A Trial Evaluating the Safety and Immunogenicity of 3 COVID-19 SARS-CoV-2 RNA Vaccines in Healthy Adults

COVID-19 Clinical Trial

Official title:

A Phase 1/2 Randomized, Observer-Blind Study of the Safety, Reactogenicity, and Immunogenicity of 3 SARS-CoV-2 RNA Vaccine Candidates in Adults Previously Vaccinated and Not Previously Vaccinated Against SARS-CoV-2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05037097
• Other study ID #: ARCT-165-01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 30, 2021
• Est. completion date: March 2023

Study information

• Verified date: November 2021
• Source: Arcturus Therapeutics, Inc.
• Contact: Arcturus Therapeutics
• Phone: (858) 900-2660
• Email: clinicaltrials[@]arcturusrx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 1/2, randomized, observer-blind study in healthy adults. The study will evaluate the safety, reactogenicity, and immunogenicity of 3 SARS-CoV-2 self-amplifying RNA vaccine candidates against COVID-19 in adults previously vaccinated and not previously vaccinated against SARS-CoV-2.

Description:

The study will initially enroll approximately 72 adult participants into 2 cohorts and may expand enrollment up to 144 participants if additional cohorts are added.

The first cohort (Cohort A) will include a total of 36 adult participants ≥21 to ≤65 years of age who have not been previously vaccinated with a SARS-CoV-2 vaccine. Study vaccines will be given as 2 doses separated by 28 days.

The second cohort (Cohort B) will include a total of 36 adult participants ≥21 to ≤65 years of age who have been previously vaccinated (5 months or longer prior to study enrollment) with SARS-CoV-2 vaccine. Study vaccines will be given as single doses.

Additional cohorts may increase the age range of participants up to 80 years of age.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

Individuals who:

1. Are able to provide consent

2. Agree to comply with all study visits and procedures

3. Are willing and able to adhere to study restrictions

4. Are sexually active and willing to adhere to contraceptive requirements

5. Are male, female, or transgender =21 to =80 years of age

6. For the previously vaccinated groups only, received 2 doses of SARS-CoV-2 vaccine 5 months or longer prior to study enrollment

Exclusion Criteria:

Individuals who:

1. For the unvaccinated groups only, previously received any investigational or authorized MERS-CoV, SARS-CoV, and SARS-CoV-2 vaccines (including ARCT-021)

2. For the previously vaccinated groups only, previously received BNT162b2 but have not received 2 doses within at least 5 months prior to study enrollment

3. Are planning to receive other COVID-19 vaccines during the study period

4. Recently received other vaccines

5. Have a fever or are feeling sick close to the time of the first study vaccination

6. Have a known history of COVID-19 disease or asymptomatic SARS-CoV-2 infection

7. Are pregnant or breastfeeding

8. Have had a severe reaction to previous vaccines

9. Have a severe or uncontrolled disease(s) that may interfere with the interpretation of the study

10. Have some respiratory diseases

11. Have some significant heart diseases

12. Have some neurological conditions

13. Have sickle cell disease or some other blood disorders

14. Have had a major surgery within the past 6 months

15. Have a history of chronic liver disease

16. Have a history of autoimmune disease or immunodeficiency

17. Have received allergy injections, interferon, immunomodulators, cytotoxic drugs or other similar toxic drugs.

18. Have received blood products

19. Have a positive test for hepatitis B or C or human immunodeficiency virus

20. Have uncontrolled hypertension

21. Have had cancer except for cancers that were treated and that have low risk of returning

22. Are obese

23. Are Investigator site staff members, employees of Arcturus or the contract research organization (CRO) directly involved in the conduct of the study, or site staff members otherwise supervised by the Investigator or immediate family members of any of the previously mentioned individuals

Related Conditions & MeSH terms

• Communicable Diseases
• Corona Virus Infection
• Coronavirus Infections
• COVID-19
• Infections
• SARS-CoV-2 Infection

Intervention

Biological:
• ARCT-165
Dose 3
• ARCT-154
Dose 2
• ARCT-021
Dose 1

Locations

Country	Name	City	State
Singapore	Arcturus Investigational Site 101	Singapore
United States	Arcturus Investigational Site 201	Kansas City	Missouri
United States	Arcturus Investigational Site 202	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Arcturus Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants reporting solicited local or systemic adverse events	Solicited adverse events reported daily in a diary that reflect generalized symptoms or findings at the injection site following each vaccination	For 7 days following each study vaccination
Primary	Percentage of participants reporting unsolicited adverse events	Spontaneously reported adverse events	For 28 days following each study vaccination
Primary	Percentage of participants reporting medically attended adverse events	Medically attended adverse event is an AE that leads to an unscheduled visit with a health care provider	Through Final Visit (365 days after last study vaccine dose)
Primary	Percentage of participants reporting adverse events leading to discontinuation from study vaccine/study withdrawal	Unsolicited adverse events that meet stopping rules	Through Final Visit (365 days after last study vaccine dose)
Primary	Percentage of participants reporting serious adverse events	Unsolicited adverse events that meet the definition of serious	Through Final Visit (365 days after last study vaccine dose)
Primary	SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs	Neutralizing antibody response	Through Final Visit (365 days after last study vaccine dose)
Primary	Changes in SARS-CoV-2 serum neutralizing levels from before vaccination to each subsequent time point, expressed as GMFRs	Neutralizing antibody response	Through Final Visit (365 days after last study vaccine dose)
Primary	Percentages of participants achieving greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 serum neutralizing antibody levels	Neutralizing antibody response	Through Final Visit (365 days after last study vaccine dose)
Primary	GMT ratio (ARCT-021/ARCT-165, ARCT-165/ARCT-154, and ARCT-021/ARCT-154)	Neutralizing antibody response	Through Final Visit (365 days after last study vaccine dose)
Primary	SARS-CoV-2 full-length spike, RBD, and N binding antibody levels, expressed as GMCs	Binding antibody response	Through Final Visit (365 days after last study vaccine dose)
Primary	Changes in SARS-CoV-2 full-length spike, RBD, and N binding antibody levels from before vaccination to each subsequent time point, expressed as GMFRs	Binding antibody response	Through Final Visit (365 days after last study vaccine dose)
Primary	Percentages of participants achieving greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 full-length spike, RBD, and N binding antibody levels	Binding antibody response	Through Final Visit (365 days after last study vaccine dose)