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SARS-CoV 2 InfectionNCT04993560

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

An observational study of SARS-CoV 2 Infection and Covid19, run by Royal College of Surgeons in Ireland - Medical University of Bahrain at 1 site in Bahrain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
SARS-CoV 2 Infection, Covid19
What is being tested?
BBIBP-CorV and BNT162b2
Type of treatment
Vaccines
How many people
305 participants
Where
1 siteBahrain
Study dates
18 Jul 2021to 19 Oct 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Bahrain1 site

  • Royal College of Surgeons in Ireland - Bahrain

    Manama

Other trials in Bahrain

About this study

Official title: Comparing the Safety and Efficacy of Homologous and Heterologous COVID-19 Prime-boost Vaccination in Bahrain

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.

Read the detailed description

According to the World Health Organization COVID-19 Dashboard, the coronavirus disease 2019 pandemic, has caused over 181 million infections and more than 3 million deaths worldwide as of July 1, 2021. 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. This has become a serious concern for public health.

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.

Being tested
BBIBP-CorV, BNT162b2
Keywords
Safety, Efficacy, Prime-boost vaccine, COVID-19, BBIBP-CorV booster, BNT162b2 booster
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BBIBP-CorVBiological

    Also called Sinopharm COVID-19 vaccine

    Inactivated virus COVID-19 vaccine

  • BNT162b2Biological

    Also called Pfizer-BioNTech vaccine

    mRNA-based COVID-19 vaccine

Study groups in NCT04993560
Study groupRoleWhat they receive
Homologous boosterTwo doses of BBIBP-CorV, followed by BBIBP-CorV
Receives: Biological: BBIBP-CorV
Heterologous boosterTwo doses of BBIBP-CorV, followed by BNT162b2
Receives: Biological: BNT162b2

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

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

Secondary outcomes (1)

  1. Reactogenicity

    The intensity of adverse events will be graded according to a 4-grade scale:

    Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), and Grade 4 (life-threatening).

    Reactogenicity symptoms can be:

    Local: (Hardness, Itch, Pain, Warmth, Redness, and Swelling)

    • Systemic: (Chills, Fatigue, Fever, Feverish, Headache, Joint pain, Malaise, Muscle ache, Nausea, Vomiting, Diarrhea)

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2021
  2. Study start18 Jul 2021
  3. Primary completion17 Sep 2021
  4. Study completion19 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Cross-sectional
Enrolment
305 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04993560
Sponsor's protocol ID
CRT- COVID2021-143
Status last verified
Aug 2021
First submitted
4 Aug 2021
Last updated
26 Oct 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Monitoring, audits, and Research Ethics Committee review will be permitted and provide direct access to source data and documents. The Lead PI and the researchers assigned by him will have access to the stored data/specimens. Only the Lead PI and the researchers assigned working on this study will be eligible to obtain the data/specimens from the participants during data collection.

Publications

  • 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.

    PubMed 32007143

  • 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.

    PubMed 31986257

  • 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.

    PubMed 33069281

  • 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.

    PubMed 33507218

  • 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.

    PubMed 32730807

  • 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.

    PubMed 33735608

  • 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.

    PubMed 10740236

  • 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.

    PubMed 33991480

  • 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.

    PubMed 34929493

  • 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.

    PubMed 36725431

Questions about this trial

What is this clinical trial studying?

An observational study of SARS-CoV 2 Infection and Covid19, run by Royal College of Surgeons in Ireland - Medical University of Bahrain at 1 site in Bahrain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bahrain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Immunogenicity at 8 weeks (time frame: before the reception of the booster dose and on the 8th week after the reception of the booster dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04993560, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2021.

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