NCT04550351

Recombinant New Coronavirus Vaccine (CHO Cells) to Prevent SARS-CoV-2 Phase I Clinical Trial (≥60 Years Old)

Status unknown Phase 1 Last updated 27 January 2021

What this trial tests

Phase 1 trial testing Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cell) low-dose group in Coronavirus in 50 participants. Status unknown.

Timeline

19 August 2020

Primary endpoint
18 December 2020

31 December 2021

Quick facts

Lead sponsor	Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	prevention
Enrollment	50
Start date	19 August 2020
Primary completion	18 December 2020
Estimated completion	31 December 2021
Sites	1 location across China

Drugs / interventions tested

• Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cell) low-dose group — full drug profile →
• Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) high-dose group — full drug profile →
• Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) placebo group — full drug profile →

Conditions studied

• Coronavirus — all drugs for Coronavirus →

Sponsor

Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. — full company profile →

Who can join

60 and older, any sex, with Coronavirus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Popular topic: Phase I clinical trial of recombinant new coronavirus vaccine (CHO cell) (≥60 years old) Research purpose: Main purpose: To evaluate the safety and tolerability of different doses of recombinant new coronavirus vaccine (CHO cells) in healthy people aged 60 years and above. Secondary purpose: to initially explore the immunogenicity and durability of different doses of recombinant new coronavirus vaccine (CHO cells).

Overall design: A single-center, randomized, double-blind, placebo-controlled trial design was adopted.

Study population: a healthy population of 60 years and above, a total of 50 cases, both men and women.

Test groups: 20 cases in the low-dose group, 5 cases in the placebo group; 20 cases in the high-dose group, 5 cases in the placebo group.

Publications & conference data

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

1. Safety and immunogenicity of a recombinant tandem-repeat dimeric RBD-based protein subunit vaccine (ZF2001) against COVID-19 in adults: two randomised, double-blind, placebo-controlled, phase 1 and 2 trials.
   Yang S, Li Y, Dai L, Wang J, et al · · 2021 · cited 354× · PMID 33773111 · DOI 10.1016/s1473-3099(21)00127-4
2. 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
3. Efficacy and safety of COVID-19 vaccines.
   Graña C, Ghosn L, Evrenoglou T, Jarde A, et al · · 2022 · cited 227× · PMID 36473651 · DOI 10.1002/14651858.cd015477
4. COVID-19 Vaccines: A Review of the Safety and Efficacy of Current Clinical Trials.
   Yan ZP, Yang M, Lai CL. · · 2021 · cited 89× · PMID 33923054 · DOI 10.3390/ph14050406
5. A tandem-repeat dimeric RBD protein-based covid-19 vaccine zf2001 protects mice and nonhuman primates.
   An Y, Li S, Jin X, Han JB, et al · · 2022 · cited 72× · PMID 35311493 · DOI 10.1080/22221751.2022.2056524
6. The 2020 race towards SARS-CoV-2 specific vaccines.
   Karpiński TM, Ożarowski M, Seremak-Mrozikiewicz A, Wolski H, et al · · 2021 · cited 65× · PMID 33408775 · DOI 10.7150/thno.53691
7. A COVID-19 Vaccine: Big Strides Come with Big Challenges.
   Mellet J, Pepper MS. · · 2021 · cited 59× · PMID 33440895 · DOI 10.3390/vaccines9010039
8. An update review of globally reported SARS-CoV-2 vaccines in preclinical and clinical stages.
   Motamedi H, Ari MM, Dashtbin S, Fathollahi M, et al · · 2021 · cited 34× · PMID 34162141 · DOI 10.1016/j.intimp.2021.107763