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author Atmar, Robert L.
Lyke, Kirsten E.
Deming, Meagan E.
Jackson, Lisa A.
Branche, Angela R.
El Sahly, Hana M.
Rostad, Christina A.
Martin, Judith M.
Johnston, Christine
Rupp, Richard E.
Mulligan, Mark J.
Brady, Rebecca C.
Frenck, Robert W.
Bäcker, Martín
Kottkamp, Angelica C.
Babu, Tara M.
Rajakumar, Kumaravel
Edupuganti, Srilatha
Dobryzynski, David
Posavad, Christine M.
Archer, Janet I.
Crandon, Sonja
Nayak, Seema U.
Szydlo, Daniel
Zemanek, Jillian
Dominguez Islas, Clara P.
Brown, Elizabeth R.
Suthar, Mehul S.
McElrath, M. Juliana
McDermott, Adrian B.
O’Connell, Sarah E.
Montefiori, David C.
Eaton, Amanda
Neuzil, Kathleen M.
Stephens, David S.
Roberts, Paul C.
Beigel, John H.
author_facet Atmar, Robert L.
Lyke, Kirsten E.
Deming, Meagan E.
Jackson, Lisa A.
Branche, Angela R.
El Sahly, Hana M.
Rostad, Christina A.
Martin, Judith M.
Johnston, Christine
Rupp, Richard E.
Mulligan, Mark J.
Brady, Rebecca C.
Frenck, Robert W.
Bäcker, Martín
Kottkamp, Angelica C.
Babu, Tara M.
Rajakumar, Kumaravel
Edupuganti, Srilatha
Dobryzynski, David
Posavad, Christine M.
Archer, Janet I.
Crandon, Sonja
Nayak, Seema U.
Szydlo, Daniel
Zemanek, Jillian
Dominguez Islas, Clara P.
Brown, Elizabeth R.
Suthar, Mehul S.
McElrath, M. Juliana
McDermott, Adrian B.
O’Connell, Sarah E.
Montefiori, David C.
Eaton, Amanda
Neuzil, Kathleen M.
Stephens, David S.
Roberts, Paul C.
Beigel, John H.
author_sort Atmar, Robert L.
collection PubMed
description BACKGROUND: While Coronavirus disease 2019 (Covid-19) vaccines are highly effective, breakthrough infections are occurring. Booster vaccinations have recently received emergency use authorization (EUA) for certain populations but are restricted to homologous mRNA vaccines. We evaluated homologous and heterologous booster vaccination in persons who had received an EUA Covid-19 vaccine regimen. METHODS: In this phase 1/2 open-label clinical trial conducted at ten U.S. sites, adults who received one of three EUA Covid-19 vaccines at least 12 weeks prior to enrollment and had no reported history of SARS-CoV-2 infection received a booster injection with one of three vaccines (Moderna mRNA-1273 100-μg, Janssen Ad26.COV2.S 5×10(10) virus particles, or Pfizer-BioNTech BNT162b2 30-μg; nine combinations). The primary outcomes were safety, reactogenicity, and humoral immunogenicity on study days 15 and 29. RESULTS: 458 individuals were enrolled: 154 received mRNA-1273, 150 received Ad26.CoV2.S, and 153 received BNT162b2 booster vaccines. Reactogenicity was similar to that reported for the primary series. Injection site pain, malaise, headache, and myalgia occurred in more than half the participants. Booster vaccines increased the neutralizing activity against a D614G pseudovirus (4.2–76-fold) and binding antibody titers (4.6–56-fold) for all combinations; homologous boost increased neutralizing antibody titers 4.2–20-fold whereas heterologous boost increased titers 6.2–76-fold. Day 15 neutralizing and binding antibody titers varied by 28.7-fold and 20.9-fold, respectively, across the nine prime-boost combinations. CONCLUSION: Homologous and heterologous booster vaccinations were well-tolerated and immunogenic in adults who completed a primary Covid-19 vaccine regimen at least 12 weeks earlier.
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spelling pubmed-85280812021-10-21 Heterologous SARS-CoV-2 Booster Vaccinations – Preliminary Report Atmar, Robert L. Lyke, Kirsten E. Deming, Meagan E. Jackson, Lisa A. Branche, Angela R. El Sahly, Hana M. Rostad, Christina A. Martin, Judith M. Johnston, Christine Rupp, Richard E. Mulligan, Mark J. Brady, Rebecca C. Frenck, Robert W. Bäcker, Martín Kottkamp, Angelica C. Babu, Tara M. Rajakumar, Kumaravel Edupuganti, Srilatha Dobryzynski, David Posavad, Christine M. Archer, Janet I. Crandon, Sonja Nayak, Seema U. Szydlo, Daniel Zemanek, Jillian Dominguez Islas, Clara P. Brown, Elizabeth R. Suthar, Mehul S. McElrath, M. Juliana McDermott, Adrian B. O’Connell, Sarah E. Montefiori, David C. Eaton, Amanda Neuzil, Kathleen M. Stephens, David S. Roberts, Paul C. Beigel, John H. medRxiv Article BACKGROUND: While Coronavirus disease 2019 (Covid-19) vaccines are highly effective, breakthrough infections are occurring. Booster vaccinations have recently received emergency use authorization (EUA) for certain populations but are restricted to homologous mRNA vaccines. We evaluated homologous and heterologous booster vaccination in persons who had received an EUA Covid-19 vaccine regimen. METHODS: In this phase 1/2 open-label clinical trial conducted at ten U.S. sites, adults who received one of three EUA Covid-19 vaccines at least 12 weeks prior to enrollment and had no reported history of SARS-CoV-2 infection received a booster injection with one of three vaccines (Moderna mRNA-1273 100-μg, Janssen Ad26.COV2.S 5×10(10) virus particles, or Pfizer-BioNTech BNT162b2 30-μg; nine combinations). The primary outcomes were safety, reactogenicity, and humoral immunogenicity on study days 15 and 29. RESULTS: 458 individuals were enrolled: 154 received mRNA-1273, 150 received Ad26.CoV2.S, and 153 received BNT162b2 booster vaccines. Reactogenicity was similar to that reported for the primary series. Injection site pain, malaise, headache, and myalgia occurred in more than half the participants. Booster vaccines increased the neutralizing activity against a D614G pseudovirus (4.2–76-fold) and binding antibody titers (4.6–56-fold) for all combinations; homologous boost increased neutralizing antibody titers 4.2–20-fold whereas heterologous boost increased titers 6.2–76-fold. Day 15 neutralizing and binding antibody titers varied by 28.7-fold and 20.9-fold, respectively, across the nine prime-boost combinations. CONCLUSION: Homologous and heterologous booster vaccinations were well-tolerated and immunogenic in adults who completed a primary Covid-19 vaccine regimen at least 12 weeks earlier. Cold Spring Harbor Laboratory 2021-10-15 /pmc/articles/PMC8528081/ /pubmed/34671773 http://dx.doi.org/10.1101/2021.10.10.21264827 Text en https://creativecommons.org/licenses/by-nc-nd/4.0/This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (https://creativecommons.org/licenses/by-nc-nd/4.0/) , which allows reusers to copy and distribute the material in any medium or format in unadapted form only, for noncommercial purposes only, and only so long as attribution is given to the creator.
spellingShingle Article
Atmar, Robert L.
Lyke, Kirsten E.
Deming, Meagan E.
Jackson, Lisa A.
Branche, Angela R.
El Sahly, Hana M.
Rostad, Christina A.
Martin, Judith M.
Johnston, Christine
Rupp, Richard E.
Mulligan, Mark J.
Brady, Rebecca C.
Frenck, Robert W.
Bäcker, Martín
Kottkamp, Angelica C.
Babu, Tara M.
Rajakumar, Kumaravel
Edupuganti, Srilatha
Dobryzynski, David
Posavad, Christine M.
Archer, Janet I.
Crandon, Sonja
Nayak, Seema U.
Szydlo, Daniel
Zemanek, Jillian
Dominguez Islas, Clara P.
Brown, Elizabeth R.
Suthar, Mehul S.
McElrath, M. Juliana
McDermott, Adrian B.
O’Connell, Sarah E.
Montefiori, David C.
Eaton, Amanda
Neuzil, Kathleen M.
Stephens, David S.
Roberts, Paul C.
Beigel, John H.
Heterologous SARS-CoV-2 Booster Vaccinations – Preliminary Report
title Heterologous SARS-CoV-2 Booster Vaccinations – Preliminary Report
title_full Heterologous SARS-CoV-2 Booster Vaccinations – Preliminary Report
title_fullStr Heterologous SARS-CoV-2 Booster Vaccinations – Preliminary Report
title_full_unstemmed Heterologous SARS-CoV-2 Booster Vaccinations – Preliminary Report
title_short Heterologous SARS-CoV-2 Booster Vaccinations – Preliminary Report
title_sort heterologous sars-cov-2 booster vaccinations – preliminary report
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8528081/
https://www.ncbi.nlm.nih.gov/pubmed/34671773
http://dx.doi.org/10.1101/2021.10.10.21264827
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