Reactogenicity and Humoral Immune Response after Heterologous Vaxzevria/Comirnaty Vaccination in a Group of Individuals Vaccinated in the AOU Policlinic “G. Martino” (Messina, Italy): A Retrospective Cohort Study
Abstract
:1. Introduction
- (a)
- An evaluation of the reactogenicity of the heterologous COVID-19 vaccination, searching for undesirable effects reported by the vaccinated people after the administration of the first dose of the Vaxzevria vaccine and after the administration of the second dose of the Comirnaty vaccine, as well as the presence of statistically significant associations with age, sex, and comorbidities.
- (b)
- An evaluation of the antibody response after 28 days from the administration of the second dose, searching for the presence of statistically significant associations with age, sex, and comorbidities.
- (c)
- A comparison of the antibody responses after the homologous and heterologous vaccination regimens.
2. Materials and Methods
2.1. Inclusion Criteria
- –
- Age ≥ 18 years.
- –
- Administration of a dose of Vaxzevria vaccine.
- –
- Administration of a dose of Comirnaty vaccine for completing the vaccination course in the AOU Policlinic “G. Martino” (Messina, Italy).
- –
- Administration of a questionnaire before the administration of the Comirnaty vaccine and a week after the administration of the Comirnaty vaccine.
2.2. Evaluation of Reactogenicity
- (a)
- The first one regarded sociodemographic characteristics (Section 1).
- (b)
- The second one concerned the presence of comorbidities (Section 2). We divided the enrolled individuals into non-vulnerable, vulnerable, and extremely vulnerable. This classification was based on a table developed by the Sicilian region, defining as extremely vulnerable the individuals affected by some conditions characterized by pre-existing organ damage or by an immune deficiency, with a particularly elevated risk of developing severe or lethal forms of COVID-19. Vulnerable individuals were considered those with at least a chronic disease not included in the previous category. Finally, non-vulnerable individuals were those with no chronic diseases.
- (c)
- The third one concerned the presence of undesirable effects reported within 7 days of vaccine administration (Section 3).
2.3. Evaluation of Humoral Immune Response
2.4. Statistical Analysis
3. Results
Evaluation of the Humoral Immune Response
4. Discussion
4.1. Reactogenicity and Humoral Immune Response
4.2. Limitations of the Study
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
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Section 1. Sociodemographic Characteristics. | |||
---|---|---|---|
Sex | |||
Age | |||
Section 2. Presence of Comorbidities. | |||
Yes | No | ||
Extremely vulnerable: | |||
If yes: | |||
Respiratory diseases | |||
Cardiocirculatory disease | |||
Neurological diseases or disability | |||
Diabetes/other severe endocrinopathies | |||
Kidney diseases | |||
Autoimmune diseases | |||
Liver diseases | |||
Cerebrovascular diseases | |||
Onco-hematological diseases or haemoglobinopathies | |||
Graft | |||
Severe obesity (BMI > 35) | |||
Severe underweight (BMI < 16.5) | |||
Vulnerable: | |||
If yes, specify what chronic disease: _______________________________________________________ | |||
Section 3. Presence of Adverse Events. | |||
No | |||
Yes | Specify if a local (i.e., rash, pain, etc.) or general reaction (tiredness, headache, myalgia, arthralgia, chills, fever, etc.), its type, and duration____________________________ |
N° | % | |
---|---|---|
Sex | ||
Male | 48 | 27.6 |
Female | 126 | 72.4 |
Mean age ± SD | 51.83 ± 14.40 SD | |
Age | ||
21–30 | 12 | 6.90 |
31–39 | 21 | 12.07 |
40–49 | 39 | 22.41 |
50–59 | 60 | 34.50 |
60–69 | 18 | 10.35 |
70–79 | 23 | 13.21 |
>80 | 1 | 0.56 |
Vaxzevria * | Comirnaty * | |||
---|---|---|---|---|
M (%) | F (%) | M (%) | F (%) | |
Pain at injection site | 44.83% (78) | 55.17% (96) | 43.10% (75) | 56.90% (99) |
Fatigue | 44.83% (78) | 55.17% (96) | 18.97% (33) | 81.03% (141) |
Fever (≥38.5 °C) | 46.55% (81) | 53.45% (93) | 8.62% (15) | 91.38% (159) |
Chills | 29.31% (51) | 70.69% (123) | 25.86% (45) | 74.14% (129) |
Headache | 48.28% (84) | 51.72% (90) | 12.07% (21) | 87.93% (153) |
Nausea | 20.69% (36) | 79.31% (138) | 27.59% (48) | 72.41% (126) |
Myalgia/arthralgia | 34.48% (60) | 65.52% (114) | 3.45% (6) | 96.55% (168) |
Vomiting | 6.90% (12) | 93.10% (162) | 3.45% (6) | 96.55% (168) |
Swollen lymph nodes | 3.45% (6) | 96.55% (168) | 3.45% (6) | 96.55% (168) |
Diarrhea | 3.45% (21) | 96.55% (153) | 3.45% (6) | 96.55% (168) |
Swelling at injection site | 12.07% (18) | 87.93% (156) | 1.72% (3) | 98.28% (171) |
Allergic reactions | 10.34% (33) | 89.66% (141) | 10.34% (18) | 89.66% (156) |
Sleep disorders | 18.97% (12) | 81.03% (162) | 8.62% (15) | 91.38% (159) |
Neurological disorders | 60.34% (105) | 39.66% (69) | 0.00% (0) | 0.00% (0) |
Vaxzevria | |||
---|---|---|---|
Comorbidities | Non-Vulnerable | Vulnerable | Extremely Vulnerable |
Pain at injection site | 32.76% (57) | 12.07% (21) | 17.24% (30) |
Fatigue | 31.03% (54) | 12.07% (21) | 17.24% (30) |
Fever (≥ 38.5 °C) | 31.03% (54) | 10.34% (18) | 17.24% (30) |
Chills | 22.41% (39) | 8.62% (15) | 10.34% (18) |
Headache | 31.03% (54) | 10.34% (18) | 17.24% (30) |
Nausea | 10.34% (18) | 6.90% (12) | 8.62% (15) |
Myalgia/arthralgia | 18.97% (33) | 10.34% (18) | 17.24% (30) |
Vomiting | 3.45% (6) | 0.00% (0) | 5.17% (9) |
Swollen lymph nodes | 1.72% (3) | 0.00% (0) | 1.72% (3) |
Diarrhea | 1.72% (3) | 0.00% (0) | 1.72% (3) |
Swelling at injection site | 3.45% (6) | 1.72% (3) | 10.34% (18) |
Allergic reactions | 10.34% (18) | 3.45% (6) | 1.72% (3) |
Sleep disorders | 12.07% (21) | 5.17% (9) | 10.34% (18) |
Neurological disorders | 5.17% (9) | 5.17% (9) | 3.45% (6) |
Comirnaty | |||
Pain at injection site | 39.66% (69) | 20.69% (36) | 22.41% (39) |
Fatigue | 29.31% (51) | 10.34% (18) | 12.07% (21) |
Fever (≥ 38.5 °C) | 13.79% (24) | 3.45% (6) | 3.45% (6) |
Chills | 3.45% (6) | 1.72% (3) | 3.45% (6) |
Headache | 13.79% (24) | 5.17% (9) | 8.62% (15) |
Nausea | 8.62% (15) | 0.00% (0) | 3.45% (6) |
Myalgia/arthralgia | 15.52% (27) | 3.45% (6) | 12.07% (21) |
Vomiting | 3.45% (6) | 0.00% (0) | 0.00% (0) |
Swollen lymph nodes | 5.17% (9) | 0.00% (0) | 0.00% (0) |
Diarrhea | 5.17% (9) | 1.72% (3) | 1.72% (3) |
Swelling at injection site | 5.17% (9) | 1.72% (3) | 1.72% (3) |
Allergic reactions | 0.00% (0) | 1.72% (3) | 3.45% |
Sleep disorders | 0.00% (0) | 0.00% (0) | 1.72% (3) |
Neurological disorders | 6.90% (12) | 0.00% (0) | 5.17% (9) |
Age | <50 | 51–60 | >60 |
---|---|---|---|
Vaxzevria | |||
Pain at injection site | 28% (48) | 26% (45) | 9% (15) |
Fatigue | 29% (51) | 17% (30) | 14% (24) |
Fever (≥38.5 °C) | 34% (60) | 16% (27) | 9% (15) |
Chills | 22% (39) | 16% (27) | 3% (6) |
Headache | 31% (54) | 22% (39) | 5% (9) |
Nausea | 17% (30) | 7% (12) | 2% (3) |
Myalgia/arthralgia | 24% (42) | 12% (21) | 10% (18) |
Vomiting | 7% (12) | 0% (0) | 2% (3) |
Swollen lymph nodes | 2% (3) | 2% (3) | 0% (0) |
Diarrhea | 0% (0) | 0% (0) | 3% (6) |
Swelling at injection site | 7% (12) | 7% (12) | 2% (3) |
Allergic reactions | 9% (15) | 2% (3) | 5% (9) |
Sleep disorders | 16% (27) | 7% (12) | 5% (9) |
Neurological disorders | 3% (6) | 9% (15) | 2% (3) |
Comirnaty | |||
Pain at injection site | 40% (69) | 26% (45) | 17% (30) |
Fatigue | 31% (54) | 16% (27) | 5% (9) |
Fever (≥38.5 °C) | 14% (27) | 5% (9) | 2% (3) |
Chills | 2% (3) | 7% (12) | 0% (0) |
Headache | 16% (27) | 10% (18) | 2% (3) |
Nausea | 5% (9) | 7% (12) | 0% (0) |
Myalgia/arthralgia | 14% (24) | 12% (21) | 5% (9) |
Vomiting | 0% (0) | 2% (3) | 2% (3) |
Swollen lymph nodes | 2% (3) | 3% (6) | 0% (0) |
Diarrhea | 3% (6) | 3% (6) | 2% (3) |
Swelling at injection site | 2% (3) | 0% (0) | 3% (6) |
Allergic reactions | 0% (0) | 0% (0) | 2% (3) |
Sleep disorders | 9% (15) | 2% (3) | 2% (3) |
Neurological disorders | 9% (15) | 3% (6) | 2% (3) |
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Venuto, R.; Giunta, I.; Vaccaro, M.; La Fauci, V.; Ceccio, C.; Fedele, F.; Privitera, A.; Denaro, F.; Pantò, G.; Cortese, R.; et al. Reactogenicity and Humoral Immune Response after Heterologous Vaxzevria/Comirnaty Vaccination in a Group of Individuals Vaccinated in the AOU Policlinic “G. Martino” (Messina, Italy): A Retrospective Cohort Study. Vaccines 2022, 10, 1803. https://doi.org/10.3390/vaccines10111803
Venuto R, Giunta I, Vaccaro M, La Fauci V, Ceccio C, Fedele F, Privitera A, Denaro F, Pantò G, Cortese R, et al. Reactogenicity and Humoral Immune Response after Heterologous Vaxzevria/Comirnaty Vaccination in a Group of Individuals Vaccinated in the AOU Policlinic “G. Martino” (Messina, Italy): A Retrospective Cohort Study. Vaccines. 2022; 10(11):1803. https://doi.org/10.3390/vaccines10111803
Chicago/Turabian StyleVenuto, Roberto, Ioselita Giunta, Mario Vaccaro, Vincenza La Fauci, Concetta Ceccio, Francesco Fedele, Antonino Privitera, Federica Denaro, Giuseppe Pantò, Rosaria Cortese, and et al. 2022. "Reactogenicity and Humoral Immune Response after Heterologous Vaxzevria/Comirnaty Vaccination in a Group of Individuals Vaccinated in the AOU Policlinic “G. Martino” (Messina, Italy): A Retrospective Cohort Study" Vaccines 10, no. 11: 1803. https://doi.org/10.3390/vaccines10111803
APA StyleVenuto, R., Giunta, I., Vaccaro, M., La Fauci, V., Ceccio, C., Fedele, F., Privitera, A., Denaro, F., Pantò, G., Cortese, R., Visalli, G., D’Amato, S., Squeri, A., Squeri, R., & Genovese, C. (2022). Reactogenicity and Humoral Immune Response after Heterologous Vaxzevria/Comirnaty Vaccination in a Group of Individuals Vaccinated in the AOU Policlinic “G. Martino” (Messina, Italy): A Retrospective Cohort Study. Vaccines, 10(11), 1803. https://doi.org/10.3390/vaccines10111803