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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04993560
• Other study ID #: CRT- COVID2021-143
• Status: Completed
• Start date: July 18, 2021
• Est. completion date: October 19, 2021

Study information

• Verified date: August 2021
• Source: Royal College of Surgeons in Ireland - Medical University of Bahrain
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 305
• Est. completion date: October 19, 2021
• Est. primary completion date: September 17, 2021
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• COVID-19
• Covid19
• SARS-CoV 2 Infection

Intervention

Biological:
• BBIBP-CorV
Inactivated virus COVID-19 vaccine
• BNT162b2
mRNA-based COVID-19 vaccine

Locations

Country	Name	City	State
Bahrain	Royal College of Surgeons in Ireland - Bahrain	Manama

Sponsors (5)

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

Country where clinical trial is conducted

Bahrain, 

References & Publications (12)

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. — View Citation

Groß R, Zanoni M, Seidel A, Conzelmann C, Gilg A, Krnavek D, et al. Heterologous ChAdOx1 nCoV-19 and BNT162b2 prime-boost vaccination elicits potent neutralizing antibody responses and T cell reactivity. 2021;

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

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. — View Citation

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. — View Citation

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. — View Citation

Ramshaw IA, Ramsay AJ. The prime-boost strategy: exciting prospects for improved vaccination. Immunol Today. 2000 Apr;21(4):163-5. Review. — View Citation

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;

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. Erratum in: Lancet. 2021 May 18;:. — View Citation

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. Erratum in: Lancet. 2020 Jan 29;:. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	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.