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1. Comparison of bivalent and monovalent SARS-CoV-2 variant vaccines: the phase 2 randomized open-label COVAIL trial

Author

Branche, Angela R., Rouphael, Nadine G., Diemert, David J., Falsey, Ann R., Losada, Cecilia, Baden, Lindsey R., Frey, Sharon E., Whitaker, Jennifer A., Little, Susan J., Anderson, Evan J., Walter, Emmanuel B., Novak, Richard M., Rupp, Richard, Jackson, Lisa A., Babu, Tara M., Kottkamp, Angelica C., Luetkemeyer, Anne F., Immergluck, Lilly C., Presti, Rachel M., Bäcker, Martín, Winokur, Patricia L., Mahgoub, Siham M., Goepfert, Paul A., Fusco, Dahlene N., Malkin, Elissa, Bethony, Jeffrey M., Walsh, Edward E., Graciaa, Daniel S., Samaha, Hady, Sherman, Amy C., Walsh, Stephen R., Abate, Getahun, Oikonomopoulou, Zacharoula, El Sahly, Hana M., Martin, Thomas C. S., Kamidani, Satoshi, Smith, Michael J., Ladner, Benjamin G., Porterfield, Laura, Dunstan, Maya, Wald, Anna, Davis, Tamia, Atmar, Robert L., Mulligan, Mark J., Lyke, Kirsten E., Posavad, Christine M., Meagher, Megan A., Stephens, David S., Neuzil, Kathleen M., Abebe, Kuleni, Hill, Heather, Albert, Jim, Telu, Kalyani, Mu, Jinjian, Lewis, Teri C., Giebeig, Lisa A., Eaton, Amanda, Netzl, Antonia, Wilks, Samuel H., Türeli, Sina, Makhene, Mamodikoe, Crandon, Sonja, Montefiori, David C., Makowski, Mat, Smith, Derek J., Nayak, Seema U., Roberts, Paul C., and Beigel, John H.

Published
2023
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2. Immunogenicity of NVX-CoV2373 heterologous boost against SARS-CoV-2 variants

Author

Lyke, Kirsten E., Atmar, Robert L., Dominguez Islas, Clara, Posavad, Christine M., Deming, Meagan E., Branche, Angela R., Johnston, Christine, El Sahly, Hana M., Edupuganti, Srilatha, Mulligan, Mark J., Jackson, Lisa A., Rupp, Richard E., Rostad, Christina A., Coler, Rhea N., Bäcker, Martín, Kottkamp, Angelica C., Babu, Tara M., Dobrzynski, David, Martin, Judith M., Brady, Rebecca C., Frenck, Jr., Robert W., Rajakumar, Kumaravel, Kotloff, Karen, Rouphael, Nadine, Szydlo, Daniel, PaulChoudhury, Rahul, Archer, Janet I., Crandon, Sonja, Ingersoll, Brian, Eaton, Amanda, Brown, Elizabeth R., McElrath, M. Juliana, Neuzil, Kathleen M., Stephens, David S., Post, Diane J., Lin, Bob C., Serebryannyy, Leonid, Beigel, John H., Montefiori, David C., and Roberts, Paul C.

Published
2023
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3. Severe Acute Respiratory Syndrome Coronavirus 2 Omicron Subvariant Neutralization Following a Primary Vaccine Series of NVX-CoV2373 and BNT162b2 Monovalent Booster Vaccine

Author

Babu, Tara M, primary, Shen, Xiaoying, additional, McClelland, R Scott, additional, Wang, Zijun, additional, Selke, Stacy, additional, Wilkens, Chloe, additional, Hauge, Kirsten A, additional, McClurkan, Christopher L, additional, Goecker, Erin, additional, Laing, Kerry J, additional, Koelle, David M, additional, Greninger, Alexander L, additional, Nussenzweig, Michel C, additional, Montefiori, David C, additional, Corey, Lawrence, additional, and Wald, Anna, additional

Published
2024
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4. 2395. An Interim Report of the Safety, Reactogenicity, and Immunogenicity of a Self-amplifying mRNA (samRNA) COVID-19 Vaccine GRT-R910 as a Booster in Healthy Adults

Author

Whitaker, Jennifer, primary, Rebolledo, Paulina, additional, Rouphael, Nadine, additional, Abate, Getahun, additional, Babu, Tara M, additional, Wald, Anna, additional, Sahly, Hana El, additional, Garbes, Pedro, additional, Jooss, Karin, additional, Allen, Andrew, additional, McQuarrie, Lisa, additional, Sitaula, Ranjan, additional, Roberts, Paul C, additional, Makhene, Mamodikoe, additional, Posavad, Christine M, additional, Juliana McElrath, M, additional, De Rosa, Stephen, additional, Coler, Rhea, additional, Montefiori, David, additional, Eaton, Amanda, additional, Koelle, David M, additional, and Hoft, Daniel F, additional

Published
2023
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5. CASCADIA: a prospective community-based study protocol for assessing SARS-CoV-2 vaccine effectiveness in children and adults using a remote nasal swab collection and web-based survey design

Author

Babu, Tara M, primary, Feldstein, Leora R, additional, Saydah, Sharon, additional, Acker, Zachary, additional, Boisvert, Cassandra L, additional, Briggs-Hagen, Melissa, additional, Carone, Marco, additional, Casto, Amanda, additional, Cox, Sarah N, additional, Ehmen, Brenna, additional, Englund, Janet A, additional, Fortmann, Stephen P, additional, Frivold, Collrane J, additional, Groom, Holly, additional, Han, Peter D, additional, Kuntz, Jennifer L, additional, Lockwood, Tina, additional, Midgley, Claire M, additional, Mularski, Richard A, additional, Ogilvie, Tara, additional, Reich, Sacha L, additional, Schmidt, Mark A, additional, Smith, Ning, additional, Starita, Lea, additional, Stone, Jeremy, additional, Vandermeer, Meredith, additional, Weil, Ana A, additional, Wolf, Caitlin R, additional, Chu, Helen Y, additional, and Naleway, Allison L, additional

Published
2023
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6. Immunogenicity of a Two Dose Regimen of Moderna mRNA Beta/Omicron BA.1 Bivalent Variant Vaccine Boost in a Randomized Clinical Trial

Author

Rouphael, Nadine G., Branche, Angela R., Diemert, David J., Falsey, Ann R., Losada, Cecilia, Baden, Lindsey R., Frey, Sharon E., Whitaker, Jennifer A., Little, Susan J., Kamidani, Satoshi, Walter, Emmanuel B., Novak, Richard M., Rupp, Richard, Jackson, Lisa A., Babu, Tara M., Kottkamp, Angelica C., Luetkemeyer, Anne F., Immergluck, Lilly C., Presti, Rachel M., Bäcker, Martín, Winokur, Patricia L., Mahgoub, Siham M., Goepfert, Paul A., Fusco, Dahlene N., Atmar, Robert L., Posavad, Christine M., Netzl, Antonia, Smith, Derek J., Telu, Kalyani, Mu, Jinjian, Makowski, Mat, Makhene, Mamodikoe K., Crandon, Sonja, Montefiori, David C., Roberts, Paul C., and Beigel, John H.

Subjects
Article
Abstract

In this brief report, we compare the magnitude and durability of the serologic response of one versus two doses (separated by 56 days) of a variant vaccine (Moderna mRNA-1273 Beta/Omicron BA.1 bivalent vaccine) in adults.

Published
2023

7. Genital Herpes Simplex Virus Type 2 Suppression With Valacyclovir Is Not Associated With Changes in Nugent Score or Absolute Abundance of Key Vaginal Bacteria

Author

Babu, Tara M, primary, Srinivasan, Sujatha, additional, Magaret, Amalia, additional, Proll, Sean, additional, Karita, Helen Stankiewicz, additional, Wallis, Jacqueline M, additional, Selke, Stacy, additional, Varon, Dana, additional, Pholsena, Thepthara, additional, Fredricks, David, additional, Marrazzo, Jeanne, additional, Wald, Anna, additional, and Johnston, Christine, additional

Published
2023
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8. 1948. Evaluation of a heterologous booster vaccine regimen: Pfizer-BioNTech BNT162b2 mRNA booster vaccine following priming with Novavax NVX-CoV2373

Author

Babu, Tara M, primary, Scott McClelland, R, additional, Johnston, Christine, additional, Selke, Stacy, additional, Singh, Dilpreet, additional, Moreno, Jessica, additional, Taub, Jina, additional, Pertik, Morissa, additional, Varon, Dana, additional, Pholsena, Thepthara, additional, Murphy, Britt, additional, Drummond, Mark, additional, McClellan, Lindsey, additional, Braun, Alyssa, additional, Seymour, Matthew, additional, Hauge, Kirsten, additional, McClurkan, Chris L, additional, Wilkens, Chloe, additional, Goecker, Erin, additional, Laing, Kerry J, additional, Koelle, David M, additional, Greninger, Alexander L, additional, and Wald, Anna, additional

Published
2022
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9. 2202. Influenza Surveillance of Families in an Observational Household Study 2019-2021

Author

Babu, Tara M, primary, Casto, Amanda M, additional, Heimonen, Jessica, additional, Wang, Yongzhe Wang, additional, Emanuels, Annie, additional, Chow, Eric J, additional, Hoag, Samara, additional, Hughes, James, additional, Ogokeh, Constance E, additional, Rolfes, Melissa A, additional, Uyeki, Timothy M, additional, Starita, Lea, additional, Englund, Janet A, additional, and Chu, Helen Y, additional

Published
2022
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10. SARS-CoV-2 Variant Vaccine Boosters Trial: Preliminary Analyses

Author

Branche, Angela R., Rouphael, Nadine G., Diemert, David J., Falsey, Ann R., Losada, Cecilia, Baden, Lindsey R., Frey, Sharon E., Whitaker, Jennifer A., Little, Susan J., Anderson, Evan J., Walter, Emmanuel B., Novak, Richard M., Rupp, Richard, Jackson, Lisa A., Babu, Tara M., Kottkamp, Angelica C., Luetkemeyer, Anne F., Immergluck, Lilly C., Presti, Rachel M., Bäcker, Martín, Winokur, Patricia L., Mahgoub, Siham M., Goepfert, Paul A., Fusco, Dahlene N., Malkin, Elissa, Bethony, Jeffrey M., Walsh, Edward E., Graciaa, Daniel S., Samaha, Hady, Sherman, Amy C., Walsh, Stephen R., Abate, Getahun, Oikonomopoulou, Zacharoula, El Sahly, Hana M., Martin, Thomas C.S., Rostad, Christina A., Smith, Michael J., Ladner, Benjamin G., Porterfield, Laura, Dunstan, Maya, Wald, Anna, Davis, Tamia, Atmar, Robert L., Mulligan, Mark J., Lyke, Kirsten E., Posavad, Christine M., Meagher, Megan A., Stephens, David S., Neuzil, Kathleen M., Abebe, Kuleni, Hill, Heather, Albert, Jim, Lewis, Teri C., Giebeig, Lisa A., Eaton, Amanda, Netzl, Antonia, Wilks, Samuel H., Türeli, Sina, Makhene, Mamodikoe, Crandon, Sonja, Lee, Marina, Nayak, Seema U., Montefiori, David C., Makowski, Mat, Smith, Derek J., Roberts, Paul C., and Beigel, John H.

Subjects
Article
Abstract

BackgroundProtection from SARS-CoV-2 vaccines wanes over time and is compounded by emerging variants including Omicron subvariants. This study evaluated safety and immunogenicity of SARS-CoV-2 variant vaccines.MethodsThis phase 2 open-label, randomized trial enrolled healthy adults previously vaccinated with a SARS-CoV-2 primary series and a single boost. Eligible participants were randomized to one of six Moderna COVID19 mRNA vaccine arms (50µg dose): Prototype (mRNA-1273), Omicron BA.1+Beta (1 or 2 doses), Omicron BA.1+Delta, Omicron BA.1 monovalent, and Omicron BA.1+Prototype. Neutralization antibody titers (ID50) were assessed for D614G, Delta, Beta and Omicron BA.1 variants and Omicron BA.2.12.1 and BA.4/BA.5 subvariants 15 days after vaccination.ResultsFrom March 30 to May 6, 2022, 597 participants were randomized and vaccinated. Median age was 53 years, and 20% had a prior SARS-CoV-2 infection. All vaccines were safe and well-tolerated. Day 15 geometric mean titers (GMT) against D614G were similar across arms and ages, and higher with prior infection. For uninfected participants, Day 15 Omicron BA.1 GMTs were similar across Omicron-containing vaccine arms (3724-4561) and higher than Prototype (1,997 [95%CI:1,482-2,692]). The Omicron BA.1 monovalent and Omicron BA.1+Prototype vaccines induced a geometric mean ratio (GMR) to Prototype for Omicron BA.1 of 2.03 (97.5%CI:1.37-3.00) and 1.56 (97.5%CI:1.06-2.31), respectively. A subset of samples from uninfected participants in four arms were also tested in a different laboratory at Day 15 for neutralizing antibody titers to D614G and Omicron subvariants BA.1, BA.2.12.2 and BA.4/BA.5. Omicron BA.4/BA.5 GMTs were approximately one third BA.1 GMTs (Prototype 517 [95%CI:324-826] vs. 1503 [95%CI:949-2381]; Omicron BA.1+Beta 628 [95%CI:367-1,074] vs. 2125 [95%CI:1139-3965]; Omicron BA.1+Delta 765 [95%CI:443-1,322] vs. 2242 [95%CI:1218-4128] and Omicron BA.1+Prototype 635 [95%CI:447-903] vs. 1972 [95%CI:1337-2907).ConclusionsHigher Omicron BA.1 titers were observed with Omicron-containing vaccines compared to Prototype vaccine and titers against Omicron BA.4/BA.5 were lower than against BA.1 for all candidate vaccines.Clinicaltrials.govNCT05289037

Published
2022

11. Rapid decline in vaccine-boosted neutralizing antibodies against SARS-CoV-2 Omicron variant

Author

Lyke, Kirsten E., primary, Atmar, Robert L., additional, Islas, Clara Dominguez, additional, Posavad, Christine M., additional, Szydlo, Daniel, additional, Paul Chourdhury, Rahul, additional, Deming, Meagan E., additional, Eaton, Amanda, additional, Jackson, Lisa A., additional, Branche, Angela R., additional, El Sahly, Hana M., additional, Rostad, Christina A., additional, Martin, Judith M., additional, Johnston, Christine, additional, Rupp, Richard E., additional, Mulligan, Mark J., additional, Brady, Rebecca C., additional, Frenck, Robert W., additional, Bäcker, Martín, additional, Kottkamp, Angelica C., additional, Babu, Tara M., additional, Rajakumar, Kumaravel, additional, Edupuganti, Srilatha, additional, Dobrzynski, David, additional, Coler, Rhea N., additional, Archer, Janet I., additional, Crandon, Sonja, additional, Zemanek, Jillian A., additional, Brown, Elizabeth R., additional, Neuzil, Kathleen M., additional, Stephens, David S., additional, Post, Diane J., additional, Nayak, Seema U., additional, Suthar, Mehul S., additional, Roberts, Paul C., additional, Beigel, John H., additional, Montefiori, David C., additional, Husson, Jennifer S., additional, Price, Angie, additional, Whitaker, Jennifer A., additional, Keitel, Wendy A., additional, Falsey, Ann R., additional, Shannon, Ian, additional, Graciaa, Daniel, additional, Rouphael, Nadine, additional, Anderson, Evan J., additional, Kamidani, Satoshi, additional, Muniz, Gysella B., additional, Bhatnagar, Sonika, additional, Wald, Anna, additional, Berman, Megan, additional, Porterfield, Laura, additional, Stanford, Amber, additional, Dong, Jennifer Lee, additional, Carsons, Steven E., additional, Badillo, Diana, additional, Parker, Susan, additional, Dickey, Michelle, additional, Larsen, Sasha E., additional, Hural, John, additional, Ingersoll, Brian, additional, Lee, Marina, additional, Lai, Lilin, additional, Floyd, Katharine, additional, Ellis, Madison, additional, Moore, Kathryn M., additional, Manning, Kelly, additional, Foster, Stephanie L., additional, and Patel, Mit, additional

Published
2022
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12. Neutralizing antibody immune correlates in COVAIL trial recipients of an mRNA second COVID-19 vaccine boost

Author

Zhang, Bo, Fong, Youyi, Dang, Lauren, Fintzi, Jonathan, Chen, Shiyu, Wang, Jing, Rouphael, Nadine G., Branche, Angela R., Diemert, David J., Falsey, Ann R., Graciaa, Daniel S., Baden, Lindsey R., Frey, Sharon E., Whitaker, Jennifer A., Little, Susan J., Kamidani, Satoshi, Walter, Emmanuel B., Novak, Richard M., Rupp, Richard, Jackson, Lisa A., Yu, Chenchen, Magaret, Craig A., Molitor, Cindy, Borate, Bhavesh, Busch, Sydney, Benkeser, David, Netzl, Antonia, Smith, Derek J., Babu, Tara M., Kottkamp, Angelica C., Luetkemeyer, Anne F., Immergluck, Lilly C., Presti, Rachel M., Bäcker, Martín, Winokur, Patricia L., Mahgoub, Siham M., Goepfert, Paul A., Fusco, Dahlene N., Atmar, Robert L., Posavad, Christine M., Mu, Jinjian, Makowski, Mat, Makhene, Mamodikoe K., Nayak, Seema U., Roberts, Paul C., Gilbert, Peter B., and Follmann, Dean

Published
2025
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14. Probable Donor-Derived Human Adenovirus Type 34 Infection in 2 Kidney Transplant Recipients From the Same Donor.

Author

Pettengill, Matthew A., Babu, Tara M., Prasad, Paritosh, Chuang, Sally, Drage, Michael G., Menegus, Marilyn, Lamson, Daryl M., Lu, Xiaoyan, Erdman, Dean, Pecora, Nicole, Pettengill, Matthew A., Babu, Tara M., Prasad, Paritosh, Chuang, Sally, Drage, Michael G., Menegus, Marilyn, Lamson, Daryl M., Lu, Xiaoyan, Erdman, Dean, and Pecora, Nicole

Abstract

Human adenovirus type 34 (HAdV-34) infection is a recognized cause of transplant-associated hemorrhagic cystitis and, in rare cases, tubulointerstitial nephritis. The source of such infections is often difficult to assess, that is, whether acquired as a primary infection, exposure to a pathogen in the transplanted organ, or reactivation of an endogenous latent infection. We present here 2 cases of likely transplant-acquired HAdV-34 infection from the same organ donor, manifesting as tubulointerstitial nephritis in 1.

Published
2019

15. CNS Melioidosis in a Traveler Returning from Cabo, Mexico

Author

Donahue, Matthew A, primary, Newcomb, Geoffrey, additional, Spinella, Sara, additional, Prasad, Paritosh, additional, Liesveld, Jane, additional, Egan, Cristina T, additional, Smith, Glenda L, additional, Newman, Alexandra P, additional, Bower, William A, additional, Blaney, David D, additional, Gee, Jay E, additional, Elrod, Mindy G, additional, Chuang, Sally, additional, and Babu, Tara M, additional

Published
2019
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17. Clinical and Demographic Factors Associated With COVID-19, Severe COVID-19, and SARS-CoV-2 Infection in Adults: A Secondary Cross-Protocol Analysis of 4 Randomized Clinical Trials.

Author

Theodore, Deborah A., Branche, Angela R., Zhang, Lily, Graciaa, Daniel S., Choudhary, Madhu, Hatlen, Timothy J., Osman, Raadhiya, Babu, Tara M., Robinson, Samuel T., Gilbert, Peter B., Follmann, Dean, Janes, Holly, Kublin, James G., Baden, Lindsey R., Goepfert, Paul, Gray, Glenda E., Grinsztejn, Beatriz, Kotloff, Karen L., Gay, Cynthia L., and Leav, Brett

Published
2023
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18. Invasive Aspergillus infections in hospitalized patients with chronic lung disease

Author

Wessolossky,Mireya, Welch,Verna L, Sen,Ajanta, Babu,Tara M, Luke,David R, Wessolossky,Mireya, Welch,Verna L, Sen,Ajanta, Babu,Tara M, and Luke,David R

Abstract

Mireya Wessolossky,1 Verna L Welch,2 Ajanta Sen,1 Tara M Babu,1 David R Luke21Division of Infectious Diseases, University of Massachusetts Medical School, Worcester, MA, USA; 2Medical Affairs, Pfizer Inc, Collegeville, PA, USABackground: Although invasive pulmonary aspergillosis (IPA) is more prevalent in immunocompromised patients, critical care clinicians need to be aware of the occurrence of IPA in the nontraditional host, such as a patient with chronic lung disease. The purpose of this study was to describe the IPA patient with chronic lung disease and compare the data with that of immunocompromised patients.Methods: The records of 351 patients with Aspergillus were evaluated in this single-center, retrospective study for evidence and outcomes of IPA. The outcomes of 57 patients with chronic lung disease and 56 immunocompromised patients were compared. Patients with chronic lung disease were defined by one of the following descriptive terms: emphysema, asthma, idiopathic lung disease, bronchitis, bronchiectasis, sarcoid, or pulmonary leukostasis.Results: Baseline demographics were similar between the two groups. Patients with chronic lung disease were primarily defined by emphysema (61%) and asthma (18%), and immunocompromised patients primarily had malignancies (27%) and bone marrow transplants (14%). A higher proportion of patients with chronic lung disease had a diagnosis of IPA by bronchoalveolar lavage versus the immunocompromised group (P < 0.03). The major risk factors for IPA were found to be steroid use in the chronic lung disease group and neutropenia and prior surgical procedures in the immunocompromised group. Overall, 53% and 69% of chronic lung disease and immunocompromised patients were cured (P = 0.14); 55% of chronic lung patients and 47% of immunocompromised patients survived one month (P = 0.75).Conclusion: Nontraditional patients with IPA, such as those with chronic lung disease, have outcomes and mortality similar to that in the more

Published
2013

19. Invasive Aspergillus infections in hospitalized patients with chronic lung disease.

Author

Wessolossky, Mireya, Welch, Verna L., Sen, Ajanta, Babu, Tara M., and Luke, David R.

Subjects
PULMONARY aspergillosis, MYCOSES, LUNG disease diagnosis, IMMUNOCOMPROMISED patients, PULMONARY emphysema, NEUTROPENIA
Abstract

Background: Although invasive pulmonary aspergillosis (IPA) is more prevalent in immunocompromised patients, critical care clinicians need to be aware of the occurrence of IPA in the nontraditional host, such as a patient with chronic lung disease. The purpose of this study was to describe the IPA patient with chronic lung disease and compare the data with that of immunocompromised patients. Methods: The records of 351 patients with Aspergillus were evaluated in this single-center, retrospective study for evidence and outcomes of IPA. The outcomes of 57 patients with chronic lung disease and 56 immunocompromised patients were compared. Patients with chronic lung disease were defined by one of the following descriptive terms: emphysema, asthma, idiopathic lung disease, bronchitis, bronchiectasis, sarcoid, or pulmonary leukostasis. Results: Baseline demographics were similar between the two groups. Patients with chronic lung disease were primarily defined by emphysema (61%) and asthma (18%), and immunocompromised patients primarily had malignancies (27%) and bone marrow transplants (14%). A higher proportion of patients with chronic lung disease had a diagnosis of IPA by bronchoalveolar lavage versus the immunocompromised group (P < 0.03). The major risk factors for IPA were found to be steroid use in the chronic lung disease group and neutropenia and prior surgical procedures in the immunocompromised group. Overall, 53% and 69% of chronic lung disease and immunocompromised patients were cured (P = 0.14); 55% of chronic lung patients and 47% of immunocompromised patients survived one month (P = 0.75). Conclusion: Nontraditional patients with IPA, such as those with chronic lung disease, have outcomes and mortality similar to that in the more traditional immunocompromised population. [ABSTRACT FROM AUTHOR]

Published
2013
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