NCT04445194

Phase I Clinical Study of Recombinant Novel Coronavirus Vaccine

Status unknown Phase 1 Last updated 3 December 2020

What this trial tests

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

Timeline

22 June 2020

Primary endpoint
22 October 2020

20 September 2021

Quick facts

Lead sponsor	Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	50
Start date	22 June 2020
Primary completion	22 October 2020
Estimated completion	20 September 2021
Sites	1 location across China

Drugs / interventions tested

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

Adults 18 to 59, any sex, with Coronavirus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In this trial, a total of 50 subjects were recruited; the test vaccines were divided into 3 groups, low-dose vaccine groups, high-dose vaccine groups, and placebo groups. The first-stage randomized participants in the low-dose group (20 cases) and the placebo group (5 cases) were evaluated for 7 days. After the 7-day safety data was evaluated and agreed by the DSMB, the second-stage study was conducted. Into the high-dose group (20 cases) and placebo group (5 cases) subjects; follow-up to 30 days, after the safety assessment by the investigator and consent, then inoculate the second dose. Observation was performed for 1.0 hour after the second dose. The researchers conducted a safety evaluation and agreed to follow-up after discharge.

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. 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
3. 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
4. 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
5. Vaccines for COVID-19.
   Tregoning JS, Brown ES, Cheeseman HM, Flight KE, et al · · 2020 · cited 154× · PMID 32935331 · DOI 10.1111/cei.13517
6. Evaluation of the safety profile of COVID-19 vaccines: a rapid review.
   Wu Q, Dudley MZ, Chen X, Bai X, et al · · 2021 · cited 151× · PMID 34315454 · DOI 10.1186/s12916-021-02059-5
7. COVID-19 vaccine: where are we now and where should we go?
   Soleimanpour S, Yaghoubi A. · · 2021 · cited 98× · PMID 33435774 · DOI 10.1080/14760584.2021.1875824
8. 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