Of 513 patients enrolled in the COVIIMP study, a total of 26 SARS-CoV-2-naïve KTRs (median age 57.0 years (49.5–62.9 years), 34.6% women) (Table 1
Spikevax
Manufactured by Moderna
Sourced in United States, Germany
Spikevax is a COVID-19 vaccine developed by Moderna. It is a mRNA-based vaccine that encodes the SARS-CoV-2 spike protein.
Automatically generated - may contain errors
Lab products found in correlation
Comirnaty, by Pfizer (27 mentions)
Vaxzevria, by AstraZeneca (15 mentions)
Ad26 cov2 s, by Johnson & Johnson (5 mentions)
Cominarty, by Pfizer (3 mentions)
Comirnaty, by Moderna (3 mentions)
Covid 19 vaccine, by Johnson & Johnson (2 mentions)
Comirnaty, by AstraZeneca (2 mentions)
Cobas e601 module analyzer, by Roche (1 mentions)
Janssen, by Johnson & Johnson (1 mentions)
Azd1222, by AstraZeneca (1 mentions)
Bnt162b2, by Pfizer (1 mentions)
Mrna 1273, by Moderna (1 mentions)
Bbibp corv, by Sinopharm (1 mentions)
Bnt162b2, by Moderna (1 mentions)
Vacuette gel tubes, by Greiner (1 mentions)
Chadox1 ncov 19, by AstraZeneca (1 mentions)
53 protocols using spikevax
1
SARS-CoV-2 Immunity in Kidney Transplant Recipients
2
Longitudinal SARS-CoV-2 Immune Responses Post-Vaccination
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In December 2020, we established a prospective longitudinal study in Vancouver, Canada, to examine SARS-CoV-2 specific humoral immune responses following vaccination with BNT162b2 (Comirnaty; BioNTech/Pfizer) or mRNA-1273 (Spikevax; Moderna) in a cohort of adults aged 24-98 years [described in (25 (link), 26 (link))]. Serum and plasma were collected longitudinally up to 6 months following the third dose (Figure 1A
3
Booster Vaccine Study in mRNA Primed
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We conducted a phase 2A, open-label, randomised-controlled, proof-of-concept vaccine study at the Leiden University Medical Centre in the Netherlands. Eligible participants were healthy adults aged 18–50 years who have received a primary vaccination series of mRNA-1273 (SpikeVax, Moderna) or BNT162b2 (Comirnaty, Pfizer-BioNTech) mRNA vaccine against SARS-CoV-2. A mid-turbinate/ throat swab was taken to exclude a concurrent SARS-CoV-2 infection before enrolment and during every on-site visit. Main exclusion criteria included a previous microbiological diagnosis of COVID-19 or COVID-19 revaccination less than 3 months ago, autoimmune disease, immunodeficiency, risk factors for developing severe COVID-19, history of severe allergic reaction, use of systemic or topical corticosteroids, bleeding condition, pregnancy and breastfeeding. For women a urine pregnancy test was performed at screening.
All participants provided written informed consent before participation in the study. The study was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice principles. The protocol was approved by the Medical Ethical Committee Leiden, Den Haag, Delft (NL80101.058.22) and registered in the clinicaltrials.gov. The vaccine manufacturer was not involved in this trial.
All participants provided written informed consent before participation in the study. The study was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice principles. The protocol was approved by the Medical Ethical Committee Leiden, Den Haag, Delft (NL80101.058.22) and registered in the clinicaltrials.gov. The vaccine manufacturer was not involved in this trial.
4
COVID-19 Vaccine Effectiveness in RA/PsA
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We conducted a prospective observational study of patients diagnosed with RA or PsA included in COVIDSER–BIOBADASER III who were vaccinated with any of the vaccines for COVID-19 available in Spain between 22 April 2021 and 11 December 2021 (n=1765). All patients had received at least two doses of Comirnaty (BioNTech/Pfizer, Mainz, Germany) (1022, 58%) or Spikevax (Moderna Biotech, Cambridge, USA) (255, 14.4%), and one dose of the Vaxzevria (Oxford/AztraZeneca, Nijmegen, Netherlands) (403, 22.8%) or Janssen (Johnson & Johnson, Leiden, Netherlands) (85, 4.8%) vaccines, all of which were considered to be complete COVID-19 vaccination regimens by the end of 2021.
5
COVID-19 Vaccine Response in Healthy Adults
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A total of 124 study participants (83 female, 41 male, mean age 46 years, median age of 50 years) were recruited at the University Hospital of the Heinrich Heine University, Düsseldorf. All participants were employees of these institutions and underwent a program of two vaccinations with the COVID-19 vaccine Spikevax (Moderna Biotech, Cambridge, MA, USA) spaced exactly four weeks apart. Vaccinations were performed according to the instructions of the manufacturer and the recommendations of the German vaccination commission (STIKO). None of the participants tested positive for SARS-CoV-2 or exhibited symptoms of COVID-19, or exhibited debilitating symptoms of co-morbidities.
6
COVID-19 Vaccination in RA Patients
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All RA patients aged ≥16 years of the Sint Maartenskliniek (Nijmegen, the Netherlands) were invited to participate in the cohort, if (i) they received at least one dose of rituximab (200 mg, 500 mg or 1000 mg) in the year prior to their first dose of COVID-19 vaccination and (ii) COVID-19 vaccination was performed according to the registered dose and interval. The RTX dose was based on the treating physician’s discretion. At the time of the study, the Dutch national vaccine programme included four vaccines against COVID-19, of which three were two-dose regimens: BNT162b2 (Comirnaty; Pfizer-BioNtech), ChAdOx1 nCoV-19 (Vaxzevria; AstraZeneca) and CX-024414 (Spikevax; Moderna), and one was single-dose: Ad.26.COV2.S (COVID-19 vaccine Janssen) [10 ]. If a COVID-19 infection had occurred in the six months prior to first vaccination, the Dutch government also approved one dose of a two-dose vaccine as fully vaccinated [11 ].
This study has been approved by the ethics committee (CMO Arnhem-Nijmegen, 2021–7406) and the competent authority (CCMO, NL76709.091.21). The study protocol was registered in the Netherlands Trial Register (NL9342) before start. All participants provided written informed consent.
This study has been approved by the ethics committee (CMO Arnhem-Nijmegen, 2021–7406) and the competent authority (CCMO, NL76709.091.21). The study protocol was registered in the Netherlands Trial Register (NL9342) before start. All participants provided written informed consent.
7
SARS-CoV-2 Testing and Vaccination Status
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By questionnaire, participants were asked whether they had undergone a SARS-CoV-2 test by trained staff (at medical practitioner, test site, or hospital) and whether this test was positive: ever (BL), since 17 July 2020 (FU1), or since 27 November 2020 (FU2). Self-reported positive tests were validated by health authorities. At FU2, participants were also asked whether they were vaccinated against SARS-CoV-2 and, if yes, how often, which vaccine, and when. Individuals were classified as fully vaccinated, if they had two vaccinations by Comirnaty (BionNTech, Mainz, Germany), SpikeVax (Moderna, Cambridge, MA, USA), or Vaxzevria (AstraZeneca, Cambridge, UK) ≥ 14 days before their respective blood draw.
8
Antibody Response to COVID-19 Vaccination in PWH
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PWH (n=25) and healthy donors (n=16) were recruited between March and July 2021 at the Hospital Universitario Severo Ochoa (Madrid, Spain) and the Primary Healthcare Center Doctor Pedro Laín Entralgo (Madrid, Spain), respectively, for this prospective, longitudinal, observational study. Sample size was calculated using the sample size calculator Granmo (29 ) based on a level of confidence α=0.05 (95%) and power of the analysis β=0.2 (80%). The inclusion criteria were to be over 18 years old, CD4 > 500 cells/μl, not having a previous diagnosis of COVID-19, and to have been vaccinated through the Spanish Vaccination Program with two doses of one vaccine approved at the time for these participants: Comirnaty (BioNTech, Mainz, Germany; Pfizer, New York, NY) or Spikevax (Moderna, Cambridge, MA); or with one dose of Jcovden (Janssen, Titusville, NJ).
Blood samples were obtained before vaccination and 4–6 weeks after receiving the full vaccination schedule. Basal serology to detect IgG against SARS-CoV-2 was performed in plasma from the first blood sample to discard an asymptomatic infection before vaccination. All participants were followed up for 12 months after receiving the full vaccination schedule to record SARS-CoV-2 breakthrough infections.
Blood samples were obtained before vaccination and 4–6 weeks after receiving the full vaccination schedule. Basal serology to detect IgG against SARS-CoV-2 was performed in plasma from the first blood sample to discard an asymptomatic infection before vaccination. All participants were followed up for 12 months after receiving the full vaccination schedule to record SARS-CoV-2 breakthrough infections.
9
COVID-19 Vaccination of Japanese Students
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Osaka Medical and Pharmaceutical University (OMPU) provided mass COVID-19
vaccination to students at Takatsuki Junior and Senior High Schools who were 12
to 18 years old. The family members of the students and staff members at the
schools could also receive the vaccine based on individual preference.
Vaccination was conducted by doctors and nurses affiliated with OMPU. Initially,
two doses of elasomeran (0.1 mg [mRNA-1273] SPIKEVAX®; Moderna, Inc., Cambridge,
MA, USA) were administered at intervals of 27 to 29 days. However, the Ministry
of Health, Labour and Welfare (MHLW) allowed males in their teens and twenties
to be vaccinated with tozinameran at a dose of 0.225 mg (BNT162b2, COMIRNATY®;
Pfizer Inc., New York, NY, USA) as a second dose. This decision was based on the
higher likelihood of developing AEs including myocarditis after receiving
SPIKEVAX® than after receiving COMIRNATY®.9 Therefore, some males
received COMIRNATY® as the second dose. Because this MHLW policy was announced
immediately before the second dose was made available, the vaccine interval was
set at 28 to 33 days even if COMIRNATY® was chosen for the second dose.
vaccination to students at Takatsuki Junior and Senior High Schools who were 12
to 18 years old. The family members of the students and staff members at the
schools could also receive the vaccine based on individual preference.
Vaccination was conducted by doctors and nurses affiliated with OMPU. Initially,
two doses of elasomeran (0.1 mg [mRNA-1273] SPIKEVAX®; Moderna, Inc., Cambridge,
MA, USA) were administered at intervals of 27 to 29 days. However, the Ministry
of Health, Labour and Welfare (MHLW) allowed males in their teens and twenties
to be vaccinated with tozinameran at a dose of 0.225 mg (BNT162b2, COMIRNATY®;
Pfizer Inc., New York, NY, USA) as a second dose. This decision was based on the
higher likelihood of developing AEs including myocarditis after receiving
SPIKEVAX® than after receiving COMIRNATY®.9 Therefore, some males
received COMIRNATY® as the second dose. Because this MHLW policy was announced
immediately before the second dose was made available, the vaccine interval was
set at 28 to 33 days even if COMIRNATY® was chosen for the second dose.
10
SARS-CoV-2 Vaccine Effectiveness Study
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