Dataset Information

Immunogenicity and Reactogenicity of Messenger RNA Coronavirus Disease 2019 Vaccine Booster Administered by Intradermal or Intramuscular Route in Thai Older Adults.

ABSTRACT:

Background

Intradermal (ID) vaccination may alleviate COVID-19 vaccine shortages and vaccine hesitancy.

Methods

Persons aged ≥65 years who were vaccinated with 2-dose ChAdOx1 12-24 weeks earlier were randomized to receive a booster vaccination by either ID (20 µg mRNA-1273 or 10 µg BNT162b2) or intramuscular (IM) (100 µg mRNA-1273 or 30 µg BNT162b2) route. Anti-receptor-binding domain (RBD) immunoglobulin G (IgG), neutralizing antibody (NAb), and interferon gamma (IFN-γ)-producing cells were measured at 2-4 weeks following vaccination.

Results

Of 210 participants enrolled, 70.5% were female and median age was 77.5 (interquartile range, 71-84) years. Following booster dose, both ID vaccinations induced 37% lower levels of anti-RBD IgG compared with IM vaccination of the same vaccine. NAb titers against ancestral and Omicron BA.1 were highest following IM mRNA-1273 (geometric mean, 1718 and 617), followed by ID mRNA-1273 (1212 and 318), IM BNT162b2 (713 and 230), and ID BNT162b2 (587 and 148), respectively. Spike-specific IFN-γ responses were similar or higher in the ID groups compared with IM groups. ID route tended to have fewer systemic adverse events (AEs), although more local AEs were reported in the ID mRNA-1273 group.

Conclusions

Fractional ID vaccination induced lower humoral but comparable cellular immunity compared to IM and may be an alternative for older people.

Clinical trials registration

TCTR20220112002.

SUBMITTER: Assantachai P

PROVIDER: S-EPMC10547455 | biostudies-literature | 2023 Oct

REPOSITORIES: biostudies-literature

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Publications

Immunogenicity and Reactogenicity of Messenger RNA Coronavirus Disease 2019 Vaccine Booster Administered by Intradermal or Intramuscular Route in Thai Older Adults.

Assantachai Prasert P Niyomnaitham Suvimol S Chatthanawaree Wichai W Intalapaporn Somboon S Muangpaisan Weerasak W Phannarus Harisd H Saichompoo Rangsimatiti Binda RB Sura-Amonrattana Unchana U Wongprompitak Patimaporn P Toh Zheng Quan ZQ Licciardi Paul V PV Srisutthisamphan Kanjana K Chokephaibulkit Kulkanya K

The Journal of infectious diseases 20231001 7

<h4>Background</h4>Intradermal (ID) vaccination may alleviate COVID-19 vaccine shortages and vaccine hesitancy.<h4>Methods</h4>Persons aged ≥65 years who were vaccinated with 2-dose ChAdOx1 12-24 weeks earlier were randomized to receive a booster vaccination by either ID (20 µg mRNA-1273 or 10 µg BNT162b2) or intramuscular (IM) (100 µg mRNA-1273 or 30 µg BNT162b2) route. Anti-receptor-binding domain (RBD) immunoglobulin G (IgG), neutralizing antibody (NAb), and interferon gamma (IFN-γ)-producing ...[more]

PMID: 37141388

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Project description:BackgroundGeriatric populations are at an increased risk of severe presentations, hospitalization, and loss of life from COVID-19. Few studies have explored vaccination regimens in adults >65 years old. Repeated booster vaccination is required for high-risk populations as COVID-19 vaccine efficacy is short-lived. We compared the immunogenicity and reactogenicity of second intradermal (ID) COVID-19 booster vaccination with second intramuscular (IM) vaccination in older adults.MethodsThis single-center, open-labeled, prospective, cohort study conducted at Siriraj Hospital enrolled older adults ≥65 years old who previously received a first booster (third dose) mRNA vaccine (mRNA-1273 or BNT162b2) via ID or IM administration. Participants were allocated to receive a second booster of the same vaccine type and route as their first booster 16-17 weeks thereafter. Anti-SARS-CoV-2 receptor binding domain IgG and neutralizing antibody titers against Wuhan and Omicron subvariants (BA.1, BA.2, and BA.4/5) were measured 2 weeks after vaccination.ResultsOf 91 enrolled participants, 72.5% were women, with a median age of 75 years. Forty-nine participants (53.8%) received a second ID booster, and 42 (46.2%) received a second IM booster. Two weeks after the second booster, all groups generated anamnestic IgG antibody responses that were 5.41- to 10.00-fold higher than at baseline. Overall, higher antibody GMTs against Wuhan and Omicron subvariants were observed in IM compared with ID regimens. ID mRNA-1273 induced similar GMTs to IM BNT162b2 2 weeks after the second booster against Wuhan (486.77 [321.48, 737.05] vs. 472.63 [291.24, 767.01], respectively; p = 0.072). Higher GMTs against Omicron BA.1 (GMR [95% CI], 1.71 [1.39, 2.11]; p = 0.023), BA.2 (1.34 [1.11, 1.62]; p = 0.845), and BA.4/5 (1.10 [0.92, 1.33]; p = 0.531) were seen in all groups at 2 weeks after the second booster compared with 2-4 weeks after the first booster. Both local and systemic AEs were less frequent after the second than after the first booster, regardless of administrative route and vaccine type. Local AEs were significantly more frequent in ID mRNA-1273 arms than their respective BNT162b2 arms 2 weeks after the second booster (ID-mRNA-1273 vs. ID-BNT162b2: p ≤ 0.001).ConclusionRepeated fractional ID vaccination may be an alternative booster vaccination strategy for geriatric populations.

Project description:BackgroundCurrently, booster dose is needed after 2 doses of non-live COVID-19 vaccine. With limited resources and shortage of COVID-19 vaccines, intradermal(ID) administration might be a potential dose-sparing strategy.ObjectiveTo determine immunologic response and reactogenicity of ID ChAdOx1 nCoV-19 vaccine (AZD1222,Oxford/AstraZeneca) as a booster dose after completion of 2-dose CoronaVac(SV) in healthy adult.MethodsThis is a prospective cohort study of adult aged 18-59 years who received 2-dose SV at 14-35 days apart for more than 2 months. Participants received ID AZD1222 at fractional low dose(1×1010 viral particles,0.1 ml). Antibody responses were evaluated by surrogate virus neutralization test(sVNT) against delta variant and wild type, and anti-spike-receptor-binding-domain immunoglobulin G(anti-S-RBD IgG) at prior, day14, 28, 90, and 180 post booster. Solicited reactogenicity was collected for 7 days post-booster. Primary endpoint was the differences of sVNT against delta strain ≥ 80% inhibition at day14 and 90 compared with the parallel cohort study of 0.5-ml intramuscular(IM) route.ResultsFrom August2021, 100 adults with median age of 46 years(IQR 41-52) participated. Prior to booster, geometric mean(GM) of sVNT against delta strain was 22.4% inhibition(95 %CI 18.7-26.9) and of anti-S-RBD IgG was 109.3 BAU/ml(95.4-125.1). Post ID booster, GMs of sVNT against delta strain were 95.5% inhibition (95%CI 94.2-96.8) at day14, 73.1% inhibition (66.7-80.2) at day90, and 22.7% inhibition (14.9-34.6) at day180. The differences of proportion of participants achieving sVNT against delta strain ≥ 80% inhibition in ID recipients versus IM were + 4.2% (95 %CI -2.0to10.5) at day14, and -37.3%(-54.2to-20.3) at day90. Anti-S-RBD IgG GMs were 2037.1 BAU/ml (95%CI 1770.9-2343.2) at day14 and 744.6 BAU/ml(650.1-852.9) at day90, respectively. Geometric mean ratios(GMRs) of anti-S-RBD IgG were 0.99(0.83-1.20) at day14, and 0.82(0.66-1.02) at day90. Only 18% reported feverish, compared with 37% of IM (p = 0.003). Common reactogenicity was erythema at injection site(53%) while 7% reported blister.ConclusionLow-dose ID AZD1222 booster enhanced lower neutralizing antibodies at 3 months compared with IM route. Less systemic reactogenicity occurred, but higher local reactogenicity.

Dataset Information

Immunogenicity and Reactogenicity of Messenger RNA Coronavirus Disease 2019 Vaccine Booster Administered by Intradermal or Intramuscular Route in Thai Older Adults.

Background

Methods

Results

Conclusions

Clinical trials registration

Publications

Immunogenicity and Reactogenicity of Messenger RNA Coronavirus Disease 2019 Vaccine Booster Administered by Intradermal or Intramuscular Route in Thai Older Adults.

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