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COVID-19Phase 3NCT05668065

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

A Phase 3 study testing CoronaVac/CoronaVac and CoronaVac/BNT162b2 in people with COVID-19, run by Institut Pasteur de Tunis at 5 sites in Tunisia.

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

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). Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
CoronaVac/CoronaVac and CoronaVac/BNT162b2
Could I receive a placebo?
No, everyone receives an active treatment
How many people
199 participants
Where
5 sitesTunisia
Study dates
22 Nov 2021to 25 Jun 2022
Phase
Phase 3
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 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Tunisia5 sites

  • Géant supermarket (Governorate of Ariana)

    Aryanah, Mnihla, 2094

  • Vaccination center of Ariana

    Aryanah, 2080

  • Leoni factory (Governorate of Bizerte)

    Bizerte, Mateur, 7030

  • STEG head office (Governorate of Tunis)

    Tunis, 1000

  • Institut Pasteur de Tunis

    Tunis, 1002

Other trials in Tunisia

About this study

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

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.

Read the 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.

Conditions
COVID-19
Being tested
CoronaVac/CoronaVac, CoronaVac/BNT162b2
Keywords
Vaccine, Immunogenicity, Heterologous prime-boost, Coronavac, Pfizer-BioNtech
Medical subject headings
COVID-19

What participants receive

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

  • CoronaVac/CoronaVacBiological

    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.

  • CoronaVac/BNT162b2Biological

    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

Study groups in NCT05668065
Study groupRoleWhat they receive
CoronaVac/CoronaVacExperimentalBiological: 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.
Receives: Biological: CoronaVac/CoronaVac
CoronaVac/BNT162b2Active comparatorBiological: 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.
Receives: Biological: CoronaVac/BNT162b2

What is being measured

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

  1. Superiority of the heterologous prime-boost immunization with mRNA vaccine after vaccination with an inactivated vaccine versus homologous immunization with inactivated vaccines

    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.

    Measured: Between day 21 and day 35 after the second dose of vaccination

Secondary outcomes (4)

  1. Immunogenicity parameters (Neutralizing antibody and IgG antibody titers) between day 21 and day 35

    The level of neutralizing antibodies and anti-spike IgG antibody responses

    Measured: Between day 21 and day 35 after the second dose of vaccination

  2. Immunogenicity parameters (Neutralizing antibody and IgG antibody titers) at day 0 (at baseline)

    The level of neutralizing antibodies and anti-spike IgG antibody responses

    Measured: At day 0 (at baseline)

  3. Immunogenicity parameters (Neutralizing antibody and IgG antibody titers) at day 21 +/- 3 days

    The level of neutralizing antibodies and anti-spike IgG antibody responses

    Measured: At day 21 +/- 3 days after the first dose of vaccination

  4. Safety indexes of adverse reactions at day 30

    The incidence of adverse reactions at day 30 of the second dose of vaccination

    Measured: At day 30 after the second dose of vaccination

Timeline

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

  1. First posted29 Dec 2022
  2. Study start22 Nov 2021
  3. Primary completion31 Jan 2022
  4. Study completion25 Jun 2022

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized simple-blinded comparative phase III clinical trial
Masking
Single blind
Who is masked
Participant
Enrolment
199 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05668065
Sponsor's protocol ID
TN2021-NAT-INS-70
Status last verified
Jan 2023
First submitted
27 Dec 2022
Last updated
5 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Tanriover MD, Doganay HL, Akova M, Guner HR, Azap A, Akhan S, Kose S, Erdinc FS, Akalin EH, Tabak OF, Pullukcu H, Batum O, Simsek Yavuz S, Turhan O, Yildirmak MT, Koksal I, Tasova Y, Korten V, Yilmaz G, Celen MK, Altin S, Celik I, Bayindir Y, Karaoglan I, Yilmaz A, Ozkul A, Gur H, Unal S; CoronaVac Study Group. Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey. Lancet. 2021 Jul 17;398(10296):213-222. doi: 10.1016/S0140-6736(21)01429-X. Epub 2021 Jul 8.

    PubMed 34246358

  • Khoury DS, Cromer D, Reynaldi A, Schlub TE, Wheatley AK, Juno JA, Subbarao K, Kent SJ, Triccas JA, Davenport MP. Neutralizing antibody levels are highly predictive of immune protection from symptomatic SARS-CoV-2 infection. Nat Med. 2021 Jul;27(7):1205-1211. doi: 10.1038/s41591-021-01377-8. Epub 2021 May 17.

    PubMed 34002089

  • Souza WM, Amorim MR, Sesti-Costa R, Coimbra LD, Brunetti NS, Toledo-Teixeira DA, de Souza GF, Muraro SP, Parise PL, Barbosa PP, Bispo-Dos-Santos K, Mofatto LS, Simeoni CL, Claro IM, Duarte ASS, Coletti TM, Zangirolami AB, Costa-Lima C, Gomes ABSP, Buscaratti LI, Sales FC, Costa VA, Franco LAM, Candido DS, Pybus OG, de Jesus JG, Silva CAM, Ramundo MS, Ferreira GM, Pinho MC, Souza LM, Rocha EC, Andrade PS, Crispim MAE, Maktura GC, Manuli ER, Santos MNN, Camilo CC, Angerami RN, Moretti ML, Spilki FR, Arns CW, Addas-Carvalho M, Benites BD, Vinolo MAR, Mori MAS, Gaburo N, Dye C, Marques-Souza H, Marques RE, Farias AS, Diamond MS, Faria NR, Sabino EC, Granja F, Proenca-Modena JL. Neutralisation of SARS-CoV-2 lineage P.1 by antibodies elicited through natural SARS-CoV-2 infection or vaccination with an inactivated SARS-CoV-2 vaccine: an immunological study. Lancet Microbe. 2021 Oct;2(10):e527-e535. doi: 10.1016/S2666-5247(21)00129-4. Epub 2021 Jul 8.

    PubMed 34258603

  • Vacharathit V, Aiewsakun P, Manopwisedjaroen S, Srisaowakarn C, Laopanupong T, Ludowyke N, Phuphuakrat A, Setthaudom C, Ekronarongchai S, Srichatrapimuk S, Wongsirisin P, Sangrajrang S, Imsuwansri T, Kirdlarp S, Nualkaew S, Sensorn I, Sawaengdee W, Wichukchinda N, Sungkanuparph S, Chantratita W, Kunakorn M, Rojanamatin J, Hongeng S, Thitithanyanont A. CoronaVac induces lower neutralising activity against variants of concern than natural infection. Lancet Infect Dis. 2021 Oct;21(10):1352-1354. doi: 10.1016/S1473-3099(21)00568-5. Epub 2021 Aug 26. No abstract available.

    PubMed 34454652

  • Lim WW, Mak L, Leung GM, Cowling BJ, Peiris M. Comparative immunogenicity of mRNA and inactivated vaccines against COVID-19. Lancet Microbe. 2021 Sep;2(9):e423. doi: 10.1016/S2666-5247(21)00177-4. Epub 2021 Jul 16. No abstract available.

    PubMed 34308395

  • 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

  • Borobia AM, Carcas AJ, Perez-Olmeda M, Castano L, Bertran MJ, Garcia-Perez J, Campins M, Portoles A, Gonzalez-Perez M, Garcia Morales MT, Arana-Arri E, Aldea M, Diez-Fuertes F, Fuentes I, Ascaso A, Lora D, Imaz-Ayo N, Baron-Mira LE, Agusti A, Perez-Ingidua C, Gomez de la Camara A, Arribas JR, Ochando J, Alcami J, Belda-Iniesta C, Frias J; CombiVacS Study Group. Immunogenicity and reactogenicity of BNT162b2 booster in ChAdOx1-S-primed participants (CombiVacS): a multicentre, open-label, randomised, controlled, phase 2 trial. Lancet. 2021 Jul 10;398(10295):121-130. doi: 10.1016/S0140-6736(21)01420-3. Epub 2021 Jun 25.

    PubMed 34181880

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CoronaVac/CoronaVac and CoronaVac/BNT162b2 in people with COVID-19, run by Institut Pasteur de Tunis at 5 sites in Tunisia.

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 3 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 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Tunisia. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

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). 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 NCT05668065, which also lists 7 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 5 Jan 2023.

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