Immunogenicity of Heterologous Versus Homologous Prime Boost Schedule With mRNA and Inactivated COVID-19 Vaccines

January 4, 2023 updated by: Samar Samoud, Institut Pasteur de Tunis

Immunogenicity of Heterologous Versus Homologous Prime Boost Schedule With mRNA and Inactivated COVID-19 Vaccines: a Single-blinded, Randomized, Parallel Group Superiority Trial

This study is a randomized, simple-blinded comparative phase III clinical trial comparing the immunogenicity of two doses Coronovac to that of a first dose of Coronovac (Sinovac, Beijing, China) followed by a booster shot with the mRNA-based BNT162b2 SARS-CoV-2 vaccine (Comirnaty, Pfizer-BioNTech).

The purpose of this study is to evaluate the superiority, safety and immunogenicity of the heterologous prime-boost CoronaVac/BNT162b2 vaccination to the homologous CoronaVac/CoronaVac regimen.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized simple-blinded comparative phase III clinical trial in COVID-19 vaccine naïve volunteers adults aged between 18 and 60 years. The purpose of this study is to evaluate the superiority, safety and immunogenicity of the heterologous prime-boost CoronaVac/BNT162b2 vaccination to the homologous CoronaVac/CoronaVac regimen. The study is conducted in four different sites located in the North of Tunisia.

A total of 240 eligible participants were included. Among them, the primary end point data were available for 100 participants randomly allocated to heterologous boost group versus 99 participants randomly allocated to homologous boost dose group.

Participants are assigned to receive either two injections of the CoronaVac vaccine (1st and 2nd vaccine), or CoronaVac as 1st dose and Pfizer as 2nd dose in 3 to 4 weeks interval.

A blood sample (5ml of the whole blood) is collected for each participant at the vaccination center before the first dose injection. After verifying the absence of a SARS-CoV-2 infection during the interrogation (a follow-up survey), a 2nd blood sample (5ml of whole blood) is taken for each participant at the vaccination center before the second dose injection. After the two injections, a 3rd blood sample (5ml of whole blood) will be taken for each participant between day 21 and day 35 after the second dose. Data collection and all samples are treated at Institute Pasteur of Tunis.

Study Type

Interventional

Enrollment (Actual)

199

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Ariana, Tunisia, 2080
        • Vaccination center of Ariana
      • Tunis, Tunisia, 1000
        • STEG head office (Governorate of Tunis)
      • Tunis, Tunisia, 1002
        • Institut Pasteur de Tunis
    • Mateur
      • Bizerte, Mateur, Tunisia, 7030
        • Leoni factory (Governorate of Bizerte)
    • Mnihla
      • Ariana, Mnihla, Tunisia, 2094
        • Géant supermarket (Governorate of Ariana)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Acceptance to participate in the study.
  • Age: 18-60 years old.

Non-inclusion criteria:

  • Presence of disability (mainly mental disability).
  • Pregnancy.
  • Patients under immunosuppressive treatment or immunocompromised individuals.
  • Prior Covid-19 infection.

Exclusion Criteria:

  • Occurrence of a serious adverse event (death, anaphylactic shock, ...).
  • Subjects wishing to withdraw from the study.
  • Occurrence of a SARS-CoV-2 symptomatic infection during the follow-up period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CoronaVac/CoronaVac
Biological: Coronavac Two doses at 21-day +/- 3 days. Each innoculation dose is 0.5 ml containing 600 SU in-house unit (equals to 3μg) of SARS-CoV-2 antigen.
Biological: CoronaVac/CoronaVac
Two doses at 21-day +/- 3 days. Each innoculation dose is 0.5 ml containing 600 SU in-house unit (equals to 3μg) of SARS-CoV-2 antigen.
Active Comparator: CoronaVac/BNT162b2

Biological: CoronaVac/BNT162b2 First dose of Coronavac. Each innoculation dose is 0.5 ml containing 600 SU in-house unit (equals to 3μg) of SARS-CoV-2 antigen.

Second dose of BNT162b2 at 21-day +/- 3 days. Each dose of the Pfizer-BioNTech COVID-19 Vaccine is 0.3 ml. Each prefilled syringe contains 30 mcg of a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2.
Biological: CoronaVac/BNT162b2

First dose of Coronavac. Each innoculation dose is 0.5 ml containing 600 SU in-house unit (equals to 3μg) of SARS-CoV-2 antigen.

Second dose of BNT162b2 at 21-day +/- 3 days. Each dose of the Pfizer-BioNTech COVID-19 Vaccine is 0.3 ml. Each prefilled syringe contains 30 mcg of a nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Superiority of the heterologous prime-boost immunization with mRNA vaccine after vaccination with an inactivated vaccine versus homologous immunization with inactivated vaccines
Time Frame: Between day 21 and day 35 after the second dose of vaccination
The primary end point for immunogenicity was the serum neutralizing antibody level with a percentage of inhibition at 90% at 21-35 days after boost. A difference of 25% between groups was considered clinically relevant.
Between day 21 and day 35 after the second dose of vaccination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunogenicity parameters (Neutralizing antibody and IgG antibody titers) between day 21 and day 35
Time Frame: Between day 21 and day 35 after the second dose of vaccination
The level of neutralizing antibodies and anti-spike IgG antibody responses
Between day 21 and day 35 after the second dose of vaccination
Immunogenicity parameters (Neutralizing antibody and IgG antibody titers) at day 0 (at baseline)
Time Frame: At day 0 (at baseline)
The level of neutralizing antibodies and anti-spike IgG antibody responses
At day 0 (at baseline)
Immunogenicity parameters (Neutralizing antibody and IgG antibody titers) at day 21 +/- 3 days
Time Frame: At day 21 +/- 3 days after the first dose of vaccination
The level of neutralizing antibodies and anti-spike IgG antibody responses
At day 21 +/- 3 days after the first dose of vaccination
Safety indexes of adverse reactions at day 30
Time Frame: At day 30 after the second dose of vaccination
The incidence of adverse reactions at day 30 of the second dose of vaccination
At day 30 after the second dose of vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Pasteur de Tunis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2021

Primary Completion (Actual)

January 31, 2022

Study Completion (Actual)

June 25, 2022

Study Registration Dates

First Submitted

December 27, 2022

First Submitted That Met QC Criteria

December 27, 2022

First Posted (Actual)

December 29, 2022

Study Record Updates

Last Update Posted (Actual)

January 5, 2023

Last Update Submitted That Met QC Criteria

January 4, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TN2021-NAT-INS-70

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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