A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of SARS-CoV-2 Variant (BA.4/5) mRNA Vaccine (ABO1020) in Healthy Subjects Aged 18 Years and Older Who Have Completed the Full Vaccination

A Randomized, Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of SARS-CoV-2 Variant (BA.4 /5) mRNA Vaccine (ABO1020) in Healthy Subjects Aged 18 Years and Older Who Have Completed the Full Vaccination

Start Date23 Nov 2022

Sponsor / Collaborator

Suzhou Abogen Biosciences Co., Ltd.

100 Clinical Results associated with SARS-CoV-2 Variant (BA.4 /5) mRNA Vaccine(Suzhou Abogen Biosciences Co., Ltd.)

100 Translational Medicine associated with SARS-CoV-2 Variant (BA.4 /5) mRNA Vaccine(Suzhou Abogen Biosciences Co., Ltd.)

100 Patents (Medical) associated with SARS-CoV-2 Variant (BA.4 /5) mRNA Vaccine(Suzhou Abogen Biosciences Co., Ltd.)

Literatures (Medical) associated with SARS-CoV-2 Variant (BA.4 /5) mRNA Vaccine(Suzhou Abogen Biosciences Co., Ltd.)

01 Oct 2024·Med

Efficacy, immunogenicity, and safety of a monovalent mRNA vaccine, ABO1020, in adults: A randomized, double-blind, placebo-controlled, phase 3 trial

Article

Author: Roa, Camilo C ; Yu, Dan-Dan ; Wang, Meng ; Ang, Blake Warren C ; Wu, Xiao-Hong ; Zoleta-De Jesus, Loreta ; Gupta, Rakesh Kumar ; Wu, Yan ; Mae A Zabat, Gelza ; Ying, Bo ; Hannawi, Suad ; Lallaine Borra, Ma Dovie ; Aquitania, Grace P ; Qin, Cheng-Feng ; Villalobos, Ralph Elvi ; Song, Wen-Jie ; Burhan, Erlina

BACKGROUNDABO1020 is a monovalent COVID-19 mRNA vaccine. Results from a phase 1 trial showed ABO1020 was safe and well tolerated, and phase 3 trials to evaluate the efficacy, immunogenicity, and safety of ABO1020 in healthy adults are urgently needed.METHODSWe conducted a multinational, randomized, placebo-controlled, double-blind, phase 3 trial among healthy adults (ClinicalTrials.gov: NCT05636319). Participants were randomly assigned (1:1) to receive either 2 doses of ABO1020 (15 μg per dose) or placebo, administered 28 days apart. The primary endpoint was the vaccine efficacy in preventing symptomatic COVID-19 cases that occurred at least 14 days post-full vaccination. The second endpoint included the neutralizing antibody titers against Omicron BA.5 and XBB and safety assessments.FINDINGSA total of 14,138 participants were randomly assigned to receive either vaccine or placebo (7,069 participants in each group). A total of 366 symptomatic COVID-19 cases were confirmed 14 days after the second dose among 93 participants in the ABO1020 group and 273 participants in the placebo group, yielding a vaccine efficacy of 66.18% (95% confidence interval: 57.21-73.27, p < 0.0001). A single dose or two doses of ABO1020 elicited potent neutralizing antibodies against both BA.5 and XBB.1.5. The safety profile of ABO1020 was characterized by transient, mild-to-moderate fever, pain at the injection site, and headache.CONCLUSIONABO1020 was well tolerated and conferred 66.18% protection against symptomatic COVID-19 in adults.FUNDINGNational Key Research and Development Project of China, Innovation Fund for Medical Sciences from the CAMS, National Natural Science Foundation of China.

Immunogenicity of the BA.1 and BA.4/BA.5 SARS-CoV-2 Bivalent Boosts: Preliminary Results from the COVAIL Randomized Clinical Trial

Author: Diemert, David J ; Telu, Kalyani ; Frey, Sharon E ; Kottkamp, Angelica C ; Mu, Jinjian ; Posavad, Christine M ; Whitaker, Jennifer A ; Smith, Derek J ; Luetkemeyer, Anne F ; Falsey, Ann R ; Walter, Emmanuel B ; Branche, Angela R ; Babu, Tara M ; Rupp, Richard ; Makhene, Mamodikoe K ; Makowski, Mat ; Baden, Lindsey R ; Losada, Cecilia ; Presti, Rachel M ; Atmar, Robert L ; Goepfert, Paul A ; Little, Susan J ; Novak, Richard M ; Immergluck, Lilly C ; Netzl, Antonia ; Winokur, Patricia L ; Rouphael, Nadine G ; Jackson, Lisa A ; Mahgoub, Siham M ; Bäcker, Martín ; Sonja, Crandon ; Fusco, Dahlene N ; Anderson, Evan J ; Montefiori, David C ; Roberts, Paul C ; Beigel, John H

AbstractIn a randomized clinical trial, we compare early neutralizing antibody responses after boosting with bivalent SARS-CoV-2 mRNA vaccines based on either BA.1 or BA.4/BA.5 Omicron spike protein combined with wildtype spike. Responses against SARS-CoV-2 variants exhibited the greatest reduction in titers against currently circulating Omicron subvariants for both bivalent vaccines.

100 Deals associated with SARS-CoV-2 Variant (BA.4 /5) mRNA Vaccine(Suzhou Abogen Biosciences Co., Ltd.)

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 3	AE	Suzhou Abogen Biosciences Co., Ltd.	23 Nov 2022
COVID-19	Phase 3	PH	Suzhou Abogen Biosciences Co., Ltd.	23 Nov 2022
COVID-19	Phase 3	ID	Suzhou Abogen Biosciences Co., Ltd.	23 Nov 2022
COVID-19	Phase 3	PK	Suzhou Abogen Biosciences Co., Ltd.	23 Nov 2022
Severe Acute Respiratory Syndrome	Phase 3	AE	Suzhou Abogen Biosciences Co., Ltd.	23 Nov 2022
Severe Acute Respiratory Syndrome	Phase 3	PK	Suzhou Abogen Biosciences Co., Ltd.	23 Nov 2022
Severe Acute Respiratory Syndrome	Phase 3	ID	Suzhou Abogen Biosciences Co., Ltd.	23 Nov 2022
Severe Acute Respiratory Syndrome	Phase 3	PH	Suzhou Abogen Biosciences Co., Ltd.	23 Nov 2022

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