Immunogenicity and Safety of a Recombinant COVID-19 Vaccine (ZF2001) As Heterologous Booster After Priming with Inactivated Vaccine in Healthy Children and Adolescents Aged 3-17 Years: an Open-labeled, Single-arm Clinical Trial

Overview

Journal BMC Infect Dis

Publisher Biomed Central

Specialty Infectious Diseases

Date 2024 Apr 19

PMID 38641791

Authors

Tao Huang

Qianqian Hu

Xiang Zhou

Huaiyu Yang

Wei Xia

Feng Cao

Minglu Deng

Xiaoxue Teng

Fan Ding

Zaixin Zhong

Lidong Gao

Jiufeng Sun

Lihui Gong

Affiliations

Soon will be listed here.

Abstract

Considering that neutralizing antibody levels induced by two doses of the inactivated vaccine decreased over time and had fallen to low levels by 6 months, and homologous and heterologous booster immunization programs have been implemented in adults in China. The booster immunization of recombinant COVID-19 vaccine (ZF2001) after priming with inactivated vaccine in healthy children and adolescents has not been reported. We performed an open-labeled, single-arm clinical trial to evaluate the safety and immunogenicity of heterologous booster immunization with ZF2001 after priming with inactivated vaccine among 240 population aged 3-17 years in China. The primary outcome was immunogenicity, including geometric mean titers (GMTs), geometric mean ratios (GMRs) and seroconversion rates of SARS-CoV-2 neutralizing antibodies against prototype SARS-CoV-2 and Omicron BA.2 variant at 14 days after vaccination booster. On day 14 post-booster, a third dose booster of the ZF2001 provided a substantial increase in antibody responses in minors, and the overall occurrence rate of adverse reactions after heterologous vaccination was low and all adverse reactions were mild or moderate. The results showed that the ZF2001 heterologous booster had high immunogenicity and good safety profile in children and adolescents, and can elicit a certain level of neutralizing antibodies against Omicron.Trial registration NCT05895110 (Retrospectively registered, First posted in ClinicalTrials.gov date: 08/06/2023).

Citing Articles

Immunogenicity and Safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (IndoVac) as a Heterologous Booster Dose against COVID-19 in Indonesian Adolescents.

Fadlyana E, Rusmil K, Dwi Putra M, Fulendry F, Somantri N, Putri A Vaccines (Basel). 2024; 12(8).

PMID: 39204062 PMC: 11360245. DOI: 10.3390/vaccines12080938.

References

Vadrevu K, Reddy S, Jogdand H, Ganneru B, Mirza N, Tripathy V . Immunogenicity and reactogenicity of an inactivated SARS-CoV-2 vaccine (BBV152) in children aged 2-18 years: interim data from an open-label, non-randomised, age de-escalation phase 2/3 study. Lancet Infect Dis. 2022; 22(9):1303-1312. PMC: 9212880. DOI: 10.1016/S1473-3099(22)00307-3. View

Zhang Y, Ma X, Yan G, Wu Y, Chen Y, Zhou Z . Immunogenicity, durability, and safety of an mRNA and three platform-based COVID-19 vaccines as a third dose following two doses of CoronaVac in China: A randomised, double-blinded, placebo-controlled, phase 2 trial. EClinicalMedicine. 2022; 54:101680. PMC: 9517939. DOI: 10.1016/j.eclinm.2022.101680. View

Li J, Wu S, Guo X, Tang R, Huang B, Chen X . Safety and immunogenicity of heterologous boost immunisation with an orally administered aerosolised Ad5-nCoV after two-dose priming with an inactivated SARS-CoV-2 vaccine in Chinese adults: a randomised, open-label, single-centre trial. Lancet Respir Med. 2022; 10(8):739-748. PMC: 9122540. DOI: 10.1016/S2213-2600(22)00087-X. View

Jia Z, Wang K, Xie M, Wu J, Hu Y, Zhou Y . A third dose of inactivated vaccine augments the potency, breadth, and duration of anamnestic responses against SARS-CoV-2. Protein Cell. 2024; 15(12):930-937. PMC: 11637481. DOI: 10.1093/procel/pwae033. View

Ai J, Zhang H, Zhang Y, Lin K, Zhang Y, Wu J . Omicron variant showed lower neutralizing sensitivity than other SARS-CoV-2 variants to immune sera elicited by vaccines after boost. Emerg Microbes Infect. 2021; 11(1):337-343. PMC: 8788341. DOI: 10.1080/22221751.2021.2022440. View

Wang L, Wu Z, Ying Z, Li M, Hu Y, Shu Q . Safety and immunogenicity following a homologous booster dose of CoronaVac in children and adolescents. Nat Commun. 2022; 13(1):6952. PMC: 9663200. DOI: 10.1038/s41467-022-34280-y. View

Zhu F, Jin P, Zhu T, Wang W, Ye H, Pan H . Safety and Immunogenicity of a Recombinant Adenovirus Type-5-Vectored Coronavirus Disease 2019 (COVID-19) Vaccine With a Homologous Prime-Boost Regimen in Healthy Participants Aged ≥6 Years: A Randomized, Double-Blind, Placebo-Controlled, Phase 2b.... Clin Infect Dis. 2021; 75(1):e783-e791. PMC: 8522421. DOI: 10.1093/cid/ciab845. View

Cao Y, Hao X, Wang X, Wu Q, Song R, Zhao D . Humoral immunogenicity and reactogenicity of CoronaVac or ZF2001 booster after two doses of inactivated vaccine. Cell Res. 2021; 32(1):107-109. PMC: 8640508. DOI: 10.1038/s41422-021-00596-5. View

Zeng G, Wu Q, Pan H, Li M, Yang J, Wang L . Immunogenicity and safety of a third dose of CoronaVac, and immune persistence of a two-dose schedule, in healthy adults: interim results from two single-centre, double-blind, randomised, placebo-controlled phase 2 clinical trials. Lancet Infect Dis. 2021; 22(4):483-495. PMC: 8651254. DOI: 10.1016/S1473-3099(21)00681-2. View

10.

Clemens S, Weckx L, Clemens R, Mendes A, Ramos Souza A, Silveira M . Heterologous versus homologous COVID-19 booster vaccination in previous recipients of two doses of CoronaVac COVID-19 vaccine in Brazil (RHH-001): a phase 4, non-inferiority, single blind, randomised study. Lancet. 2022; 399(10324):521-529. PMC: 8782575. DOI: 10.1016/S0140-6736(22)00094-0. View

11.

Ai J, Zhang H, Zhang Q, Zhang Y, Lin K, Fu Z . Recombinant protein subunit vaccine booster following two-dose inactivated vaccines dramatically enhanced anti-RBD responses and neutralizing titers against SARS-CoV-2 and Variants of Concern. Cell Res. 2021; 32(1):103-106. PMC: 8609258. DOI: 10.1038/s41422-021-00590-x. View

12.

Li J, Hou L, Guo X, Jin P, Wu S, Zhu J . Heterologous AD5-nCOV plus CoronaVac versus homologous CoronaVac vaccination: a randomized phase 4 trial. Nat Med. 2022; 28(2):401-409. PMC: 8863573. DOI: 10.1038/s41591-021-01677-z. View

13.

Al Kaabi N, Yang Y, Du L, Xu K, Shao S, Liang Y . Safety and immunogenicity of a hybrid-type vaccine booster in BBIBP-CorV recipients in a randomized phase 2 trial. Nat Commun. 2022; 13(1):3654. PMC: 9237056. DOI: 10.1038/s41467-022-31379-0. View

14.

Wang X, Mahmood S, Jin F, Cheah W, Ahmad M, Sohail M . Efficacy of heterologous boosting against SARS-CoV-2 using a recombinant interferon-armed fusion protein vaccine (V-01): a randomized, double-blind and placebo-controlled phase III trial. Emerg Microbes Infect. 2022; 11(1):1910-1919. PMC: 9347473. DOI: 10.1080/22221751.2022.2088406. View

15.

Nemet I, Kliker L, Lustig Y, Zuckerman N, Erster O, Cohen C . Third BNT162b2 Vaccination Neutralization of SARS-CoV-2 Omicron Infection. N Engl J Med. 2021; 386(5):492-494. PMC: 8823651. DOI: 10.1056/NEJMc2119358. View

16.

Liao Y, Chen Y, Chen B, Liang Z, Hu X, Xing B . Safety and immunogenicity of heterologous recombinant protein subunit vaccine (ZF2001) booster against COVID-19 at 3-9-month intervals following two-dose inactivated vaccine (CoronaVac). Front Immunol. 2022; 13:1017590. PMC: 9679005. DOI: 10.3389/fimmu.2022.1017590. View

17.

Han B, Song Y, Li C, Yang W, Ma Q, Jiang Z . Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy children and adolescents: a double-blind, randomised, controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021; 21(12):1645-1653. PMC: 8238449. DOI: 10.1016/S1473-3099(21)00319-4. View

18.

Gao L, Li Y, He P, Chen Z, Yang H, Li F . Safety and immunogenicity of a protein subunit COVID-19 vaccine (ZF2001) in healthy children and adolescents aged 3-17 years in China: a randomised, double-blind, placebo-controlled, phase 1 trial and an open-label, non-randomised, non-inferiority,.... Lancet Child Adolesc Health. 2023; 7(4):269-279. PMC: 9937662. DOI: 10.1016/S2352-4642(22)00376-5. View

19.

Liu X, Li Y, Wang Z, Cao S, Huang W, Yuan L . Safety and superior immunogenicity of heterologous boosting with an RBD-based SARS-CoV-2 mRNA vaccine in Chinese adults. Cell Res. 2022; 32(8):777-780. PMC: 9197092. DOI: 10.1038/s41422-022-00681-3. View

20.

Xia S, Zhang Y, Wang Y, Wang H, Yang Y, Gao G . Safety and immunogenicity of an inactivated COVID-19 vaccine, BBIBP-CorV, in people younger than 18 years: a randomised, double-blind, controlled, phase 1/2 trial. Lancet Infect Dis. 2021; 22(2):196-208. PMC: 8443232. DOI: 10.1016/S1473-3099(21)00462-X. View