Booster Vaccination Against COVID-19

NCT04979949 | Completed Phase 2 DMC

• 1 other identifier: Hibrid COV-Rapel TR
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

COVID-19; Sars-CoV-2 Infection

Keywords

COVID-19; SARS-CoV-2 Vaccine; Booster; Efficacy; Immunogenicity; Safety

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse reactions

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

  7 days after vaccination

• Incidence of Serious Adverse Events (SAE)

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

  168 days after vaccination

Secondary Outcomes (1)

• Neutralizing antibody and anti-spike protein immunoglobulin G

  On days 0, 28 and 84

Study Arms (2)

CoronaVac

ACTIVE COMPARATOR

Inactivated SARS-CoV-2 virus antigen, single intramuscular injection for boosting dose.

Biological: CoronaVac

Turkovac

EXPERIMENTAL

Inactivated SARS-CoV-2 virus antigen, single intramuscular injection for boosting dose.

Biological: Turkovac

Interventions

CoronaVac BIOLOGICAL

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.

CoronaVac

Turkovac BIOLOGICAL

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.

Turkovac

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Participant eligibility is based on self-representation of gender identity.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Health Institutes of Turkey: lead

Study Sites (4)

Ankara City Hospital Internal Medicine Clinic

Ankara, Turkey (Türkiye)

Location

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

Istanbul, Turkey (Türkiye)

Location

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

Istanbul, Turkey (Türkiye)

Location

Ümraniye Training and Research Hospital Infectious Diseases

Istanbul, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 33859951 BACKGROUND

• 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.

  PMID: 33408181 BACKGROUND

• 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.

  PMID: 33822494 BACKGROUND

• 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.

  PMID: 33730471 BACKGROUND

• 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.

  PMID: 33725432 BACKGROUND

• 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.

  PMID: 36315843 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

sinovac COVID-19 vaccine; TURKOVAC

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ahmet Omma, Assoc. Prof.

  Faculty Member

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double-Blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 28, 2021
• Study Start: July 12, 2021
• Primary Completion: March 9, 2022
• Study Completion: June 6, 2022
• Last Updated: November 29, 2023

Record last verified: 2023-02

Locations

TU (4)