Mix-and-match trial finds additional dose of COVID-19 vaccine safe, immunogenic
Study assessed dose in adults fully vaccinated with any EUA or approved COVID-19 vaccine
Date:
January 26, 2022
Source:
NIH/National Institute of Allergy and Infectious Diseases
Summary:
In adults who had previously received a full regimen of any of
three COVID-19 vaccines granted Emergency Use Authorization (EUA)
or approved by the Food and Drug Administration (FDA), an additional
booster dose of any of these vaccines was safe and prompted an
immune response, according to preliminary clinical trial results.
FULL STORY ==========================================================================
In adults who had previously received a full regimen of any of three
COVID-19 vaccines granted Emergency Use Authorization (EUA) or approved by
the Food and Drug Administration (FDA), an additional booster dose of any
of these vaccines was safe and prompted an immune response, according to preliminary clinical trial results reported in The New England Journal
of Medicine. The findings served 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 describes findings from 458 adults who had been fully
vaccinated 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 dose was administered to
each participant: 150 received Janssen/ Johnson & Johnson's Ad26.COV2.S vaccine; 154 received Moderna's mRNA-1273 vaccine; and 154 received Pfizer-BioNTech's BNT162b2 vaccine. Depending on which primary vaccine
regimen a participant had received, the booster vaccine was either
different (mixed, or heterologous) than or the same (matched, or
homologous) as the original vaccine.
The trial participants kept diaries of any side effects. More than half of participants reported headache, pain at the injection site, muscle aches
and malaise. No serious vaccine-related adverse events were reported.
All combinations of primary and booster vaccine resulted in increased neutralizing antibody levels (ranging from 4.2- to 76-fold higher
levels than those detected prior to boost.) Likewise, all primary-boost combinations increased binding antibody levels 4.6- to 56-fold. For each primary EUA COVID- 19 vaccine, heterologous boosts elicited similar
or higher antibody responses as compared to responses to a homologous
booster. Cellular responses (CD4 and CD8 T cell) also increased in all
but the homologous Ad26.CoV2.S-boosted group, though CD8+ T cells were
highest at baseline in those participants who had received the Ad26.CoV2.S
EUA vaccine.
Taken together, the investigators concluded, "these data strongly suggest
that homologous and heterologous booster vaccine will increase protective efficacy against symptomatic SARS-CoV-2 infection." These interim
results cover available immunogenicity data through the initial 29 days following booster vaccination. Investigators will continue to follow participants for one year to assess what impact booster vaccination has
on longer-term immune responses. Additional arms of the trial may test
other investigational, EUA or FDA-approved COVID-19 vaccines and/or
vaccines based on SARS-CoV-2 variants as the boosting vaccine.
The trial began in May 2021 and is continuing to enroll participants. Its principal investigators 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
NIAID's Infectious Diseases Clinical Research Consortium, a clinical
trials network that encompasses the Institute's longstanding Vaccine
and Treatment Evaluation Units (VTEUs). Additional information about
the trial, including a listing of trial sites enrolling volunteers,
is available at ClinicalTrials.gov using the identifier NCT04889209.
NIAID grants supporting this research were UM1AI48372, UM1AI148373, UM1AI148450, UM1AI148452, UM1AI148573, UM1AI148574, UM1AI148575,
UM1AI148576, UM1AI148684 and UM1AI148689. Contract 75N93019C00050 from
the NIAID Collaborative Influenza Vaccine Innovation Centers (CIVICs)
also provided support.
========================================================================== Story Source: Materials provided by NIH/National_Institute_of_Allergy_and_Infectious Diseases. Note: Content
may be edited for style and length.
========================================================================== Journal Reference:
1. Robert L. Atmar, Kirsten E. Lyke, Meagan E. Deming, Lisa A. Jackson,
Angela R. Branche, Hana M. El Sahly, Christina A. Rostad, Judith M.
Martin, Christine Johnston, Richard E. Rupp, Mark J. Mulligan,
Rebecca C.
Brady, Robert W. Frenck, Marti'n Ba"cker, Angelica C. Kottkamp,
Tara M.
Babu, Kumaravel Rajakumar, Srilatha Edupuganti, David Dobrzynski,
Rhea N.
Coler, Christine M. Posavad, Janet I. Archer, Sonja Crandon,
Seema U.
Nayak, Daniel Szydlo, Jillian A. Zemanek, Clara P. Dominguez Islas,
Elizabeth R. Brown, Mehul S. Suthar, M. Juliana McElrath, Adrian B.
McDermott, Sarah E. O'Connell, David C. Montefiori, Amanda Eaton,
Kathleen M. Neuzil, David S. Stephens, Paul C. Roberts, John
H. Beigel.
Homologous and Heterologous Covid-19 Booster Vaccinations. New
England Journal of Medicine, 2022; DOI: 10.1056/NEJMoa2116414 ==========================================================================
Link to news story:
https://www.sciencedaily.com/releases/2022/01/220126170601.htm
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