Clinical Trials


Last updated: 2021 Aug 3
Total hit(s): 35
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In a randomised, placebo-controlled phase 1 trial, protein subunit vaccine SCB-2019 formulated with either AS03 or CpG/Alum adjuvants had a good safety profile and was well-tolerated. The vaccine was considered for further clinical development. The SCB-2019 vaccine, comprising S-Trimer protein formulated with either AS03 or CpG/Alum adjuvants, elicited robust humoral and cellular immune responses against SARS-CoV-2, with high viral neutralising activity.
33524311
(Lancet)
PMID
33524311
Date of Publishing: 2021 Feb 20
Title Safety and immunogenicity of S-Trimer (SCB-2019), a protein subunit vaccine candidate for COVID-19 in healthy adults: a phase 1, randomised, double-blind, placebo-controlled trial
Author(s) nameRichmond P, Hatchuel L et al.
Journal Lancet
Impact factor
43.38
Citation count: 2
Date of Entry 2021 Aug 3


In a randomised, placebo-controlled phase 1 trial, S protein subunit vaccine SCB-2019 without adjuvant had a poor immunogenic response with 3 seroconversions by day 50. However, with adjuvants- either AS03 or CpG/Alum a good humoral and cellular responses were elicited. Based on these results, 9 g SCB-2019 adjuvanted with AS03 and 30 g SCB-2019 adjuvanted with CpG/Alum are the preferred candidates for the phase 2/3 trials. All the formulation had a good safety profile.
33524311
(Lancet)
PMID
33524311
Date of Publishing: 2021 Feb 20
Title Safety and immunogenicity of S-Trimer (SCB-2019), a protein subunit vaccine candidate for COVID-19 in healthy adults: a phase 1, randomised, double-blind, placebo-controlled trial
Author(s) nameRichmond P, Hatchuel L et al.
Journal Lancet
Impact factor
43.38
Citation count: 2
Date of Entry 2021 Aug 3


In an open, non-randomised, combined phase 1/2 trial, heterologous vector-based vaccine rAd26 and rAd5 COVID vaccines, was found to be safe. The vaccine did not elicit any severe adverse reaction in the recipients. The vaccine was available in two formulations, frozen form (Gam-COVID-Vac) and lyophilised form (Gam-COVID-Vac-Lyo). The frozen form had a volume of 0.5mL and the lyophilised form was reconstituted in 1.0mL of sterile water.
32896291
(Lancet)
PMID
32896291
Date of Publishing: 2020 Sep 26
Title Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia
Author(s) nameLogunov DY, Dolzhikova IV et al.
Journal Lancet
Impact factor
43.38
Citation count: 65
Date of Entry 2021 Aug 3


In an open, non-randomised, combined phase 1/2 trial, heterologous vector-based vaccine rAd26 and rAd5 COVID vaccines induced strong humoral and cellular immune responses.
32896291
(Lancet)
PMID
32896291
Date of Publishing: 2020 Sep 26
Title Safety and immunogenicity of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine in two formulations: two open, non-randomised phase 1/2 studies from Russia
Author(s) nameLogunov DY, Dolzhikova IV et al.
Journal Lancet
Impact factor
43.38
Citation count: 65
Date of Entry 2021 Aug 3


In the phase 1/2 trial, the ChAdOx1 nCov-19 vaccine was found to be safe with no severe adverse reactions. The side effects resulted in mild and moderate symptoms but were reduced by taking paracetamol after taking the vaccination. 1. ChAdOx1 nCoV-19 vaccine was found to be safe. Local and sytemic side effects were very minimum after the administeration of prophylactic paracetamol. One severe adverse effect, haemolytic anaemia, was associated with the control group after nine days of administeration. 2. Reactogenicity profile appeared less severe in the participants who received the vaccine booster dose.
32702298
(Lancet)
PMID
32702298
Date of Publishing: 2020 Aug 15
Title Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial
Author(s) nameFolegatti PM, Ewer KJ et al.
Journal Lancet
Impact factor
43.38
Citation count: 162
Date of Entry 2021 Aug 3


In a placebo-controlled, randomised, double-blind phase 2 clinical trial, the safety of two dosage groups ( 5*10^10 viral particles and 1*10^11 viral particles) of Ad5 vectored vaccine was evaluated. The safety profile of the 5*10^10 dosage group was better and chosen for phase the 3 trial.
32702299
(Lancet)
PMID
32702299
Date of Publishing: 2020 Aug 15
Title Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial
Author(s) nameZhu FC, Guan XH et al.
Journal Lancet
Impact factor
43.38
Citation count: 81
Date of Entry 2021 Aug 3


In a phase 1/2 trial, ChAdOx1 nCoV-19 vaccine induced both cellular and humoral immune responses. Spike-specific T cells responses were detectable by day 14 and spike-specifc IgG antibodies were detectable by day 28. Both responses were boosted after the second dose. Neutralising antibody responses were seen in all participants after the booster dose.
32702298
(Lancet)
PMID
32702298
Date of Publishing: 2020 Aug 15
Title Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial
Author(s) nameFolegatti PM, Ewer KJ et al.
Journal Lancet
Impact factor
43.38
Citation count: 162
Date of Entry 2021 Aug 3


In a placebo-controlled, randomised, double-blind phase 2 clinical trial of Adv5 vectored COVID-19 vaccine, it was found that a single dose of 510^10 viral particles was significantly immunogenic. The vaccine-induced seroconversion of neutralising antibodies and good T cell responses.
32702299
(Lancet)
PMID
32702299
Date of Publishing: 2020 Aug 15
Title Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial
Author(s) nameZhu FC, Guan XH et al.
Journal Lancet
Impact factor
43.38
Citation count: 81
Date of Entry 2021 Aug 3


In phase 2, double-blind, randomised, multicentre clinical trial, BBV152, an inactivated vaccine, elicited mild symptoms in participants and hence was considered to be safe 1. 27 unsolicited adverse events were reported and 9 of them were related to the vaccine.
33705727
(Lancet Infect Dis)
PMID
33705727
Date of Publishing: 2021 Mar 8
Title Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: interim results from a double-blind, randomised, multicentre, phase 2 trial, and 3-month follow-up of a double-blind, randomised phase 1 tria
Author(s) nameElla R, Reddy S et al.
Journal Lancet Infect Dis
Impact factor
21.77
Citation count: 9
Date of Entry 2021 Jun 22


In phase 1 trial for an inactivated vaccine BBV152, the high neutralising antibody response elicited in phase 1 participants remained elevated even after three months. In the phase 2 trial participants, a better humoral and cell-mediated immune response was produced. The phase 3 trials would be conducted with the 6ug-Algel-IMDG formulation. The study was conducted at a time when the number of COVID-19 cases was increasing in India. The participants in the study could have been exposed to possible infection. In case of such natural exposure to the virus, it is possible the antibody titre values were slightly inflated
33705727
(Lancet Infect Dis)
PMID
33705727
Date of Publishing: 2021 Mar 8
Title Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: interim results from a double-blind, randomised, multicentre, phase 2 trial, and 3-month follow-up of a double-blind, randomised phase 1 trial
Author(s) nameElla R, Reddy S et al.
Journal Lancet Infect Dis
Impact factor
21.77
Citation count: 9
Date of Entry 2021 Jun 22


In a phase 1 trial with an inactivated viral vaccine, BBV152 elicited mild to moderate adverse effects in a few study participants and hence was declared safe. The overall incidence of solicited local and systemic adverse events in this study was 1421% in all vaccine-treated groups.
33485468
(Lancet Infect Dis)
PMID
33485468
Date of Publishing: 2021 Jan 21
Title Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomised, phase 1 trial
Author(s) nameElla R, Vadrevu KM et al.
Journal Lancet Infect Dis
Impact factor
21.77
Citation count: 1
Date of Entry 2021 Jun 22


In phase 1, double blind, randomised trial, the immune response of the BBV152 vaccine was investigated. The vaccine was able to elicit a good immune response.
33485468
(Lancet Infect Dis)
PMID
33485468
Date of Publishing: 2021 Jan 21
Title Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: a double-blind, randomised, phase 1 trial
Author(s) nameElla R, Vadrevu KM et al.
Journal Lancet Infect Dis
Impact factor
21.77
Citation count: 1
Date of Entry 2021 Jun 22


In a placebo-controlled, observer-blinded, dose-escalation, phase 1 trial, the two vaccine candidates; BNT162b1 and BNT162b2 were observed to have similar immunogenicity. The SARS-CoV-2-neutralizing geometric mean titers, obtained in both the vaccine groups were similar to SARS-CoV-2 convalescent serum samples.
33053279
(N Engl J Med)
PMID
33053279
Date of Publishing: 2020 Dec 17
Title Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates
Author(s) nameWalsh EE, Frenck RW Jr et al.
Journal N Engl J Med
Impact factor
37.91
Citation count: 46
Date of Entry 2021 Jun 22


In phase 1, dose-escalation trial, mRNA vaccine mRNA-1273 was found to be safe with a very low occurrence of adverse side effects. Most of the adverse effects observed were mild to moderate and mostly occurs after the second dose of the vaccine. One participant did not receive second dose of vaccine after experiencing paronychia two days after receiving the first dose of the vaccine. However, the rash was considered to be unrelated to vaccination by the investigators
32991794
(N Engl J Med)
PMID
32991794
Date of Publishing: 2020 Dec 17
Title Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults
Author(s) nameAnderson EJ, Rouphael NG et al.
Journal N Engl J Med
Impact factor
37.91
Citation count: 62
Date of Entry 2021 Jun 22


In a phase 1 trial, two types of RNA based vaccines were tested: a) BNT162b2, coding for membrane-bound full-length spike protein; b) BNT162b1 coding secreted domain which is trimerized. Milder systemic events were found with BNT162b2. Hence BNT162b2 was chosen for the next phase of trials. 1. 100ug dose of vaccine was included in the clinical trial study but was discontinued after one dose because of reactogenicity in the participants ( BNT162b1 vaccine and placebo)
33053279
(N Engl J Med)
PMID
33053279
Date of Publishing: 2020 Dec 17
Title Safety and Immunogenicity of Two RNA-Based Covid-19 Vaccine Candidates
Author(s) nameWalsh EE, Frenck RW Jr et al.
Journal N Engl J Med
Impact factor
37.91
Citation count: 46
Date of Entry 2021 Jun 22


In phase 1, the dose-escalation trial, the immune response of the mRNA-1273 vaccine was assessed. The 100ug dose of the vaccine elicited higher binding- and neutralizing-antibody response than the 25ug dose. Hence, 100ug of the vaccine was used in phase 3.
32991794
(N Engl J Med)
PMID
32991794
Date of Publishing: 2020 Dec 17
Title Safety and Immunogenicity of SARS-CoV-2 mRNA-1273 Vaccine in Older Adults
Author(s) nameAnderson EJ, Rouphael NG et al.
Journal N Engl J Med
Impact factor
37.91
Citation count: 62
Date of Entry 2021 Jun 22


In a dose-escalating phase 1 trial, Ad5 vectored COVID-19 vaccine was found to be well-tolerated and immunogenic at 28 days post-vaccination. T cell responses were seen 14-days post-vaccination. Some patients in all three groups had high pre-existing Ad5 neutralising antibody titre. The pre-existing antibody titre had a negative impact on the pattern of T cell responses.
32450106
(Lancet)
PMID
32450106
Date of Publishing: 2020 Jun 13
Title Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial
Author(s) nameZhu FC, Li YH et al.
Journal Lancet
Impact factor
43.38
Citation count: 205
Date of Entry 2021 Jun 22


In a dose-escalating phase 1 trial, Ad5 vectored COVID-19 vaccine was found to be safe with minimal severe adverse events. Most of the symptoms observed across the three dosage group were mild or moderate in severity.
32450106
(Lancet)
PMID
32450106
Date of Publishing: 2020 Jun 13
Title Safety, tolerability, and immunogenicity of a recombinant adenovirus type-5 vectored COVID-19 vaccine: a dose-escalation, open-label, non-randomised, first-in-human trial
Author(s) nameZhu FC, Li YH et al.
Journal Lancet
Impact factor
43.38
Citation count: 205
Date of Entry 2021 Jun 22


A phase2/3 trial of the ChAdOx1 nCoV-19 vaccine shows that it is safe and well-tolerated in older and young adults. Local reactions were more common than systemic reactions. Fewer adverse reactions were reported after the booster dose and reduced with increasing age. The ChAdOx1 nCoV-19 (AZD1222) vaccine was found to be safe and well-tolerated with better reactogenicity profile in older adults than in younger adults.
33220855
(Lancet)
PMID
33220855
Date of Publishing: 2021 Dec 19
Title Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial
Author(s) nameRamasamy MN, Minassian AM et al.
Journal Lancet
Impact factor
43.38
Citation count: 26


In a phase2/3 trial of the ChAdOx1 nCoV-19 vaccine, immunogenecity was found to be similar across all age groups after the booster dose.
33220855
(Lancet)
PMID
33220855
Date of Publishing: 2021 Dec 19
Title Safety and immunogenicity of ChAdOx1 nCoV-19 vaccine administered in a prime-boost regimen in young and old adults (COV002): a single-blind, randomised, controlled, phase 2/3 trial
Author(s) nameRamasamy MN, Minassian AM et al.
Journal Lancet
Impact factor
43.38
Citation count: 26


Among the 175 adverse events reported during the clinical trial with the Pfizer-BioNTech COVID-19 vaccine, severe allergic reactions including anaphylaxis were reviewed.
33444297
(MMWR Morb Mortal Wkly Rep)
PMID
33444297
Date of Publishing: 2021 Jan 15
Title Allergic Reactions Including Anaphylaxis After Receipt of the First Dose of Pfizer-BioNTech COVID-19 Vaccine United States, December 1423, 2020
Author(s) name CDC COVID-19 Response Team; Food and Drug Administration.
Journal MMWR Morb Mortal Wkly Rep
Impact factor
14.4
Citation count: 9


In a phase1/2 clinical trial, BBIBP-CorV inactivated vaccine given in a 2 dose regimen was found to be safe and well-tolerated. The inactivated SARS-CoV-2 vaccine BBIBP-CorV was found to be safe and well-tolerated in the age groups between 18-59 years and above 60 years of age.
33069281
(Lancet Infect Dis)
PMID
33069281
Date of Publishing: 2021 Jan
Title Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial
Author(s) nameXia S, Zhang Y et al.
Journal Lancet Infect Dis
Impact factor
21.77
Citation count: 17


In a phase1/2 clinical trial, BBIBP-CorV inactivated vaccine given in a 2 dose regimen was found to be safe and well-tolerated. The vaccine-induced a robust humoral response in 100% of the vaccine recipients. The inactivated SARS-CoV-2 vaccine BBIBP-CorV was found to be safe and well-tolerated in the age groups.
33069281
(Lancet Infect Dis)
PMID
33069281
Date of Publishing: 2021 Jan
Title Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial
Author(s) nameXia S, Zhang Y et al.
Journal Lancet Infect Dis
Impact factor
21.77
Citation count: 17


In a phase1/2 clinical trail, BBIBP-CorV inactivated vaccine given in a 2 dose regimen was found to be safe and well tolerated. The vaccine induced a robust humoral response 1n 100% of the vaccine recipients.
33069281
(Lancet Infect Dis)
PMID
33069281
Date of Publishing: 2021 Jan
Title Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial
Author(s) nameXia S, Zhang Y et al.
Journal Lancet Infect Dis
Impact factor
21.77
Citation count: 17


In a phase1/2 clinical trial, BBIBP-CorV inactivated vaccine given in a 2 dose regimen was found to be safe and well-tolerated. The vaccine-induced a robust humoral response in 100% of the vaccine recipients.
33069281
(Lancet Infect Dis)
PMID
33069281
Date of Publishing: 2021 Jan
Title Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBIBP-CorV: a randomised, double-blind, placebo-controlled, phase 1/2 trial
Author(s) nameXia S, Zhang Y et al.
Journal Lancet Infect Dis
Impact factor
21.77
Citation count: 17