Efficacy and Safety of Heterologous Booster Vaccination after Ad5-nCoV (CanSino Biologics) Vaccine: A Preliminary Descriptive Study
Abstract
:1. Introduction
2. Materials and Methods
2.1. Subjects
2.2. Quantification of Neutralizing Antibodies
2.3. Statistical Analysis
3. Results
3.1. Clinical and Demographic Characteristics
3.2. Adverse Effects in Individuals with or without Booster Doses
4. Discussion
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
- Sánchez-Zuno, G.A.; Matuz-Flores, M.G.; González-Estevez, G.; Nicoletti, F.; Turrubiates-Hernández, F.J.; Mangano, K.; Muñoz-Valle, J.F. A Review: Antibody-Dependent Enhancement in COVID-19: The Not so Friendly Side of Antibodies. Int. J. Immunopathol. Pharmacol. 2021, 35, 205873842110501. [Google Scholar] [CrossRef] [PubMed]
- Hotez, P.J.; Batista, C.; Amor, Y.B.; Ergonul, O.; Figueroa, J.P.; Gilbert, S.; Gursel, M.; Hassanain, M.; Kang, G.; Kaslow, D.C.; et al. Global Public Health Security and Justice for Vaccines and Therapeutics in the COVID-19 Pandemic. EClinicalMedicine 2021, 39, 101053. [Google Scholar] [CrossRef] [PubMed]
- Brisse, M.; Vrba, S.M.; Kirk, N.; Liang, Y.; Ly, H. Emerging Concepts and Technologies in Vaccine Development. Front. Immunol. 2020, 11, 583077. [Google Scholar] [CrossRef]
- Salud, S.D. Estatus Regulatorio de Las Vacunas Contra El Virus SARS-CoV2 En México 2021. Available online: http://vacunacovid.gob.mx/wordpress/informacion-de-la-vacuna/ (accessed on 7 December 2021).
- Salud, S.D. Calendario de Vacunación 2021. Available online: http://vacunacovid.gob.mx/wordpress/informacion-de-la-vacuna/ (accessed on 7 December 2021).
- Zhu, F.-C.; Li, Y.-H.; Guan, X.-H.; Hou, L.-H.; Wang, W.-J.; Li, J.-X.; Wu, S.-P.; Wang, B.-S.; Wang, Z.; Wang, L.; et al. 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. Lancet 2020, 395, 1845–1854. [Google Scholar] [CrossRef]
- Coronavirus Disease (COVID-19) Situation Reports. 2021. Available online: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports (accessed on 12 December 2021).
- Daian e Silva, D.S.D.O.; da Fonseca, F.G. The Rise of Vectored Vaccines: A Legacy of the COVID-19 Global Crisis. Vaccines 2021, 9, 1101. [Google Scholar] [CrossRef] [PubMed]
- Godeau, D.; Petit, A.; Richard, I.; Roquelaure, Y.; Descatha, A. Return-to-Work, Disabilities and Occupational Health in the Age of COVID-19. Scand. J. Work. Environ. Health 2021, 47, 408–409. [Google Scholar] [CrossRef]
- Institute of Biotechnology; Academy of Military Medical Sciences; PLA of China. A Phase II Clinical Trial to Evaluate the Recombinant Vaccine for COVID-19 (Adenovirus Vector) (CTII-NCoV); Hubei Provincial Center for Disease Control and Prevention: Wuhan, China, 2022. [Google Scholar]
- Hernández-Bello, J.; Morales-Núñez, J.J.; Machado-Sulbarán, A.C.; Díaz-Pérez, S.A.; Torres-Hernández, P.C.; Balcázar-Félix, P.; Gutiérrez-Brito, J.A.; Lomelí-Nieto, J.A.; Muñoz-Valle, J.F. Neutralizing Antibodies against SARS-CoV-2, Anti-Ad5 Antibodies, and Reactogenicity in Response to Ad5-NCoV (CanSino Biologics) Vaccine in Individuals with and without Prior SARS-CoV-2. Vaccines 2021, 9, 1047. [Google Scholar] [CrossRef] [PubMed]
- Nordström, P.; Ballin, M.; Nordström, A. Effectiveness of Heterologous ChAdOx1 NCoV-19 and mRNA Prime-Boost Vaccination against Symptomatic Covid-19 Infection in Sweden: A Nationwide Cohort Study. Lancet Reg. Health-Eur. 2021, 11, 100249. [Google Scholar] [CrossRef]
- Pozzetto, B.; Legros, V.; Djebali, S.; Barateau, V.; Guibert, N.; Villard, M.; Peyrot, L.; Allatif, O.; Fassier, J.-B.; Massardier-Pilonchéry, A.; et al. Immunogenicity and Efficacy of Heterologous ChAdOx1–BNT162b2 Vaccination. Nature 2021, 600, 701–706. [Google Scholar] [CrossRef]
- Munro, A.P.S.; Janani, L.; Cornelius, V.; Aley, P.K.; Babbage, G.; Baxter, D.; Bula, M.; Cathie, K.; Chatterjee, K.; Dodd, K.; et al. Safety and Immunogenicity of Seven COVID-19 Vaccines as a Third Dose (Booster) Following Two Doses of ChAdOx1 Nov-19 or BNT162b2 in the UK (COV-BOOST): A Blinded, Multicentre, Randomised, Controlled, Phase 2 Trial. Lancet 2021, 398, 2258–2276. [Google Scholar] [CrossRef]
- Romero-Ibarguengoitia, M.E.; González Cantú, A.; Hernández-Ruíz, Y.G.; Amerndariz-Vázquez, A.G.; Rivera-Salinas, D.; Montelongo-Cruz, L.P.; del Río-Parra, G.F.; Barco-Flores, I.A.; González-Facio, R.; Sanz-Sánchez, M.Á. Effect of Heterologous Vaccination Regimen with Ad5-NCoV CanSinoBio and BNT162b2 Pfizer in SARS-CoV-2 IgG Antibodies Titers. Vaccines 2021, 10, 392. [Google Scholar] [CrossRef]
- Halperin, S.A.; Ye, L.; MacKinnon-Cameron, D.; Smith, B.; Cahn, P.E.; Ruiz-Palacios, G.M.; Ikram, A.; Lanas, F.; Lourdes Guerrero, M.; Muñoz Navarro, S.R.; et al. Final Efficacy Analysis, Interim Safety Analysis, and Immunogenicity of a Single Dose of Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) in Adults 18 Years and Older: An International, Multicentre, Randomised, Double-Blinded, Placebo-Controlled Phase 3 Trial. Lancet 2022, 399, 237–248. [Google Scholar] [CrossRef] [PubMed]
- Kennedy, R.B. Efficacy of an Adenovirus Type 5 Vectored SARS-CoV-2 Vaccine. Lancet 2021, 399, 212–213. [Google Scholar] [CrossRef]
- Barros-Martins, J.; Hammerschmidt, S.I.; Cossmann, A.; Odak, I.; Stankov, M.V.; Morillas Ramos, G.; Dopfer-Jablonka, A.; Heidemann, A.; Ritter, C.; Friedrichsen, M.; et al. Immune Responses against SARS-CoV-2 Variants after Heterologous and Homologous ChAdOx1 NCoV-19/BNT162b2 Vaccination. Nat. Med. 2021, 27, 1525–1529. [Google Scholar] [CrossRef] [PubMed]
- Borobia, A.M.; Carcas, A.J.; Pérez-Olmeda, M.; Castaño, L.; Bertran, M.J.; García-Pérez, J.; Campins, M.; Portolés, A.; González-Pérez, M.; García Morales, M.T.; et al. Immunogenicity and Reactogenicity of BNT162b2 Booster in ChAdOx1-S-Primed Participants (CombiVacS): A Multicentre, Open-Label, Randomised, Controlled, Phase 2 Trial. Lancet 2021, 398, 121–130. [Google Scholar] [CrossRef]
- Schmidt, T.; Kemmis, V.; Schub, D.; Mihm, J.; Hielscher, F.; Marx, S.; Abu-Omar, A.; Ziegler, L.; Guckelmus, C.; Urschel, R.; et al. Immunogenicity and Reactogenicity of Heterologous ChAdOx1 NCoV-19/MRNA Vaccination. Nat. Med. 2021, 27, 1530–1535. [Google Scholar] [CrossRef]
- Liu, Y.; Liu, J.; Xia, H.; Zhang, X.; Fontes-Garfias, C.R.; Swanson, K.A.; Cai, H.; Sarkar, R.; Chen, W.; Cutler, M.; et al. Neutralizing Activity of BNT162b2-Elicited Serum. N. Engl. J. Med. 2021, 384, 1466–1468. [Google Scholar] [CrossRef]
- Sapkota, B.; Saud, B.; Shrestha, R.; Al-Fahad, D.; Sah, R.; Shrestha, S.; Rodriguez-Morales, A.J. Heterologous Prime–Boost Strategies for COVID-19 Vaccines. J. Travel Med. 2021, taab191. [Google Scholar] [CrossRef]
- Sprent, J.; King, C. COVID-19 Vaccine Side Effects: The Positives about Feeling Bad. Sci. Immunol. 2021, 6, eabj9256. [Google Scholar] [CrossRef]
- Folegatti, P.M.; Ewer, K.J.; Aley, P.K.; Angus, B.; Becker, S.; Belij-Rammerstorfer, S.; Bellamy, D.; Bibi, S.; Bittaye, M.; Clutterbuck, E.A.; et al. 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, 396, 467–478. [Google Scholar] [CrossRef]
- Rosete, D.P.; Manjarrez, M.E.; Barrón, B.L. Adenoviruses C in Non-Hospitalized Mexican Children Older than Five Years of Age with Acute Respiratory Infection. Mem. Inst. Oswaldo Cruz 2008, 103, 195–200. [Google Scholar] [CrossRef][Green Version]
- Dolgin, E. Omicron Is Supercharging the COVID Vaccine Booster Debate. Nature 2021, 10, 1–8. [Google Scholar] [CrossRef] [PubMed]
Immunized with Ad5-nCoV Vaccine | p-Value | ||
---|---|---|---|
With a Different Vaccine Booster n = 62 | Without any Booster n = 62 | ||
Age (years), mean ± SD | 41.00 ± 9.96 | 41.34 ± 10.55 | 0.854 |
Gender, n (%) | |||
Female | 47 (75.81) | 43 (69.35) | 0.420 |
Male | 15 (24.19) | 19 (30.65) | |
COVID-19 prior to vaccination, n (%) | 19 (30.65) | 19 (30.65) | 1.000 |
Basal neutralizing antibodies (%), median (IQR) | 78.16 (50.31–97.72) | 78.65 (65.94–97.67) | 0.303 |
Comorbidities, n (%) | |||
None | 28 (45.16) | 26 (41.94) | 0.717 |
Overweight/obesity | 18 (29.03) | 22 (35.48) | 0.442 |
Allergic diseases | 8 (12.90) | 9 (14.52) | 0.794 |
SAH | 3 (4.84) | 5 (8.06) | 0.465 |
Diabetes | 1 (1.61) | 4 (6.45) | 0.364 |
Hypothyroidism | 3 (4.84) | 1 (1.61) | 0.618 |
Autoimmune diseases | 4 (6.45) | 0 (0.00) | 0.119 |
Dermatitis | 2 (3.23) | 1 (1.61) | 1.000 |
Dyslipidemia | 2 (3.23) | 1 (1.61) | 1.000 |
Heart diseases | 0 (0.00) | 2 (3.23) | 0.495 |
Treatment, n (%) | |||
Antidepressants | 10 (16.13) | 5 (8.06) | 0.455 |
Antihypertensive | 4 (6.45) | 5 (8.06) | 0.729 |
Hormonal | 6 (9.68) | 2 (3.23) | 0.272 |
Hypoglycemic agents | 2 (3.23) | 3 (4.84) | 1.000 |
Hypolipidemic agents | 1 (1.61) | 1 (1.61) | 1.000 |
NSAIDs | 1 (1.61) | 1 (1.61) | 1.000 |
Antihistamines | 2 (3.23) | 0 (0.00) | 0.495 |
Immunosuppressants | 1 (1.61) | 0 (0.00) | 1.000 |
Immunized with Ad5-nCoV Vaccine | p-Value | ||||
---|---|---|---|---|---|
AstraZeneca (ChAdOx1-S-nCoV-19) n = 30 | Moderna (mRNA-127) n = 15 | Pfizer (BNT162b2) n = 12 | Johnson & Johnson (Janssen COVID-19 Vaccine) n = 5 | ||
Age (years), mean ± SD | 42.4 ± 10.1 | 37.8 ± 9.5 | 42.3 ± 10.6 | 38.8 ± 8.5 | 0.462 |
Gender, n (%) | |||||
Female | 24 (80.00) | 13 (86.67) | 6 (50.00) | 4 (80.00) | 0.132 |
Male | 6 (20.00) | 2 (13.33) | 6 (50.00) | 1 (20.00) | |
COVID-19 prior to vaccination, n (%) | 11 (36.67) | 3 (20.00) | 3 (25.00) | 2 (40.00) | 0.679 |
Basal neutralizing antibodies, (%), median (IQR) | 80.66 (51.95–97.95) | 71.22 (55.77–93.73) | 67.03 (39.96–89.06) | 88.95 (84.51–98.07) | 0.288 |
Days elapsed between the first and last vaccination, mean ± sd | 155.2 ± 31.05 | 147.6 ± 47.07 | 134.3 ± 31.80 | 132.2 ± 86.63 | 0.413 |
Comorbidities, n (%) | |||||
None | 15 (50.00) | 3 (25.00) | 6 (50.00) | 4 (80.00) | 0.079 |
Overweight/obesity | 7 (23.33) | 7 (46.67) | 4 (33.33) | 0 (0.00) | 0.189 |
Allergic diseases | 4 (13.33) | 2 (13.33) | 1 (8.33) | 1 (10.00) | 0.890 |
Autoimmune diseases | 1 (3.33) | 2 (13.33) | 1 (8.33) | 0 (0.00) | 0.581 |
SAH | 2 (6.67) | 1 (6.67) | 0 (0.00) | 0 (0.00) | 1.000 |
Hypothyroidism | 2 (6.67) | 1 (6.67) | 0 (0.00) | 0 (0.00) | 1.000 |
Dyslipidemia | 1 (3.33) | 0 (0.00) | 1 (8.33) | 0 (0.00) | 0.532 |
Dermatitis | 1 (3.33) | 1 (6.67) | 0 (0.00) | 0 (0.00) | 1.000 |
Diabetes | 1 (3.33) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 1.000 |
Treatment, n (%) | |||||
At least one | 18 (60.00) | 7 (46.67) | 5 (41.67) | 0 (0.00) | 0.091 |
Antidepressants | 6 (20.00) | 0 (0.00) | 4 (33.33) | 0 (0.00) | 0.069 |
Hormonal | 3 (10.00) | 3 (20.00) | 0 (0.00) | 0 (0.00) | 0.394 |
Antihypertensive | 3 (10.00) | 1 (6.67) | 0 (0.00) | 0 (0.00) | 0.859 |
Antihistamines | 0 (0.00) | 2 (13.33) | 0 (0.00) | 0 (0.00) | 0.167 |
Hypoglycemic agents | 1 (3.33) | 0 (0.00) | 1 (8.33) | 0 (0.00) | 0.532 |
Hypolipidemic agents | 0 (0.00) | 0 (0.00) | 1 (8.33) | 0 (0.00) | 0.274 |
NSAIDs | 0 (0.00) | 1 (6.67) | 0 (0.00) | 0 (0.00) | 0.516 |
Immunosuppressants | 1 (3.33) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 1.000 |
Side Effects | Immunized with Ad5-nCoV Vaccine | p-Value | |
---|---|---|---|
With a Different Vaccine Booster n = 62 n (%) | Without any Booster n = 62 n (%) | ||
At least one | 34 (54.84) | 41 (66.13) | 0.1985 |
Headache | 22 (35.48) | 27 (43.55) | 0.3584 |
Shivers | 20 (32.26) | 16 (25.81) | 0.4287 |
Myalgia | 12 (19.35) | 22 (35.48) | 0.0441 |
Fever | 17 (27.42) | 13 (20.97) | 0.4016 |
Arthralgia | 9 (14.52) | 9 (14.52) | 1.0000 |
Irritability | 9 (14.52) | 9 (14.52) | 1.0000 |
Fatigue | 1 (1.61) | 24 (38.71) | <0.0000 |
Application site-pain | 4 (6.45) | 0 (0.00) | 0.1189 |
Immunized with Ad5-nCoV Vaccine | p-Value | ||||
---|---|---|---|---|---|
AstraZeneca (ChAdOx1-S-nCoV-19) n = 30 n (%) | Moderna (mRNA-127) n = 15 n (%) | Pfizer (BNT162b2) n = 12 n (%) | Johnson & Johnson (Janssen COVID-19 Vaccine) n = 5 n (%) | ||
At least one | 17 (56.67) | 9 (60.00) | 5 (41.67) | 3 (60.00) | 0.810 |
Headache | 10 (33.33) | 6 (40.00) | 4 (33.33) | 2 (40.00) | 0.976 |
Shivers | 8 (26.67) | 7 (46.67) | 4 (33.33) | 1 (20.00) | 0.586 |
Myalgia | 6 (20.00) | 5 (33.33) | 3 (25.00) | 3 (60.00) | 0.264 |
Fever | 5 (16.67) | 5 (33.33) | 1 (8.33) | 1 (20.00) | 0.379 |
Arthralgia | 4 (13.33) | 2 (13.33) | 2 (16.67) | 1 (20.00) | 0.951 |
Irritability | 5 (16.67) | 3 (20.00) | 1 (8.33) | 0 (0.00) | 0.819 |
Application site-pain | 1 (3.33) | 1 (6.67) | 1 (8.33) | 1 (20.00) | 0.301 |
Fatigue | 1 (3.33) | 0 (0.00) | 0 (0.00) | 0 (0.00) | 1.000 |
Publisher’s Note: MDPI stays neutral with regard to jurisdictional claims in published maps and institutional affiliations. |
© 2022 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
Share and Cite
Muñoz-Valle, J.F.; Sánchez-Zuno, G.A.; Matuz-Flores, M.G.; Hernández-Ramírez, C.O.; Díaz-Pérez, S.A.; Baños-Hernández, C.J.; Turrubiates-Hernández, F.J.; Vega-Magaña, A.N.; Hernández-Bello, J. Efficacy and Safety of Heterologous Booster Vaccination after Ad5-nCoV (CanSino Biologics) Vaccine: A Preliminary Descriptive Study. Vaccines 2022, 10, 400. https://doi.org/10.3390/vaccines10030400
Muñoz-Valle JF, Sánchez-Zuno GA, Matuz-Flores MG, Hernández-Ramírez CO, Díaz-Pérez SA, Baños-Hernández CJ, Turrubiates-Hernández FJ, Vega-Magaña AN, Hernández-Bello J. Efficacy and Safety of Heterologous Booster Vaccination after Ad5-nCoV (CanSino Biologics) Vaccine: A Preliminary Descriptive Study. Vaccines. 2022; 10(3):400. https://doi.org/10.3390/vaccines10030400
Chicago/Turabian StyleMuñoz-Valle, José Francisco, Gabriela Athziri Sánchez-Zuno, Mónica Guadalupe Matuz-Flores, Cristian Oswaldo Hernández-Ramírez, Saúl Alberto Díaz-Pérez, Christian Johana Baños-Hernández, Francisco Javier Turrubiates-Hernández, Alejandra Natali Vega-Magaña, and Jorge Hernández-Bello. 2022. "Efficacy and Safety of Heterologous Booster Vaccination after Ad5-nCoV (CanSino Biologics) Vaccine: A Preliminary Descriptive Study" Vaccines 10, no. 3: 400. https://doi.org/10.3390/vaccines10030400