• Homologous and Heterologous Covid-19 Booster Vaccinations.

      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; et al. (Massachusetts Medical Society, 2022-01-26)
      In this phase 1-2, open-label clinical trial conducted at 10 sites in the United States, adults who had completed a Covid-19 vaccine regimen at least 12 weeks earlier and had no reported history of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection received a booster injection with one of three vaccines: mRNA-1273 (Moderna) at a dose of 100 μg, Ad26.COV2.S (Johnson & Johnson-Janssen) at a dose of 5×1010 virus particles, or BNT162b2 (Pfizer-BioNTech) at a dose of 30 μg. The primary end points were safety, reactogenicity, and humoral immunogenicity on trial days 15 and 29.
    • Multi-site observational maternal and infant COVID-19 vaccine study (MOMI-vax): a study protocol.

      Munoz, Flor M; Beigi, Richard H; Posavad, Christine M; Richardson, Barbra A; Chu, Helen Y; Bok, Karin; Campbell, James; Cardemil, Cristina; DeFranco, Emily; Frenck, Robert W; et al. (Springer Nature, 2022-05-12)
      Background: Pregnant women were excluded from investigational trials of COVID-19 vaccines. Limited data are available to inform pregnant and postpartum women on their decisions to receive a COVID-19 vaccine. Methods: The goal of this observational, prospective cohort study is to evaluate the immunogenicity and safety of various Emergency Use Authorization (EUA) or licensed COVID-19 vaccines administered to pregnant or lactating women and describe the transplacental antibody transfer and kinetics of antibodies in mothers and infants. The study is adaptive, allowing additional groups to be added as new vaccines or vaccine regimens are authorized. Up to 20 clinical research institutions in the United States (U.S.) will be included. Approximately 200 pregnant women and 65 postpartum women will be enrolled per EUA or licensed COVID-19 vaccine formulation in the U.S. This study will include pregnant and postpartum women of all ages with and without chronic medical conditions. Their infants will be enrolled and followed beginning at birth in the pregnant cohort and beginning at the earliest possible time point in the postpartum cohort. Blood samples will be collected for immunogenicity outcomes and pregnancy and birth outcomes assessed among women and infants. Primary analyses will be descriptive and done by vaccine type and/or platform. Discussion: Given the long-standing and legitimate challenges of enrolling pregnant individuals into clinical trials early in the vaccine development pipeline, this study protocol describes our current study and provides a template to inform the collection of data for pregnant individuals receiving COVID-19 or other vaccines. Trial registration: NCT05031468 .
    • Rapid decline in vaccine-boosted neutralizing antibodies against SARS-CoV-2 Omicron variant.

      Lyke, Kirsten E; Atmar, Robert L; Islas, Clara Dominguez; Posavad, Christine M; Szydlo, Daniel; Paul Chourdhury, Rahul; Deming, Meagan E; Eaton, Amanda; Jackson, Lisa A; Branche, Angela R; et al. (Elsevier, 2022-06-20)
      ctive immunity. We assess the magnitude and short-term durability of neutralizing antibodies after homologous and heterologous boosting with mRNA and Ad26.COV2.S vaccines. All prime-boost combinations substantially increase the neutralization titers to Omicron, although the boosted titers decline rapidly within 2 months from the peak response compared with boosted titers against the prototypic D614G variant. Boosted Omicron neutralization titers are substantially higher for homologous mRNA vaccine boosting, and for heterologous mRNA and Ad26.COV2.S vaccine boosting, compared with homologous Ad26.COV2.S boosting. Homologous mRNA vaccine boosting generates nearly equivalent neutralizing activity against Omicron sublineages BA.1, BA.2, and BA.3 but modestly reduced neutralizing activity against BA.2.12.1 and BA.4/BA.5 compared with BA.1. These results have implications for boosting requirements to protect against Omicron and future variants of SARS-CoV-2. This trial was conducted under ClincalTrials.gov: NCT04889209.
    • SARS-CoV-2 Omicron Variant Neutralization after mRNA-1273 Booster Vaccination.

      Pajon, Rolando; Doria-Rose, Nicole A; Shen, Xiaoying; Schmidt, Stephen D; O'Dell, Sijy; McDanal, Charlene; Feng, Wenhong; Tong, Jin; Eaton, Amanda; Maglinao, Maha; et al. (Massachusetts Medical Society, 2022-01-26)