Safety and Efficacy of COVID-19 Prime-boost Vaccine in Bahrain

NCT04993560 | Completed DMC

• 1 other identifier: CRT- COVID2021-143
• Study Type: observational
• Target: 305
• Locations: 1 country
• Sites: 1

Brief Summary

Coronavirus disease 2019 (COVID-19) is potentially a deadly disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that targets the lung mainly, resulting in respiratory tract infections in humans. It has developed into a pandemic with serious global public health problems. 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.

Conditions

SARS-CoV 2 Infection; Covid19

Keywords

Safety; Efficacy; Prime-boost vaccine; COVID-19; BBIBP-CorV booster; BNT162b2 booster

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Immunogenicity at 8 weeks

  Antigen-specific humoral immune response will be analyzed using one commercial immunoassay (S, N) and one pseudovirus neutralization assay (sVNT)

  before the reception of the booster dose and on the 8th week after the reception of the booster dose

Secondary Outcomes (1)

• Reactogenicity

  A follow-up call will be made to participants that received booster doses on day 1 and day 5. To review any adverse events a weekly phone call will be made for a total of 8 weeks from the date of recruitment.

Study Arms (2)

Homologous booster

Two doses of BBIBP-CorV, followed by BBIBP-CorV

Biological: BBIBP-CorV

Heterologous booster

Two doses of BBIBP-CorV, followed by BNT162b2

Biological: BNT162b2

Interventions

BBIBP-CorV BIOLOGICAL

Inactivated virus COVID-19 vaccine

Also known as: Sinopharm COVID-19 vaccine

Homologous booster

BNT162b2 BIOLOGICAL

mRNA-based COVID-19 vaccine

Also known as: Pfizer-BioNTech vaccine

Heterologous booster

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults aged ≥21yo. Asymptomatic 24h before the administration of booster dose. Has no active or previous RT-PCR lab-confirmed COVID-19 diagnosis. Tested negative using Rapid Antigen Detection Test on the day of receiving the booster

You may qualify if:

• Adults aged ≥21yo.
• 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.

You may not qualify if:

• Children aged \<21yo.
• 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.

Sponsors & Collaborators

• Royal College of Surgeons in Ireland - Medical University of Bahrain: lead
• The National Taskforce for Combatting COVID-19- Kingdom of Bahrain: collaborator
• Bahrain Defence Force Royal Medical Services: collaborator
• Ministry of Health, Bahrain: collaborator
• Bahrain International Exhibition & Convention Centre: collaborator

Study Sites (1)

Royal College of Surgeons in Ireland - Bahrain

Manama, Bahrain

Location

Related Publications (13)

• 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.

  PMID: 32007143 BACKGROUND

• 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.

  PMID: 31986257 BACKGROUND

• WHO Coronavirus (COVID-19) Dashboard [Internet]. World Health Organization. World Health Organization; [cited 2021Jul1]. Available from: https://covid19.who.int/

  BACKGROUND

• 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.

  PMID: 33069281 BACKGROUND

• https://cdn.who.int/media/docs/default-source/immunization/sage/2021/april/2_sage29apr2021_critical-evidence_sinopharm.pdf

  BACKGROUND

• 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.

  PMID: 33507218 BACKGROUND

• 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.

  PMID: 32730807 BACKGROUND

• 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.

  PMID: 33735608 BACKGROUND

• 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.

  PMID: 10740236 BACKGROUND

• 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.

  PMID: 33991480 BACKGROUND

• 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;

  BACKGROUND

• 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.

  PMID: 34929493 BACKGROUND

• 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.

  PMID: 36725431 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

BIBP COVID-19 vaccine; BNT162 Vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Study Officials

• Manaf AlQahtani, Dr.

  Royal College of Surgeons in Ireland - Bahrain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 6, 2021
• Study Start: July 18, 2021
• Primary Completion: September 17, 2021
• Study Completion: October 19, 2021
• Last Updated: October 26, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Dr Manaf will act as the data custodian and is responsible for the storage, handling and quality of the study data. Data will be collected in the case report form to allow for cross referencing to check validity. Study documents (paper and electronic) will be retained in a secure (kept locked when not in use) location during and after the trial has finished. All essential documents including source documents will be retained for a period of 5 years after study completion (last patient, last study point). A label stating the date after which the documents can be destroyed will be placed on the inside front cover of the case notes of trial participants.
• Access Criteria: Study documents (paper and electronic) will be retained in a secure (kept locked when not in use) location during and after the trial has finished.

Locations

BA (1)