A Study to Evaluate Immunogenicity and Safety of MVC-COV1901 Vaccine Compared With AZD1222

NCT05426343 | Completed Phase 3 DMC

• 1 other identifier: CT-COV-34
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to measure the anti-SARS-CoV-2 neutralizing antibody titres in adult participants, in particular elderly, so as to demonstrate immunogenic superiority of MVC-COV1901 to the active control, AZD1222 vaccine, in terms of the GMT of neutralizing antibodies at 14 days after the second dose of the study intervention. This study also assesses the safety and tolerability of the study intervention and explores the immunogenicity in terms of antigen-specific immunoglobulin as well as the potential efficacy of MVC-COV1901 in preventing COVID-19.

Conditions

COVID-19 Vaccine

Keywords

COVID-19 Vaccine

Outcome Measures

Primary Outcomes (2)

• Immunogenicity of neutralizing antibody (GMT)

  To demonstrate the immunogenic superiority of MVC-COV1901 to AZD1222 in terms of neutralizing antibody titers at 14 days after the second vaccination. -GMT ratio

  Day 1 to Day 43

• Incidence of Adverse Event within 28 days post the second study intervention

  To evaluate the safety and tolerability of MVC-COV1901 compared to AZD1222 from Day 1 to 28 days after the second vaccination The number and percentage of participants with the occurrence of Adverse Events

  Day 1 to 28 days post the second study intervention

Secondary Outcomes (4)

• Immunogenicity of antigen-specific immunoglobulin (GMT)

  Day 1 to Day 209

• Immunogenicity of antigen-specific immunoglobulin (SCR)

  Day 1 to Day 209

• Immunogenicity of antigen-specific immunoglobulin(GMT ratio)

  Day 29 to Day 209

• Incidence of Adverse Event throughout study conduct

  Day 1 to Day 209

Other Outcomes (2)

• Incidence of confirmed COVID-19 cases

  Day 43 to Day 209

• Cell Mediated Immunity

  Day 1 to Day 43

Study Arms (2)

MVC-COV1901

EXPERIMENTAL

S-2P protein with CpG and Aluminum Hydroxide/0.5mL

Biological: MVC-COV1901

AZD1222

ACTIVE COMPARATOR

n=ChAdOx1 nCoV-19 vaccine

Biological: AZD1222

Interventions

MVC-COV1901 BIOLOGICAL

Approximately 125 participants will receive 2 doses of MVC-COV1901(S-2P protein with adjuvant) at Day 1 and Day 29 via intramuscular (IM) injection in the deltoid region

MVC-COV1901

AZD1222 BIOLOGICAL

Approximately 125 participants will receive 2 doses of AZD1222 at Day 1 and Day 29 via intramuscular (IM) injection in the deltoid region

AZD1222

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participant aged 18 years and above at randomization.
• Healthy adult or adult with pre-existing medical conditions who is in a stable condition. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease 3 months before enrollment and expected to remain stable for the duration of the study.
• Female participant:
• A female participant is eligible if the participant is a woman of non-childbearing potential, i.e., surgically sterilized (defined as having undergone hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy; tubal ligation alone is not considered sufficient) or one year post-menopausal.
• If the participant is a woman of childbearing potential, she must agree to practice sexual abstinence or agree to use medically effective contraception from 14 days before screening to 30 days following the last administration of study intervention. Highly effective methods of contraception include:
• i. Implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine hormonal-releasing system ii. Established use of hormonal methods (injectable, pill, patch or ring) combined with barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository iii. Azoospermic partner (vasectomized or due to medical cause), provided the partner is the sole sexual partner of the female participant and the absence of sperm has been confirmed (from medical records/examination/history).
• c. Have a negative pregnancy test
• Participant is willing and able to comply with all required study visits and follow-up required by this protocol.
• Participant or the participant's legal representative must understand the procedures of the study and provide written informed consent.

You may not qualify if:

• Pregnant or breastfeeding or have plan to become pregnant within 30 days after the last administration of the study intervention.
• Employees at the investigator's site, of the Sponsor or delegate (e.g., contract research organization) who are directly involved in the conduct of the study
• Currently receiving or received any investigational intervention within 30 days prior to the first dose of the study intervention.
• Administered any licensed live-attenuated vaccines within 28 days or other licensed non- live-attenuated vaccines within 7 days prior to the first dose of the study intervention.
• Administered any blood product or intravenous immunoglobulin administration within 12 weeks prior to the first dose of the study intervention.
• Currently receiving or anticipate receiving concomitant immunosuppressive or immune- modifying therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or \< 2 weeks of daily receipt of prednisone less than 20 mg or equivalent) within 12 weeks prior to the first dose of the study intervention.
• Currently receiving or anticipate receiving treatment with tumor necrosis factor (TNF)-α inhibitors, e.g., infliximab, adalimumab, etanercept within 12 weeks prior to the first dose of the study intervention.
• Major surgery or any radiation therapy within 12 weeks prior to the first dose of the study intervention.
• Has received any other investigational or approved COVID-19 vaccine.
• Immunosuppressive illness or immunodeficient state, including hematologic malignancy, history of solid organ, bone marrow transplantation, or asplenia.
• A history of malignancy with potential risk for recurrence after curative treatment, or current diagnosis of or treatment for cancer (exceptions are squamous and basal cell carcinomas of the skin and treated uterine cervical carcinoma in situ, at the discretion of the investigator).
• Bleeding disorder considered a contraindication to intramuscular (IM) injection or phlebotomy.
• Documented SARS-CoV-2 infection prior to the first dose of study intervention, or an individual with positive anti-SARS-CoV-2 antibody test at screening.
• A history of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia, thrombosis with thrombocytopenia syndrome (TTS), antiphospholipid syndrome, or capillary leak syndrome.
• Participant who, in the investigator's judgement, is not in a stable condition and by participating in the study could adversely affect the safety of the participant, interfere with adherence to study requirements or evaluation of any study endpoint. This may include a participant with ongoing acute diseases, severe infections, autoimmune disease, laboratory abnormality or serious medical conditions in the following systems: cardiovascular, pulmonary, hepatic, neurologic, metabolic, renal, or psychiatric.

Sponsors & Collaborators

• Medigen Vaccine Biologics Corp.: lead

Study Sites (1)

Hospital Fundación Tesai

Ciudad del Este, Paraguay

Location

MeSH Terms

Interventions

MVC-COV1901 vaccine; ChAdOx1 nCoV-19

Intervention Hierarchy (Ancestors)

Vaccines, DNA; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines

Study Officials

• Allen Lien, MD. Dr.PH

  Medigen Vaccine Biologics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 22, 2022
• Study Start: July 9, 2022
• Primary Completion: October 10, 2022
• Study Completion: January 7, 2023
• Last Updated: October 23, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)