Mathieu Le Gars
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View article: Safety, immunogenicity and pregnancy outcomes in mothers and infants after vaccination with an adenovirus-vector COVID-19 vaccine during pregnancy.
Safety, immunogenicity and pregnancy outcomes in mothers and infants after vaccination with an adenovirus-vector COVID-19 vaccine during pregnancy. Open
COVID-19 during pregnancy can be associated with adverse pregnancy and infant outcomes. We assessed the safety, reactogenicity, and immunogenicity of maternal vaccination with Ad26.COV2.S COVID-19 vaccine and monitored serum and breast mil…
View article: Immune correlates analysis of antibody responses against SARS-CoV-2 variants in the ENSEMBLE vaccine efficacy trial
Immune correlates analysis of antibody responses against SARS-CoV-2 variants in the ENSEMBLE vaccine efficacy trial Open
In Latin American sites of the ENSEMBLE trial of the Ad26.COV2.S vaccine vs. placebo, binding antibodies and neutralizing antibodies measured 4 weeks post-vaccination (∼peak) against circulating lineages (Ancestral, Gamma, Lambda, Mu, Zeta…
View article: The epigenomic landscape of bronchial epithelial cells reveals the establishment of trained immunity
The epigenomic landscape of bronchial epithelial cells reveals the establishment of trained immunity Open
Innate immune memory, also called trained immunity, refers to the ability of innate immune cells to gain memory characteristics after transient stimulation, resulting in a nonspecific modified inflammatory response upon secondary remote ch…
View article: P-100. Durable immune response induced by self-amplifying mRNA (samRNA) SARS-CoV-2 vaccine candidates against variants of concern (VOC) in HIV-negative and people living with HIV (PLWH) populations in South Africa, irrespective of prior SARS-CoV-2 vaccination
P-100. Durable immune response induced by self-amplifying mRNA (samRNA) SARS-CoV-2 vaccine candidates against variants of concern (VOC) in HIV-negative and people living with HIV (PLWH) populations in South Africa, irrespective of prior SARS-CoV-2 vaccination Open
Background Protection against COVID-19 from authorized SARS-CoV-2 vaccines diminishes after six months, so it is evident we need a second-generation vaccine that provides durable cross-variant protection through durable antibody responses …
View article: Safety and immunogenicity of Ad26.COV2.S in adolescents: Phase 2 randomized clinical trial
Safety and immunogenicity of Ad26.COV2.S in adolescents: Phase 2 randomized clinical trial Open
We conducted a randomized, Phase 2 trial to assess the safety and humoral immunogenicity of reduced doses/dose volume of the standard dose of Ad26.COV2.S COVID-19 vaccine (5 × 1010 viral particles [vp]) in healthy adolescents ag…
View article: Safety, reactogenicity, and immunogenicity of Ad26.COV2.S co-administered with a quadrivalent standard-dose or high-dose seasonal influenza vaccine: a non-inferiority randomised controlled trial
Safety, reactogenicity, and immunogenicity of Ad26.COV2.S co-administered with a quadrivalent standard-dose or high-dose seasonal influenza vaccine: a non-inferiority randomised controlled trial Open
View article: Safety and Humoral Immunogenicity of Different Dose Levels of Ad26.COV2.S as a 2-Dose Regimen in COVID-19 Vaccine-Naïve Healthy Adults: A Phase 3 Randomized Clinical Trial
Safety and Humoral Immunogenicity of Different Dose Levels of Ad26.COV2.S as a 2-Dose Regimen in COVID-19 Vaccine-Naïve Healthy Adults: A Phase 3 Randomized Clinical Trial Open
Background: This study aimed to support the end-of-shelf life specification (2.5 × 1010 virus particles [vp]) for the standard Ad26.COV2.S dose (5 × 1010 vp). Methods: This randomized, double-blind Phase 3 study evaluated immunogenicity, r…
View article: Ad26.COV2.S COVID-19 Vaccine Safety And Immunogenicity in Adolescents 16–17 Years of Age
Ad26.COV2.S COVID-19 Vaccine Safety And Immunogenicity in Adolescents 16–17 Years of Age Open
2.5 × 1010 vp Ad26.COV2.S elicited robust SARS-CoV-2–specific antibody responses in adolescents through 6 months, with acceptable safety and reactogenicity profiles. Compared with adults immunized with 5 × 1010 vp Ad26.COV2.S, adolescents …
View article: Safety, reactogenicity, and immunogenicity of Ad26.COV2.S as homologous or heterologous COVID-19 booster vaccination: Results of a randomized, double-blind, phase 2 trial
Safety, reactogenicity, and immunogenicity of Ad26.COV2.S as homologous or heterologous COVID-19 booster vaccination: Results of a randomized, double-blind, phase 2 trial Open
COVID-19 vaccine boosters may optimize durability of protection against variants of concern (VOCs). In this randomized, double-blind, phase 2 trial, participants received 3 different dose levels of an Ad26.COV2.S booster (5 × 1010
View article: Safety and immunogenicity of Ad26.COV2.S in adults: A randomised, double-blind, placebo-controlled Phase 2a dose-finding study
Safety and immunogenicity of Ad26.COV2.S in adults: A randomised, double-blind, placebo-controlled Phase 2a dose-finding study Open
View article: B cell somatic hypermutation following COVID-19 vaccination with Ad26.COV2.S
B cell somatic hypermutation following COVID-19 vaccination with Ad26.COV2.S Open
An expansion in the breadth of viral variant neutralization from month 1 to month 8 following vaccination in SARS-CoV-2 naive individuals vaccinated with Ad26.COV2.S.14 was observed and this study aims to evaluate the mechanism for this ob…
View article: Quantifying how single dose Ad26.COV2.S vaccine efficacy depends on Spike sequence features
Quantifying how single dose Ad26.COV2.S vaccine efficacy depends on Spike sequence features Open
View article: Mechanistic modeling projections of antibody persistence after homologous booster regimens of COVID‐19 vaccine Ad26.COV2.S in humans
Mechanistic modeling projections of antibody persistence after homologous booster regimens of COVID‐19 vaccine Ad26.COV2.S in humans Open
Mechanistic model‐based simulations can be deployed to project the persistence of humoral immune response following vaccination. We used this approach to project the antibody persistence through 24 months from the data pooled across five c…
View article: Quantifying how single dose Ad26.COV2.S vaccine efficacy depends on Spike sequence features
Quantifying how single dose Ad26.COV2.S vaccine efficacy depends on Spike sequence features Open
It is of interest to pinpoint SARS-CoV-2 sequence features defining vaccine resistance. In the ENSEMBLE randomized, placebo-controlled phase 3 trial, estimated single-dose Ad26.COV2.S vaccine efficacy (VE) was 56% against moderate to sever…
View article: Safety, reactogenicity, and immunogenicity of Ad26.COV2.S: Results of a phase 1, randomized, double-blind, placebo-controlled COVID-19 vaccine trial in Japan
Safety, reactogenicity, and immunogenicity of Ad26.COV2.S: Results of a phase 1, randomized, double-blind, placebo-controlled COVID-19 vaccine trial in Japan Open
View article: Quantifying Antibody Persistence After a Single Dose of <scp>COVID</scp>‐19 Vaccine Ad26.<scp>COV2</scp>.S in Humans Using a Mechanistic Modeling and Simulation Approach
Quantifying Antibody Persistence After a Single Dose of <span>COVID</span>‐19 Vaccine Ad26.<span>COV2</span>.S in Humans Using a Mechanistic Modeling and Simulation Approach Open
Understanding persistence of humoral immune responses elicited by vaccination against coronavirus disease 2019 (COVID‐19) is critical for informing the duration of protection and appropriate booster timing. We developed a mechanistic model…
View article: Efficacy, safety, and immunogenicity of a booster regimen of Ad26.COV2.S vaccine against COVID-19 (ENSEMBLE2): results of a randomised, double-blind, placebo-controlled, phase 3 trial
Efficacy, safety, and immunogenicity of a booster regimen of Ad26.COV2.S vaccine against COVID-19 (ENSEMBLE2): results of a randomised, double-blind, placebo-controlled, phase 3 trial Open
View article: Durability of Heterologous and Homologous COVID-19 Vaccine Boosts
Durability of Heterologous and Homologous COVID-19 Vaccine Boosts Open
Heterologous Ad26.COV2.S boosting was associated with durable humoral and cellular immune responses in individuals who originally received the BNT162b2 vaccine. These data suggest potential benefits of heterologous prime-boost vaccine regi…
View article: Immunogenicity and efficacy of Ad26.<scp>COV2</scp>.S: An adenoviral vector–based <scp>COVID</scp>‐19 vaccine
Immunogenicity and efficacy of Ad26.<span>COV2</span>.S: An adenoviral vector–based <span>COVID</span>‐19 vaccine Open
Since its emergence in late 2019, the coronavirus disease 2019 (COVID‐19) pandemic has caused substantial morbidity and mortality. Despite the availability of efficacious vaccines, new variants with reduced sensitivity to vaccine‐induced p…
View article: Durable antibody responses elicited by 1 dose of Ad26.COV2.S and substantial increase after boosting: 2 randomized clinical trials
Durable antibody responses elicited by 1 dose of Ad26.COV2.S and substantial increase after boosting: 2 randomized clinical trials Open
View article: Impact of Preexisting Anti–Adenovirus 26 Humoral Immunity on Immunogenicity of the Ad26.COV2.S Coronavirus Disease 2019 Vaccine
Impact of Preexisting Anti–Adenovirus 26 Humoral Immunity on Immunogenicity of the Ad26.COV2.S Coronavirus Disease 2019 Vaccine Open
This secondary analysis of the phase 3 ENSEMBLE trial (NCT04505722) assessed the impact of preexisting humoral immunity to adenovirus 26 (Ad26) on the immunogenicity of Ad26.COV2.S-elicited severe acute respiratory syndrome coronavirus 2 (…
View article: Immune Correlates Analysis of a Single Ad26.COV2.S Dose in the ENSEMBLE COVID-19 Vaccine Efficacy Clinical Trial
Immune Correlates Analysis of a Single Ad26.COV2.S Dose in the ENSEMBLE COVID-19 Vaccine Efficacy Clinical Trial Open
Anti-spike IgG binding antibody, anti-receptor binding domain IgG antibody, and pseudovirus neutralizing antibody measurements four weeks post-vaccination were assessed as correlates of risk of moderate to severe-critical COVID-19 outcomes…
View article: Safety and immunogenicity of 3 formulations of a Sabin inactivated poliovirus vaccine produced on the PER.C6® cell line: A phase 2, double-blind, randomized, controlled study in infants vaccinated at 6, 10 and 14 weeks of age
Safety and immunogenicity of 3 formulations of a Sabin inactivated poliovirus vaccine produced on the PER.C6® cell line: A phase 2, double-blind, randomized, controlled study in infants vaccinated at 6, 10 and 14 weeks of age Open
An inactivated poliovirus vaccine candidate using Sabin strains (sIPV) grown on the PER.C6® cell line was assessed in infants after demonstrated immunogenicity and safety in adults. The study recruited 300 infants who were randomized (1:1:…
View article: Efficacy and Safety of a Booster Regimen of Ad26.COV2.S Vaccine against Covid-19
Efficacy and Safety of a Booster Regimen of Ad26.COV2.S Vaccine against Covid-19 Open
Background Despite the availability of effective vaccines against coronavirus disease 2019 (Covid-19), the emergence of variant strains and breakthrough infections pose a challenging new reality. Booster vaccinations are needed to maintain…
View article: LB7. Ad26.COV2.S-Elicted Neutralizing Activities Against SARS-CoV-2 Variants of Concern in Phase 1/2a and Phase 3 Clinical Trials
LB7. Ad26.COV2.S-Elicted Neutralizing Activities Against SARS-CoV-2 Variants of Concern in Phase 1/2a and Phase 3 Clinical Trials Open
Background In a Phase 3 trial, the Janssen COVID-19 vaccine, Ad26.COV2.S, showed robust efficacy against severe–critical COVID-19 in countries where different SARS-CoV-2 variants were circulating. We evaluated Ad26.COV2.S-elicited antibody…
View article: SARS-CoV-2 binding and neutralizing antibody levels after Ad26.COV2.S vaccination predict durable protection in rhesus macaques
SARS-CoV-2 binding and neutralizing antibody levels after Ad26.COV2.S vaccination predict durable protection in rhesus macaques Open
Several COVID-19 vaccines have recently gained authorization for emergency use. Limited knowledge on duration of immunity and efficacy of these vaccines is currently available. Data on other coronaviruses after natural infection suggest th…
View article: Durability of antibody responses elicited by a single dose of Ad26.COV2.S and substantial increase following late boosting
Durability of antibody responses elicited by a single dose of Ad26.COV2.S and substantial increase following late boosting Open
Background We evaluated the durability of SARS-CoV-2 antibody levels elicited by the single dose Janssen COVID-19 vaccine, Ad26.COV2.S, and the impact on antibody responses of boosting with Ad26.COV2.S after 6 months in clinical trial part…
View article: Durable Humoral and Cellular Immune Responses Following Ad26.COV2.S Vaccination for COVID-19
Durable Humoral and Cellular Immune Responses Following Ad26.COV2.S Vaccination for COVID-19 Open
Interim immunogenicity and efficacy data for the Ad26.COV2.S vaccine for COVID-19 have recently been reported 1-3 . We describe here the 8-month durability of humoral and cellular immune responses in 20 individuals who received one or two …
View article: Ad26.COV2.S elicited neutralizing activity against Delta and other SARS-CoV-2 variants of concern
Ad26.COV2.S elicited neutralizing activity against Delta and other SARS-CoV-2 variants of concern Open
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to evolve and recently emerging variants with substitutions in the Spike protein have led to growing concerns over increased transmissibility and decreased vaccine cove…
View article: Neutralizing antibodies elicited by the Ad26.COV2.S COVID-19 vaccine show reduced activity against 501Y.V2 (B.1.351), despite protection against severe disease by this variant
Neutralizing antibodies elicited by the Ad26.COV2.S COVID-19 vaccine show reduced activity against 501Y.V2 (B.1.351), despite protection against severe disease by this variant Open
The emergence of SARS-CoV-2 variants, such as 501Y.V2, with immune evasion mutations in the spike has resulted in reduced efficacy of several COVID-19 vaccines. However, the efficacy of the Ad26.COV2.S vaccine, when tested in South Africa …