Immunogenicity and safety of NVX-CoV2373 as a booster: A phase 3 randomized clinical trial in adults
•NVX-CoV2373 manufacturing lots are consistently immunogenic and well-tolerated.•NVX-CoV2373 can be used as a first booster dose or a later booster dose.•NVX-CoV2373 is also immunogenic against Omicron BA.1/BA.5 SARS-CoV-2 variants. To combat the SARS-CoV-2 pandemic, multiple vaccines using differen...
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Published in | Vaccine Vol. 41; no. 41; pp. 5965 - 5973 |
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Main Authors | , , , , , , , , , , , |
Format | Journal Article |
Language | English |
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Kidlington
Elsevier Ltd
22.09.2023
Elsevier Limited |
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Abstract | •NVX-CoV2373 manufacturing lots are consistently immunogenic and well-tolerated.•NVX-CoV2373 can be used as a first booster dose or a later booster dose.•NVX-CoV2373 is also immunogenic against Omicron BA.1/BA.5 SARS-CoV-2 variants.
To combat the SARS-CoV-2 pandemic, multiple vaccines using different manufacturing platforms have been developed, including NVX-CoV2373 (an adjuvanted recombinant protein vaccine). As SARS-CoV-2 variants have emerged, some of which evade vaccine-induced immunity, introduction of vaccine booster doses has become critical. Employing different vaccine types for primary series vaccination and boosting could expand vaccine coverage and access. This study assessed whether NVX-CoV2373 would induce robust responses when used as a booster.
The 2019nCoV-307 study was a phase 3, randomized, observer-blinded trial evaluating immunogenicity and safety of NVX-CoV2373 in previously vaccinated adults aged 18–49 years in the United States (NCT05463068). Participants were randomized 1:1:1 to receive one intramuscular injection of NVX-CoV2373 from one of three different manufacturing lots. Immunogenicity was assessed by immunoglobulin G (IgG) and neutralizing antibodies (NAb). These responses were compared for the three lots, and for participants with primary series with or without a prior booster dose of the mRNA-1273, BNT162b2, Ad26.COV2.S, or NVX-CoV2373 COVID-19 vaccines.
A total of 911 participants were randomized between July 11 and 13, 2022, with 905 being assessed for safety and 848 for immunogenicity. Immunogenicity of NVX-CoV2373 met prespecified equivalence criteria between lots, and the booster dose was well-tolerated. NVX-CoV2373 induced robust IgG and NAb responses when used as a first or later booster dose, regardless of primary series vaccine type. Seroconversion rates were also similar across previous vaccine types. Induced antibodies were strongly reactive, even to the immune-evasive Omicron BA.1 and BA.5 variants.
NVX-CoV2373 showed consistent immunogenicity between lots, with no new safety signals identified. Use of NVX-CoV2373 as a booster dose (first or later) is supported. |
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AbstractList | •NVX-CoV2373 manufacturing lots are consistently immunogenic and well-tolerated.•NVX-CoV2373 can be used as a first booster dose or a later booster dose.•NVX-CoV2373 is also immunogenic against Omicron BA.1/BA.5 SARS-CoV-2 variants.
To combat the SARS-CoV-2 pandemic, multiple vaccines using different manufacturing platforms have been developed, including NVX-CoV2373 (an adjuvanted recombinant protein vaccine). As SARS-CoV-2 variants have emerged, some of which evade vaccine-induced immunity, introduction of vaccine booster doses has become critical. Employing different vaccine types for primary series vaccination and boosting could expand vaccine coverage and access. This study assessed whether NVX-CoV2373 would induce robust responses when used as a booster.
The 2019nCoV-307 study was a phase 3, randomized, observer-blinded trial evaluating immunogenicity and safety of NVX-CoV2373 in previously vaccinated adults aged 18–49 years in the United States (NCT05463068). Participants were randomized 1:1:1 to receive one intramuscular injection of NVX-CoV2373 from one of three different manufacturing lots. Immunogenicity was assessed by immunoglobulin G (IgG) and neutralizing antibodies (NAb). These responses were compared for the three lots, and for participants with primary series with or without a prior booster dose of the mRNA-1273, BNT162b2, Ad26.COV2.S, or NVX-CoV2373 COVID-19 vaccines.
A total of 911 participants were randomized between July 11 and 13, 2022, with 905 being assessed for safety and 848 for immunogenicity. Immunogenicity of NVX-CoV2373 met prespecified equivalence criteria between lots, and the booster dose was well-tolerated. NVX-CoV2373 induced robust IgG and NAb responses when used as a first or later booster dose, regardless of primary series vaccine type. Seroconversion rates were also similar across previous vaccine types. Induced antibodies were strongly reactive, even to the immune-evasive Omicron BA.1 and BA.5 variants.
NVX-CoV2373 showed consistent immunogenicity between lots, with no new safety signals identified. Use of NVX-CoV2373 as a booster dose (first or later) is supported. BACKGROUNDTo combat the SARS-CoV-2 pandemic, multiple vaccines using different manufacturing platforms have been developed, including NVX-CoV2373 (an adjuvanted recombinant protein vaccine). As SARS-CoV-2 variants have emerged, some of which evade vaccine-induced immunity, introduction of vaccine booster doses has become critical. Employing different vaccine types for primary series vaccination and boosting could expand vaccine coverage and access. This study assessed whether NVX-CoV2373 would induce robust responses when used as a booster. METHODSThe 2019nCoV-307 study was a phase 3, randomized, observer-blinded trial evaluating immunogenicity and safety of NVX-CoV2373 in previously vaccinated adults aged 18-49 years in the United States (NCT05463068). Participants were randomized 1:1:1 to receive one intramuscular injection of NVX-CoV2373 from one of three different manufacturing lots. Immunogenicity was assessed by immunoglobulin G (IgG) and neutralizing antibodies (NAb). These responses were compared for the three lots, and for participants with primary series with or without a prior booster dose of the mRNA-1273, BNT162b2, Ad26.COV2.S, or NVX-CoV2373 COVID-19 vaccines. RESULTSA total of 911 participants were randomized between July 11 and 13, 2022, with 905 being assessed for safety and 848 for immunogenicity. Immunogenicity of NVX-CoV2373 met prespecified equivalence criteria between lots, and the booster dose was well-tolerated. NVX-CoV2373 induced robust IgG and NAb responses when used as a first or later booster dose, regardless of primary series vaccine type. Seroconversion rates were also similar across previous vaccine types. Induced antibodies were strongly reactive, even to the immune-evasive Omicron BA.1 and BA.5 variants. CONCLUSIONSNVX-CoV2373 showed consistent immunogenicity between lots, with no new safety signals identified. Use of NVX-CoV2373 as a booster dose (first or later) is supported. |
Author | Chau, Gordon Plested, Joyce Eickhoff, Mark Cloney-Clark, Shane Zhu, Mingzhu Cai, Miranda R. Raiser, Fritz Davis, Matthew Dunkle, Lisa M. Adelglass, Jeffrey McKnight, Irene Kalkeri, Raj |
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Snippet | •NVX-CoV2373 manufacturing lots are consistently immunogenic and well-tolerated.•NVX-CoV2373 can be used as a first booster dose or a later booster... BackgroundTo combat the SARS-CoV-2 pandemic, multiple vaccines using different manufacturing platforms have been developed, including NVX-CoV2373 (an... BACKGROUNDTo combat the SARS-CoV-2 pandemic, multiple vaccines using different manufacturing platforms have been developed, including NVX-CoV2373 (an... |
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SubjectTerms | Adults Booster Clinical trials COVID-19 COVID-19 vaccines Disease transmission FDA approval IgG antibody Immunogenicity Immunoglobulin G Manufacturing mRNA mRNA vaccines Myocarditis NVX-CoV2373 Pandemics Pericarditis Proteins Public health Robustness Safety SARS-CoV-2 variants Seroconversion Severe acute respiratory syndrome coronavirus 2 Vaccines |
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Title | Immunogenicity and safety of NVX-CoV2373 as a booster: A phase 3 randomized clinical trial in adults |
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