COVID-19 Vaccines Under Clinical Development

Published on 02 Jun, 2020

Last Updated : 27 May, 2020

Candidate	Platform	Company/University	Collaborator	Primary Endpoint	Primary Comp. Date	Comments
Vaccines Listed under WHO (as of 11th May, 2020)
Ad5-nCoV (Recombinant Novel Coronavirus Vaccine - Adenovirus Type 5 Vector) Phase - II	Non- Replicating Viral Vector	CanSino Biologics Inc. Hubei, China	Insitute of Biotechnology, Academy of Military Medical Sciences, PLA of China	Adverse reactions (Time frame: 0-14 days post vaccination) Anti-S antibody IgG titer (Time frame: on day 28 post vaccination) Anti-SARS-CoV-2 neutralizing antibody titer (Time frame: on day 28 post vaccination)	December 30, 2020	On March 17, 2020, China approved the first clinical trial of the recombinant novel coronavirus vaccine jointly developed by Cansino and the Institute of Biotechnology; the trial will enroll 108 subjects at Tongji Hospital in Wuhan, China Ad5-nCov is a genetically engineered vaccine candidate with the replication-defective adenovirus type 5 as the vector to express SARS-CoV-2 spike protein; used Sartorius' Biostat STR single-use bioreactor system for the upstream preparation of the recombinant vaccine
	Non- Replicating Viral Vector	CanSino Biologics Inc. Hubei, China		Occurrence of adverse reactions (Time frame: 0-14 days post vaccination) Anti SARS-CoV-2 S antibody response(ELISA) (Time frame: 28 days post vaccination) Neutralizing antibody response to SARS-CoV-2 (Time frame: 28 days post vaccination)	January 31, 2021
ChAdOx1 nCoV-19 Phase - II	Non- Replicating Viral Vector	University of Oxford Hampshire, United Kingdom	-NA-	Assess efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19 - Number of virologically confirmed (PCR positive) symptomatic cases (6 months) Assess the safety of the candidate vaccine ChAdOx1 nCoV - Occurrence of serious adverse events (SAEs) (6 months)	May 2021	-NA-
mRNA-1273 Phase - II (IND Accepted)	LNP-encapsulated mRNA	National Institute of Allergy and Infectious Diseases (NIAID) United States	Moderna	Frequency of: solicited local reactogenicity adverse events (AEs) (Through 7 days post-vaccination) any medically-attended adverse events (MAAEs) (Day 1 to Day 394) new-onset chronic medical conditions (NOCMCs) (Day 1 to Day 394)	June 1, 2021	As of April 17, BARDA's commitment of up to $483M would enable the company to ramp their supply if the vaccine candidate is successful in the clinic
INO-4800 Phase - I	DNA plasmid vaccine with electroporation	Inovio Pharmaceuticals United States	Coalition for Epidemic Preparedness Innovations (CEPI)	Percentage of Participants with Adverse Events (AEs) (Baseline up to Week 52) Administration (Injection) Site Reactions (Day 0 up to Week 52) Adverse Events of Special Interest (AESIs) (Baseline up to Week 52) Change from Baseline in - Antigen-Specific Binding Antibody Titers ((Baseline up to Week 52) Antigen-Specific Interferon-Gamma (IFN-γ) Cellular Immune Response (Baseline up to Week 52)	April 2021	As of April 16, the International Vaccine Institute said the Coalition for Epidemic Preparedness Innovations granted $6.9M to Inovio to work with the IVI and the Korea National Institute of Health in a phase I/II trial of INO-4800 in South Korea
BNT162a1 (BNT162a1, BNT162b1, BNT162b2, BNT162c2) Phase - II	mRNA	Biontech SE	Pfizer	Percentage of participants reporting local reactions [ Time Frame: For 7 days after dose 1 and dose 2 ] Pain at the injection site, redness, and swelling as self-reported on electronic diaries. Percentage of participants reporting systemic events (Time Frame: For 7 days after dose 1 and dose 2) Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on electronic diaries.	January 27, 2023	Pfizer confirmed lead compound shows antiviral activity; as of April 9, clinical study could start in third quarter; as of April 23, Biontech announced German regulator approved phase I/II program The company will test four different candidates, two of which have nucleoside modified mRNA, one with a uridine containing mRNA and another with a self-amplifying mRNA construct All are lipid nanoparticle formulations and as of April 29, they completed dosing of 12 patients in first cohort of the COVID-19 prophylaxis study in Germany As of May 5, first participants dosed in phase I/II trial in U.S. Study is designed to determine safety, immunogenicity and optimal dose of four candidates; estimated enrollment is 7,600
Inactivated vaccine Phase - I/II	Inactivated	Wuhan Institute of Biological Products Hubei, China	Sinopharm	Incidence of adverse reactions/events (Time Frame: 0-7 days after each dose of vaccination)	November 2021	-NA-
Inactivated vaccine Phase - I/II	Inactivated	Beijing Institute of Biological Products Hubei, China	Sinopharm	Incidence of adverse reactions/events (Time Frame: 0-7 days after each dose of vaccination)	November 2021	-NA-
Inactivated SARS-CoV-2 vaccine Phase - I/II	Inactivated + alum	Sinovac Research and Development Hubei, China	-NA-	A. Clinical Trial Identifier - NCT04383574 - Safety index-incidence of adverse reactions (Day 0-28 after each dose vaccination) Incidence of adverse reactions after each dose vaccination Immunogenicity index-seroconversion rates of neutralizing antibody (30th day after the second dose vaccination) Neutralizing antibody assay will be performed using the micro-neutralization method. Seroconversion will be defined as a change from seronegative (<1:8) to seropositive (≥1:8), or ≥4 fold increase from baseline.	July 20, 2020	-NA-
Inactivated SARS-CoV-2 vaccine Phase - I/II	Inactivated + alum	Sinovac Research and Development Hubei, China	-NA-	B. Clinical Trial Identifier - NCT04352608 Safety indexes of adverse reactions (beginning of the vaccination to 28 days after the whole schedule vaccination) Occurence of adverse reactions post vaccination Immunogenicity indexes of neutralizing-antibody seroconversion rates for the emergency vaccination schedule (14th day after two doses of vaccination) The seroconversion rates of neutralizing antibodies against 2019 novel coronavirus tested by micro-neutralization assay in serum Immunogenicity indexes of neutralizing-antibody seroconversion rates for the routine vaccination schedule (28th day after two doses of vaccination) The seroconversion rates of neutralizing antibodies against 2019 novel coronavirus tested by micro-neutralization assay in serum	August 13, 2020	-NA-
Other Vaccines under Development
Pathogen-specific aAPC Vaccine Phase - I	-NA-	Shenzhen Geno-Immune Medical Institute Guangdong, China	Shenzhen Third People's Hospital; Shenzhen Second People's Hospital	Frequency of vaccine events (Time frame: Measured from Day 0 through Day 28) Frequency of serious vaccine events (Time frame: Measured from Day 0 through Day 28) Proportion of subjects with positive T cell response (Time frame: 14 and 28 days after randomization)	July 31, 2023	-NA-
Lentiviral Minigene Vaccine (LV-SMENP) Phase - II	-NA-	Shenzhen Geno-Immune Medical Institute Guangdong, China	Shenzhen Third People's Hospital; Shenzhen Second People's Hospital	Clinical improvement based on the 7-point scale (Time frame: 28 days after randomization) Lower Murray lung injury score (Time frame: 7 days after randomization)	July 31, 2023	A decline of 2 points on the 7-point scale from admission means better outcome. The 7-category ordinal scale that ranges from 1 (discharged with normal activity) to 7 (death) Murray lung injury score decrease more than one point means better outcome. The Murray scoring system range from 0 to 4 according to the severity of the condition."
BCG Vaccine (Intradermal) Phase - III	-NA-	Ain Shams University Cairo, Non-US, Egypt	-NA-	Estimate the incidence of confirmed COVID-19 among the healthcare workers in isolation hospitals (Time frame: 9 months) Evaluate the effectiveness of BCG vaccine in protecting the healthcare workers in isolation hospitals against the risk of COVID-19 infection (Time frame: 9 months)	October 1, 2020	-NA-
BCG Vaccine Phase - III	-NA-	UMC Utrecht Netherlands	Radboud University	Health Care Workers absenteeism (Maximum of 180 days)	October 25, 2020	-NA
Inactivated SARS-CoV-2 vaccine	Inactivated + alum	Sinovac Research and Development Co., Ltd.
Measles-Mumps-Rubella Vaccine (MV-COVID19) Phase - III	-NA-	Kasr El Aini Hospital Cairo, Egypt	-NA-	Number of participants with asymptomatic or mild COVID-19 disease defined as fever, plus at least one sign or symptom of respiratory disease including cough, runny/blocked nose, plus positive SARS-Cov-2 test (Time frame: Measured over the 6 months following randomization)	October 1, 2020	-NA-
BCG Vaccine Phase - III	-NA-	Universidad de Antioquia Antioquia, Colombia	-NA-	Incidence of COVID-19 cases confirmed or probable in the study population (From date of randomization to 360 day of the study)	June 2021	-NA-
BCG Vaccine Phase - III	-NA-	Murdoch Childrens Research Institute Australia	Royal Children's Hospital	Number of participants with COVID-19 disease defined as (Measured over the 6 months following randomisation) - fever (using self-reported questionnaire), plus at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire), plus positive SARS-Cov-2 test (PCR or serology) Severe COVID-19 disease incidence - Number of participants who were admitted to hospital or died (Time frame: Measured over the 6 months following randomisation)	October 30, 2020	-NA-
BCG Vaccine Phase - IV	NA	Texas A&M University United States	Baylor College of Medicine; M.D. Anderson Cancer Center; Cedars-Sinai Medical Center; Harvard University	Incidence of COVID 19 Infection (Time frame: 6 months)	May 2022	-NA-
CAR-NK Cells Phase - II	-NA-	Chongqing Public Health Medical Center Chongqing, China	Chongqing Sidemu Biotechnology Technology Co.,Ltd.	Clinical response Efficacy of NKG2D-ACE2 CAR-NK cells in treating severe and critical 2019 new coronavirus (COVID-19) pneumonia Side effects in the treatment group Safety and tolerability of NKG2D-ACE2 CAR-NK cells in patients with severe and critical 2019 new coronavirus (COVID-19) pneumonia	May 31, 2020	-NA-