Clinical trial NCT05668065: Immunogenicity of Heterologous Versus Homologous Prime Boost Schedule With mRNA and Inactivated COVID-19 Vaccines
Official title: Immunogenicity of Heterologous Versus Homologous Prime Boost Schedule With mRNA and Inactivated COVID-19 Vaccines: a Single-blinded, Randomized, Parallel Group Superiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COVID-19
Keywords: Vaccine
Immunogenicity
Heterologous prime-boost
Coronavac
Pfizer-BioNtech
Lead sponsor: Institut Pasteur de Tunis
Sponsor class: OTHER
First posted: 2022-12-29
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized simple-blinded comparative phase III clinical trial
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Superiority of the heterologous prime-boost immunization with mRNA vaccine after vaccination with an inactivated vaccine versus homologous immunization with inactivated vaccines
timeFrame: Between day 21 and day 35 after the second dose of vaccination
Secondary outcomes:
measure: Immunogenicity parameters (Neutralizing antibody and IgG antibody titers) between day 21 and day 35
timeFrame: Between day 21 and day 35 after the second dose of vaccination
measure: Immunogenicity parameters (Neutralizing antibody and IgG antibody titers) at day 0 (at baseline)
timeFrame: At day 0 (at baseline)
measure: Immunogenicity parameters (Neutralizing antibody and IgG antibody titers) at day 21 +/- 3 days
timeFrame: At day 21 +/- 3 days after the first dose of vaccination
measure: Safety indexes of adverse reactions at day 30
timeFrame: At day 30 after the second dose of vaccination
Other outcomes:
Locations:
city: Bizerte
country: Tunisia
facility: Leoni factory (Governorate of Bizerte)
state: Mateur
city: Ariana
country: Tunisia
facility: Géant supermarket (Governorate of Ariana)
state: Mnihla
city: Ariana
country: Tunisia
facility: Vaccination center of Ariana
city: Tunis
country: Tunisia
facility: STEG head office (Governorate of Tunis)
city: Tunis
country: Tunisia
facility: Institut Pasteur de Tunis
Study officials:
References:
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