11 results on '"van der Laan, Lars W. P."'
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2. Publisher Correction: Immune correlates analysis of the PREVENT-19 COVID-19 vaccine efficacy clinical trial
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Fong, Youyi, Huang, Yunda, Benkeser, David, Carpp, Lindsay N., Áñez, Germán, Woo, Wayne, McGarry, Alice, Dunkle, Lisa M., Cho, Iksung, Houchens, Christopher R., Martins, Karen, Jayashankar, Lakshmi, Castellino, Flora, Petropoulos, Christos J., Leith, Andrew, Haugaard, Deanne, Webb, Bill, Lu, Yiwen, Yu, Chenchen, Borate, Bhavesh, van der Laan, Lars W. P., Hejazi, Nima S., Randhawa, April K., Andrasik, Michele P., Kublin, James G., Hutter, Julia, Keshtkar-Jahromi, Maryam, Beresnev, Tatiana H., Corey, Lawrence, Neuzil, Kathleen M., Follmann, Dean, Ake, Julie A., Gay, Cynthia L., Kotloff, Karen L., Koup, Richard A., Donis, Ruben O., and Gilbert, Peter B.
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- 2023
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3. Immune correlates analysis of the PREVENT-19 COVID-19 vaccine efficacy clinical trial
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Fong, Youyi, Huang, Yunda, Benkeser, David, Carpp, Lindsay N., Áñez, Germán, Woo, Wayne, McGarry, Alice, Dunkle, Lisa M., Cho, Iksung, Houchens, Christopher R., Martins, Karen, Jayashankar, Lakshmi, Castellino, Flora, Petropoulos, Christos J., Leith, Andrew, Haugaard, Deanne, Webb, Bill, Lu, Yiwen, Yu, Chenchen, Borate, Bhavesh, van der Laan, Lars W. P., Hejazi, Nima S., Randhawa, April K., Andrasik, Michele P., Kublin, James G., Hutter, Julia, Keshtkar-Jahromi, Maryam, Beresnev, Tatiana H., Corey, Lawrence, Neuzil, Kathleen M., Follmann, Dean, Ake, Julie A., Gay, Cynthia L., Kotloff, Karen L., Koup, Richard A., Donis, Ruben O., and Gilbert, Peter B.
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- 2023
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4. Immune correlates analysis of a phase 3 trial of the AZD1222 (ChAdOx1 nCoV-19) vaccine
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Benkeser, David, Fong, Youyi, Janes, Holly E., Kelly, Elizabeth J., Hirsch, Ian, Sproule, Stephanie, Stanley, Ann Marie, Maaske, Jill, Villafana, Tonya, Houchens, Christopher R., Martins, Karen, Jayashankar, Lakshmi, Castellino, Flora, Ayala, Victor, Petropoulos, Christos J., Leith, Andrew, Haugaard, Deanne, Webb, Bill, Lu, Yiwen, Yu, Chenchen, Borate, Bhavesh, van der Laan, Lars W. P., Hejazi, Nima S., Carpp, Lindsay N., Randhawa, April K., Andrasik, Michele P., Kublin, James G., Isaacs, Margaret Brewinski, Makhene, Mamodikoe, Tong, Tina, Robb, Merlin L., Corey, Lawrence, Neuzil, Kathleen M., Follmann, Dean, Hoffman, Corey, Falsey, Ann R., Sobieszczyk, Magdalena, Koup, Richard A., Donis, Ruben O., and Gilbert, Peter B.
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- 2023
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5. Immune correlates analysis of the ENSEMBLE single Ad26.COV2.S dose vaccine efficacy clinical trial
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Fong, Youyi, McDermott, Adrian B., Benkeser, David, Roels, Sanne, Stieh, Daniel J., Vandebosch, An, Le Gars, Mathieu, Van Roey, Griet A., Houchens, Christopher R., Martins, Karen, Jayashankar, Lakshmi, Castellino, Flora, Amoa-Awua, Obrimpong, Basappa, Manjula, Flach, Britta, Lin, Bob C., Moore, Christopher, Naisan, Mursal, Naqvi, Muhammed, Narpala, Sandeep, O’Connell, Sarah, Mueller, Allen, Serebryannyy, Leo, Castro, Mike, Wang, Jennifer, Petropoulos, Christos J., Luedtke, Alex, Hyrien, Ollivier, Lu, Yiwen, Yu, Chenchen, Borate, Bhavesh, van der Laan, Lars W. P., Hejazi, Nima S., Kenny, Avi, Carone, Marco, Wolfe, Daniel N., Sadoff, Jerald, Gray, Glenda E., Grinsztejn, Beatriz, Goepfert, Paul A., Little, Susan J., Paiva de Sousa, Leonardo, Maboa, Rebone, Randhawa, April K., Andrasik, Michele P., Hendriks, Jenny, Truyers, Carla, Struyf, Frank, Schuitemaker, Hanneke, Douoguih, Macaya, Kublin, James G., Corey, Lawrence, Neuzil, Kathleen M., Carpp, Lindsay N., Follmann, Dean, Gilbert, Peter B., Koup, Richard A., and Donis, Ruben O.
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- 2022
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6. Antibody Correlates of Protection From Severe Respiratory Syncytial Virus Disease in a Vaccine Efficacy Trial
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Fong, Youyi, primary, Huang, Ying, additional, Borate, Bhavesh, additional, van der Laan, Lars W P, additional, Zhang, Wenbo, additional, Carpp, Lindsay N, additional, Cho, Iksung, additional, Glenn, Greg, additional, Fries, Louis, additional, Gottardo, Raphael, additional, and Gilbert, Peter B, additional
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- 2023
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7. Immune Correlates Analysis of the mRNA-1273 COVID-19 Vaccine Efficacy Trial
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Gilbert, Peter B., primary, Montefiori, David C., additional, McDermott, Adrian, additional, Fong, Youyi, additional, Benkeser, David, additional, Deng, Weiping, additional, Zhou, Honghong, additional, Houchens, Christopher R., additional, Martins, Karen, additional, Jayashankar, Lakshmi, additional, Castellino, Flora, additional, Flach, Britta, additional, Lin, Bob C., additional, O’Connell, Sarah, additional, McDanal, Charlene, additional, Eaton, Amanda, additional, Sarzotti-Kelsoe, Marcella, additional, Lu, Yiwen, additional, Yu, Chenchen, additional, Borate, Bhavesh, additional, van der Laan, Lars W. P., additional, Hejazi, Nima, additional, Huynh, Chuong, additional, Miller, Jacqueline, additional, El Sahly, Hana M., additional, Baden, Lindsey R., additional, Baron, Mira, additional, De La Cruz, Luis, additional, Gay, Cynthia, additional, Kalams, Spyros, additional, Kelley, Colleen F., additional, Kutner, Mark, additional, Andrasik, Michele P., additional, Kublin, James G., additional, Corey, Lawrence, additional, Neuzil, Kathleen M., additional, Carpp, Lindsay N., additional, Pajon, Rolando, additional, Follmann, Dean, additional, Donis, Ruben O., additional, and Koup, Richard A., additional
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- 2021
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8. Comparing antibody assays as correlates of protection against COVID-19 in the COVE mRNA-1273 vaccine efficacy trial
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Benkeser, David, Montefiori, David C., McDermott, Adrian B., Fong, Youyi, Janes, Holly E., Deng, Weiping, Zhou, Honghong, Houchens, Christopher R., Martins, Karen, Jayashankar, Lakshmi, Castellino, Flora, Flach, Britta, Lin, Bob C., O’Connell, Sarah, McDanal, Charlene, Eaton, Amanda, Sarzotti-Kelsoe, Marcella, Lu, Yiwen, Yu, Chenchen, Borate, Bhavesh, van der Laan, Lars W. P., Hejazi, Nima S., Kenny, Avi, Carone, Marco, Williamson, Brian D., Garver, Jennifer, Altonen, Erin, Rudge, Thomas, Huynh, Chuong, Miller, Jacqueline, El Sahly, Hana M., Baden, Lindsey R., Frey, Sharon, Malkin, Elissa, Spector, Stephen A., Andrasik, Michele P., Kublin, James G., Corey, Lawrence, Neuzil, Kathleen M., Carpp, Lindsay N., Pajon, Rolando, Follmann, Dean, Donis, Ruben O., Koup, Richard A., and Gilbert, Peter B.
- Abstract
The best assay or marker to define mRNA-1273 vaccine–induced antibodies as a correlate of protection (CoP) is unclear. In the COVE trial, participants received two doses of the mRNA-1273 COVID-19 vaccine or placebo. We previously assessed IgG binding antibodies to the spike protein (spike IgG) or receptor binding domain (RBD IgG) and pseudovirus neutralizing antibody 50 or 80% inhibitory dilution titer measured on day 29 or day 57, as correlates of risk (CoRs) and CoPs against symptomatic COVID-19 over 4 months after dose. Here, we assessed a new marker, live virus 50% microneutralization titer (LV-MN50), and compared and combined markers in multivariable analyses. LV-MN50was an inverse CoR, with a hazard ratio of 0.39 (95% confidence interval, 0.19 to 0.83) at day 29 and 0.51 (95% confidence interval, 0.25 to 1.04) at day 57 per 10-fold increase. In multivariable analyses, pseudovirus neutralization titers and anti-spike binding antibodies performed best as CoRs; combining antibody markers did not improve correlates. Pseudovirus neutralization titer was the strongest independent correlate in a multivariable model. Overall, these results supported pseudovirus neutralizing and binding antibody assays as CoRs and CoPs, with the live virus assay as a weaker correlate in this sample set. Day 29 markers performed as well as day 57 markers as CoPs, which could accelerate immunogenicity and immunobridging studies.
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- 2023
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9. Immune Correlates Analysis of a Single Ad26.COV2.S Dose in the ENSEMBLE COVID-19 Vaccine Efficacy Clinical Trial.
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Fong Y, McDermott AB, Benkeser D, Roels S, Stieh DJ, Vandebosch A, Gars ML, Van Roey GA, Houchens CR, Martins K, Jayashankar L, Castellino F, Amoa-Awua O, Basappa M, Flach B, Lin BC, Moore C, Naisan M, Naqvi M, Narpala S, O'Connell S, Mueller A, Serebryannyy L, Castro M, Wang J, Petropoulos CJ, Luedtke A, Hyrien O, Lu Y, Yu C, Borate B, van der Laan LWP, Hejazi NS, Kenny A, Carone M, Wolfe DN, Sadoff J, Gray GE, Grinsztejn B, Goepfert PA, Little SJ, de Sousa LP, Maboa R, Randhawa AK, Andrasik MP, Hendriks J, Truyers C, Struyf F, Schuitemaker H, Douoguih M, Kublin JG, Corey L, Neuzil KM, Carpp LN, Follmann D, Gilbert PB, Koup RA, and Donis RO
- Abstract
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 through 83 days post-vaccination and as correlates of protection following a single dose of Ad26.COV2.S COVID-19 vaccine in the placebo-controlled phase of ENSEMBLE, an international, randomized efficacy trial. Each marker had evidence as a correlate of risk and of protection, with strongest evidence for 50% inhibitory dilution (ID50) neutralizing antibody titer. The outcome hazard ratio was 0.49 (95% confidence interval 0.29, 0.81; p=0.006) per 10-fold increase in ID50; vaccine efficacy was 60% (43, 72%) at nonquantifiable ID50 (< 2.7 IU50/ml) and rose to 89% (78, 96%) at ID50 = 96.3 IU50/ml. Comparison of the vaccine efficacy by ID50 titer curves for ENSEMBLE-US, the COVE trial of the mRNA-1273 vaccine, and the COV002-UK trial of the AZD1222 vaccine supported consistency of the ID50 titer correlate of protection across trials and vaccine types.
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- 2022
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10. Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial.
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Gilbert PB, Montefiori DC, McDermott AB, Fong Y, Benkeser D, Deng W, Zhou H, Houchens CR, Martins K, Jayashankar L, Castellino F, Flach B, Lin BC, O'Connell S, McDanal C, Eaton A, Sarzotti-Kelsoe M, Lu Y, Yu C, Borate B, van der Laan LWP, Hejazi NS, Huynh C, Miller J, El Sahly HM, Baden LR, Baron M, De La Cruz L, Gay C, Kalams S, Kelley CF, Andrasik MP, Kublin JG, Corey L, Neuzil KM, Carpp LN, Pajon R, Follmann D, Donis RO, and Koup RA
- Subjects
- Adolescent, Adult, Aged, Antibodies, Neutralizing immunology, Antibodies, Viral immunology, Clinical Trials, Phase III as Topic, Female, Humans, Immunogenicity, Vaccine, Male, Middle Aged, Randomized Controlled Trials as Topic, Sensitivity and Specificity, Spike Glycoprotein, Coronavirus immunology, Young Adult, 2019-nCoV Vaccine mRNA-1273 immunology, Antibodies, Neutralizing blood, Antibodies, Viral blood, COVID-19 prevention & control, SARS-CoV-2 immunology, Vaccine Efficacy
- Abstract
In the coronavirus efficacy (COVE) phase 3 clinical trial, vaccine recipients were assessed for neutralizing and binding antibodies as correlates of risk for COVID-19 disease and as correlates of protection. These immune markers were measured at the time of second vaccination and 4 weeks later, with values reported in standardized World Health Organization international units. All markers were inversely associated with COVID-19 risk and directly associated with vaccine efficacy. Vaccine recipients with postvaccination 50% neutralization titers 10, 100, and 1000 had estimated vaccine efficacies of 78% (95% confidence interval, 54 to 89%), 91% (87 to 94%), and 96% (94 to 98%), respectively. These results help define immune marker correlates of protection and may guide approval decisions for messenger RNA (mRNA) COVID-19 vaccines and other COVID-19 vaccines.
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- 2022
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11. Immune Correlates Analysis of the mRNA-1273 COVID-19 Vaccine Efficacy Trial.
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Gilbert PB, Montefiori DC, McDermott A, Fong Y, Benkeser D, Deng W, Zhou H, Houchens CR, Martins K, Jayashankar L, Castellino F, Flach B, Lin BC, O'Connell S, McDanal C, Eaton A, Sarzotti-Kelsoe M, Lu Y, Yu C, Borate B, van der Laan LWP, Hejazi N, Huynh C, Miller J, El Sahly HM, Baden LR, Baron M, De La Cruz L, Gay C, Kalams S, Kelley CF, Kutner M, Andrasik MP, Kublin JG, Corey L, Neuzil KM, Carpp LN, Pajon R, Follmann D, Donis RO, and Koup RA
- Abstract
Background: In the Coronavirus Efficacy (COVE) trial, estimated mRNA-1273 vaccine efficacy against coronavirus disease-19 (COVID-19) was 94%. SARS-CoV-2 antibody measurements were assessed as correlates of COVID-19 risk and as correlates of protection., Methods: Through case-cohort sampling, participants were selected for measurement of four serum antibody markers at Day 1 (first dose), Day 29 (second dose), and Day 57: IgG binding antibodies (bAbs) to Spike, bAbs to Spike receptor-binding domain (RBD), and 50% and 80% inhibitory dilution pseudovirus neutralizing antibody titers calibrated to the WHO International Standard (cID50 and cID80). Participants with no evidence of previous SARS-CoV-2 infection were included. Cox regression assessed in vaccine recipients the association of each Day 29 or 57 serologic marker with COVID-19 through 126 or 100 days of follow-up, respectively, adjusting for risk factors., Results: Day 57 Spike IgG, RBD IgG, cID50, and cID80 neutralization levels were each inversely correlated with risk of COVID-19: hazard ratios 0.66 (95% CI 0.50, 0.88; p=0.005); 0.57 (0.40, 0.82; p=0.002); 0.42 (0.27, 0.65; p<0.001); 0.35 (0.20, 0.61; p<0.001) per 10-fold increase in marker level, respectively, multiplicity adjusted P-values 0.003-0.010. Results were similar for Day 29 markers (multiplicity adjusted P-values <0.001-0.003). For vaccine recipients with Day 57 reciprocal cID50 neutralization titers that were undetectable (<2.42), 100, or 1000, respectively, cumulative incidence of COVID-19 through 100 days post Day 57 was 0.030 (0.010, 0.093), 0.0056 (0.0039, 0.0080), and 0.0023 (0.0013, 0.0036). For vaccine recipients at these titer levels, respectively, vaccine efficacy was 50.8% (-51.2, 83.0%), 90.7% (86.7, 93.6%), and 96.1% (94.0, 97.8%). Causal mediation analysis estimated that the proportion of vaccine efficacy mediated through Day 29 cID50 titer was 68.5% (58.5, 78.4%)., Conclusions: Binding and neutralizing antibodies correlated with COVID-19 risk and vaccine efficacy and likely have utility in predicting mRNA-1273 vaccine efficacy against COVID-19., Trial Registration Number: COVE ClinicalTrials.gov number, NCT04470427.
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- 2021
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