NIAID-sponsored research study assessed dosage in grownups fully immunized with any EUA or authorized COVID-19 vaccine.
In grownups who had actually previously received a complete routine of any of three COVID-19 vaccines given Emergency Use Authorization (EUA) or authorized by the Food and Drug Administration (FDA), an additional booster dose of any of these vaccines was safe and triggered an immune action, according to preliminary clinical trial results reported in The New England Journal of Medicine. The findings worked as the basis for recommendations by the FDA and the Centers for Disease Control and Prevention in late fall 2021 to permit mix-and-match COVID-19 booster vaccinations in the United States. Additional data from the ongoing Phase 1/2 trial, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, are expected in the coming months.
The new report explains findings from 458 grownups who had been totally immunized with any of three EUA COVID-19 vaccines at least 12 weeks prior to enrollment and who had no reported history of SARS-CoV-2 infection. At enrollment, a single booster dosage was administered to each individual: 150 got Janssen/Johnson & & Johnsons Ad26.COV2.S vaccine; 154 received Modernas mRNA-1273 vaccine; and 154 got Pfizer-BioNTechs BNT162b2 vaccine. Depending on which primary vaccine program an individual had actually received, the booster vaccine was either various (combined, or heterologous) than or the same (matched, or homologous) as the original vaccine.
Transmission electron micrograph of SARS-CoV-2 virus particles (gold) within endosomes of a heavily infected nasal Olfactory Epithelial Cell. Credit: NIAID
The trial participants kept journals of any adverse effects. More than half of individuals reported headache, discomfort at the injection site, muscle pains, and malaise. No major vaccine-related negative events were reported.
For each primary EUA COVID-19 vaccine, heterologous increases elicited similar or higher antibody responses as compared to responses to a homologous booster. Cellular reactions (CD4 and CD8 T cell) likewise increased in all but the homologous Ad26.CoV2.S-boosted group, though CD8+ T cells were greatest at baseline in those individuals who had actually received the Ad26.CoV2.S EUA vaccine.
Taken together, the detectives concluded, “these information highly suggest that homologous and heterologous booster vaccine will increase protective efficacy against symptomatic SARS-CoV-2 infection.”
These interim results cover readily available immunogenicity information through the initial 29 days following booster vaccination. Investigators will continue to follow individuals for one year to evaluate what effect booster vaccination has on longer-term immune actions. Additional arms of the trial may test other investigational, EUA or FDA-approved COVID-19 vaccines and/or vaccines based on SARS-CoV-2 variations as the boosting vaccine.
The trial started in May 2021 and is continuing to enroll participants. Its principal detectives are Robert L. Atmar, M.D., of Baylor College of Medicine, Houston; and Kirsten E. Lyke, M.D., of the University of Maryland School of Medicine, Baltimore. It is being conducted through NIAIDs Infectious Diseases Clinical Research Consortium, a scientific trials network that incorporates the Institutes longstanding Vaccine and Treatment Evaluation Units (VTEUs). Extra info about the trial, consisting of a listing of trial websites enrolling volunteers, is available at ClinicalTrials.gov utilizing the identifier NCT04889209.
Recommendation: “Heterologous and homologous COVID-19 booster vaccinations” by RL Atmar et al., 26 January 2022, The New England Journal of Medicine.DOI: 10.1056/ NEJMoa2116414.
NIAID grants supporting this research were UM1AI48372, UM1AI148373, UM1AI148450, UM1AI148452, UM1AI148573, UM1AI148574, UM1AI148575, UM1AI148576, UM1AI148684 and UM1AI148689. Agreement 75N93019C00050 from the NIAID Collaborative Influenza Vaccine Innovation Centers (CIVICs) also provided assistance.
In adults who had formerly received a full program of any of 3 COVID-19 vaccines given Emergency Use Authorization (EUA) or approved by the Food and Drug Administration (FDA), an extra booster dosage of any of these vaccines was safe and triggered an immune response, according to initial scientific trial results reported in The New England Journal of Medicine. At registration, a single booster dose was administered to each individual: 150 received Janssen/Johnson & & Johnsons Ad26.COV2.S vaccine; 154 got Modernas mRNA-1273 vaccine; and 154 got Pfizer-BioNTechs BNT162b2 vaccine. Depending on which primary vaccine routine a participant had actually gotten, the booster vaccine was either various (blended, or heterologous) than or the exact same (matched, or homologous) as the original vaccine.
For each primary EUA COVID-19 vaccine, heterologous increases elicited comparable or higher antibody responses as compared to responses to a homologous booster. Extra arms of the trial might check other investigational, EUA or FDA-approved COVID-19 vaccines and/or vaccines based on SARS-CoV-2 versions as the enhancing vaccine.