Safety and Efficacy of COVID-19 Prime-boost Vaccine in Bahrain
NCT ID: NCT04993560
Last Updated: 2021-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
305 participants
OBSERVATIONAL
2021-07-18
2021-10-19
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Recent research has shown that the new SARS-CoV-2 variants reduces the efficacy of the vaccinations and are predominantly more transmissible or infective. A few countries namely Bahrain, United Arab Emirates, and Turkey have recently started introducing a booster dose following primary two doses of the COVID-19 immunization series.
This study aims to identify which booster dose is more effective; taking a booster dose from the same vaccine initially taken or a booster dose from a different vaccine than initially taken.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Among the currently approved COVID-19 vaccines in the Kingdom of Bahrain, BBIBP-CorV (inactivated virus) vaccine and BNT162b2 (mRNA vaccine) is being administered to the population.
Inactivated vaccines have been extensively studied. In a phase 1/2 trial, the BBIBP-CorV vaccine has shown to be generally safe against COVID-19 and induce antibody responses. However, WHO's Strategic Advisory Group of Experts (SAGE) experts have summarized information from clinical trials in Bahrain, United Arab Emirates, Egypt, Jordan, and China indicating that individuals with comorbidities and older adults (≥60 years) who received 2 doses of BBIBP-CorV have low confidence in the efficacy of preventing COVID-19.
Current clinical trials have played a key role in the approval of different COVID vaccines based on their efficacy data, however, there is still uncertainty regarding the duration of protection from these vaccines towards the COVID -19 virus. Recent evidence has shown that the new SARS-CoV-2 variants reduces the efficacy of the vaccinations and are predominantly more transmissible or infective.
A few countries namely Bahrain, United Arab Emirates, and Turkey have recently started introducing a booster dose following primary two doses of the COVID-19 immunization series. The enhanced humoral response has been seen in homologous vaccination. Heterologous vaccination has shown to significantly induce more immunogenicity than homologous vector boost, and higher or comparable to the homologous mRNA regimens. Strong humoral and immune response has also been induced by heterologous vector-mRNA boosting with an acceptable reactogenicity profile.
To our knowledge, there has been no research conducted to date on the reactogenic and immunogenetic response of a COVID-19 booster dose after completing the primary two doses of the COVID-19 immunization series. This study will compare the reactogenic and immunogenetic response of heterologous BNT162b2 booster dose after completing two doses of BBIBP-CorV vaccination versus homologous BBIBP-CorV booster after completing two doses of BBIBP-CorV vaccination.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
ECOLOGIC_OR_COMMUNITY
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Homologous booster
Two doses of BBIBP-CorV, followed by BBIBP-CorV
BBIBP-CorV
Inactivated virus COVID-19 vaccine
Heterologous booster
Two doses of BBIBP-CorV, followed by BNT162b2
BNT162b2
mRNA-based COVID-19 vaccine
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BBIBP-CorV
Inactivated virus COVID-19 vaccine
BNT162b2
mRNA-based COVID-19 vaccine
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Asymptomatic 24h before the administration of booster dose.
* Has no active or previous RT-PCR lab-confirmed COVID-19 diagnosis.
* Completed three months to six months after the second dose of BBIBP-CorV.
* Have at least one Antibody test done before receiving the BBIBP-CorV booster dose OR can be done if the participant is yet to receive the BNT162b2 booster dose.
* Tested negative using Rapid Antigen Detection Test on the day of receiving the booster (positive results will confirm with RT-PCR).
* Study participants must have the ability to give informed consent.
Exclusion Criteria
* Symptomatic within 24h before the administration of booster dose.
* Has active or previous RT-PCR lab-confirmed COVID-19 diagnosis.
* Did not complete three months to six months after the second dose of BBIBP-CorV.
* Does not have at least one Antibody test done before receiving the BBIBP-CorV booster dose
* Tested positive using Rapid Antigen Detection Test on the day of receiving the booster (positive results will be confirmed with PCR).
* Patients unable to give informed consent.
21 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The National Taskforce for Combatting COVID-19- Kingdom of Bahrain
UNKNOWN
Bahrain Defence Force Royal Medical Services
UNKNOWN
Ministry of Health, Bahrain
OTHER_GOV
Bahrain International Exhibition & Convention Centre
UNKNOWN
Royal College of Surgeons in Ireland - Medical University of Bahrain
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Manaf AlQahtani, Dr.
Role: PRINCIPAL_INVESTIGATOR
Royal College of Surgeons in Ireland - Bahrain
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Royal College of Surgeons in Ireland - Bahrain
Manama, , Bahrain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.
Wang C, Horby PW, Hayden FG, Gao GF. A novel coronavirus outbreak of global health concern. Lancet. 2020 Feb 15;395(10223):470-473. doi: 10.1016/S0140-6736(20)30185-9. Epub 2020 Jan 24. No abstract available.
WHO Coronavirus (COVID-19) Dashboard [Internet]. World Health Organization. World Health Organization; [cited 2021Jul1]. Available from: https://covid19.who.int/
Xia S, Zhang Y, Wang Y, Wang H, Yang Y, Gao GF, Tan W, Wu G, Xu M, Lou Z, Huang W, Xu W, Huang B, Wang H, Wang W, Zhang W, Li N, Xie Z, Ding L, You W, Zhao Y, Yang X, Liu Y, Wang Q, Huang L, Yang Y, Xu G, Luo B, Wang W, Liu P, Guo W, Yang X. Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial. Lancet Infect Dis. 2021 Jan;21(1):39-51. doi: 10.1016/S1473-3099(20)30831-8. Epub 2020 Oct 15.
https://cdn.who.int/media/docs/default-source/immunization/sage/2021/april/2_sage29apr2021_critical-evidence_sinopharm.pdf
Moore JP, Offit PA. SARS-CoV-2 Vaccines and the Growing Threat of Viral Variants. JAMA. 2021 Mar 2;325(9):821-822. doi: 10.1001/jama.2021.1114. No abstract available.
Li Q, Wu J, Nie J, Zhang L, Hao H, Liu S, Zhao C, Zhang Q, Liu H, Nie L, Qin H, Wang M, Lu Q, Li X, Sun Q, Liu J, Zhang L, Li X, Huang W, Wang Y. The Impact of Mutations in SARS-CoV-2 Spike on Viral Infectivity and Antigenicity. Cell. 2020 Sep 3;182(5):1284-1294.e9. doi: 10.1016/j.cell.2020.07.012. Epub 2020 Jul 17.
Li Q, Nie J, Wu J, Zhang L, Ding R, Wang H, Zhang Y, Li T, Liu S, Zhang M, Zhao C, Liu H, Nie L, Qin H, Wang M, Lu Q, Li X, Liu J, Liang H, Shi Y, Shen Y, Xie L, Zhang L, Qu X, Xu W, Huang W, Wang Y. SARS-CoV-2 501Y.V2 variants lack higher infectivity but do have immune escape. Cell. 2021 Apr 29;184(9):2362-2371.e9. doi: 10.1016/j.cell.2021.02.042. Epub 2021 Feb 23.
Ramshaw IA, Ramsay AJ. The prime-boost strategy: exciting prospects for improved vaccination. Immunol Today. 2000 Apr;21(4):163-5. doi: 10.1016/s0167-5699(00)01612-1. No abstract available.
Shaw RH, Stuart A, Greenland M, Liu X, Nguyen Van-Tam JS, Snape MD; Com-COV Study Group. Heterologous prime-boost COVID-19 vaccination: initial reactogenicity data. Lancet. 2021 May 29;397(10289):2043-2046. doi: 10.1016/S0140-6736(21)01115-6. Epub 2021 May 12. No abstract available.
Schmidt T, Klemis V, Schub D, Mihm J, Hielscher F, Marx S, et al. Immunogenicity and reactogenicity of a heterologous COVID-19 prime-boost vaccination compared with homologous vaccine regimens. 2021;
Gross R, Zanoni M, Seidel A, Conzelmann C, Gilg A, Krnavek D, Erdemci-Evin S, Mayer B, Hoffmann M, Pohlmann S, Liu W, Hahn BH, Beil A, Kroschel J, Jahrsdorfer B, Schrezenmeier H, Kirchhoff F, Munch J, Muller JA. Heterologous ChAdOx1 nCoV-19 and BNT162b2 prime-boost vaccination elicits potent neutralizing antibody responses and T cell reactivity against prevalent SARS-CoV-2 variants. EBioMedicine. 2022 Jan;75:103761. doi: 10.1016/j.ebiom.2021.103761. Epub 2021 Dec 17.
Mallah SI, Alawadhi A, Jawad J, Wasif P, Alsaffar B, Alalawi E, Mohamed AM, Butler AE, Alalawi B, Qayed D, Almahari SA, Mubarak A, Mubarak A, Saeed S, Humaidan A, Kumar N, Atkin S, Alqahtani M. Safety and efficacy of COVID-19 prime-boost vaccinations: Homologous BBIBP-CorV versus heterologous BNT162b2 boosters in BBIBP-CorV-primed individuals. Vaccine. 2023 Mar 17;41(12):1925-1933. doi: 10.1016/j.vaccine.2023.01.032. Epub 2023 Jan 23.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CRT- COVID2021-143
Identifier Type: -
Identifier Source: org_study_id