A Study on the Safety and Immune Response of Investigational COVID-19 mRNA Vaccines in Healthy Adults

SARS-CoV-2 Clinical Trial

Official title:

A Phase 2 Randomized, Active-controlled, Observer-blind Study to Assess the Safety, Reactogenicity, and Immunogenicity of a Booster Dose of Investigational COVID-19 mRNA Vaccines in Healthy Adults Who Previously Received a Complete Primary Vaccination Series With or Without Booster Dose(s)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05960097
• Other study ID #: 219075
• Secondary ID: 2023-504596-25-0
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 1, 2023
• Est. completion date: August 28, 2024

Study information

• Verified date: March 2024
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of Part A of this study is to assess the immune response and safety of a booster dose of investigational COVID-19 mRNA vaccines in healthy adults. The study will compare the investigational vaccines to control vaccine.

The purpose of Part B of this study is to assess the immune response and safety of a booster dose of investigational COVID-19 mRNA vaccines in healthy adults. The study will compare the investigational vaccine under three different storage conditions.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 675
• Est. completion date: August 28, 2024
• Est. primary completion date: August 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Participants are eligible to be included in the study only if all of the following criteria apply:

1. Is at least 18 years old and has achieved legal age according to local regulations in each participating country.

2. Must provide documented informed consent prior to any study procedures being performed.

3. Can and will comply with the requirements of the protocol, in the opinion of the investigator.

4. Is healthy or medically stable as determined by the investigator's judgment based on medical history, vital sign measurements, and physical examination findings. Participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included.

5. Prior receipt of an mRNA COVID-19 vaccine. This may be from a completed primary vaccination series or booster dose(s) of an approved or authorized mRNA COVID-19 vaccine. The last vaccination must be an mRNA COVID-19 vaccination received at least 3 months prior to randomization.

6. If the participant is a woman of childbearing potential, the participant may be enrolled in the study, if they:

• have practiced adequate contraception for 30 days prior to study intervention administration; and

• have a negative pregnancy test result on the day of study intervention administration; and

• have agreed to continue adequate contraception for 2 months after study intervention administration.

Female participants of non-childbearing potential may be enrolled in the study. Nonchildbearing potential is defined as current salpingectomy, hysterectomy, ovariectomy, or postmenopausal.

Participants are excluded from the study if any of the following criteria apply:

1. Is pregnant or has a positive pregnancy test result at Visit 1.

2. Is breastfeeding or will (re)start breastfeeding from the study intervention administration to 3 months after study intervention administration.

3. Has any medical disease or psychiatric condition that, in the opinion of the investigator, precludes study participation because it would place the participant at an unacceptable risk of injury, would render them unable to meet the requirements of the protocol or may interfere with successful completion of the study.

4. Has any history of an immunosuppressive or immunodeficient condition resulting from disease.

5. Has used immunosuppressants or other immune-modifying drugs for 14 consecutive days or more within 3 months prior to the study intervention administration. Non-systemic corticosteroids are allowed. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration.

6. Has an acute medical illness or acute febrile illness with oral temperature =38.0°C or =100.4°F within 72 hours prior to study intervention administration.

7. Has participated in another study involving any investigational product, vaccine, or device within 28 days before the study intervention administration and/or planned participation through end of study (EoS).

8. Has participated in Part A of this study.

9. Has a history of hypersensitivity or severe allergic reaction including anaphylaxis, generalized urticaria, angioedema, and other significant reactions to any previous mRNA vaccine or any component of the study intervention(s).

10. Has received or plans to receive immunoglobulins or any blood or blood products within 3 months before study intervention administration through EoS.

11. Has a bleeding disorder, or prior history of significant bleeding or bruising following intramuscular injections.

12. Has a history of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures.

13. Has a 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 and persistent myocardial infection.

14. Has received a live vaccine 30 days before the study intervention administration or has a planned administration within 30 days after the study intervention administration.

15. Has received a non-replicating vaccine 8 days before the study intervention administration or has a planned administration within 14 days after the study intervention administration.

16. Has a documented history of confirmed SARS-CoV-2 infection within 3 months before study intervention administration.

17. Has had known close contact with anyone who had a confirmed SARS-CoV-2 infection within 2 weeks before study intervention administration.

18. Is an employee or family member of the investigator or study site staff.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2

Intervention

Biological:
• CV0701 Bivalent High dose
Study vaccine is administered as a single intramuscular injection in the deltoid area on Day 1.
• CV0701 Bivalent Medium dose
Study vaccine is administered as a single intramuscular injection in the deltoid area on Day 1.
• CV0701 Bivalent Low dose
Study vaccine is administered as a single intramuscular injection in the deltoid area on Day 1.
• CV0601 Monovalent High dose
Study vaccine is administered as a single intramuscular injection in the deltoid area on Day 1.
• Control vaccine
Study vaccine is administered as a single intramuscular injection in the deltoid area on Day 1.
• CV0801 Monovalent
Study vaccine is administered as a single intramuscular injection in the deltoid area on Day 1.

Locations

Country	Name	City	State
Australia	Paratus Clinical Research - Western Sydney - PPDS	Blacktown	New South Wales
Australia	Emeritus Research - Sydney - PPDS	Botany	New South Wales
Australia	Northern Beaches Clinical Research	Brookvale	New South Wales
Australia	Paratus Clinical Research - Canberra - PPDS	Bruce	Australian Capital Territory
Australia	Emeritus Research- Melbourne PPDS	Camberwell	Victoria
Australia	Northside Health	Coffs Harbour	New South Wales
Australia	East Sydney Doctors	Darlinghurst	New South Wales
Australia	Paratus Clinical Research - Brisbane Clinic - PPDS	Herston	Queensland
Australia	Paratus Clinical Research - Central Coast - PPDS	Kanwal	New South Wales
Australia	Australian Clinical Research Network	Maroubra	New South Wales
Australia	Hunter Diabetes Center	Merewether
Australia	Cmax - Ppds	Norwood	South Australia
Australia	Austrials Pty Ltd - Taringa	Taringa	Queensland
Australia	AusTrials Wellers Hill	Tarragindi	Queensland
United States	AES - DRS - Optimal Research Illinois - Peoria	Creve Coeur	Illinois
United States	Research Centers of America - CenExel - PPDS	Hollywood	Florida
United States	Benchmark Research - Sacramento - HyperCore - PPDS	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
GlaxoSmithKline	CureVac

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A: Geometric mean titer of serum neutralization titers against pseudovirus bearing Omicron subvariant XX spike protein		Day 29
Primary	Part A: Geometric mean titer of serum neutralization titers against pseudovirus bearing SARS-CoV-2 strain XY spike protein		Day 29
Primary	Part A: Percentage of participants with solicited administration site adverse events (AEs)		Day 1 to Day 7
Primary	Part A: Percentage of participants with solicited administration systemic AEs		Day 1 to Day 7
Primary	Part A: Percentage of participants with unsolicited AEs		Day 1 to Day 28
Primary	Part A: Percentage of participants with medically attended adverse events (MAAEs)		Day 1 through End of Study (approximately 180 days after the study intervention administration)
Primary	Part A: Percentage of participants with serious adverse events (SAEs)		Day 1 through End of Study (approximately 180 days after the study intervention administration)
Primary	Part A: Percentage of participants with adverse events of special interest (AESIs)		Day 1 through End of Study (approximately 180 days after the study intervention administration)
Primary	Part B: Percentage of participants with solicited administration site adverse events (AEs)		Day 1 to Day 7
Primary	Part B: Percentage of participants with solicited administration systemic AEs		Day 1 to Day 7
Primary	Part B: Percentage of participants with unsolicited AEs		Day 1 to Day 28
Primary	Part B: Percentage of participants with medically attended adverse events (MAAEs)		Day 1 through End of Study (approximately 180 days after the study intervention administration)
Primary	Part B: Percentage of participants with serious adverse events (SAEs)		Day 1 through End of Study (approximately 180 days after the study intervention administration)
Primary	Part B: Percentage of participants with adverse events of special interest (AESIs) Part B: Percentage of participants with adverse events of special interest (AESIs)		Day 1 through End of Study (approximately 180 days after the study intervention administration)
Primary	Part B: Geometric mean titer of serum neutralization titers against pseudovirus bearing SARS-CoV-2 strain XY spike protein		Day 29
Secondary	Part A: Geometric mean titer of serum neutralization titers against pseudovirus bearing Omicron subvariant XX spike protein		Day 91 and Day 181
Secondary	Part A: Geometric mean titer of serum neutralization titers against pseudovirus bearing SARS-CoV-2 strain XY spike protein		Day 91 and Day 181
Secondary	Part A: Geometric mean titer of serum neutralization titers against pseudovirus bearing Omicron subvariant XZ spike protein		Days 29, 91 and 181
Secondary	Part A: Percentage of participants with seroresponse from baseline of serum neutralization titers against pseudovirus bearing Omicron subvariant XX spike protein	Seroresponse is defined as post-booster titer greater than or equal to (=) 4 times the lower limit of quantification (LLOQ) when pre-vaccination titer is below LLOQ or a post-booster titer = 4 times the pre-booster titer when pre-vaccination titer is = LLOQ.	Day 29
Secondary	Part A: Percentage of participants with seroresponse from baseline of serum neutralization titers against pseudovirus bearing SARS-CoV-2 strain XY spike protein	Seroresponse is defined as post-booster titer = 4 times the lower limit of quantification (LLOQ) when pre-vaccination titer is below LLOQ or a post-booster titer = 4 times the pre-booster titer when pre-vaccination titer is = LLOQ.	Day 29
Secondary	Part A: Percentage of participants with seroresponse from baseline of serum neutralization titers against pseudovirus bearing Omicron subvariant XZ spike protein	Seroresponse is defined as post-booster titer = 4 times the LLOQ when pre-vaccination titer is below LLOQ or a post-booster titer = 4 times the pre-booster titer when pre-vaccination titer is = LLOQ.	Day 29
Secondary	Part A: Geometric mean increase of the fold increase from baseline of serum neutralization titers against pseudovirus bearing Omicron subvariant XX spike protein		Days 29, 91 and 181
Secondary	Part A: Geometric mean increase of the fold increase from baseline of serum neutralization titers against pseudovirus bearing SARS-CoV-2 strain XY spike protein		Days 29, 91 and 181
Secondary	Part A: Geometric mean increase of the fold increase from baseline of serum neutralization titers against pseudovirus bearing Omicron subvariant XZ spike protein		Days 29, 91 and 181