Phase-I Study to Evaluate the Safety and Immunogenicity of a Prophylactic pDNA Vaccine Candidate Against COVID-19 in Healthy Adults

• Status: Not yet recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

Summary

A pneumonia of unknown cause detected in Wuhan, China, was first reported in December 2019. On 08 January 2020, the pathogen causing this outbreak was identified as a novel coronavirus 2019. The outbreak was declared a Public Health Emergency of International Concern on 30 January 2020. On 12 February 2020, the virus was officially named as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and the WHO officially named the disease caused by SARS-CoV-2 as coronavirus disease 2019 (COVID-19). On 11 March 2020, the WHO upgraded the status of the COVID-19 outbreak from epidemic to pandemic, which is now spreading globally at high speed.

There are currently few licensed vaccines to prevent infection with SARS-CoV-2 or COVID-19 and the duration of response is unknown. Given the rapid transmission of COVID-19 and incidence of disease on a worldwide basis, the rapid development of effective vaccines with sufficient protection and duration of response is of utmost importance.

IAU has developed a thermally stable plasmid DNA (pDNA)-based vaccine candidate using a platform approach that enables the rapid development of vaccines against emerging viral diseases, including SARS-CoV-2. The pDNA vaccine developed by IAU is a synthetic, codon-optimized, encode either the full-length Spike (S) gene or S1 domain of SARS-CoV-2 as genes of interest. Here, we aim to test a synthetic, codon optimized pDNA encoding S.opt.FL as vaccine candidate against COVID-19.

A key advantage of pDNA vaccine is that multiple immunization can be used without the limitations of anti-vector responses.

This study is intended to investigate the safety, immunogenicity, and tolerbilty of this prophylactic vaccine against COVID-19 administered as intramuscular immunization (i.m.).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Imam Abdulrahman Bin Faisal University
• Collaborator: ICON plc
• Treatments: Vaccines

Criteria

Inclusion criteria

Study participants should meet ALL the below inclusion criteria to be eligible for the study:

1. Male or female participants between the age of 18 to 55 years at the time of enrollment.

2. Healthy participants as determined by the medical history, physical examination, clinical verification by the investigator.

3. Participant who are committed to comply with planned scheduled visits, vaccination, laboratory tests, and any other procedures.

4. Committed to sign the informed consent which includes all the requirements and restrictions listed in the informed consent and the protocol.

Exclusion criteria

Study participants should meet NONE of the exclusion criteria listed below:

1. Participant with known infection with Hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV).

2. Individuals with previous infection and diagnosis with COVID-19.

3. Individuals with previous vaccination with any COVID-19 vaccine.

4. Individuals working in facility with high probability of infection with SARS-CoV-2.

5. History of adverse reaction associated with vaccines and/or severe allergic reaction to any component of the study intervention.

6. Individuals under immunosuppressive therapy.

7. Individuals receiving treatment or medications that can adherently affect the immune system in the last 90 days, including but not limited to: interferon, immunoglobin, immunomodulators, epinephrine injector, cytotoxic drug.

8. Individuals diagnosed any diseases that is/are associated with sever COVID-19, including the following factors:

• Diabetes

• Hypertension

• Asthma

• BMI more than 30 kg/m2

• Pregnant or lactating women.

• Chronic pulmonary disease

• Chronic liver diseases

• Chronic renal diseases

9. Individuals with known or suspected immunological disorders, including, autoimmune disease and diabetes mellitus.

10. Individuals with current or previous neurological disorders, such as seizure or Gillian-Barre syndrome.

11. Individuals with psychiatric disorder or cognitive impairment.

12. Individuals with bleeding disorder or other conditions associated with prolonged bleeding time.

13. Individuals with abnormal safety laboratory screening.

14. Individuals receiving or planning to receive non-study vaccine 30 days prior to study enrollment.

15. Individuals receiving or donating blood or blood components 60 days prior to study enrollment.

16. Individuals participating in a clinical trial with an investigational vaccine, treatment, or device 30 days prior to study enrollment.

17. Individuals intend to participate in clinical trial during the time to participate in the study.

18. Individuals with history of alcohol or drug addiction.

19. Individual with other condition that may interfere with the health or the participants or that interfere with study's primary or secondary objectives.

20. Female participants whom are breast feeding