A phase 2 study of VLPCOV-01 in COVID-19 vaccinated healthy subjects

JRCT ID: jRCT2051220087

Registered date:12/09/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Prevention of infectious disease caused by SARS-CoV-2
• Date of first enrollment: 29/09/2022
• Target sample size: 300
• Study type: Interventional
• Intervention(s): Intramuscular injection of VLPCOV-01, placebo or BNT162b2(Coronavirus Modified Uridine RNA Vaccine (SARS-CoV-2)) in the upper arm

Outcome(s)

Primary Outcome

1. GMT (Geometric Mean Titer) of serum neutralizing antibody titer against live virus (wild type and variant) and pseudovirus (wild type and variant) (Week 0, 4, 8, 13, 26, 39, and 52)
2. SRR (Seroresponse Rate) of serum neutralizing antibody titer against live virus (wild type and variant) and pseudovirus (wild type and variant) (Week 4, 8, 13, 26, 39, and 52)
3. GMFR (Geometric Mean Fold Rise) of serum neutralizing antibody titer against live virus (wild typel and variant) and pseudovirus (wild type and variant) from baseline (Week 4, 8, 13, 26, 39, and 52)
4.Frequency and severity of the following items.
1)Solicited local adverse events observed until Day 7
2)Solicited systemic adverse events observed until Day 7
3)Solicit and unsolicited adverse events observed until Day 29

Secondary Outcome

1. IgG antibody against SARS-CoV-2 RBD Time Frame: Week 0, 4, 8, 13, 26, 39, and 52
2. Frequency and severity of the following items
1)Serious adverse events
2)COVID-19
3)Adverse event which caused discontinuation of the subject from the study

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Subjects who received two shots of primary vaccination with the same coronavirus (SARS-CoV-2) modified uridine RNA vaccine (either Comirnaty or Spikevax: mRNA), or received one shot or either Comirnaty or Spikevax in addition to two shots of primary vaccination with the same mRNA vaccine
(2) Subjects who passed at least 5 months from the previous coronavirus vaccine, on the planned dosing date of the study vaccine
(3) Subjects who are Japanese male or female aged 18 yeas or older at the time of informed consent given
(4) Subjects who are able to give written consent, comply with the compliance requirements during participation in the trial, undergo medical examinations and tests as stipulated in the trial protocol, and report their symptoms and other symptoms.
(5) Those willing and able to keep a prescribed diary on their own.

Exclude criteria

(1) Subjects who have a history of SARS-CoV-2 infection (confirmed by interview with subject regarding the results of either PCR or antigen test, screening PCR/antigen test, or anti-N-IgG antibody test)
(2) Subjects who have had close contact with a person infected with SARS-CoV-2 (including asymptomatic infected persons confirmed by testing) within 28 days prior to the study vaccine dosing
(3) Subjects who present with common cold-like symptoms within 72 hours prior to the study vaccine dosing
(4) Subjects who are pregnant, women who may be pregnant, women wishing to become pregnant while participating in the study (within 90 days of study drug dosing), and women of breastfeeding
(5) Subjects who present or have a history of serious cardiac, vascular (including thrombosis), hematological, respiratory, hepatic, renal, gastrointestinal, or neuropsychiatric disease whose medical condition is not stable.
(6) Subjects who have a history of convulsions (including febrile convulsions), Guillain-Barre syndrome or acute disseminated encephalomyelitis.
(7) Subjects who are or are suspected to be immunosuppressed or immunocompromised
(8) Subjects who are receiving or planning to receive during participation in a clinical trial any drug or therapy that may affect the immunogenicity assessment of the drug.
(9) Subjects who have a history of anaphylaxis caused by food, medicines or other substances
(10) Subjects who have a history or risk of allergy or anaphylaxis to the test vaccine or its composition (polyethylene glycol (PEG, macrogol) or polysorbate cross-reactive with PEG), including those with a history of allergy or anaphylaxis.
(11) Subjects who participated in another clinical trial and received an investigational drug (including vaccines) within 3 months prior to the screening date of this trial, or are scheduled to participate in another clinical trial while participating in this trial.
(12) Subjects who are in bleeding tendency, for which intramuscular inoculation is judged by the investigator or sub-investigator to be contraindicated.
(13) Subjects whose health condition is judged by the investigator or sub-investigator to be inadequate for participation in the study.

Related Information

• Primary Sponsor: Sato Nobuaki
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development