COVID-19Phase 1NCT05477186
Safety and Immunogenicity Study of a Booster Dose of the Investigational CV0501 mRNA COVID-19 Vaccine in Adults at Least 18 Years Old
A Phase 1 study testing CV0501 (3 μg), CV0501 (6 μg) and CV0501 (12 μg) in people with COVID-19 and SARS-CoV-2, run by GlaxoSmithKline at 17 sites in 3 countries.
Trial summary
Prevention of COVID-19 caused by SARS-CoV-2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS-CoV-2
- What is being tested?
- CV0501 (3 μg), CV0501 (6 μg) and CV0501 (12 μg)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 17 sitesin 3 countries
- Study dates
- 12 Aug 2022to 18 Aug 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must provide documented informed consent prior to any study procedures being performed
- Is capable of understanding and agrees to comply with planned study procedures and to be available for all study visits
- Has received at least 2 doses of Comirnaty or Moderna COVID-19 Vaccine (Spikevax®\), with the last dose of vaccine received at least 6 months prior to screening
- Negative for SARS-CoV-2 infection by RT-PCR test at screening
- Is a male or nonpregnant female >= 18 years old
- If the participant is a woman of childbearing potential, the participant agrees to use at least 1 highly effective form of contraception for at least 30 days prior to the study vaccination up to 3 months after study vaccination.
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- Agrees to refrain from blood or plasma donation from the first study vaccination through end of study.
- Has a body mass index of 18 to 40 kg/m^2, inclusive, at screening.
- Is healthy or medically stable as determined by investigator judgment based on medical history, clinical laboratory tests, vital sign measurements, and physical examination findings
Who cannot join
- Participant is female and has a positive pregnancy test result at screening.
- Participant is female and is breastfeeding or will (re)start breastfeeding from the study vaccination to 3 months after vaccination.
- Has an acute febrile illness with temperature >=38.0°C or >=100.4°F within 72 hours before study vaccination. Individuals with suspected COVID-19 symptoms should be excluded and referred for medical care.
- Has a history of documented SARS-CoV-2 infection or COVID-19 within 6 months before screening.
- Has a documented medical history of HIV, hepatitis B or hepatitis C infection prior to screening, or a positive test for these conditions at screening.
- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease (eg, malignancy) or immunosuppressive/cytotoxic therapy (eg, medications used during cancer chemotherapy, organ transplantation or to treat autoimmune disorders). Chronic use (more than 14 continuous days) of any medication that may be associated with changes in immune function including, but not limited to, systemic corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy immunotherapy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other similar or toxic drugs within 6 months of the first study vaccination. Inclusion of persons who use low dose topical, ophthalmic, inhaled, or intranasal steroid preparations is permitted.
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- History of myocarditis, pericarditis, or idiopathic cardiomyopathy, or presence of any medical condition that increases risk of myocarditis or pericarditis, including cocaine abuse, cardiomyopathy, endomyocardial fibrosis, hypereosinophilic syndrome, hypersensitivity myocarditis, eosinophilic granulomatosis with polyangiitis, persistent myocardial viral infection (eg, due to enterovirus or adenovirus), and celiac disease.
- Has a new onset, clinically significant, abnormal biochemistry or hematology finding (defined as >= Grade 1) at screening (adults with Grade 1 laboratory abnormalities that have been stable for at least 6 months before enrollment may be included in the study).
- Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention, including but not limited to: systemic or cutaneous lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, Guillain- Barré syndrome, multiple sclerosis, Sjögren's syndrome, idiopathic thrombocytopenia purpura, glomerulonephritis, autoimmune thyroiditis, giant cell arteritis (temporal arteritis), Takayasu arteritis, granulomatosis with polyangiitis, psoriasis, and insulin-dependent diabetes mellitus (Type 1).
- Has an unstable chronic medical condition. This refers to a condition requiring a new medication or increase in dose of current medication(s) or a condition requiring hospitalization within 6 months prior to screening.
- Has a history of hypersensitivity or severe allergic reaction, including anaphylaxis, generalized urticaria, angioedema, and other significant reactions, to vaccines or to any component of the investigational product.
- Has received or plans to receive any licensed vaccine, within 4 weeks before or 4 weeks after study vaccination. Inactivated vaccines for influenza are permitted during the study if they are administered at least 14 days before or after study vaccination.
- Has had known close contact with anyone who had a confirmed SARS-CoV-2 infection within 2 weeks before study vaccination. Rescreening of these participants permitted after quarantine period is complete.
- Has participated or plans to participate in another investigational study involving any investigational product or device within 6 months or 5 half-lives, whichever is longer, before the study vaccination through end of study.
- Has received or plans to receive immunoglobulins or any blood or blood products within 3 months before the first study vaccination through end of study.
- Has a bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
- Has a history of alcohol abuse or other recreational drug use (excluding cannabis) within 6 months before study vaccination.
- Has any abnormal skin condition or permanent body art (eg, tattoo) that would interfere with the ability to observe local reactions at the injection site.
- Has a medical disease or psychiatric condition that, in the opinion of the investigator, precludes study participation because it would place the individual at an unacceptable risk of injury, render the individual unable to meet the requirements of the protocol or interfere with the individual's successful completion of the trial.
- Participant is an employee or family member of the investigator or study site personnel.
Trial locations and contacts
17 sites in 3 countries.
17 sites in 3 countries
United States11 sites
GSK Investigational Site
Binghamton, New York, 13760
GSK Investigational Site
Cincinnati, Ohio, 45212
GSK Investigational Site
Hollywood, Florida, 33024
GSK Investigational Site
Melbourne, Florida, 32934
GSK Investigational Site
Metairie, Louisiana, 70006-5322
GSK Investigational Site
Norfolk, Virginia, 68701
GSK Investigational Site
Omaha, Nebraska, 68134
GSK Investigational Site
Peoria, Illinois, 61614-4896
GSK Investigational Site
Rockville, Maryland, 20854
GSK Investigational Site
Sacramento, California, 95864
GSK Investigational Site
Savannah, Georgia, 31406
Australia4 sites
GSK Investigational Site
Brookvale, New South Wales, 2100
GSK Investigational Site
Merewether, New South Wales, 2291
GSK Investigational Site
Sydney, New South Wales, 2010
GSK Investigational Site
Wollongong, New South Wales, 2500
Philippines2 sites
GSK Investigational Site
Cavite, 4114
GSK Investigational Site
Iloilo City, 5000
About this study
Official title: A Phase 1, Open-label, Safety and Immunogenicity Study of a Booster Dose of the Investigational CV0501 mRNA COVID-19 Vaccine in Adults at Least 18 Years Old
Prevention of COVID-19 caused by SARS-CoV-2.
- Conditions
- COVID-19, SARS-CoV-2
- Being tested
- CV0501 (3 μg), CV0501 (6 μg), CV0501 (12 μg), CV0501 (25 μg), CV0501 (50 μg)
- Keywords
- COVID-19, Pandemic, Booster vaccination
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CV0501 (3 μg)Biological
Study vaccine was administered as a single intramuscular injection.
CV0501 (6 μg)Biological
Study vaccine was administered as a single intramuscular injection.
CV0501 (12 μg)Biological
Study vaccine was administered as a single intramuscular injection.
CV0501 (25 μg)Biological
Study vaccine was administered as a single intramuscular injection.
CV0501 (50 μg)Biological
Study vaccine was administered as a single intramuscular injection.
CV0501 (100 μg)Biological
Study vaccine was administered as a single intramuscular injection.
CV0501 (200 μg)Biological
Study vaccine was administered as a single intramuscular injection.
| Study group | Role | What they receive |
|---|---|---|
| Part A: CV0501 Dose Cohort 1 (12 μg) | Experimental | Healthy participants received a single dose of 12 microgram (μg) CV0501 vaccine intramuscularly at Day 1. Receives: Biological: CV0501 (12 μg) |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Experimental | Healthy participants received a single dose of 25 μg CV0501 vaccine intramuscularly at Day 1. Receives: Biological: CV0501 (25 μg) |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Experimental | Healthy participants received a single dose of 50 μg CV0501 vaccine intramuscularly at Day 1. Receives: Biological: CV0501 (50 μg) |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Experimental | Healthy participants received a single dose of 100 μg CV0501 vaccine intramuscularly at Day 1. Receives: Biological: CV0501 (100 μg) |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Experimental | Healthy participants received a single dose of 200 μg CV0501 vaccine intramuscularly at Day 1. Receives: Biological: CV0501 (200 μg) |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Experimental | Healthy participants received a single dose of 3 μg CV0501 vaccine intramuscularly at Day 1. Receives: Biological: CV0501 (6 μg) |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Experimental | Healthy participants received a single dose of 6 μg CV0501 vaccine intramuscularly at Day 1. Receives: Biological: CV0501 (3 μg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination
Assessed solicited local adverse events were injection site pain, redness, swelling, and Lymphadenopathy.
Measured: From Day 1 to Day 7 (including Day 7)
Number of Participants With Solicited Systemic AE During 7 Days After Vaccination
Assessed solicited systemic AEs were fever, headache, fatigue, myalgia, arthralgia, and chills.
Measured: From Day 1 to Day 7 (including Day 7)
Number of Participants With Unsolicited AEs for 28 Days After Study Vaccination
An unsolicited AE is defined as any AE that is volunteered from the participant and occurs within 28 days after vaccination.
Measured: From Day 1 to day 28 (including day 28)
Number of Participants With Medically Attended Adverse Events (MAAEs) From Study Vaccination Through the End of the Study
An MAAE is defined as an AE that results in a visit to a medical professional. Medically attended visits are defined as a telemedicine visit, physician's office visit, urgent care visit, emergency room visit, hospitalization, or death.
Measured: From Day 1 up to Day 180 (including Day 180)
Number of Participants With Adverse Events of Special Interest (AESIs) From Study Vaccination Through the End of the Study
An AESI (serious or nonserious) is defined as an AE or serious adverse event (SAE) of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor could be appropriate.
Measured: From Day 1 up to Day 180 (including Day 180)
Number of Participants With Serious Adverse Events (SAEs) From Study Vaccination Through the End of the Study
An SAE is defined as any event that: Results in death Is immediately life-threatening Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is a spontaneous miscarriage Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered SAEs when, based upon appropriate medical judgment, they may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse.
Measured: From Day 1 up to Day 180 (including Day 180)
Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination
An abnormal laboratory is defined as any value outside of the normal range. Normal ranges were: Alanine Aminotransferase: (Female: 10-32 micro (u)/ liter (L); Male: 10-40 u/L); Alkaline Phosphatase: (Female: 30-115 u/L; Male: 43-115 u/L); Aspartate Aminotransferase: (Female: 10-36 u/L; Male: 10-43 u/L); Bilirubin total: 0.1-1.1 milligram (mg)/deciliter (dL); Bilirubin, Direct: 0-0.4 mg/dL ;Creatinine:0.7-1.4 mg/dL; Eosinophils: 0%-7%; Eosinophils/Leukocytes: 0.00-0.80 x 10^3/uL ; Erythrocytes: (Female: 3.70-5.20 x 10^6/uL; Male: 4.63-6.08x 10^6/uL); Hemoglobin: (Female: 11.0-15.5 gram (g)/dL; Male: 12.5-17.0 g/dL); Leukocytes: 3.70-11.00 x 10^3/uL; Lymphocytes 12.0%-46.0%; Lymphocytes/Leukocytes: 0.90-3.60 x 10^3/uL; Monocytes/Leukocytes: 0.00-1.20 x 10^3/uL; Neutrophils: 4.0% - 71.0%; Neutrophils/Leukocytes:1.70-7.90x 10^3/uL; Platelets: 163-375 x 10^3/uL; Urea Nitrogen: 5-20 mg/dL.
Measured: 8 days from vaccination at Day 1
Secondary outcomes (3)
Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint
Measured: At Day 1, Day 15, Day 29, Day 91, and Day 181
Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point
Measured: At Day 15, Day 29, Day 91, and Day 181
Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29
Seroresponse was defined as post-boost titers >= 4 times pre-boost (baseline) titers for participants with titer >= LLOQ at pre-vaccination and as post-booster titer >= 4 times LLOQ for participants with titer < LLOQ at pre vaccination.
Measured: At day 29 (28 days after the booster dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start12 Aug 2022
- Primary completion18 Aug 2023
- Study completion18 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05477186
- Sponsor's protocol ID
- 218595
- Status last verified
- Jan 2025
- First submitted
- 27 Jul 2022
- Last updated
- 21 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf.
Publications
Essink BJ, Shapiro C, Isidro MGD, Bradley P, Pragalos A, Bloch M, Santiaguel J, Frias MV, Miyakis S, Alves de Mesquita M, Berre S, Servais C, Waugh N, Hoffmann C, Baba E, Schonborn-Kellenberger O, Wolz OO, Koch SD, Ganyani T, Boutet P, Mann P, Mueller SO, Ramanathan R, Gaudinski MR, Vanhoutte N. Safety and immunogenicity of a modified mRNA-lipid nanoparticle vaccine candidate against COVID-19: Results from a phase 1, dose-escalation study. Hum Vaccin Immunother. 2024 Dec 31;20(1):2408863. doi: 10.1080/21645515.2024.2408863. Epub 2024 Oct 18.
PubMed 39422261Roth N, Gergen J, Kovacikova K, Mueller SO, Ulrich L, Schon J, Halwe NJ, Fricke C, Corleis B, Dorhoi A, Hoffmann D, Beer M, Maione D, Petsch B, Rauch S. Assessment of Immunogenicity and Efficacy of CV0501 mRNA-Based Omicron COVID-19 Vaccination in Small Animal Models. Vaccines (Basel). 2023 Jan 31;11(2):318. doi: 10.3390/vaccines11020318.
PubMed 36851196
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Safety and Immunogenicity Study of a Booster Dose of the Investigational CV0501 mRNA COVID-19 Vaccine in Adults at Least 18 Years Old
- ClinicalTrials.gov ID
- NCT05477186
- Acronym / sponsor ID
- 218595
- Conditions
- COVID-19, SARS-CoV-2
- Keywords
- COVID-19, Pandemic, Booster vaccination
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 12 Aug 2022 (actual)
- Primary completion
- 18 Aug 2023 (actual)
- Study completion
- 18 Aug 2023 (actual)
- First posted
- 28 Jul 2022 (actual)
- Results
- Posted 21 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prevention of COVID-19 caused by SARS-CoV-2.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part A: CV0501 Dose Cohort 1 (12 μg) | Experimental | Biological: CV0501 (12 μg)Healthy participants received a single dose of 12 microgram (μg) CV0501 vaccine intramuscularly at Day 1. |
| Part A: CV0501 Dose Cohort 2 (25 μg) | Experimental | Biological: CV0501 (25 μg)Healthy participants received a single dose of 25 μg CV0501 vaccine intramuscularly at Day 1. |
| Part A: CV0501 Dose Cohort 3 (50 μg) | Experimental | Biological: CV0501 (50 μg)Healthy participants received a single dose of 50 μg CV0501 vaccine intramuscularly at Day 1. |
| Part A: CV0501 Dose Cohort 4 (100 μg) | Experimental | Biological: CV0501 (100 μg)Healthy participants received a single dose of 100 μg CV0501 vaccine intramuscularly at Day 1. |
| Part A: CV0501 Dose Cohort 5 (200 μg) | Experimental | Biological: CV0501 (200 μg)Healthy participants received a single dose of 200 μg CV0501 vaccine intramuscularly at Day 1. |
| Part B: CV0501 Dose Cohort 6 (3 μg) | Experimental | Biological: CV0501 (6 μg)Healthy participants received a single dose of 3 μg CV0501 vaccine intramuscularly at Day 1. |
| Part B: CV0501 Dose Cohort 7 (6 μg) | Experimental | Biological: CV0501 (3 μg)Healthy participants received a single dose of 6 μg CV0501 vaccine intramuscularly at Day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Must provide documented informed consent prior to any study procedures being performed
- Is capable of understanding and agrees to comply with planned study procedures and to be available for all study visits
- Has received at least 2 doses of Comirnaty or Moderna COVID-19 Vaccine (Spikevax®\), with the last dose of vaccine received at least 6 months prior to screening
- Negative for SARS-CoV-2 infection by RT-PCR test at screening
- Is a male or nonpregnant female >= 18 years old
Key exclusion criteria (20 listed)
- Participant is female and has a positive pregnancy test result at screening.
- Participant is female and is breastfeeding or will (re)start breastfeeding from the study vaccination to 3 months after vaccination.
- Has an acute febrile illness with temperature >=38.0°C or >=100.4°F within 72 hours before study vaccination. Individuals with suspected COVID-19 symptoms should be excluded and referred for medical care.
- Has a history of documented SARS-CoV-2 infection or COVID-19 within 6 months before screening.
- Has a documented medical history of HIV, hepatitis B or hepatitis C infection prior to screening, or a positive test for these conditions at screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CV0501 (3 μg)Study vaccine was administered as a single intramuscular injection. | Biological | Part B: CV0501 Dose Cohort 7 (6 μg) |
| CV0501 (6 μg)Study vaccine was administered as a single intramuscular injection. | Biological | Part B: CV0501 Dose Cohort 6 (3 μg) |
| CV0501 (12 μg)Study vaccine was administered as a single intramuscular injection. | Biological | Part A: CV0501 Dose Cohort 1 (12 μg) |
| CV0501 (25 μg)Study vaccine was administered as a single intramuscular injection. | Biological | Part A: CV0501 Dose Cohort 2 (25 μg) |
| CV0501 (50 μg)Study vaccine was administered as a single intramuscular injection. | Biological | Part A: CV0501 Dose Cohort 3 (50 μg) |
| CV0501 (100 μg)Study vaccine was administered as a single intramuscular injection. | Biological | Part A: CV0501 Dose Cohort 4 (100 μg) |
| CV0501 (200 μg)Study vaccine was administered as a single intramuscular injection. | Biological | Part A: CV0501 Dose Cohort 5 (200 μg) |
Primary outcome
Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination
Time frame: From Day 1 to Day 7 (including Day 7)
Assessed solicited local adverse events were injection site pain, redness, swelling, and Lymphadenopathy.
Number of Participants With Solicited Systemic AE During 7 Days After Vaccination
Time frame: From Day 1 to Day 7 (including Day 7)
Assessed solicited systemic AEs were fever, headache, fatigue, myalgia, arthralgia, and chills.
Number of Participants With Unsolicited AEs for 28 Days After Study Vaccination
Time frame: From Day 1 to day 28 (including day 28)
An unsolicited AE is defined as any AE that is volunteered from the participant and occurs within 28 days after vaccination.
Number of Participants With Medically Attended Adverse Events (MAAEs) From Study Vaccination Through the End of the Study
Time frame: From Day 1 up to Day 180 (including Day 180)
An MAAE is defined as an AE that results in a visit to a medical professional. Medically attended visits are defined as a telemedicine visit, physician's office visit, urgent care visit, emergency room visit, hospitalization, or death.
Number of Participants With Adverse Events of Special Interest (AESIs) From Study Vaccination Through the End of the Study
Time frame: From Day 1 up to Day 180 (including Day 180)
An AESI (serious or nonserious) is defined as an AE or serious adverse event (SAE) of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor could be appropriate.
Number of Participants With Serious Adverse Events (SAEs) From Study Vaccination Through the End of the Study
Time frame: From Day 1 up to Day 180 (including Day 180)
An SAE is defined as any event that: Results in death Is immediately life-threatening Requires inpatient hospitalization or prolongation of existing hospitalization Results in persistent or significant disability/incapacity Is a congenital anomaly/birth defect Is a spontaneous miscarriage Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered SAEs when, based upon appropriate medical judgment, they may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse.
Number of Participants With Each Abnormal Clinical Safety Laboratory Finding for 8 Days After Study Vaccination
Time frame: 8 days from vaccination at Day 1
An abnormal laboratory is defined as any value outside of the normal range. Normal ranges were: Alanine Aminotransferase: (Female: 10-32 micro (u)/ liter (L); Male: 10-40 u/L); Alkaline Phosphatase: (Female: 30-115 u/L; Male: 43-115 u/L); Aspartate Aminotransferase: (Female: 10-36 u/L; Male: 10-43 u/L); Bilirubin total: 0.1-1.1 milligram (mg)/deciliter (dL); Bilirubin, Direct: 0-0.4 mg/dL ;Creatinine:0.7-1.4 mg/dL; Eosinophils: 0%-7%; Eosinophils/Leukocytes: 0.00-0.80 x 10^3/uL ; Erythrocytes: (Female: 3.70-5.20 x 10^6/uL; Male: 4.63-6.08x 10^6/uL); Hemoglobin: (Female: 11.0-15.5 gram (g)/dL; Male: 12.5-17.0 g/dL); Leukocytes: 3.70-11.00 x 10^3/uL; Lymphocytes 12.0%-46.0%; Lymphocytes/Leukocytes: 0.90-3.60 x 10^3/uL; Monocytes/Leukocytes: 0.00-1.20 x 10^3/uL; Neutrophils: 4.0% - 71.0%; Neutrophils/Leukocytes:1.70-7.90x 10^3/uL; Platelets: 163-375 x 10^3/uL; Urea Nitrogen: 5-20 mg/dL.
3 secondary outcomes
Geometric Mean Titers (GMTs) of Neutralizing Antibody (Ab) Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Timepoint
Time frame: At Day 1, Day 15, Day 29, Day 91, and Day 181
Geometric Mean Increase (GMI) From Baseline of Neutralizing Ab Titers Against Pseudovirus Bearing S Protein From SARS-CoV-2 WT, Omicron, and Delta Variants at Each Collection Time Point
Time frame: At Day 15, Day 29, Day 91, and Day 181
Percentage of Participants With Neutralizing Seroresponse of Serum SARS-CoV-2 WT, Omicron BA.1, BA.2 and BA.5 Variants Specific Ab at Day 29
Time frame: At day 29 (28 days after the booster dose)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 39422261Essink BJ, Shapiro C, Isidro MGD, Bradley P, Pragalos A, Bloch M, Santiaguel J, Frias MV, Miyakis S, Alves de Mesquita M, Berre S, Servais C, Waugh N, Hoffmann C, Baba E, Schonborn-Kellenberger O, Wolz OO, Koch SD, Ganyani T, Boutet P, Mann P, Mueller SO, Ramanathan R, Gaudinski MR, Vanhoutte N. Safety and immunogenicity of a modified mRNA-lipid nanoparticle vaccine candidate against COVID-19: Results from a phase 1, dose-escalation study. Hum Vaccin Immunother. 2024 Dec 31;20(1):2408863. doi: 10.1080/21645515.2024.2408863. Epub 2024 Oct 18.
- Derived from this study: PubMed 36851196Roth N, Gergen J, Kovacikova K, Mueller SO, Ulrich L, Schon J, Halwe NJ, Fricke C, Corleis B, Dorhoi A, Hoffmann D, Beer M, Maione D, Petsch B, Rauch S. Assessment of Immunogenicity and Efficacy of CV0501 mRNA-Based Omicron COVID-19 Vaccination in Small Animal Models. Vaccines (Basel). 2023 Jan 31;11(2):318. doi: 10.3390/vaccines11020318.
- Individual participant dataSharing planned: Yes. GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf.
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Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CV0501 (3 μg), CV0501 (6 μg) and CV0501 (12 μg) in people with COVID-19 and SARS-CoV-2, run by GlaxoSmithKline at 17 sites in 3 countries.
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 9 inclusion and 20 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 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, Australia, Philippines. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Solicited Local Adverse Events (AE) During 7 Days After Vaccination (time frame: From Day 1 to Day 7 (including Day 7)). The study lists 7 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 NCT05477186, which also lists 2 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 21 Feb 2025.