distant Beta strain had similar effectiveness to the bivalent mRNA vaccine targeting more closely matched Omicron sub-lineages is notable and highlights the need for further real-world studies into the effectiveness of vaccines from different vaccine platforms and formulations in the presence of matched and unmatched strains. No external funding."

Journal • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

A Study to Learn About New COVID-19 RNA Vaccine Candidates in COVID-19 Vaccine-Experienced Healthy Individuals (clinicaltrials.gov) - P2/3 | N=1454 | Completed | Sponsor: BioNTech SE | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

SARS-CoV-2 Neutralization Capacity in Hemodialysis Patients with and without a Fifth Vaccination with the Updated Comirnaty Original/Omicron BA.4-5 Vaccine. (PubMed, Vaccines (Basel)) - "A fifth SARS-CoV-2 vaccination with the adapted vaccine improves both wild-type specific antibody titers and the neutralizing capacity of the current Omicron variants BA.5, BQ.1.1, and XBB.1.5 in hemodialysis patients. Additional booster vaccinations with adapted vaccines will likely improve immunity towards current and original SARS-CoV-2 variants and are, therefore, recommended in hemodialysis patients. Further longitudinal studies must show the extent to which this booster vaccination avoids a breakthrough infection."

Journal • Infectious Disease • Novel Coronavirus Disease • Renal Disease • Respiratory Diseases

I-SPARC: COVID-19: Immune Response in Patients With Cancer Undergoing mRNA Vaccination Against SARS-CoV-2 (clinicaltrials.gov) - P4 | N=152 | Terminated | Sponsor: Jules Bordet Institute | N=440 ➔ 152 | Trial completion date: Dec 2024 ➔ Jan 2024 | Recruiting ➔ Terminated; The population as defined by the inclusion/exclusion criteria and the study logistics were leading to a poor recruitment over the past years.

Enrollment change • Trial completion date • Trial termination • Infectious Disease • Novel Coronavirus Disease • Oncology • Respiratory Diseases

I-SPARC: COVID-19: Immune Response in Patients With Cancer Undergoing mRNA Vaccination Against SARS-CoV-2 (clinicaltrials.gov) - P4 | N=440 | Recruiting | Sponsor: Jules Bordet Institute

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Oncology • Respiratory Diseases

Tozinameran+riltozinameran and tozinameran+famtozinameran for prevention of COVID-19. (PubMed, Aust Prescr) - No abstract available

Journal • Review • Infectious Disease • Novel Coronavirus Disease

A Study to Learn About New COVID-19 RNA Vaccine Candidates in COVID-19 Vaccine-Experienced Healthy Individuals (clinicaltrials.gov) - P2/3 | N=1424 | Active, not recruiting | Sponsor: BioNTech SE | Recruiting ➔ Active, not recruiting | N=700 ➔ 1424

Enrollment change • Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Riding the Omicron BA.5 Wave: Improved Humoral Response after Vaccination with Bivalent Omicron BA.4-5-Adapted mRNA SARS-CoV-2 Vaccine in Chronic Hemodialysis Patients. (PubMed, Vaccines (Basel)) - "We assessed their humoral response using an anti-SARS-CoV-2 spike receptor binding domain IgG antibody assay (S-RBD-ab), measuring neutralizing antibodies against ancestral strain of SARS-CoV-2, Delta, and Omicron in a surrogate virus neutralization test (SVNT), and specifically against BA.5 in a plaque reduction neutralization test (PRNT) before and four weeks after vaccination with Comirnaty Original/Omicron BA.4-5. The bivalent mRNA vaccine improved the SARS-CoV-2 virus variant-specific humoral immunity in chronic hemodialysis patients. Measurement of S-RBD-ab can be used in hemodialysis patients to estimate their humoral immunity status against Omicron BA.5."

Journal • Infectious Disease • Novel Coronavirus Disease • Renal Disease • Respiratory Diseases