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AzTrials

COVID-19Phase 2NCT04979949

Booster Vaccination Against COVID-19

A Phase 2 study testing CoronaVac and Turkovac in people with COVID-19 and Sars-CoV-2 Infection, run by Health Institutes of Turkey at 4 sites in Turkey (Türkiye).

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

A booster dose of vaccine (Turkovac or CoronaVac) will be administered to subjects who have passed at least 90 days and at most 270 days after the second dose of the first course of CoronaVac vaccine. 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, Sars-CoV-2 Infection
What is being tested?
CoronaVac and Turkovac
Could I receive a placebo?
No, everyone receives an active treatment
How many people
222 participants
Where
4 sitesTurkey (Türkiye)
Study dates
12 Jul 2021to 6 Jun 2022
Phase
Phase 2
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

  • Signed informed consent
  • Healthy male or female aged 18 - 60 years (including both groups)
  • Subjects who were vaccinated with CoronaVac for 2 doses and who had a minimum of 90 days and a maximum of 270 days after the second dose
  • Subjects may have a controlled or moderate comorbidity
  • Female subjects of childbearing potential should be willing to ensure that they or their partner use effective birth control methods continuously from 1 month before and up to 3 months after vaccination
  • Subjects agreed to comply with all study requirements
  • Subjects are willing to share their medical history with their physician and allow access to all medical records when relevant to study procedures
  • Subjects are willing to agree to abstain from donating blood during the study

Who cannot join

  • Subjects meeting any of the following criteria will be excluded from the study:
  • Administration of any vaccine (registered or investigational) other than study intervention within 30 days before and after each study vaccine (one week for authorized seasonal flu vaccine or pneumococcal vaccine)
  • Positive for COVID-19 after primary vaccination
  • Pre-or planned use of another vaccine or product likely to affect the study (e.g. adenovirus vectored vaccines, any coronavirus vaccine)
  • Subjects who were pregnant at the time of enrollment or who plan to become pregnant within the first 3 months following vaccination and who are breastfeeding
  • Subjects with fever (above 38°C) at the time of vaccination and/or up to 72 hours before
Show all 26Show fewer
  • Administration of immunoglobulins and/or any blood product within 3 months prior to vaccination
  • Any confirmed or suspected immunosuppressive or immunodeficiency state; asplenia; recurrent severe infections and use of immunosuppressants (less than ≤14 days) in the last 6 months, excluding topical steroids or short-term oral steroids
  • Possible history of allergic disease or reaction (e.g. to the active substance) by any component of the study vaccines
  • Any history of anaphylaxis
  • Current cancer diagnosis or treatment (excluding basal cell carcinoma of the skin and cervical carcinoma in situ)
  • History of bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venipuncture
  • Continued use of anticoagulants such as coumarins and related anticoagulants (i.e. warfarin) or new oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban)
  • Cerebral venous sinus thrombosis, antiphospholipid syndrome, or a history of heparin-induced thrombocytopenia and thrombosis (HITT or HIT type 2).
  • Suspected or known current alcohol or drug addiction
  • Any other significant disease, disorder or finding that could significantly increase the subject's risk for participation in the study, affect the subject's ability to participate in the study, or impair the interpretation of study data; severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, kidney disease, endocrine disorder, and neurological disease (mild/moderate well-controlled comorbidities are permitted)
  • History of active or previous autoimmune neurological disorders (e.g. multiple sclerosis, Guillain-Barre syndrome, transverse myelitis) (Bell's palsy will not be an exclusion criterion)
  • Subjects with severe renal impairment or liver failure
  • Subjects who will undergo scheduled elective surgery during the study
  • Subjects with a life expectancy of less than 6 months
  • Subject who participated in another clinical trial study involving an investigational product in the past 12 weeks
  • In case of clinical necessity, a COVID-19 PCR (polymerase chain reaction) test will be requested from the subjects, and subjects who are positive will be excluded from the study
  • Known history of SARS-CoV-2 infection
  • Acute respiratory disease (moderate or severe illness with or without fever) (Subjects may be screened again after acute condition has resolved)
  • Fever (oral temperature > 37.8°C) (Subjects can be enrolled again after acute condition improves)
  • Insufficient level of Turkish to perform the informed consent, except where briefing by an independent witness can be provided and is available

Trial locations and contacts

4 sites in 1 country.

Turkey (Türkiye)4 sites

  • Ankara City Hospital Internal Medicine Clinic

    Ankara

  • Sancaktepe Martyr Professor Dr. İlhan Varank Training and Research Hospital Infectious Diseases and Clinical Microbiology Clinic

    Istanbul

  • T.R. Ministry of Health Kartal Dr. Lütfi Kirdar City Hospital Infectious Diseases

    Istanbul

  • Ümraniye Training and Research Hospital Infectious Diseases

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Double-Blind, Randomized, Controlled, Multi-Centered, Phase 2 Clinical Trial to Determine the Safety, Efficacy, and Immunogenicity of Booster Vaccination Against SARS-CoV-2

A booster dose of vaccine (Turkovac or CoronaVac) will be administered to subjects who have passed at least 90 days and at most 270 days after the second dose of the first course of CoronaVac vaccine.

Read the detailed description

To determine the safety and immunogenicity of booster doses of vaccine against SARS-CoV2 after a minimum of 90 days and a maximum of 270 days after the 2nd dose of a homologous 2 dose primary regimen.

It is planned to recruit 111 subjects for 2 vaccines (Turkovac and CoronaVac). There will be a total of 222 subjects.

Being tested
CoronaVac, Turkovac
Keywords
COVID-19, SARS-CoV-2 Vaccine, Booster, Efficacy, Immunogenicity, Safety
Medical subject headings
COVID-19

What participants receive

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

  • CoronaVacBiological

    One dose vaccine will be administered to subjects who have passed at least 90 days and at most 270 days after the second dose of the first course of CoronaVac vaccine.

  • TurkovacBiological

    One dose vaccine will be administered to subjects who have passed at least 90 days and at most 270 days after the second dose of the first course of CoronaVac vaccine.

Study groups in NCT04979949
Study groupRoleWhat they receive
CoronaVacActive comparatorInactivated SARS-CoV-2 virus antigen, single intramuscular injection for boosting dose.
Receives: Biological: CoronaVac
TurkovacExperimentalInactivated SARS-CoV-2 virus antigen, single intramuscular injection for boosting dose.
Receives: Biological: Turkovac

What is being measured

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

  1. Incidence of adverse reactions

    Incidence of adverse reactions within 7 days of vaccination in all subjects

    Measured: 7 days after vaccination

  2. Incidence of Serious Adverse Events (SAE)

    Incidence of Serious Adverse Events (SAE) in all subjects 168 days after vaccination

    Measured: 168 days after vaccination

Secondary outcomes (1)

  1. Neutralizing antibody and anti-spike protein immunoglobulin G

    Amount of SARS-CoV2 anti-spike protein immunoglobulin G and SARS-CoV2 neutralizing antibody amount

    Measured: On days 0, 28 and 84

Timeline

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

  1. First posted28 Jul 2021
  2. Study start12 Jul 2021
  3. Primary completion9 Mar 2022
  4. Study completion6 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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double-Blind, Randomized, Controlled, Multi-Center Phase 2 Clinical Trial to Determine Safety, Efficacy, and Immunogenicity of Booster Vaccination Against SARS-CoV-2 (Hybrid COV-Rapel TR)
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
222 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04979949
Sponsor's protocol ID
Hibrid COV-Rapel TR
Status last verified
Feb 2023
First submitted
15 Jul 2021
Last updated
29 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Kumar A, Singh R, Kaur J, Pandey S, Sharma V, Thakur L, Sati S, Mani S, Asthana S, Sharma TK, Chaudhuri S, Bhattacharyya S, Kumar N. Wuhan to World: The COVID-19 Pandemic. Front Cell Infect Microbiol. 2021 Mar 30;11:596201. doi: 10.3389/fcimb.2021.596201. eCollection 2021.

    PubMed 33859951

  • Dan JM, Mateus J, Kato Y, Hastie KM, Yu ED, Faliti CE, Grifoni A, Ramirez SI, Haupt S, Frazier A, Nakao C, Rayaprolu V, Rawlings SA, Peters B, Krammer F, Simon V, Saphire EO, Smith DM, Weiskopf D, Sette A, Crotty S. Immunological memory to SARS-CoV-2 assessed for up to 8 months after infection. Science. 2021 Feb 5;371(6529):eabf4063. doi: 10.1126/science.abf4063. Epub 2021 Jan 6.

    PubMed 33408181

  • Doria-Rose N, Suthar MS, Makowski M, O'Connell S, McDermott AB, Flach B, Ledgerwood JE, Mascola JR, Graham BS, Lin BC, O'Dell S, Schmidt SD, Widge AT, Edara VV, Anderson EJ, Lai L, Floyd K, Rouphael NG, Zarnitsyna V, Roberts PC, Makhene M, Buchanan W, Luke CJ, Beigel JH, Jackson LA, Neuzil KM, Bennett H, Leav B, Albert J, Kunwar P; mRNA-1273 Study Group. Antibody Persistence through 6 Months after the Second Dose of mRNA-1273 Vaccine for Covid-19. N Engl J Med. 2021 Jun 10;384(23):2259-2261. doi: 10.1056/NEJMc2103916. Epub 2021 Apr 6. No abstract available.

    PubMed 33822494

  • Wu K, Werner AP, Koch M, Choi A, Narayanan E, Stewart-Jones GBE, Colpitts T, Bennett H, Boyoglu-Barnum S, Shi W, Moliva JI, Sullivan NJ, Graham BS, Carfi A, Corbett KS, Seder RA, Edwards DK. Serum Neutralizing Activity Elicited by mRNA-1273 Vaccine. N Engl J Med. 2021 Apr 15;384(15):1468-1470. doi: 10.1056/NEJMc2102179. Epub 2021 Mar 17. No abstract available.

    PubMed 33730471

  • Madhi SA, Baillie V, Cutland CL, Voysey M, Koen AL, Fairlie L, Padayachee SD, Dheda K, Barnabas SL, Bhorat QE, Briner C, Kwatra G, Ahmed K, Aley P, Bhikha S, Bhiman JN, Bhorat AE, du Plessis J, Esmail A, Groenewald M, Horne E, Hwa SH, Jose A, Lambe T, Laubscher M, Malahleha M, Masenya M, Masilela M, McKenzie S, Molapo K, Moultrie A, Oelofse S, Patel F, Pillay S, Rhead S, Rodel H, Rossouw L, Taoushanis C, Tegally H, Thombrayil A, van Eck S, Wibmer CK, Durham NM, Kelly EJ, Villafana TL, Gilbert S, Pollard AJ, de Oliveira T, Moore PL, Sigal A, Izu A; NGS-SA Group; Wits-VIDA COVID Group. Efficacy of the ChAdOx1 nCoV-19 Covid-19 Vaccine against the B.1.351 Variant. N Engl J Med. 2021 May 20;384(20):1885-1898. doi: 10.1056/NEJMoa2102214. Epub 2021 Mar 16.

    PubMed 33725432

  • Omma A, Batirel A, Aydin M, Yilmaz Karadag F, Erden A, Kucuksahin O, Armagan B, Guven SC, Karakas O, Gokdemir S, Altunal LN, Buber AA, Gemcioglu E, Zengin O, Inan O, Sahiner ES, Korukluoglu G, Sezer Z, Ozdarendeli A, Kara A, Ates I. Safety and immunogenicity of inactive vaccines as booster doses for COVID-19 in Turkiye: A randomized trial. Hum Vaccin Immunother. 2022 Nov 30;18(6):2122503. doi: 10.1080/21645515.2022.2122503. Epub 2022 Oct 31.

    PubMed 36315843

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CoronaVac and Turkovac in people with COVID-19 and Sars-CoV-2 Infection, run by Health Institutes of Turkey at 4 sites in Turkey (Türkiye).

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 8 inclusion and 26 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 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Turkey (Türkiye). 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Incidence of adverse reactions (time frame: 7 days after vaccination). The study lists 2 primary outcomes in all. 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 NCT04979949, which also lists 6 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 29 Nov 2023.

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