Trial jRCT2051210164
Publication Akahata W , SSRN, 2023
Dates: 2022-02-16 to 2022-03-17
Funding: Mixed (Japan Agency for Medical Research and Development, VLP Therapeutics Japan, LLC)
Conflict of interest: Yes

Methods
RCT
Location : Single center / Japan
Follow-up duration (months): 6
VLPCOV-01 0.3 mcg= (n=10)
VLPCOV-01 1.0 mcg= (n=10)
VLPCOV-01 3.0 mcg= (n=10)
BNT162b2= (n=10)
Placebo = (n=6)
Inclusion criteria
  • Participants who are within 6-12 months from the second vaccination of BNT162b2
  • Healthy Japanese male and female subjects who are 65 years of age or older
  • Participants who understand and agree to comply with the study procedures and provide written informed consent.
  • Participants whose BMI is 18-35 kg/m^2.
  • Participants whose body temperature is below 37.5 degree Celsius at screening.
  • Participants who have negative results of SARS-CoV-2 PCR test at screening and SARS-CoV-2 antigen test on Day 1 before vaccination.
  • Participants who is willing and able to keep diary by himself/herself.
Exclusion criteria
  • Participants who have history of COVID-19.
  • Female participants who are confirmed or suspected pregnant, planned to be pregnant within 90 days of the investigational agent administration or who are breast-feeding.
  • Participants who have history of significant diseases of cardiac, vascular system (including thrombosis), blood, respiratory, hepatic, renal, GI, psychiatric diseases or disorders.
  • Participants who have history of allergy such as systemic skin rash.
  • Participants who have history of convulsion (including febrile convulsions), Guillain-Barre syndrome, acute disseminated encephalomyelitis.
  • Participants who were diagnosed immune system disorder.
  • Participants who are receiving or scheduling any medicine and/or therapy that could interfere with immunogenicity assessment of test medications.
  • Participants who have history of anaphylaxis caused by food or medicines.
  • Participants who have history or risk of allergy or anaphylaxis caused by any components of study medications.
  • Participants who received any investigational product or vaccine 28 days prior to screening of this study, or who are planning to join any other investigation study during this study.
  • Participants who are bleeding tendency and considered a contraindication to intramuscular injection by Principal investigator or Sub-investigator.
  • Participants who are judged inappropriate in their health condition by Principal investigator or Sub-investigator.
Interventions
Intervention
1 IM doses of VLPCOV-01 0.3 mcg 6 to 12 months after prime vaccination with BNT162b2
1 IM doses of VLPCOV-01 1.0 mcg 6 to 12 months after prime vaccination with BNT162b2
1 IM doses of VLPCOV-01 3.0 mcg 6 to 12 months after prime vaccination with BNT162b2
1 IM doses of BNT162b2 6 to 12 months after prime vaccination with BNT162b2
Control
1 IM doses of placebo 6 to 12 months after prime vaccination with BNT162b2
Participants
Randomized
46 participants
Characteristics of participants
Type of participants: Healthy volunteers
N=46
24 males
Children: 0
Pregnant women: 0
Immunocompromized patients: 0
Mean age:
Age range: 68-77
Description of participants
Healthy adults, ≥65 years years of age, SARS-CoV-2 infection-free in a single centre in Japan.
Primary outcome
In the register
1. Frequency and severity of solicited local and systemic reactogenicity AEs for 7 days following vaccination. 2. Frequency and severity of unsolicited AEs until 28 days after vaccination. 3. GMT of neutralizing antibodies against SARS-CoV-2 up to 4 weeks after vaccination. 4. SRR of neutralizing antibodies against SARS-CoV-2 at 4 weeks after vaccination.
In the report
Neutralising antibody titres against SARS-CoV-2 variants up to 4 weeks after study drug administration; Occurrence of solicited local and systemic adverse events that occurred up to 6 days (Day 7) after study drug administration, and any unsolicited adverse events that occurred up to 4 weeks after study drug administration.
Documents
available

Protocol

Yes. In English

Statistical plan

Yes

Data-sharing stated: Unclear
Data accessibility: clinical@vlptherapeutics.com
Risk of bias
Overall
The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review
Some concerns
General comment In addition to all available versions of the pre-print article, the study registry and protocol were used in data extraction and risk of bias assessment.The study was a preliminary analysis of participants aged 65 years and older. The target sample size was achieved (n=46),and preliminary results are reported up to day 29. There is no change from the trial registration in the intervention and control treatments. Follow up is on-going