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  • 1
    In: Science, American Association for the Advancement of Science (AAAS), Vol. 373, No. 6561 ( 2021-09-17), p. 1372-1377
    Abstract: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mutations may diminish vaccine-induced protective immune responses, particularly as antibody titers wane over time. Here, we assess the effect of SARS-CoV-2 variants B.1.1.7 (Alpha), B.1.351 (Beta), P.1 (Gamma), B.1.429 (Epsilon), B.1.526 (Iota), and B.1.617.2 (Delta) on binding, neutralizing, and angiotensin-converting enzyme 2 (ACE2)–competing antibodies elicited by the messenger RNA (mRNA) vaccine mRNA-1273 over 7 months. Cross-reactive neutralizing responses were rare after a single dose. At the peak of response to the second vaccine dose, all individuals had responses to all variants. Binding and functional antibodies against variants persisted in most subjects, albeit at low levels, for 6 months after the primary series of the mRNA-1273 vaccine. Across all assays, B.1.351 had the lowest antibody recognition. These data complement ongoing studies to inform the potential need for additional boost vaccinations.
    Type of Medium: Online Resource
    ISSN: 0036-8075 , 1095-9203
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    Language: English
    Publisher: American Association for the Advancement of Science (AAAS)
    Publication Date: 2021
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  • 2
    In: eBioMedicine, Elsevier BV, Vol. 96 ( 2023-10), p. 104799-
    Type of Medium: Online Resource
    ISSN: 2352-3964
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2023
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  • 3
    In: The Journal of Infectious Diseases, Oxford University Press (OUP), ( 2023-08-10)
    Abstract: We compared the serologic responses of 1 dose versus 2 doses of a variant vaccine (Moderna mRNA-1273 Beta/Omicron BA.1 bivalent vaccine) in adults. A 2-dose boosting regimen with a variant vaccine did not increase the magnitude or the durability of the serological responses compared to a single variant vaccine boost.
    Type of Medium: Online Resource
    ISSN: 0022-1899 , 1537-6613
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    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2023
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  • 4
    In: Nature Medicine, Springer Science and Business Media LLC, Vol. 29, No. 9 ( 2023-09), p. 2334-2346
    Abstract: Vaccine protection against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection wanes over time, requiring updated boosters. In a phase 2, open-label, randomized clinical trial with sequentially enrolled stages at 22 US sites, we assessed safety and immunogenicity of a second boost with monovalent or bivalent variant vaccines from mRNA and protein-based platforms targeting wild-type, Beta, Delta and Omicron BA.1 spike antigens. The primary outcome was pseudovirus neutralization titers at 50% inhibitory dilution (ID 50 titers) with 95% confidence intervals against different SARS-CoV-2 strains. The secondary outcome assessed safety by solicited local and systemic adverse events (AEs), unsolicited AEs, serious AEs and AEs of special interest. Boosting with prototype/wild-type vaccines produced numerically lower ID 50 titers than any variant-containing vaccine against all variants. Conversely, boosting with a variant vaccine excluding prototype was not associated with decreased neutralization against D614G. Omicron BA.1 or Beta monovalent vaccines were nearly equivalent to Omicron BA.1 + prototype or Beta + prototype bivalent vaccines for neutralization of Beta, Omicron BA.1 and Omicron BA.4/5, although they were lower for contemporaneous Omicron subvariants. Safety was similar across arms and stages and comparable to previous reports. Our study shows that updated vaccines targeting Beta or Omicron BA.1 provide broadly crossprotective neutralizing antibody responses against diverse SARS-CoV-2 variants without sacrificing immunity to the ancestral strain. ClinicalTrials.gov registration: NCT05289037 .
    Type of Medium: Online Resource
    ISSN: 1078-8956 , 1546-170X
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2023
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  • 5
    In: Cell Reports Medicine, Elsevier BV, Vol. 3, No. 7 ( 2022-07), p. 100679-
    Type of Medium: Online Resource
    ISSN: 2666-3791
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2022
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  • 6
    In: npj Vaccines, Springer Science and Business Media LLC, Vol. 8, No. 1 ( 2023-07-11)
    Abstract: As part of a multicenter study evaluating homologous and heterologous COVID-19 booster vaccines, we assessed the magnitude, breadth, and short-term durability of binding and pseudovirus-neutralizing antibody (PsVNA) responses following a single booster dose of NVX-CoV2373 in adults primed with either Ad26.COV2.S, mRNA-1273, or BNT162b2 vaccines. NVX-CoV2373 as a heterologous booster was immunogenic and associated with no safety concerns through Day 91. Fold-rises in PsVNA titers from baseline (Day 1) to Day 29 were highest for prototypic D614G variant and lowest for more recent Omicron sub-lineages BQ.1.1 and XBB.1. Peak humoral responses against all SARS-CoV-2 variants were lower in those primed with Ad26.COV2.S than with mRNA vaccines. Prior SARS CoV-2 infection was associated with substantially higher baseline PsVNA titers, which remained elevated relative to previously uninfected participants through Day 91. These data support the use of heterologous protein-based booster vaccines as an acceptable alternative to mRNA or adenoviral-based COVID-19 booster vaccines. This trial was conducted under ClinicalTrials.gov: NCT04889209.
    Type of Medium: Online Resource
    ISSN: 2059-0105
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2023
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  • 7
    In: Clinical Infectious Diseases, Oxford University Press (OUP), ( 2024-03-27)
    Abstract: A surge of human influenza A(H7N9) cases began in 2016 in China from an antigenically distinct lineage. Data are needed about the safety and immunogenicity of 2013 and 2017 A(H7N9) inactivated influenza vaccines (IIVs) and the effects of AS03 adjuvant, prime-boost interval, and priming effects of 2013 and 2017 A(H7N9) IIVs. Methods Healthy adults (n = 180), ages 19–50 years, were enrolled into this partially blinded, randomized, multicenter phase 2 clinical trial. Participants were randomly assigned to 1 of 6 vaccination groups evaluating homologous versus heterologous prime-boost strategies with 2 different boost intervals (21 vs 120 days) and 2 dosages (3.75 or 15 μg of hemagglutinin) administered with or without AS03 adjuvant. Reactogenicity, safety, and immunogenicity measured by hemagglutination inhibition and neutralizing antibody titers were assessed. Results Two doses of A(H7N9) IIV were well tolerated, and no safety issues were identified. Although most participants had injection site and systemic reactogenicity, these symptoms were mostly mild to moderate in severity; injection site reactogenicity was greater in vaccination groups receiving adjuvant. Immune responses were greater after an adjuvanted second dose, and with a longer interval between prime and boost. The highest hemagglutination inhibition geometric mean titer (95% confidence interval) observed against the 2017 A(H7N9) strain was 133.4 (83.6–212.6) among participants who received homologous, adjuvanted 3.75 µg + AS03/2017 doses with delayed boost interval. Conclusions Administering AS03 adjuvant with the second H7N9 IIV dose and extending the boost interval to 4 months resulted in higher peak antibody responses. These observations can broadly inform strategic approaches for pandemic preparedness. Clinical Trials Registration. NCT03589807.
    Type of Medium: Online Resource
    ISSN: 1058-4838 , 1537-6591
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    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2024
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  • 8
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 9, No. Supplement_2 ( 2022-12-15)
    Abstract: Studies show that past SARS-CoV-2 infection provides a protective immune response against subsequent COVID-19, but the degree of protection from prior infection has not been determined. History of previous SARS-COV-2 Infection and Current SARS-COV-2 Infection Status at Admission. *Adjusted for chronic respiratory disease and prior COVID-19 vaccination Methods From May 2021 through Feb 2022, adults (≥ 18 years of age) hospitalized at Emory University Hospital and Emory University Hospital Midtown with acute respiratory infection (ARI) symptoms, who were PCR tested for SARS-CoV-2 were enrolled. A prior history of SARS-CoV-2 infection was obtained from patient interview and medical record review. Previous infection was defined as a self-reported prior SARS-CoV-2 infection or previous evidence of a positive SARS-CoV-2 PCR test ≥ 90 days before ARI hospital admission. We performed a test negative design to evaluate the protection provided by prior SARS-CoV-2 infection against subsequent COVID-19-related hospitalization. Effectiveness was determined using logistic regression analysis adjusted for patient sociodemographic and clinical characteristics and COVID-19 vaccination status. Results Of 1152 adults hospitalized for ARI, 704/1152 (61%) were SARS-CoV-2 positive. 96/1152 (8%) had a prior SARS-CoV-2 infection before hospital admission. Patients with a previous history of SARS-CoV-2 infection were less likely to test positive for SARS-CoV-2 upon admission for ARI compared to those who did not have evidence of prior infection (31/96 [32%] vs 673/1056 [64%] ; adjusted OR: 0.25 [0.15, 0.41] (Table). Conclusion Reinfections represented a small proportion ( & lt; 10%) of COVID-19-related hospitalizations. Prior SARS-CoV-2 infection provided meaningful protection against subsequent COVID-19-related hospitalization. The durability of this infection-induced immunity, variant-specific estimates, and the additive impact of vaccination are needed to further elucidate these findings. Disclosures Laura A. Puzniak, PhD. MPH, Merck & Co., Inc.: Stocks/Bonds|Pfizer, Inc.: Stocks/Bonds Robin Hubler, MS, Pfizer Inc.: Employee|Pfizer Inc.: Stocks/Bonds Srinivas Valluri, PhD, Pfizer: Employee|Pfizer: Stocks/Bonds Benjamin Lopman, PhD, Epidemiological Research and Methods, LLC: Advisor/Consultant Satoshi Kamidani, MD, NIH: His institution (Emory University) receives funds from Pfizer for his work as a co-investigator on clinical trials of Pfizer COVID-19 vaccine.|Pfizer: His institution (Emory University) receives funds from Pfizer for his work as a co-investigator on clinical trials of Pfizer COVID-19 vaccine. Christina A. Rostad, MD, BioFire Inc, GSK, MedImmune, Micron, Merck, Novavax, PaxVax, Pfizer, Regeneron, Sanofi-Pasteur.: Grant/Research Support|Meissa Vaccines, Inc.: Co-inventor of RSV vaccine technology licensed to Meissa Vaccines, Inc.|NIH (Funding from NIH to conduct clinical trials of Moderna and Janssen COVID-19 vaccines): Grant/Research Support John M. McLaughlin, PhD, Pfizer: Employee|Pfizer: Stocks/Bonds Evan J. Anderson, MD, GSK: Advisor/Consultant|GSK: Grant/Research Support|Janssen: Advisor/Consultant|Janssen: Grant/Research Support|Kentucky Bioprocessing, Inc: Data Safety Monitoring Board|MedImmune: Grant/Research Support|Medscape: Advisor/Consultant|Merck: Grant/Research Support|Micron: Grant/Research Support|NIH: Funding from NIH to conduct clinical trials of Moderna and Janssen COVID-19 vaccines|PaxVax: Grant/Research Support|Pfizer: Advisor/Consultant|Pfizer: Grant/Research Support|Regeneron: Grant/Research Support|Sanofi Pasteur: Advisor/Consultant|Sanofi Pasteur: Grant/Research Support|Sanofi Pasteur: Data Adjudication and Data Safety Monitoring Boards|WCG and ACI Clinical: Data Adjudication Board.
    Type of Medium: Online Resource
    ISSN: 2328-8957
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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  • 9
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 9, No. Supplement_2 ( 2022-12-15)
    Abstract: Whether receipt of COVID-19 vaccine associates with receipt of other routinely-recommended adult vaccines such as, influenza and pneumococcal vaccines is not well described. We evaluated this relationship in a population of adults who were hospitalized for acute respiratory infection (ARI). *Odds ratio describing odds of receiving at least one COVID-19 vaccine (vs not) by influenza vaccination status adjusted for race, employment status, chronic cardiac diseases, cancer, solid organ transplant, and chronic kidney disease.**Odds ratio describing odds of receiving at least one COVID-19 vaccine (vs not) by pneumococcal vaccination status adjusted for race and chronic kidney disease. Methods We enrolled adults (≥ 18 years of age) who were hospitalized at Emory University Hospital and Emory University Hospital Midtown with symptoms consistent with ARI. Participants were interviewed and medical records abstracted to gather demographic information, including social behaviors during the pandemic, medical history, and prior vaccination history (i.e., COVID-19, influenza, and pneumococcal). Using two separate logistic regression analyses, we determined the association between i) receipt of influenza vaccine in the prior year among adults ≥ 18 years and ii) receipt of any pneumococcal vaccine in the prior 5 years among adults ≥ 65 years on the receipt of at least one COVID-19 vaccine≥ 14 days prior to admission. Adjusted models included demographic information (e.g., age, sex, race/ethnicity, employment status), social behaviors, and history of chronic medical conditions. Results Overall, 1056 participants were enrolled and had vaccination records available. Of whom, 509/1056 (48.2%) had received at least one dose of COVID-19 vaccine. Adults ≥ 18 years who received influenza vaccine were more likely to have received ≥1 dose of COVID-19 vaccine compared to those who did not (267/373 [71.6%] vs 242/683 [35.4%] P= & lt; .0001; adjusted odds ratio [OR]: 3.3 [95%CI: 2.4, 4.4] ). Similarly, adults ≥65 years who received pneumococcal vaccine were more likely to have received ≥ 1 dose of COVID-19 vaccine compared to those who did not (195/257 [75.9%] vs 41/84 [48.8%] P= & lt; .0001; adjusted odds ratio [OR]: 3.0 [95%CI: 1.8, 5.1] ). Conclusion In this study of adults hospitalized for ARI, receipt of influenza and pneumococcal vaccination strongly correlated with receipt of COVID-19 vaccination. Continued efforts are needed to reach adults who remain hesitant to not only receive COVID-19 vaccines, but also other vaccines that lessen the burden of respiratory illness. Disclosures Laura A. Puzniak, PhD. MPH, Merck & Co., Inc.: Stocks/Bonds|Pfizer, Inc.: Stocks/Bonds Robin Hubler, MS, Pfizer Inc.: Employee|Pfizer Inc.: Stocks/Bonds Srinivas Valluri, PhD, Pfizer: Employee|Pfizer: Stocks/Bonds Benjamin Lopman, PhD, Epidemiological Research and Methods, LLC: Advisor/Consultant Satoshi Kamidani, MD, NIH: His institution (Emory University) receives funds from Pfizer for his work as a co-investigator on clinical trials of Pfizer COVID-19 vaccine.|Pfizer: His institution (Emory University) receives funds from Pfizer for his work as a co-investigator on clinical trials of Pfizer COVID-19 vaccine. Christina A. Rostad, MD, BioFire Inc, GSK, MedImmune, Micron, Merck, Novavax, PaxVax, Pfizer, Regeneron, Sanofi-Pasteur.: Grant/Research Support|Meissa Vaccines, Inc.: Co-inventor of RSV vaccine technology licensed to Meissa Vaccines, Inc.|NIH (Funding from NIH to conduct clinical trials of Moderna and Janssen COVID-19 vaccines): Grant/Research Support John M. McLaughlin, PhD, Pfizer: Employee|Pfizer: Stocks/Bonds Evan J. Anderson, MD, GSK: Advisor/Consultant|GSK: Grant/Research Support|Janssen: Advisor/Consultant|Janssen: Grant/Research Support|Kentucky Bioprocessing, Inc: Data Safety Monitoring Board|MedImmune: Grant/Research Support|Medscape: Advisor/Consultant|Merck: Grant/Research Support|Micron: Grant/Research Support|NIH: Funding from NIH to conduct clinical trials of Moderna and Janssen COVID-19 vaccines|PaxVax: Grant/Research Support|Pfizer: Advisor/Consultant|Pfizer: Grant/Research Support|Regeneron: Grant/Research Support|Sanofi Pasteur: Advisor/Consultant|Sanofi Pasteur: Grant/Research Support|Sanofi Pasteur: Data Adjudication and Data Safety Monitoring Boards|WCG and ACI Clinical: Data Adjudication Board.
    Type of Medium: Online Resource
    ISSN: 2328-8957
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
    detail.hit.zdb_id: 2757767-3
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  • 10
    In: Open Forum Infectious Diseases, Oxford University Press (OUP), Vol. 9, No. Supplement_2 ( 2022-12-15)
    Abstract: During the COVID-19 pandemic, social interventions such as social distancing and mask wearing have been encouraged. Social risk factors for SARS-CoV-2 infection and subsequent hospitalization remain uncertain. Methods Adult patients were eligible if admitted to Emory University Hospital or Emory University Hospital Midtown with acute respiratory infection (ARI) symptoms (≤ 14 days) or an admitting ARI diagnosis from May 2021 – Feb 2022. After enrollment, an in-depth interview identified demographic and social factors (e.g., employment status, smoking history, alcohol use), household characteristics, and pandemic social behaviors. All patients were tested for SARS-CoV-2 using PCR. We evaluated whether these demographic and social factors were related to a positive SARS-CoV-2 test upon admission to hospital with ARI using a logistic regression model. Results 1141 subjects were enrolled and had SARS-CoV-2 PCR results available (700 positive and 441 negative). The median age was greater in the SARS-CoV-2 negative cohort than in the positive cohort (60 and 53 years, respectively; P & lt; .0001). Those who tested positive were more likely to have had at least some college education compared to those who tested negative (64.3% vs 52.3%, P & lt; .0001; adjusted odds ratio [aOR]: 1.4 [95%CI: 1.1, 2.0] ). Compared to those who tested negative, those who were SARS-CoV-2 positive were also more likely to be employed (48.9% vs 26.5%, P & lt; .0001; aOR: 1.7 [95%CI: 1.1, 2.3]), have children 5-17 yo at home (27.6% vs 17.9%, P=.0002; aOR: 1.5 [95%CI: 1.1, 2.1] ). Those with COVID-19 were less likely to receive home healthcare (6.2% vs 13.3%, P & lt; .0001; aOR: 0.5 [95%CI: 0.4, 0.9]) and to be a current or previous smoker (7.6% vs 17.7%, P & lt; .0001; aOR: 0.3 [95%CI: 0.2, 0.5]). Conclusion Among adults admitted to the hospital for ARI, those who tested positive for SARS-CoV-2 were typically younger, more likely to care for school-aged children, more likely to work outside the home, but were less likely to receive home healthcare or smoke. Personal and public health strategies to mitigate COVID-19 should take into consideration modifiable social risk factors. Disclosures Laura A. Puzniak, PhD. MPH, Merck & Co., Inc.: Stocks/Bonds|Pfizer, Inc.: Stocks/Bonds Robin Hubler, MS, Pfizer Inc.: Employee|Pfizer Inc.: Stocks/Bonds Srinivas Valluri, PhD, Pfizer: Employee|Pfizer: Stocks/Bonds Benjamin Lopman, PhD, Epidemiological Research and Methods, LLC: Advisor/Consultant Satoshi Kamidani, MD, NIH: His institution (Emory University) receives funds from Pfizer for his work as a co-investigator on clinical trials of Pfizer COVID-19 vaccine.|Pfizer: His institution (Emory University) receives funds from Pfizer for his work as a co-investigator on clinical trials of Pfizer COVID-19 vaccine. Christina A. Rostad, MD, BioFire Inc, GSK, MedImmune, Micron, Merck, Novavax, PaxVax, Pfizer, Regeneron, Sanofi-Pasteur.: Grant/Research Support|Meissa Vaccines, Inc.: Co-inventor of RSV vaccine technology licensed to Meissa Vaccines, Inc.|NIH (Funding from NIH to conduct clinical trials of Moderna and Janssen COVID-19 vaccines): Grant/Research Support John M. McLaughlin, PhD, Pfizer: Employee|Pfizer: Stocks/Bonds Evan J. Anderson, MD, GSK: Advisor/Consultant|GSK: Grant/Research Support|Janssen: Advisor/Consultant|Janssen: Grant/Research Support|Kentucky Bioprocessing, Inc: Data Safety Monitoring Board|MedImmune: Grant/Research Support|Medscape: Advisor/Consultant|Merck: Grant/Research Support|Micron: Grant/Research Support|NIH: Funding from NIH to conduct clinical trials of Moderna and Janssen COVID-19 vaccines|PaxVax: Grant/Research Support|Pfizer: Advisor/Consultant|Pfizer: Grant/Research Support|Regeneron: Grant/Research Support|Sanofi Pasteur: Advisor/Consultant|Sanofi Pasteur: Grant/Research Support|Sanofi Pasteur: Data Adjudication and Data Safety Monitoring Boards|WCG and ACI Clinical: Data Adjudication Board.
    Type of Medium: Online Resource
    ISSN: 2328-8957
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
    detail.hit.zdb_id: 2757767-3
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