scholarly journals Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial

Science ◽  
2022 ◽  
Vol 375 (6576) ◽  
pp. 43-50
Author(s):  
Peter B. Gilbert ◽  
David C. Montefiori ◽  
Adrian B. McDermott ◽  
Youyi Fong ◽  
David Benkeser ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Vaccine Efficacy ◽  
Immune Correlates

scholarly journals Quantifying the Impact of Natural Immunity on Rotavirus Vaccine Efficacy Estimates: A Clinical Trial in Dhaka, Bangladesh (PROVIDE) and a Simulation Study

2018 ◽  
Vol 217 (6) ◽  
pp. 861-868 ◽  
Author(s):  
Elizabeth T Rogawski ◽  
James A Platts-Mills ◽  
E Ross Colgate ◽  
Rashidul Haque ◽  
K Zaman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Simulation Study ◽  
Vaccine Efficacy ◽  
Natural Immunity ◽  
Rotavirus Vaccine ◽  
The Impact

scholarly journals Correlates of Protection against Influenza in the Elderly: Results from an Influenza Vaccine Efficacy Trial

2016 ◽  
Vol 23 (3) ◽  
pp. 228-235 ◽  
Author(s):  
Andrew J. Dunning ◽  
Carlos A. DiazGranados ◽  
Timothy Voloshen ◽  
Branda Hu ◽  
Victoria A. Landolfi ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
Vaccine Efficacy ◽  
Standard Dose ◽  
The Elderly ◽  
High Dose ◽  
Efficacy Trial ◽  
Correlates Of Protection ◽  
Immune Correlates ◽  
Immunologic Assays ◽  
Dose Vaccine

ABSTRACTAlthough a number of studies have investigated and quantified immune correlates of protection against influenza in adults and children, data on immune protection in the elderly are sparse. A recent vaccine efficacy trial comparing standard-dose with high-dose inactivated influenza vaccine in persons 65 years of age and older provided the opportunity to examine the relationship between values of three immunologic assays and protection against community-acquired A/H3N2 influenza illness. The high-dose vaccine induced significantly higher antibody titers than the standard-dose vaccine for all assays. For the hemagglutination inhibition assay, a titer of 40 was found to correspond with 50% protection when the assay virus was antigenically well matched to the circulating virus—the same titer as is generally recognized for 50% protection in younger adults. A dramatically higher titer was required for 50% protection when the assay virus was a poor match to the circulating virus. With the well-matched virus, some protection was seen at the lowest titers; with the poorly matched virus, high levels of protection were not achieved even at the highest titers. Strong associations were also seen between virus neutralization test titers and protection, but reliable estimates for 50% protection were not obtained. An association was seen between titers of an enzyme-linked lectin assay for antineuraminidase N2 antibodies and protection; in particular, the proportion of treatment effect explained by assay titer in models that included both this assay and one of the other assays was consistently higher than in models that included either assay alone. (This study has been registered at ClinicalTrials.gov under registration no. NCT01427309.)

scholarly journals Complex immune correlates of protection in HIV-1 vaccine efficacy trials

2017 ◽  
Vol 275 (1) ◽  
pp. 245-261 ◽  
Author(s):  
Georgia D. Tomaras ◽  
Stanley A. Plotkin
Keyword(s):  
Vaccine Efficacy ◽  
Correlates Of Protection ◽  
Immune Correlates ◽  
Efficacy Trials ◽  
Hiv 1

Immune Correlates Identified in the RV144 Vaccine Efficacy Trial Impact HIV-1 Acquisition Only in the Presence of Certain HLA Class II Genes

2014 ◽  
Vol 30 (S1) ◽  
pp. A40-A40
Author(s):  
Heather Prentice ◽  
Daniel Geraghty ◽  
Georgia D. Tomaras ◽  
Youyi Fong ◽  
Wyatt Nelson ◽  
...  
Keyword(s):  
Vaccine Efficacy ◽  
Class Ii ◽  
Hla Class Ii ◽  
Efficacy Trial ◽  
Immune Correlates ◽  
Hiv 1 ◽  
Rv144 Vaccine

Adjuvant nivolumab in high-risk stage IIb/IIc melanoma patients: Results from investigator initiated clinical trial.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9583-9583
Author(s):  
Melissa Wilson ◽  
Larisa J. Geskin ◽  
Richard D. Carvajal ◽  
Janice M. Mehnert ◽  
Cody Chiuzan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Overall Survival ◽  
High Risk ◽  
Adverse Events ◽  
High Dose ◽  
Serious Adverse Events ◽  
Free Survival ◽  
Immune Correlates ◽  
Melanoma Patients

9583 Background: Recent studies have shown 5-yr recurrence rates for Stage IIB and IIC melanoma of up to 46%. These high-risk patients currently have few options for adjuvant therapy to prevent this inevitable recurrence, with the only FDA approved therapy being high-dose interferon-alfa, which is quite toxic. However, there are now immunotherapies (anti-PD1) and targeted therapies (anti-BRAF and anti-MEK combinations) which are approved as adjuvants for Stage III patients, some of whom will have a lower baseline recurrence risk than those with Stage IIB/IIC melanoma. We sought to determine if adjuvant PD1 inhibition with nivolumab (N) would improve the recurrence free survival (RFS) compared to historical RFS rates. Methods: Our study (NCT03405155) is a single-arm, open label, multi-center, phase 2 clinical trial evaluating RFS at 24 months in patients with Stage IIB/IIC melanoma on treatment with N at 480 mg IV every 4 weeks for 12 cycles. Overall survival is a secondary endpoint. Associated translational research includes circulating tumor cell DNA and immune correlates. Results: Twenty three patients with Stage IIB and three patients with Stage IIC melanoma were enrolled onto the study and received at least one dose of N. At data cutoff, 22 patients remain in follow up, as four patients withdrew consent at different time points in the study – one patient after one dose who wished to discontinue, one due to concern for COVID and need for repeat visits, one due to insurance issues, and one due to recurrence and wish to discontinue (which was captured in study data and RFS calculations). Seventeen patients have been on the clinical trial for at least two years with nine patients having finished treatment but with less than two years follow-up; the median follow-up is currently 21.9 months. Two patients demonstrated melanoma recurrence, one after receiving cycle six of N and another one year after completing treatment, resulting in a 87.8% RFS (90% CI (64.2%-96.3%) at 2 years, compared to the historical RFS at 2 years of 70%. No N related serious adverse events (SAEs) were observed, with only 2% Grade 3 AEs observed (varied and unrelated to treatment) and all others were Grade 1-2, including 21% GI, 18% cutaneous, and 10% musculoskeletal, respiratory, and fatigue, each; overall, 2% of these Grade 1-2 AEs were treatment related. Conclusions: Our preliminary results show a trend towards improved RFS in patients with Stage IIB/IIC melanoma treated with nivolumab. The cohort has not reached a minimum follow up of at least 2 years for RFS; patients are continuing to be monitored. On study, we observed the expected adverse events, without evidence of new toxicities. Data maturation will reveal the full effect of adjuvant N on disease relapse and overall survival and distant metastasis-free survival in stage IIB/IIC melanoma patients. Clinical trial information: NCT03405155.

scholarly journals Discerning an Effective Balance between Equine Infectious Anemia Virus Attenuation and Vaccine Efficacy

2005 ◽  
Vol 79 (5) ◽  
pp. 2666-2677 ◽  
Author(s):  
Jodi K. Craigo ◽  
Feng Li ◽  
Jonathan D. Steckbeck ◽  
Shannon Durkin ◽  
Laryssa Howe ◽  
...  
Keyword(s):  
Vaccine Efficacy ◽  
Equine Infectious Anemia Virus ◽  
Protective Efficacy ◽  
Accessory Gene ◽  
Live Attenuated Vaccine ◽  
Virus Challenge ◽  
Proviral Clone ◽  
Immune Correlates ◽  
Equine Infectious Anemia ◽  
Anemia Virus

ABSTRACT Among the diverse experimental vaccines evaluated in various animal lentivirus models, live attenuated vaccines have proven to be the most effective, thus providing an important model for examining critical immune correlates of protective vaccine immunity. We previously reported that an experimental live attenuated vaccine for equine infectious anemia virus (EIAV), based on mutation of the viral S2 accessory gene, elicited protection from detectable infection by virulent virus challenge (F. Li et al., J. Virol. 77:7244-7253, 2003). To better understand the critical components of EIAV vaccine efficacy, we examine here the relationship between the extent of virus attenuation, the maturation of host immune responses, and vaccine efficacy in a comparative study of three related attenuated EIAV proviral vaccine strains: the previously described EIAVUKΔS2 derived from a virulent proviral clone, EIAVUKΔS2/DU containing a second gene mutation in the virulent proviral clone, and EIAVPRΔS2 derived from a reference avirulent proviral clone. Inoculations of parallel groups of eight horses resulted in relatively low levels of viral replication (average of 102 to 103 RNA copies/ml) and a similar maturation of EIAV envelope-specific antibody responses as determined in quantitative and qualitative serological assays. However, experimental challenge of the experimentally immunized horses by our standard virulent EIAVPV strain by using a low-dose multiple exposure protocol (three inoculations with 10 median horse infective doses, administered intravenously) revealed a marked difference in the protective efficacy of the various attenuated proviral vaccine strains that was evidently associated with the extent of vaccine virus attenuation, time of viral challenge, and the apparent maturation of virus-specific immunity.

Sign in / Sign up

Export Citation Format

Share Document