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Article ; Online: Non-human primate to human immunobridging demonstrates a protective effect of Ad26.ZEBOV, MVA-BN-Filo vaccine against Ebola.

Bockstal, Viki / Leyssen, Maarten / Heerwegh, Dirk / Spiessens, Bart / Robinson, Cynthia / Stoop, Jeroen N / Roozendaal, Ramon / Van Effelterre, Thierry / Gaddah, Auguste / Van Roey, Griet A / Solforosi, Laura / Zahn, Roland / Callendret, Benoit / Hendriks, Jenny / Luhn, Kerstin / Douoguih, Macaya / Schuitemaker, Hanneke / Van Hoof, Johan

NPJ vaccines

2022 Volume 7, Issue 1, Page(s) 156

Abstract: Without clinical efficacy data, vaccine protective effect may be extrapolated from animals to humans using an immunologic marker that correlates with protection in animals. This immunobridging approach was used for the two-dose Ebola vaccine regimen Ad26. ...

Abstract	Without clinical efficacy data, vaccine protective effect may be extrapolated from animals to humans using an immunologic marker that correlates with protection in animals. This immunobridging approach was used for the two-dose Ebola vaccine regimen Ad26.ZEBOV, MVA-BN-Filo. Ebola virus (EBOV) glycoprotein binding antibody data obtained from 764 vaccinated healthy adults in five clinical studies (NCT02416453, NCT02564523, NCT02509494, NCT02543567, NCT02543268) were used to calculate mean predicted survival probability (with preplanned 95% confidence interval [CI]). We used a logistic regression model based on EBOV glycoprotein binding antibody responses in vaccinated non-human primates (NHPs) and NHP survival after EBOV challenge. While the protective effect of the vaccine regimen in humans can be inferred in this fashion, the extrapolated survival probability cannot be directly translated into vaccine efficacy. The primary immunobridging analysis evaluated the lower limit of the CI against predefined success criterion of 20% and passed with mean predicted survival probability of 53.4% (95% CI: 36.7-67.4).
Language	English
Publishing date	2022-11-30
Publishing country	England
Document type	Journal Article
ISSN	2059-0105
ISSN (online)	2059-0105
DOI	10.1038/s41541-022-00564-z
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: 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.

Hardt, Karin / Vandebosch, An / Sadoff, Jerald / Le Gars, Mathieu / Truyers, Carla / Lowson, David / Van Dromme, Ilse / Vingerhoets, Johan / Kamphuis, Tobias / Scheper, Gert / Ruiz-Guiñazú, Javier / Faust, Saul N / Spinner, Christoph D / Schuitemaker, Hanneke / Van Hoof, Johan / Douoguih, Macaya / Struyf, Frank

The Lancet. Infectious diseases

2022 Volume 22, Issue 12, Page(s) 1703–1715

Abstract: Background: Despite the availability of effective vaccines against COVID-19, booster vaccinations are needed to maintain vaccine-induced protection against variant strains and breakthrough infections. This study aimed to investigate the efficacy, safety, ...

Abstract	Background: Despite the availability of effective vaccines against COVID-19, booster vaccinations are needed to maintain vaccine-induced protection against variant strains and breakthrough infections. This study aimed to investigate the efficacy, safety, and immunogenicity of the Ad26.COV2.S vaccine (Janssen) as primary vaccination plus a booster dose. Methods: ENSEMBLE2 is a randomised, double-blind, placebo-controlled, phase 3 trial including crossover vaccination after emergency authorisation of COVID-19 vaccines. Adults aged at least 18 years without previous COVID-19 vaccination at public and private medical practices and hospitals in Belgium, Brazil, Colombia, France, Germany, the Philippines, South Africa, Spain, the UK, and the USA were randomly assigned 1:1 via a computer algorithm to receive intramuscularly administered Ad26.COV2.S as a primary dose plus a booster dose at 2 months or two placebo injections 2 months apart. The primary endpoint was vaccine efficacy against the first occurrence of molecularly confirmed moderate to severe-critical COVID-19 with onset at least 14 days after booster vaccination, which was assessed in participants who received two doses of vaccine or placebo, were negative for SARS-CoV-2 by PCR at baseline and on serology at baseline and day 71, had no major protocol deviations, and were at risk of COVID-19 (ie, had no PCR-positive result or discontinued the study before day 71). Safety was assessed in all participants; reactogenicity, in terms of solicited local and systemic adverse events, was assessed as a secondary endpoint in a safety subset (approximately 6000 randomly selected participants). The trial is registered with ClinicalTrials.gov, NCT04614948, and is ongoing. Findings: Enrolment began on Nov 16, 2020, and the primary analysis data cutoff was June 25, 2021. From 34 571 participants screened, the double-blind phase enrolled 31 300 participants, 14 492 of whom received two doses (7484 in the Ad26.COV2.S group and 7008 in the placebo group) and 11 639 of whom were eligible for inclusion in the assessment of the primary endpoint (6024 in the Ad26.COV2.S group and 5615 in the placebo group). The median (IQR) follow-up post-booster vaccination was 36·0 (15·0-62·0) days. Vaccine efficacy was 75·2% (adjusted 95% CI 54·6-87·3) against moderate to severe-critical COVID-19 (14 cases in the Ad26.COV2.S group and 52 cases in the placebo group). Most cases were due to the variants alpha (B.1.1.7) and mu (B.1.621); endpoints for the primary analysis accrued from Nov 16, 2020, to June 25, 2021, before the global dominance of delta (B.1.617.2) or omicron (B.1.1.529). The booster vaccine exhibited an acceptable safety profile. The overall frequencies of solicited local and systemic adverse events (evaluated in the safety subset, n=6067) were higher among vaccine recipients than placebo recipients after the primary and booster doses. The frequency of solicited adverse events in the Ad26.COV2.S group were similar following the primary and booster vaccinations (local adverse events, 1676 [55·6%] of 3015 vs 896 [57·5%] of 1559, respectively; systemic adverse events, 1764 [58·5%] of 3015 vs 821 [52·7%] of 1559, respectively). Solicited adverse events were transient and mostly grade 1-2 in severity. Interpretation: A homologous Ad26.COV2.S booster administered 2 months after primary single-dose vaccination in adults had an acceptable safety profile and was efficacious against moderate to severe-critical COVID-19. Studies assessing efficacy against newer variants and with longer follow-up are needed. Funding: Janssen Research & Development.
MeSH term(s)	Adult ; Humans ; Adolescent ; SARS-CoV-2 ; COVID-19 Vaccines/adverse effects ; COVID-19/prevention & control ; Ad26COVS1 ; Vaccines ; Double-Blind Method ; Immunogenicity, Vaccine ; Antibodies, Viral
Chemical Substances	COVID-19 Vaccines ; Ad26COVS1 (JT2NS6183B) ; Vaccines ; Antibodies, Viral
Language	English
Publishing date	2022-09-13
Publishing country	United States
Document type	Randomized Controlled Trial ; Clinical Trial, Phase III ; Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, Non-P.H.S. ; Research Support, N.I.H., Extramural
ZDB-ID	2061641-7
ISSN	1474-4457 ; 1473-3099
ISSN (online)	1474-4457
ISSN	1473-3099
DOI	10.1016/S1473-3099(22)00506-0
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Article: Durable antibody responses elicited by 1 dose of Ad26.COV2.S and substantial increase after boosting: 2 randomized clinical trials

Sadoff, Jerald / Le Gars, Mathieu / Brandenburg, Boerries / Cardenas, Vicky / Shukarev, Georgi / Vaissiere, Nathalie / Heerwegh, Dirk / Truyers, Carla / Marit de Groot, Anne / Jongeneelen, Mandy / Kaszas, Krisztian / Tolboom, Jeroen / Scheper, Gert / Hendriks, Jenny / Ruiz-Guiñazú, Javier / Struyf, Frank / Van Hoof, Johan / Douoguih, Macaya / Schuitemaker, Hanneke

Vaccine. 2022 May 19,

2022

Abstract: Ad26.COV2.S is a well-tolerated and effective vaccine against COVID-19. We evaluated durability of anti-SARS-CoV-2 antibodies elicited by single-dose Ad26.COV2.S and the impact of boosting. In randomized, double-blind, placebo-controlled, phase 1/2a and ... ...

Abstract	Ad26.COV2.S is a well-tolerated and effective vaccine against COVID-19. We evaluated durability of anti-SARS-CoV-2 antibodies elicited by single-dose Ad26.COV2.S and the impact of boosting. In randomized, double-blind, placebo-controlled, phase 1/2a and phase 2 trials, participants received single-dose Ad26.COV2.S (5×10¹⁰ viral particles [vp]) followed by booster doses of 5×10¹⁰ vp or 1.25×10¹⁰ vp. Neutralizing antibody levels were determined by a virus neutralization assay (VNA) approximately 8–9 months after dose 1. Binding and neutralizing antibody levels were evaluated by an enzyme-linked immunosorbent assay and pseudotyped VNA 6 months after dose 1 and 7 and 28 days after boosting. Data were analyzed from phase 1/2a participants enrolled from 22 July–18 December 2020 (Cohort 1a, 18–55 years [y], N=25; Cohort 2a, 18–55y, N=17; Cohort 3, ≥65y, N=22), and phase 2 participants from 14–22 September 2020 (18–55y and ≥65y, N=73). Single-dose Ad26.COV2.S elicited stable neutralizing antibodies for at least 8–9 months and stable binding antibodies for at least 6 months, irrespective of age. A 5×10¹⁰ vp 2-month booster dose increased binding antibodies by 4.9- to 6.2-fold 14 days post-boost versus 28 days after initial immunization. A 6-month booster elicited a steep and robust 9-fold increase in binding antibody levels 7 days post-boost. A 5.0-fold increase in neutralizing antibodies was observed by 28 days post-boost for the Beta variant. A 1.25×10¹⁰ vp 6-month booster elicited a 3.6-fold increase in binding antibody levels at 7 days post-boost versus pre-boost, with a similar magnitude of post-boost responses in both age groups. Single-dose Ad26.COV2.S elicited durable antibody responses for at least 8 months, and immune memory. Booster-elicited binding and neutralizing antibody responses were rapid and robust, even with a quarter vaccine dose, and stronger with a longer interval since primary vaccination. Trial Registration: ClinicalTrials.gov Identifier: NCT04436276, NCT04535453.
Keywords	COVID-19 infection ; durability ; enzyme-linked immunosorbent assay ; immunologic memory ; neutralization tests ; vaccination ; vaccines
Language	English
Dates of publication	2022-0519
Publishing place	Elsevier Ltd
Document type	Article
Note	Pre-press version
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2022.05.047
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Article ; Online: Developing Vaccines for SARS-CoV-2 and Future Epidemics and Pandemics: Applying Lessons from Past Outbreaks.

Billington, John / Deschamps, Isabelle / Erck, Stanley C / Gerberding, Julie L / Hanon, Emmanuel / Ivol, Sabrina / Shiver, John W / Spencer, Julia A / Van Hoof, Johan

Health security

2020 Volume 18, Issue 3, Page(s) 241–249

Abstract: The COVID-19 pandemic is a stark reminder of the heavy toll that emerging infectious diseases (EIDs) with epidemic and pandemic potential can inflict. Vaccine development, scale-up, and commercialization is a long, expensive, and risky enterprise that ... ...

Abstract	The COVID-19 pandemic is a stark reminder of the heavy toll that emerging infectious diseases (EIDs) with epidemic and pandemic potential can inflict. Vaccine development, scale-up, and commercialization is a long, expensive, and risky enterprise that requires substantial upfront planning and offers no guarantee of success. EIDs are a particularly challenging target for global health preparedness, including for vaccine development. Insufficient attention has been given to challenges, lessons learned, and potential solutions to support and sustain vaccine industry engagement in vaccine development for EIDs. Drawing from lessons from the most recent Ebola epidemic in the Democratic Republic of the Congo, as well as the 2009 H1N1 influenza, 2014-2016 Ebola, and 2015-16 Zika outbreaks preceding it, we offer our perspective on challenges facing EID vaccine development and recommend additional solutions to prioritize in the near term. The 6 recommendations focus on reducing vaccine development timelines and increasing business certainty to reduce risks for companies. The global health security community has an opportunity to build on the current momentum to design a sustainable model for EID vaccines.
MeSH term(s)	COVID-19 ; Communicable Disease Control/organization & administration ; Communicable Diseases, Emerging/epidemiology ; Communicable Diseases, Emerging/prevention & control ; Coronavirus Infections/epidemiology ; Coronavirus Infections/prevention & control ; Drug Approval ; Drug Development ; Drug Industry/organization & administration ; Female ; Global Health ; Humans ; Influenza Vaccines/administration & dosage ; Influenza Vaccines/pharmacology ; Male ; Needs Assessment ; Pandemics/prevention & control ; Pandemics/statistics & numerical data ; Pneumonia, Viral/epidemiology ; Pneumonia, Viral/prevention & control ; Public Health ; Security Measures ; Technology, Pharmaceutical/organization & administration
Chemical Substances	Influenza Vaccines
Keywords	covid19
Language	English
Publishing date	2020-04-29
Publishing country	United States
Document type	Journal Article ; Review
ZDB-ID	2823049-8
ISSN	2326-5108 ; 2326-5094
ISSN (online)	2326-5108
ISSN	2326-5094
DOI	10.1089/hs.2020.0043
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Article: Durable Humoral and Cellular Immune Responses Following Ad26.COV2.S Vaccination for COVID-19.

Barouch, Dan H / Stephenson, Kathryn E / Sadoff, Jerald / Yu, Jingyou / Chang, Aiquan / Gebre, Makda / McMahan, Katherine / Liu, Jinyan / Chandrashekar, Abishek / Patel, Shivani / Le Gars, Mathieu / de Groot, Anne Marit / Heerwegh, Dirk / Struyf, Frank / Douoguih, Macaya / van Hoof, Johan / Schuitemaker, Hanneke

medRxiv : the preprint server for health sciences

2021

Abstract: Interim immunogenicity and efficacy data for the Ad26.COV2.S vaccine for COVID-19 have recently been ... ...

Abstract	Interim immunogenicity and efficacy data for the Ad26.COV2.S vaccine for COVID-19 have recently been reported
Language	English
Publishing date	2021-07-07
Publishing country	United States
Document type	Preprint
DOI	10.1101/2021.07.05.21259918
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Article ; Online: Durable Humoral and Cellular Immune Responses 8 Months after Ad26.COV2.S Vaccination.

Barouch, Dan H / Stephenson, Kathryn E / Sadoff, Jerald / Yu, Jingyou / Chang, Aiquan / Gebre, Makda / McMahan, Katherine / Liu, Jinyan / Chandrashekar, Abishek / Patel, Shivani / Le Gars, Mathieu / de Groot, Anne M / Heerwegh, Dirk / Struyf, Frank / Douoguih, Macaya / van Hoof, Johan / Schuitemaker, Hanneke

The New England journal of medicine

2021 Volume 385, Issue 10, Page(s) 951–953

MeSH term(s)	Ad26COVS1 ; Antibodies, Neutralizing/blood ; Antibodies, Viral/blood ; COVID-19 Vaccines/immunology ; Follow-Up Studies ; Humans ; Immunity, Cellular ; Immunity, Humoral ; Immunogenicity, Vaccine ; SARS-CoV-2 ; T-Lymphocytes/physiology ; Vaccination
Chemical Substances	Ad26COVS1 (JT2NS6183B) ; Antibodies, Neutralizing ; Antibodies, Viral ; COVID-19 Vaccines
Language	English
Publishing date	2021-07-14
Publishing country	United States
Document type	Letter ; Research Support, Non-U.S. Gov't
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMc2108829
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Article ; Online: Durable antibody responses elicited by 1 dose of Ad26.COV2.S and substantial increase after boosting: 2 randomized clinical trials.

Sadoff, Jerald / Le Gars, Mathieu / Brandenburg, Boerries / Cárdenas, Vicky / Shukarev, Georgi / Vaissiere, Nathalie / Heerwegh, Dirk / Truyers, Carla / de Groot, Anne Marit / Jongeneelen, Mandy / Kaszas, Krisztian / Tolboom, Jeroen / Scheper, Gert / Hendriks, Jenny / Ruiz-Guiñazú, Javier / Struyf, Frank / Van Hoof, Johan / Douoguih, Macaya / Schuitemaker, Hanneke

Vaccine

2022 Volume 40, Issue 32, Page(s) 4403–4411

Abstract: Background: Ad26.COV2.S is a well-tolerated and effective vaccine against COVID-19. We evaluated durability of anti-SARS-CoV-2 antibodies elicited by single-dose Ad26.COV2.S and the impact of boosting.: Methods: In randomized, double-blind, placebo- ... ...

Abstract	Background: Ad26.COV2.S is a well-tolerated and effective vaccine against COVID-19. We evaluated durability of anti-SARS-CoV-2 antibodies elicited by single-dose Ad26.COV2.S and the impact of boosting. Methods: In randomized, double-blind, placebo-controlled, phase 1/2a and phase 2 trials, participants received single-dose Ad26.COV2.S (5 × 10 Results: Data were analyzed from phase 1/2a participants enrolled from 22 July-18 December 2020 (Cohort 1a, 18-55 years [y], N = 25; Cohort 2a, 18-55y, N = 17; Cohort 3, ≥65y, N = 22), and phase 2 participants from 14 to 22 September 2020 (18-55y and ≥ 65y, N = 73). Single-dose Ad26.COV2.S elicited stable neutralizing antibodies for at least 8-9 months and stable binding antibodies for at least 6 months, irrespective of age. A 5 × 10 Conclusions: Single-dose Ad26.COV2.S elicited durable antibody responses for at least 8 months and elicited immune memory. Booster-elicited binding and neutralizing antibody responses were rapid and robust, even with a quarter vaccine dose, and stronger with a longer interval since primary vaccination. Trial registration: ClinicalTrials.gov Identifier: NCT04436276, NCT04535453.
MeSH term(s)	Ad26COVS1 ; Antibodies, Neutralizing ; Antibodies, Viral ; Antibody Formation ; COVID-19/prevention & control ; COVID-19 Vaccines ; Humans ; Randomized Controlled Trials as Topic ; SARS-CoV-2
Chemical Substances	Ad26COVS1 (JT2NS6183B) ; Antibodies, Neutralizing ; Antibodies, Viral ; COVID-19 Vaccines
Language	English
Publishing date	2022-06-03
Publishing country	Netherlands
Document type	Journal Article ; Research Support, U.S. Gov't, Non-P.H.S. ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Extramural
ZDB-ID	605674-x
ISSN	1873-2518 ; 0264-410X
ISSN (online)	1873-2518
ISSN	0264-410X
DOI	10.1016/j.vaccine.2022.05.047
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Article ; Online: Efficacy and Safety of a Booster Regimen of Ad26.COV2.S Vaccine against Covid-19

Hardt, Karin / Vandebosch, An / Sadoff, Jerald / Le Gars, Mathieu / Truyers, Carla / Lowson, David / Van Dromme, Ilse / Vingerhoets, Johan / Kamphuis, Tobias / Scheper, Gert / Ruiz-Guinazu, Javier / Faust, Saul N. / Spinner, Christoph D. / Schuitemaker, Hanneke / Van Hoof, Johan / Douoguih, Macaya / Struyf, Frank

medRxiv

Abstract: 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 vaccine- ... ...

Abstract	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 vaccine-induced protection. Methods. ENSEMBLE2 is an ongoing, randomized, double-blind, placebo-controlled, phase 3 pivotal trial including crossover vaccination after emergency authorization of Covid-19 vaccines. Adults aged ≥18 years were randomized to receive Ad26.COV2.S or placebo as a primary dose plus a booster dose at two months. The primary endpoint was vaccine efficacy against the first occurrence of molecularly-confirmed moderate to severe-critical Covid-19 with onset ≥14 days after booster vaccination in the per-protocol population. Key efficacy, safety, and immunogenicity endpoints were also assessed. Results. The double-blind phase enrolled 31,300 participants, 14,492 of whom received 2 doses and were evaluable for efficacy (per-protocol set, Ad26.COV2.S n=7,484; placebo n=7,008). Baseline demographics and characteristics were balanced. Vaccine efficacy was 75.2% (adjusted 95% CI, 54.6-87.3) against moderate to severe-critical Covid-19 and was similar against symptomatic infection (75.6% [55.5-99.9]). Efficacy was consistent across participants with and without comorbidities, and reached 93.7% (58.5-99.9) in the US. Vaccine efficacy against severe-critical Covid-19 was 100% (32.6-100.0; 0 vs 8 cases). The booster vaccine induced robust humoral responses and exhibited an acceptable safety profile. Conclusions. A homologous Ad26.COV2.S booster administered 2 months after primary single-dose vaccination in adults led to high vaccine efficacy, including against any symptomatic infection and SARS-CoV-2 variants prevalent during the study. (Funding: Janssen Research and Development and others; ENSEMBLE2 ClinicalTrials.gov number, NCT04614948.)
Keywords	covid19
Language	English
Publishing date	2022-01-31
Publisher	Cold Spring Harbor Laboratory Press
Document type	Article ; Online
DOI	10.1101/2022.01.28.22270043
Database	COVID19

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Article: Developing Vaccines for SARS-CoV-2 and Future Epidemics and Pandemics: Applying Lessons from Past Outbreaks

Billington, John / Deschamps, Isabelle / Erck, Stanley C / Gerberding, Julie L / Hanon, Emmanuel / Ivol, Sabrina / Shiver, John W / Spencer, Julia A / Van Hoof, Johan

Health Secur

Abstract	The COVID-19 pandemic is a stark reminder of the heavy toll that emerging infectious diseases (EIDs) with epidemic and pandemic potential can inflict. Vaccine development, scale-up, and commercialization is a long, expensive, and risky enterprise that requires substantial upfront planning and offers no guarantee of success. EIDs are a particularly challenging target for global health preparedness, including for vaccine development. Insufficient attention has been given to challenges, lessons learned, and potential solutions to support and sustain vaccine industry engagement in vaccine development for EIDs. Drawing from lessons from the most recent Ebola epidemic in the Democratic Republic of the Congo, as well as the 2009 H1N1 influenza, 2014-2016 Ebola, and 2015-16 Zika outbreaks preceding it, we offer our perspective on challenges facing EID vaccine development and recommend additional solutions to prioritize in the near term. The 6 recommendations focus on reducing vaccine development timelines and increasing business certainty to reduce risks for companies. The global health security community has an opportunity to build on the current momentum to design a sustainable model for EID vaccines.
Keywords	covid19
Publisher	WHO
Document type	Article
Note	WHO #Covidence: #141511
Database	COVID19

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Article ; Online: Developing Vaccines for SARS-CoV-2 and Future Epidemics and Pandemics

Billington, John / Deschamps, Isabelle / Erck, Stanley C. / Gerberding, Julie L. / Hanon, Emmanuel / Ivol, Sabrina / Shiver, John W. / Spencer, Julia A. / Van Hoof, Johan

Health Security

Applying Lessons from Past Outbreaks

2020 Volume 18, Issue 3, Page(s) 241–249

Keywords	Public Health, Environmental and Occupational Health ; Health, Toxicology and Mutagenesis ; Emergency Medicine ; Health(social science) ; Management, Monitoring, Policy and Law ; Safety Research ; covid19
Language	English
Publisher	Mary Ann Liebert Inc
Publishing country	us
Document type	Article ; Online
ZDB-ID	2823049-8
ISSN	2326-5108 ; 2326-5094
ISSN (online)	2326-5108
ISSN	2326-5094
DOI	10.1089/hs.2020.0043
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