Level- Data

Immune response

Last updated: 2022 Aug 26

Total hit(s): 38

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Fingolimod and anti-CD20 monoclonal antibodies were linked with reduced seroconversion after the SARS-CoV-2 vaccine when compared to no disease modifying medication. Other medications did not significantly vary from the untreated cohort. The duration of treatment and the period since the last anti-CD20 medication were both strongly correlated with the vaccination response. However, in people on anti-CD20 drugs, the vaccine type did not substantially predict seroconversion. According to preliminary findings on cellular T-cell immunity, detectable anti-SARS-CoV-2 T cell responses were seen in 40% of seronegative patients.

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34687063
(Ann Neurol)

PMID	34687063 Date of Publishing: 2021 Oct 22
Title	COVID-19 Vaccine Response in People with Multiple Sclerosis
Author(s) name	Tallantyre EC, Vickaryous N et al.
Journal	Ann Neurol
Impact factor	9.55 Citation count: 24
Date of Entry	2022 Aug 26

NLM format

Tallantyre EC, Vickaryous N, Anderson V, Asardag AN, Baker D, Bestwick J, Bramhall K, Chance R, Evangelou N, George K, Giovannoni G, Godkin A, Grant L, Harding KE, Hibbert A, Ingram G, Jones M, Kang AS, Loveless S, Moat SJ, Robertson NP, Schmierer K, Scurr MJ, Shah SN, Simmons J, Upcott M, Willis M, Jolles S, Dobson R. COVID-19 Vaccine Response in People with Multiple Sclerosis. Ann Neurol. 2022 Jan;91(1):89-100. PMID:34687063

The median anti-S1 antibody level in the patients (median age 68 years; interquartile range (IQR), 53-76 years; 65 percent men) was 284 [IQR, 83-1190] AU/mL after the second dose and 7,554 [IQR, 2,268-11,736] AU/mL after the third dose. After receiving the second dose of the vaccine, three patients were nonresponders (anti-S1 antibody level 0.8 AU/mL) and 12 had weak responders (anti-S1 antibody level 0.8-50 AU/mL). One of the three original nonresponders produced anti-spike antibody after the third treatment, while all 12 initial weak responders had an increase in antibody levels. Antibody levels were lower after the second dosage and there was more time between the second and third doses in patients who experienced a higher increase in anti-S1 antibody levels after the third dose.

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34508833
(Am J Kidney Dis)

PMID	34508833 Date of Publishing: 2021 Sep 8
Title	SARS-CoV-2 Antibody Response After a Third Dose of the BNT162b2 Vaccine in Patients Receiving Maintenance Hemodialysis or Peritoneal Dialysis
Author(s) name	Bensouna I, Caudwell V et al.
Journal	Am J Kidney Dis
Impact factor	5.59 Citation count: 25
Date of Entry	2022 Aug 26

NLM format
Bensouna I, Caudwell V, Kubab S, Acquaviva S, Pardon A, Vittoz N, Bozman DF, Hanafi L, Faucon AL, Housset P. SARS-CoV-2 Antibody Response After a Third Dose of the BNT162b2 Vaccine in Patients Receiving Maintenance Hemodialysis or Peritoneal Dialysis. Am J Kidney Dis. 2022 Feb;79(2):185-192.e1. PMID:34508833

A lipid nanoparticle-encapsulated and nucleoside-unmodified mRNA (mRNA-LNP) vaccine encoding the trimerized RBD (RBD trimer), elicits strong plasma B cell response. The RBD trimer mRNA vaccine modulates the antibody response toward more conserved regions on the RBD, hence overcoming the escape mutations that attenuate the efficacy of vaccines in mouse models. The vaccine protects K18-hACE2 mice from death after infection with live SARS-CoV-2 WT D614, B.1.351, and B.1.617.2 variants. B.1.351- and B.1.617.2-infected control animals demonstrated significantly higher levels of viral load than the RBD-trimer-vaccinated animals.

The protectivity of the vaccine was correlated with RBD-specific B cell responses especially the long-lived plasma B cells in bone marrow, strong ability in triggering BCR clustering, and downstream signaling. Monoclonal antibodies isolated from vaccinated animals demonstrated broad and potent neutralizing activity against VOCs tested. The results suggest the existence of highly conserved and vulnerable regions within the RBD that could be precisely targeted for the development of next-generation vaccines capable of inducing broad and protective immunity against SARS-CoV-2 variants. ✍

35291264
(iScience)

PMID	35291264 Date of Publishing: 2022 Apr 15
Title	RBD trimer mRNA vaccine elicits broad and protective immune responses against SARS-CoV-2 variants
Author(s) name	Liang Q, Wang Y et al.
Journal	iScience
Impact factor	4.447 Citation count: 1
Date of Entry	2022 Jul 13

NLM format
Liang Q, Wang Y, Zhang S, Sun J, Sun W, Li J, Liu Y, Li M, Cheng L, Jiang Y, Wang R, Zhang R, Yang Z, Ren Y, Chen P, Gao P, Yan H, Zhang Z, Zhang Q, Shi X, Wang J, Liu W, Wang X, Ying B, Zhao J, Qi H, Zhang L RBD trimer mRNA vaccine elicits broad and protective immune responses against SARS-CoV-2 variants. iScience. 2022 Apr 15;25(4):104043. PMID:35291264

In 5 to 11-year old children, two doses of 10 g of BNT162b2 vaccination given 21 days apart were found to be safe, immunogenic, and 90.7% effective against Covid-19. These doses were chosen as the dose level to be tested in phase 2-3 studies.The geometric mean ratio of SARS-CoV-2 neutralising titers in 5-to-11-year-olds to those in 16-to-25-year-olds was 1.04 one month after the second injection.

a)The neutralising GMTs reported in phase 1 were from serum samples taken 7 days after the second dose, while the GMTs reported in phases 23 were from serum samples taken one month after the second dose.
b) Majority of participants who received BNT162b2 had higher local and systemic adverse events than those who received placebo.
c) In phase-2, adverse events were reported by 10.9% of BNT162b2 recipients and 9.2% of placebo recipients from the first dose to one month after the second dose.
d) The absence of longer-term follow-up to examine the duration of immune responses, efficacy, and safety is one of the study's limitations.
e) Concomitant administration of BNT162b2 with other vaccines was not evaluated, and cell-mediated responses to immunisation are not yet available. ✍

34752019
(N Engl J Med)

PMID	34752019 Date of Publishing: 2021 Nov 9
Title	Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age
Author(s) name	Walter EB, Talaat KR et al.
Journal	N Engl J Med
Impact factor	37.91 Citation count: 58
Date of Entry	2022 Apr 29

NLM format

Walter EB, Talaat KR, Sabharwal C, Gurtman A, Lockhart S, Paulsen GC, Barnett ED, Muñoz FM, Maldonado Y, Pahud BA, Domachowske JB, Simões EAF, Sarwar UN, Kitchin N, Cunliffe L, Rojo P, Kuchar E, Rämet M, Munjal I, Perez JL, Frenck RW Jr, Lagkadinou E, Swanson KA, Ma H, Xu X, Koury K, Mather S, Belanger TJ, Cooper D, Türeci Ö, Dormitzer PR, Şahin U, Jansen KU, Gruber WC; C4591007 Clinical Trial Group. Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age. N Engl J Med. 2022 Jan 6;386(1):35-46. PMID:34752019

Two doses of ChAdOx1 nCoV-19 vaccine given 21 to 35 days apart were found to be safe and immunogenic. Due to the B.1.351 strain, a two-dose strategy of the ChAdOx1 nCoV-19 vaccination did not provide protection against mild-to-moderate Covid-19.

a) Serious adverse events reported were equally distributed between the vaccine and placebo groups. Majority of the participants had fever which disappeared within 24 hrs after the 1st dose of ChAdOx1 nCoV-19 (AZD1222) , while no reactogenicity was observed after the second dose.
b) The neutralising antibody responses to the original SARS-CoV-2 virus in recipients of the ChAdOx1 nCoV-19 vaccine were identical to those in vaccinated recipients in studies done in the United Kingdom and Brazil.
c) It's unclear if a better antibody response from a longer gap between the first and second doses of the ChAdOx1 nCov-19 vaccine, would result in better residual neutralising activity against the B.1.351 variant.
d) T-cell responses may contribute to protection from Covid-19 even in the presence of lower neutralising antibody titers, despite the significant association between antibody response and vaccine efficacy, implying that the neutralising antibody response is important. ✍

33725432
(N Engl J Med)

PMID	33725432 Date of Publishing: 2021 Mar 16
Title	Efficacy of the ChAdOx1 nCoV-19 Covid-19 Vaccine against the B.1.351 Variant
Author(s) name	Madhi SA, Baillie V et al.
Journal	N Engl J Med
Impact factor	37.91 Citation count: 488
Date of Entry	2022 Apr 29

NLM format

Madhi SA, Baillie V, Cutland CL, Voysey M, Koen AL, Fairlie L, Padayachee SD, Dheda K, Barnabas SL, Bhorat QE, Briner C, Kwatra G, Ahmed K, Aley P, Bhikha S, Bhiman JN, Bhorat AE, du Plessis J, Esmail A, Groenewald M, Horne E, Hwa SH, Jose A, Lambe T, Laubscher M, Malahleha M, Masenya M, Masilela M, McKenzie S, Molapo K, Moultrie A, Oelofse S, Patel F, Pillay S, Rhead S, Rodel H, Rossouw L, Taoushanis C, Tegally H, Thombrayil A, van Eck S, Wibmer CK, Durham NM, Kelly EJ, Villafana TL, Gilbert S, Pollard AJ, de Oliveira T, Moore PL, Sigal A, Izu A; NGS-SA Group; Wits-VIDA COVID Group. Efficacy of the ChAdOx1 nCoV-19 Covid-19 Vaccine against the B.1.351 Variant. N Engl J Med. 2021 May 20;384(20):1885-1898. PMID:33725432

Both seronegative and seropositive groups were immunogenic to "Sputnik Light" vaccine producing both binding and neutralising antibody responses. It also ellicited cell - mediated immunity along with IFN- secretion.

The majority of the solicited adverse events seen in participants vaccinated with "Sputnik Light" were minor and temporary with just 55% of participants having moderate grade adverse effects. ✍

34746910
(Lancet Reg Health Eur)

PMID	34746910 Date of Publishing: 2021 Dec
Title	An open, non-randomised, phase 1/2 trial on the safety, tolerability, and immunogenicity of single-dose vaccine Sputnik Light for prevention of coronavirus infection in healthy adults
Author(s) name	Tukhvatulin AI, Dolzhikova IV et al.
Journal	Lancet Reg Health Eur
Impact factor	- n/a - Citation count: 6
Date of Entry	2022 Jan 25

NLM format

Tukhvatulin AI, Dolzhikova IV, Shcheblyakov DV, Zubkova OV, Dzharullaeva AS, Kovyrshina AV, Lubenets NL, Grousova DM, Erokhova AS, Botikov AG, Izhaeva FM, Popova O, Ozharovskaia TA, Esmagambetov IB, Favorskaya IA, Zrelkin DI, Voronina DV, Shcherbinin DN, Semikhin AS, Simakova YV, Tokarskaya EA, Shmarov MM, Nikitenko NA, Gushchin VA, Smolyarchuk EA, Zubkova TG, Zakharov KA, Vasilyuk VB, Borisevich SV, Naroditsky BS, Logunov DY, Gintsburg AL. An open, non-randomised, phase 1/2 trial on the safety, tolerability, and immunogenicity of single-dose vaccine Sputnik Light for prevention of coronavirus infection in healthy adults. Lancet Reg Health Eur. 2021 Dec;11:100241. PMID:34746910

The vaccine-induced antibody response was high and dose-dependent. Almost all vaccinated volunteers mounted RBD-specific TH1 cell responses which were not dose-dependent.

a) This clinical study has several limitations, including a limited sample size and a restriction on people under the age of 55.
b) The induction of tissue-resident memory CD8+ T cells was not evaluated.
c) Reactogenicity was dose-dependent. Adverse events reported were either temporary or spontaneously resolved.
d) Both the immunogenicity rate and CD8+ T cells response strength of the 60 g cohort were lower than the other cohorts, demonstrating the necessity of booster immunisation. ✍

32998157
(Nature)

PMID	32998157 Date of Publishing: 2020 Oct
Title	COVID-19 vaccine BNT162b1 elicits human antibody and TH1 T cell responses
Author(s) name	Sahin U, Muik A et al.
Journal	Nature
Impact factor	24.36 Citation count: 621
Date of Entry	2022 Jan 25

NLM format

Sahin U, Muik A, Derhovanessian E, Vogler I, Kranz LM, Vormehr M, Baum A, Pascal K, Quandt J, Maurus D, Brachtendorf S, Lörks V, Sikorski J, Hilker R, Becker D, Eller AK, Grützner J, Boesler C, Rosenbaum C, Kühnle MC, Luxemburger U, Kemmer-Brück A, Langer D, Bexon M, Bolte S, Karikó K, Palanche T, Fischer B, Schultz A, Shi PY, Fontes-Garfias C, Perez JL, Swanson KA, Loschko J, Scully IL, Cutler M, Kalina W, Kyratsous CA, Cooper D, Dormitzer PR, Jansen KU, Türeci Ö. COVID-19 vaccine BNT162b1 elicits human antibody and TH1 T cell responses. Nature. 2020 Oct;586(7830):594-599. PMID:32998157

A single dose of an adenoviral vaccine GRAd-CoV2 could be an effective tool for priming a balanced immune response that can then be enhanced to high levels by a single dose of a different vaccine platform.

Volunteer F is the lone exception, having received the first BNT162b2 only three days before the week-24 visit, resulting in an excellent internal "no-boost" control. ✍

34737309
()

PMID	34737309
Title	Strong immunogenicity of heterologous prime-boost immunizations with the experimental vaccine GRAd-CoV2 and BNT162b2 or ChAdOx1-nCOV19
Impact factor	N/A
Date of Entry	2022 Jan 25

In the combined phase 1 and phase 2 trial, the KCONOVOC vaccine elicited a strong immune response. The vaccine induced good antibody response and a moderately good T-cell response.

Based on the results, KCONOVOC vaccine at a dose of 5ug in 0/28 regimen was selected for phase 3 clinical trial ✍

33928916
(Chin Med J (Engl))

PMID	33928916 Date of Publishing: 2021 Apr 28
Title	Immunogenicity and safety of a severe acute respiratory syndrome coronavirus 2 inactivated vaccine in healthy adults: randomized, double-blind, and placebo-controlled phase 1 and phase 2 clinical trials
Author(s) name	Pan HX, Liu JK et al.
Journal	Chin Med J (Engl)
Impact factor	1.053 Citation count: 22
Date of Entry	2021 Dec 15

NLM format

Pan HX, Liu JK, Huang BY, Li GF, Chang XY, Liu YF, Wang WL, Chu K, Hu JL, Li JX, Zhu DD, Wu JL, Xu XY, Zhang L, Wang M, Tan WJ, Huang WJ, Zhu FC. Immunogenicity and safety of a severe acute respiratory syndrome coronavirus 2 inactivated vaccine in healthy adults: randomized, double-blind, and placebo-controlled phase 1 and phase 2 clinical trials. Chin Med J (Engl). 2021 Apr 28;134(11):1289-1298. PMID:33928916

Immunization of mice (C57BL/6 and BALB/c strains) and Pigs with RBD-SpyVLP vaccine showed strong dose-dependent neutralising antibody response. The polyclonal antibody response could recognize key epitopes on RBD (Receptor-Binding Domain). Besides, this vaccine is found to be thermostable making it easier for transportation globally.

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33483491
(Nat Commun)

PMID	33483491 Date of Publishing: 2021 Jan 22
Title	A COVID-19 vaccine candidate using SpyCatcher multimerization of the SARS-CoV-2 spike protein receptor-binding domain induces potent neutralising antibody responses
Author(s) name	Tan TK, Rijal P et al.
Journal	Nat Commun
Impact factor	11.8 Citation count: 69
Date of Entry	2021 Oct 31

NLM format

Tan TK, Rijal P, Rahikainen R, Keeble AH, Schimanski L, Hussain S, Harvey R, Hayes JWP, Edwards JC, McLean RK, Martini V, Pedrera M, Thakur N, Conceicao C, Dietrich I, Shelton H, Ludi A, Wilsden G, Browning C, Zagrajek AK, Bialy D, Bhat S, Stevenson-Leggett P, Hollinghurst P, Tully M, Moffat K, Chiu C, Waters R, Gray A, Azhar M, Mioulet V, Newman J, Asfor AS, Burman A, Crossley S, Hammond JA, Tchilian E, Charleston B, Bailey D, Tuthill TJ, Graham SP, Duyvesteyn HME, Malinauskas T, Huo J, Tree JA, Buttigieg KR, Owens RJ, Carroll MW, Daniels RS, McCauley JW, Stuart DI, Huang KA, Howarth M, Townsend AR. A COVID-19 vaccine candidate using SpyCatcher multimerization of the SARS-CoV-2 spike protein receptor-binding domain induces potent neutralising antibody responses. Nat Commun. 2021 Jan 22;12(1):542. PMID:33483491

A prefusion-stabilized SARS-CoV-2 spike protein, S-2P was most successful in generating antibodies that neutralised pseudovirus and wild-type live virus when combined with CpG 1018 and aluminium hydroxide adjuvants, with no vaccine-related side effects.

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33208827
(Sci Rep)

PMID	33208827 Date of Publishing: 2020 Nov 18
Title	Development of CpG-adjuvanted stable prefusion SARS-CoV-2 spike antigen as a subunit vaccine against COVID-19
Author(s) name	Kuo TY, Lin MY et al.
Journal	Sci Rep
Impact factor	4.12 Citation count: 39
Date of Entry	2021 Oct 31

NLM format
Kuo TY, Lin MY, Coffman RL, Campbell JD, Traquina P, Lin YJ, Liu LT, Cheng J, Wu YC, Wu CC, Tang WH, Huang CG, Tsao KC, Chen C. Development of CpG-adjuvanted stable prefusion SARS-CoV-2 spike antigen as a subunit vaccine against COVID-19. Sci Rep. 2020 Nov 18;10(1):20085. PMID:33208827

Nonhuman primates vaccinated with mRNA-1273 developed a strong immune response. Exposure of vaccinated animals to the SARS-CoV-2 virus protected the animals from infection. There was a significant decrease in the levels of viral RNA in the nasal passage and lungs of vaccinated animals when compared to the control.

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32722908
(N Engl J Med)

PMID	32722908 Date of Publishing: 2020 Oct 15
Title	Evaluation of the mRNA-1273 Vaccine against SARS-CoV-2 in Nonhuman Primates
Author(s) name	Corbett KS, Flynn B et al.
Journal	N Engl J Med
Impact factor	37.91 Citation count: 460
Date of Entry	2021 Oct 31

NLM format

Corbett KS, Flynn B, Foulds KE, Francica JR, Boyoglu-Barnum S, Werner AP, Flach B, O'Connell S, Bock KW, Minai M, Nagata BM, Andersen H, Martinez DR, Noe AT, Douek N, Donaldson MM, Nji NN, Alvarado GS, Edwards DK, Flebbe DR, Lamb E, Doria-Rose NA, Lin BC, Louder MK, O'Dell S, Schmidt SD, Phung E, Chang LA, Yap C, Todd JM, Pessaint L, Van Ry A, Browne S, Greenhouse J, Putman-Taylor T, Strasbaugh A, Campbell TA, Cook A, Dodson A, Steingrebe K, Shi W, Zhang Y, Abiona OM, Wang L, Pegu A, Yang ES, Leung K, Zhou T, Teng IT, Widge A, Gordon I, Novik L, Gillespie RA, Loomis RJ, Moliva JI, Stewart-Jones G, Himansu S, Kong WP, Nason MC, Morabito KM, Ruckwardt TJ, Ledgerwood JE, Gaudinski MR, Kwong PD, Mascola JR, Carfi A, Lewis MG, Baric RS, McDermott A, Moore IN, Sullivan NJ, Roederer M, Seder RA, Graham BS. Evaluation of the mRNA-1273 Vaccine against SARS-CoV-2 in Nonhuman Primates. N Engl J Med. 2020 Oct 15;383(16):1544-1555. PMID:32722908

In a phase I clinical trial, the DNA vaccine ZyCoV-D was found to be safe and immunogenic. When ZyCoV-D was administered intradermally, it induced good antibody and cellular immune responses. In comparison to the 1 mg vaccination dose, the 2 mg vaccine dose had a greater seroconversion rate, regardless of delivery method.

1) Vaccination with 2mg dose via NFIS was found to elicit significant SARS-CoV-2 specific IgG, neutralising antibody (NAB) titres and decrease in viral load was observed in animals post challenge. 2) No vaccine related severe or solicited adverse events were reported. The adverse events reported were mild to moderate and common. ✍

34308319
(EClinicalMedicine)

PMID	34308319 Date of Publishing: 2021 Aug
Title	Safety and Immunogenicity of a DNA SARS-CoV-2 vaccine (ZyCoV-D): Results of an open-label, non-randomized phase I part of phase I/II clinical study by intradermal route in healthy subjects in India
Author(s) name	Momin T, Kansagra K et al.
Journal	EClinicalMedicine
Impact factor	6.68 Citation count: 32
Date of Entry	2021 Oct 30

NLM format

Momin T, Kansagra K, Patel H, Sharma S, Sharma B, Patel J, Mittal R, Sanmukhani J, Maithal K, Dey A, Chandra H, Rajanathan CT, Pericherla HP, Kumar P, Narkhede A, Parmar D. Safety and Immunogenicity of a DNA SARS-CoV-2 vaccine (ZyCoV-D): Results of an open-label, non-randomized phase I part of phase I/II clinical study by intradermal route in healthy subjects in India. EClinicalMedicine. 2021 Aug;38:101020. PMID:34308319

In a phase 2 placebo-controlled clinical trial, the mRNA-1273 vaccine induced good immune responses in young adults aged 18 and older. Anti-SARS-CoV-2 spike binding and neutralising antibodies were induced by both doses of the vaccine within 28 days of the first injection and increased to peak titers by 14 days after the second dose. The neutralising antibody levels were higher than levels found in convalescent sera.

The mRNA-1273 vaccine was found to be safe and did not induce major adverse events. Longer the interval between the 2 doses, better the induction of antibodies. ✍

33707061
(Vaccine)

PMID	33707061 Date of Publishing: 2021 May 12
Title	A preliminary report of a randomized controlled phase 2 trial of the safety and immunogenicity of mRNA-1273 SARS-CoV-2 vaccine
Author(s) name	Chu L, McPhee R et al.
Journal	Vaccine
Impact factor	3.31 Citation count: 64
Date of Entry	2021 Oct 30

NLM format
Chu L, McPhee R, Huang W, Bennett H, Pajon R, Nestorova B, Leav B; mRNA-1273 Study Group. A preliminary report of a randomized controlled phase 2 trial of the safety and immunogenicity of mRNA-1273 SARS-CoV-2 vaccine. Vaccine. 2021 May 12;39(20):2791-2799. PMID:33707061

In the four randomised trials, the ChAdOx1 nCoV-19 (AZD1222) vaccine showed good antibody responses. The antibody responses were more than two-fold higher in participants who received the booster dose after an interval of 12 or more weeks compared with an interval of less than 6 weeks.

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33617777
(Lancet)

PMID	33617777 Date of Publishing: 2021 Feb 19
Title	Single-dose administration and the influence of the timing of the booster dose on immunogenicity and efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine: a pooled analysis of four randomised trials
Author(s) name	Voysey M, Costa Clemens SA et al.
Journal	Lancet
Impact factor	43.38 Citation count: 396
Date of Entry	2021 Oct 30

NLM format

Voysey M, Costa Clemens SA, Madhi SA, Weckx LY, Folegatti PM, Aley PK, Angus B, Baillie VL, Barnabas SL, Bhorat QE, Bibi S, Briner C, Cicconi P, Clutterbuck EA, Collins AM, Cutland CL, Darton TC, Dheda K, Dold C, Duncan CJA, Emary KRW, Ewer KJ, Flaxman A, Fairlie L, Faust SN, Feng S, Ferreira DM, Finn A, Galiza E, Goodman AL, Green CM, Green CA, Greenland M, Hill C, Hill HC, Hirsch I, Izu A, Jenkin D, Joe CCD, Kerridge S, Koen A, Kwatra G, Lazarus R, Libri V, Lillie PJ, Marchevsky NG, Marshall RP, Mendes AVA, Milan EP, Minassian AM, McGregor A, Mujadidi YF, Nana A, Padayachee SD, Phillips DJ, Pittella A, Plested E, Pollock KM, Ramasamy MN, Ritchie AJ, Robinson H, Schwarzbold AV, Smith A, Song R, Snape MD, Sprinz E, Sutherland RK, Thomson EC, Török ME, Toshner M, Turner DPJ, Vekemans J, Villafana TL, White T, Williams CJ, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. Single-dose administration and the influence of the timing of the booster dose on immunogenicity and efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine: a pooled analysis of four randomised trials. Lancet. 2021 Mar 6;397(10277):881-891. PMID:33617777

In a placebo-controlled, phase 1/2 clinical trial of two doses of inactivated virus vaccine CoronaVac was found to induce good antibody response in healthy adults aged 1859 years.

The vaccine was found to be safe and did not induce any serious adverse events. ✍

33217362
(Lancet Infect Dis)

PMID	33217362 Date of Publishing: 2020 Nov 17
Title	Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18-59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial
Author(s) name	Zhang Y, Zeng G et al.
Journal	Lancet Infect Dis
Impact factor	21.77 Citation count: 466
Date of Entry	2021 Oct 30

NLM format
Zhang Y, Zeng G, Pan H, Li C, Hu Y, Chu K, Han W, Chen Z, Tang R, Yin W, Chen X, Hu Y, Liu X, Jiang C, Li J, Yang M, Song Y, Wang X, Gao Q, Zhu F. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18-59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021 Feb;21(2):181-192. PMID:33217362

Following two doses of AZD1222, spike-specific CD4+ T cell helper type 1 (Th1) and CD8+ T-cell responses were significantly increased in AZD1222-vaccinated persons of all ages.

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34189538
()

PMID	34189538
Title	T-cell mediated immunity after AZD1222 vaccination: A polyfunctional spike-specific Th1 response with a diverse TCR repertoire
Impact factor	N/A
Date of Entry	2021 Oct 30

The safety, efficacy, and immunogenicity of the BBV152 vaccine were assessed in a multicenter, phase 3 clinical trial. In adults, the BBV152 was immunogenic and efficacious against symptomatic and asymptomatic COVID-19 variant associated disease.

The vaccine was well tolerated. with the overall occurance of adverse events being less than that observed in other COVID-19 vaccines ✍

Pre-print ( medRXiv )

Title	Efficacy, safety, and lot to lot immunogenicity of an inactivated SARS-CoV-2 vaccine (BBV152): a, double-blind, randomised, controlled phase 3 trial
Impact factor	N/A
Date of Entry	2021 Oct 30

In a phase IV clinical study, the BNT162b2 mRNA Covid-19 vaccine conferred high neutralising antibody levels (41.18-folds) after the timely administration of the second dose in a population above 85 years of age. Comorbidities in the vaccinated individuals had no significant effect on the antibody response.

In the case of chronic comorbidities and cardiovascular diseases, no relation between Type 2 diabetes or High Blood Pressure was associated with vaccine effectiveness. Recipients having a history of heart disease showed low levels of antibody titers after the first dose of the vaccine. No significant difference between genders was observed. ✍

34633648
(Aging Clin Exp Res)

PMID	34633648 Date of Publishing: 2021 Oct 11
Title	Immunogenicity of the BNT162b2 mRNA COVID-19 Vaccine in Elderly People Over 85 Years of Age in Greece
Author(s) name	Kontopoulou K, Nakas CT et al.
Journal	Aging Clin Exp Res
Impact factor	2.37 Citation count: 2
Date of Entry	2021 Sep 27

NLM format
Kontopoulou K, Nakas CT, Ainatzoglou A, Ifantidou A, Ntotsi P, Katsioulis C, Papazisis G. Immunogenicity of the BNT162b2 mRNA COVID-19 Vaccine in Elderly People Over 85 Years of Age in Greece. Aging Clin Exp Res. 2021 Dec;33(12):3385-3389. PMID:34633648

In phase 1 trial, two doses of SARS-CoV-2 sclamp vaccine, at all doses (5, 15 and 45ug) induced a robust neutralising immune response and a spike glycoprotein-specific T-cell response, which indicates protection against SARS-CoV-2 infection.

The presence of the glycoprotein 41 peptide in the clamp caused HIV diagnostic assay interference, posing a potential obstacle to successful implementation and highlighting the need of non-spike directed immunogenicity during vaccine development. Alternative molecular clamp trimerisation domains are being studied to improve this response. ✍

33887208
(Lancet Infect Dis)

PMID	33887208 Date of Publishing: 2021 Apr 19
Title	Safety and immunogenicity of an MF59-adjuvanted spike glycoprotein-clamp vaccine for SARS-CoV-2: a randomised, double-blind, placebo-controlled, phase 1 trial
Author(s) name	Chappell KJ, Mordant FL et al.
Journal	Lancet Infect Dis
Impact factor	21.77 Citation count: 30
Date of Entry	2021 Sep 27

NLM format

Chappell KJ, Mordant FL, Li Z, Wijesundara DK, Ellenberg P, Lackenby JA, Cheung STM, Modhiran N, Avumegah MS, Henderson CL, Hoger K, Griffin P, Bennet J, Hensen L, Zhang W, Nguyen THO, Marrero-Hernandez S, Selva KJ, Chung AW, Tran MH, Tapley P, Barnes J, Reading PC, Nicholson S, Corby S, Holgate T, Wines BD, Hogarth PM, Kedzierska K, Purcell DFJ, Ranasinghe C, Subbarao K, Watterson D, Young PR, Munro TP. Safety and immunogenicity of an MF59-adjuvanted spike glycoprotein-clamp vaccine for SARS-CoV-2: a randomised, double-blind, placebo-controlled, phase 1 trial. Lancet Infect Dis. 2021 Oct;21(10):1383-1394. PMID:33887208

In two randomised, placebo-controlled, phase1/ 2 trials, RBD dimer-protein subunit vaccine ZF200 was found to be safe and immunogenic. The ZF2001 induced higher neutralising antibody titers than those observed in convalescent individuals.

Increasing the vaccine dose from 25 g to 50g did not improve immunogenicity. Three-dose vaccination increased antibody responses when compared to two-dose vaccination. Thus, 25 g antigen with three-dose schedule was selected for evalution of efficacy in phase 3 trials, as it showed higher immunogenicity than 50 g dose in phase 2 trial. ✍

33773111
(Lancet Infect Dis)

PMID	33773111 Date of Publishing: 2021 Mar 24
Title	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
Author(s) name	Yang S, Li Y et al.
Journal	Lancet Infect Dis
Impact factor	21.77 Citation count: 126
Date of Entry	2021 Sep 27

NLM format

Yang S, Li Y, Dai L, Wang J, He P, Li C, Fang X, Wang C, Zhao X, Huang E, Wu C, Zhong Z, Wang F, Duan X, Tian S, Wu L, Liu Y, Luo Y, Chen Z, Li F, Li J, Yu X, Ren H, Liu L, Meng S, Yan J, Hu Z, Gao L, Gao GF. 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. Lancet Infect Dis. 2021 Aug;21(8):1107-1119. PMID:33773111

In a placebo-controlled phase 3 clinical trial, rAd26 and rAd5 vector-based heterologous COVID-19 vaccine was found to have good immunogenicity. The vaccine had 91.6% efficacy and a good safety profile.

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33545094
(Lancet)

PMID	33545094 Date of Publishing: 2021 Feb 20
Title	Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia
Author(s) name	Logunov DY, Dolzhikova IV et al.
Journal	Lancet
Impact factor	43.38 Citation count: 564
Date of Entry	2021 Sep 27

NLM format

Logunov DY, Dolzhikova IV, Shcheblyakov DV, Tukhvatulin AI, Zubkova OV, Dzharullaeva AS, Kovyrshina AV, Lubenets NL, Grousova DM, Erokhova AS, Botikov AG, Izhaeva FM, Popova O, Ozharovskaya TA, Esmagambetov IB, Favorskaya IA, Zrelkin DI, Voronina DV, Shcherbinin DN, Semikhin AS, Simakova YV, Tokarskaya EA, Egorova DA, Shmarov MM, Nikitenko NA, Gushchin VA, Smolyarchuk EA, Zyryanov SK, Borisevich SV, Naroditsky BS, Gintsburg AL; Gam-COVID-Vac Vaccine Trial Group. Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: an interim analysis of a randomised controlled phase 3 trial in Russia. Lancet. 2021 Feb 20;397(10275):671-681. PMID:33545094

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) name	Richmond P, Hatchuel L et al.
Journal	Lancet
Impact factor	43.38 Citation count: 105
Date of Entry	2021 Aug 3

NLM format
Richmond P, Hatchuel L, Dong M, Ma B, Hu B, Smolenov I, Li P, Liang P, Han HH, Liang J, Clemens R. 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. Lancet. 2021 Feb 20;397(10275):682-694. PMID:33524311

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.

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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) name	Logunov DY, Dolzhikova IV et al.
Journal	Lancet
Impact factor	43.38 Citation count: 395
Date of Entry	2021 Aug 3

NLM format

Logunov DY, Dolzhikova IV, Zubkova OV, Tukhvatullin AI, Shcheblyakov DV, Dzharullaeva AS, Grousova DM, Erokhova AS, Kovyrshina AV, Botikov AG, Izhaeva FM, Popova O, Ozharovskaya TA, Esmagambetov IB, Favorskaya IA, Zrelkin DI, Voronina DV, Shcherbinin DN, Semikhin AS, Simakova YV, Tokarskaya EA, Lubenets NL, Egorova DA, Shmarov MM, Nikitenko NA, Morozova LF, Smolyarchuk EA, Kryukov EV, Babira VF, Borisevich SV, Naroditsky BS, Gintsburg AL. 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. Lancet. 2020 Sep 26;396(10255):887-897. PMID:32896291

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.

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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) name	Folegatti PM, Ewer KJ et al.
Journal	Lancet
Impact factor	43.38 Citation count: 1005
Date of Entry	2021 Aug 3

NLM format

Folegatti PM, Ewer KJ, Aley PK, Angus B, Becker S, Belij-Rammerstorfer S, Bellamy D, Bibi S, Bittaye M, Clutterbuck EA, Dold C, Faust SN, Finn A, Flaxman AL, Hallis B, Heath P, Jenkin D, Lazarus R, Makinson R, Minassian AM, Pollock KM, Ramasamy M, Robinson H, Snape M, Tarrant R, Voysey M, Green C, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. 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. Lancet. 2020 Aug 15;396(10249):467-478. PMID:32702298