Phase I Clinical Trial With New SARS-CoV-2 CoVacHGMix Type 5 Adenoviral Vector Vaccine

NCT05526183 | Unknown Phase 1 DMC

• 1 other identifier: MON.760.159.3
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The CoVacHGMix adenoviral vector vaccine is a new vaccine developed to protect against SARS-CoV-2 and is a Phase I study designed based on adaptive clinical trial standards. In this Phase I study, it is aimed to test the safety and efficacy of the investigational product at 2 different dose levels (low: 5x1010 and high: 1x1011) in volunteers aged 18-59 years. Vaccination will be performed as two doses: on days 0 and 28. In line with adaptive design standards, Phase I will be transferred to Phase II. In this phase, 2 different dose levels will be tested, and the dose and application forms in Phase II will be determined according to the results of Phase I. One of the aims of the study is to collect sufficient data to determine the final dose and method of administration to be applied in the phase III study and clinic.

Conditions

COVID-19

Keywords

Vaccine-SARS-Cov-2-Adenoviral vector

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events

  Adverse events

  Day1 to 168 days after vaccination

Secondary Outcomes (1)

• Immunogenicity

  12 months

Study Arms (2)

Low dose arm

EXPERIMENTAL

Low dose (5x1010 VP, i.m.); CoVacHGMix (with equal amounts of CoVacHGA1320, CoVacHGB420, CoVacHGC720 and CoVacHGD1480 adenoviral vector mix, as 0.5 solution) Intramuscular injection, two injections 28 days apart

Biological: Adeno-viral vector vaccine

High dose arm

EXPERIMENTAL

High dose (1x1011 VP, i.m.); CoVacHGMix (with equal amounts of CoVacHGB420, CoVacHGC720 and CoVacHGD1480 adenoviral vector mix, as 1.0 solution) Intramuscular injections, two injections 28 days apart

Biological: Adeno-viral vector vaccine

Interventions

Adeno-viral vector vaccine BIOLOGICAL

The vaccine will be injected intramuscularly, as two doses 28 days apart. Two different dosages will be given to volunteers (low dose: 5x1010 and high dose: 1x1011)

High dose arm; Low dose arm

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• I-1 Healthy volunteers of both sexes aged 18-59 years I-2 Able to give signed informed consent, I-3 Will be able to comply with the study protocol for approximately 6 months (depending on the group), I-4 HIV, Hepatitis B and C tests are negative, I-5 Body temperature below 37.2oC I-6 COVID-19 IgG and IgM antibodies negative and no history of symptomatic disease, I-7 Those who have not previously received any COVID-19 vaccines I-8 Negative qPCR SARS-CoV-2 result in nasopharynx or sputum samples, I-9 Body mass index between 18-35 kg/m2, I-10 Abnormal finding in complete blood count, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, urea, creatinine and fasting blood sugar between the normal reference values or detected in any laboratory parameter is Grade 1 according to the opinion of the investigator\* volunteers not older (\>Grade 1) I-11 Good general health (history and physical examination within 14 days prior to enrollment in the study), I-12 if female, healthy volunteers who are not pregnant or who can use appropriate contraception within 30 days before vaccine injection and within 6 months after vaccination will be included in the study.
• I-13 Male volunteers who can use appropriate contraception within 6 months after vaccine injection will be included in the study.

You may not qualify if:

• E-1. Subjects with a history of seizures, encephalopathy or psychosis, E-2. Subjects who have a known allergy to any vaccine or are allergic to any component of the vaccine to be administered, E-3. Pregnant or lactating women, women who have a positive pregnancy test or plan to become pregnant within the next 6 months.
• E-4. Subjects whose body temperature is above 37.2oC at the time of vaccination or who have signs of active infection, E-5. Subjects with a positive history of SARS (SARS-CoV-1) (based on voluntary declaration), E-6.Subjects with severe cardiovascular disease (arrhythmia, conduction block, myocardial infarction, uncontrolled hypertension), E-7. Subjects with serious chronic diseases (asthma, diabetes, thyroid diseases, etc.), E-8. Subjects with congenital or acquired angioedema, E-9. Subjects with a diagnosis of immunodeficiency, E-10. Subjects with a diagnosis of bleeding diathesis, E-11. Subjects who take immunosuppressive treatment, those who take anti-allergic treatment, those who take cytotoxic treatment, those who take inhaled corticosteroids (except for allergic rhinitis or topical steroid ointments), E-12. Subjects who received blood and blood product transfusion in the last 4 months, E-13. Subjects who participated in any vaccine study or took experimental drugs within 1 month before starting the study, E-14. Subjects who received any live vaccines in the 1 month prior to the study E-15. Subjects who received inactivated vaccine within 14 days of starting the study E-16. Subjects receiving active tuberculosis treatment, E-17. Subjects with a personal or family history of thrombosis and thromboembolism, persons prone to thrombosis E-18. According to the researcher's evaluation, those who have any condition (medical, psychological, social, etc.) that may impair the volunteer's compliance with the study will be excluded from the study.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead
• The Scientific and Technological Research Council of Turkey: collaborator
• MonitorCRO: collaborator

Study Sites (1)

Ankara City Hospital, Bilkent

Ankara, Bilkent, 06800, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ekmel Olcay, MD

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ekmel Olcay, MD

CONTACT

90533 733 5535; ekmelolcay@gmail.com

Bedia Dinc, MD

CONTACT

905053540776; bediadinc@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Vaccines will be provided to the study pharmacist and the randomization to dose levels will be prepared by the pharmacist. The vaccines will be provided to the investigators with volunteer numbers
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel arm, double blind study with no control arm. Two doses of vaccine will be administered and the randomization will be performed for dose levels.

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 2, 2022
• Study Start: January 21, 2022
• Primary Completion: December 30, 2022
• Study Completion: March 1, 2023
• Last Updated: September 6, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)