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A Randomized Clinical Trial of a Fractional Low Dose of BNT162b2 Booster in Adults Following AZD1222
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Document Title
A Randomized Clinical Trial of a Fractional Low Dose of BNT162b2 Booster in Adults Following AZD1222
Author
Nantanee RAPS, Jantarabenjakul WSM, Jaru EEAAPRP, Sodsai PPY, Himananto ORAW, Athipunjapong JW, Sophonphan JRACY, Nanthapisal SRA, Hirankarn NTY, Puthanakit HYEE
Name from Authors Collection
Affiliations
Chulalongkorn University; Chulalongkorn University; Chulalongkorn University; National Science & Technology Development Agency - Thailand; National Center Genetic Engineering & Biotechnology (BIOTEC); Chulalongkorn University; National Science & Technology Development Agency - Thailand; National Center Genetic Engineering & Biotechnology (BIOTEC); Thai Red Cross Society; Thammasat University; Chulalongkorn University
Type
Article
Source Title
VACCINES
Year
2022
Volume
10
Issue
6
Open Access
gold, Green Published
Publisher
MDPI
DOI
10.3390/vaccines10060914
Format
Abstract
In the era of globally predominant omicron strains, a COVID-19 booster vaccine is needed. Our study aimed to evaluate the immunogenicity of a half-dose BNT162b2 booster after AZD1222 in healthy adults. A randomized trial of volunteers aged 18-69 years who received two-dose AZD1222 was conducted. The participants were randomized to receive the BNT162b2 vaccine intramuscularly- half (15 mu g) vs. standard dose (30 mu g). The immunogenicity was evaluated by a surrogate virus neutralization test (sVNT) against omicron variants and anti-spike-receptor-binding-domain IgG (anti-S-RBD IgG). From November-December 2021, 100 adults with a median age of 59.3 years (IQR 33.4-65.5) were enrolled. A booster dose was given at median of 98 days (IQR 92-128) after AZD1222. At day 14, the geometric means (GMs) of anti-S-RBD IgG in half- vs. standard-dose group were 2329.8 vs. 2574.7 BAU/mL, with a geometric mean ratio (GMR) of 0.90 (0.77-1.06). The GMs of sVNT against the omicron variant in the half- and standard-dose groups were 74.4% inhibition (95% CI 68.8-80.5) and 67.3% inhibition (57.9-78.1), respectively, with GMR of 0.95 (0.69-1.30). At day 90, the sVNT indicated 22.3% inhibition (95% CI 14.9-33.4) and 20.4% inhibition (13.1-32.0), respectively, with GMR of 1.09 (0.60-1.98). The fractional low-dose BNT162b2 mRNA booster vaccine provided non-inferior immunogenicity responses. During a shortage of vaccine supply, a fractional low dose should be considered for a booster vaccination program.
Industrial Classification
Knowledge Taxonomy Level 1
Knowledge Taxonomy Level 2
Knowledge Taxonomy Level 3
Funding Sponsor
National Vaccine Institute [2565.1/1]; Ratchadapisek Somphot Fund for Postdoctoral Fellowship, Chulalongkorn University; Ratchadaphiseksomphot Matching Fund from the Faculty of Medicine, Chulalongkorn University
License
CC BY
Rights
Authors
Publication Source
WOS