NCT04450004

Safety, Tolerability and Immunogenicinity of a Coronavirus-Like Particle COVID-19 Vaccine in Adults Aged 18-55 Years.

Completed Phase 1 Last updated 6 April 2022

What this trial tests

Phase 1 trial testing Intramuscular Vaccine in SARS-CoV 2 in 180 participants. Completed in 30 August 2021.

Timeline

10 July 2020

Primary endpoint
20 September 2020

30 August 2021

Quick facts

Lead sponsor	Medicago
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	prevention
Enrollment	180
Start date	10 July 2020
Primary completion	20 September 2020
Estimated completion	30 August 2021
Sites	2 locations across Canada

Drugs / interventions tested

• Intramuscular Vaccine — full drug profile →

Conditions studied

• SARS-CoV 2 — all drugs for SARS-CoV 2 →

Sponsor

Medicago — full company profile →

Who can join

Adults 18 to 55, any sex, with SARS-CoV 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study will be a randomized, partially-blinded, prime-boost, staggered dose-escalation Phase 1 study intended to assess the safety, tolerability, and immunogenicity of the Coronavirus-Like Particle COVID-19 Vaccine at three dose levels (3.75 µg, 7.5 µg, and 15 µg VLP) unadjuvanted or adjuvanted with either CpG 1018 or AS03 in healthy adults 18 to 55 years of age, who have been tested for the absence of SARS-CoV-2 antibodies.

At each dose level, the vaccine will initially be administered to a small number of subjects. Vaccinations of the first 6 subjects at the lowest dose level will be staggered so that each vaccination must be performed at least 30 minutes apart. Vaccination of the remaining subjects at the same dose level and the next higher vaccine dose level will be administered with approval of the Independent Data Monitoring Committee (IDMC). The same process will be followed for the second vaccine administration. All subjects will be followed for a period of 12 months after the second administration of the vaccine for safety and immunogenicity testing at the end of the follow-up period.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immunological considerations for COVID-19 vaccine strategies.
   Jeyanathan M, Afkhami S, Smaill F, Miller MS, et al · · 2020 · cited 697× · PMID 32887954 · DOI 10.1038/s41577-020-00434-6
2. Virus-like particles: preparation, immunogenicity and their roles as nanovaccines and drug nanocarriers.
   Nooraei S, Bahrulolum H, Hoseini ZS, Katalani C, et al · · 2021 · cited 541× · PMID 33632278 · DOI 10.1186/s12951-021-00806-7
3. Vaccine adjuvants: mechanisms and platforms.
   Zhao T, Cai Y, Jiang Y, He X, et al · · 2023 · cited 519× · PMID 37468460 · DOI 10.1038/s41392-023-01557-7
4. SARS-CoV-2 immunity: review and applications to phase 3 vaccine candidates.
   Poland GA, Ovsyannikova IG, Kennedy RB. · · 2020 · cited 463× · PMID 33065034 · DOI 10.1016/s0140-6736(20)32137-1
5. Coronavirus vaccine development: from SARS and MERS to COVID-19.
   Li YD, Chi WY, Su JH, Ferrall L, et al · · 2020 · cited 242× · PMID 33341119 · DOI 10.1186/s12929-020-00695-2
6. COVID-19 vaccines: rapid development, implications, challenges and future prospects.
   Kashte S, Gulbake A, El-Amin Iii SF, Gupta A. · · 2021 · cited 240× · PMID 33677814 · DOI 10.1007/s13577-021-00512-4
7. COVID-19 vaccines: The status and perspectives in delivery points of view.
   Chung JY, Thone MN, Kwon YJ. · · 2021 · cited 240× · PMID 33359141 · DOI 10.1016/j.addr.2020.12.011
8. Phase 1 randomized trial of a plant-derived virus-like particle vaccine for COVID-19.
   Ward BJ, Gobeil P, Séguin A, Atkins J, et al · · 2021 · cited 230× · PMID 34007070 · DOI 10.1038/s41591-021-01370-1