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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CoronaVac | Active Comparator | Inactivated SARS-CoV-2 virus antigen, single intramuscular injection for boosting dose. |
|
| Turkovac | Experimental | Inactivated SARS-CoV-2 virus antigen, single intramuscular injection for boosting dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Neutralizing antibody and anti-spike protein immunoglobulin G | Amount of SARS-CoV2 anti-spike protein immunoglobulin G and SARS-CoV2 neutralizing antibody amount | On days 0, 28 and 84 |
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Inclusion Criteria:
Exclusion Criteria:
Subjects meeting any of the following criteria will be excluded from the study:
Participant eligibility is based on self-representation of gender identity.
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| Name | Affiliation | Role |
|---|---|---|
| Ahmet Omma, Assoc. Prof. | Faculty Member | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara City Hospital Internal Medicine Clinic | Ankara | Turkey (Türkiye) | ||||
| Sancaktepe Martyr Professor Dr. İlhan Varank Training and Research Hospital Infectious Diseases and Clinical Microbiology Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33859951 | Background | 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. | |
| 33408181 | 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. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000722216 | sinovac COVID-19 vaccine |
| C000721868 | TURKOVAC |
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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)
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Double-Blind
| 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. |
|
| Istanbul |
| Turkey (Türkiye) |
| T.R. Ministry of Health Kartal Dr. Lütfi Kirdar City Hospital Infectious Diseases | Istanbul | Turkey (Türkiye) |
| Ümraniye Training and Research Hospital Infectious Diseases | Istanbul | Turkey (Türkiye) |
| 33822494 | 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. |
| 33730471 | 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. |
| 33725432 | 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. |
| 36315843 | Derived | 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. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |