Safety and immunogenicity of COReNAPCIN®, a SARS-CoV-2 mRNA vaccine; a randomized, double-blind, placebo-controlled phase 1 clinical trial DOI Creative Commons

Mohammadreza Salehi,

Ilad Alavi Darazam, Alireza Nematollahi

и другие.

medRxiv (Cold Spring Harbor Laboratory), Год журнала: 2023, Номер unknown

Опубликована: Ноя. 2, 2023

The repeated COVID-19 outbreaks, despite global vaccination, highlights the need for booster doses. Here, we present outcomes, up until day 90 post of a randomized, double-blind, placebo-controlled phase 1 clinical trial mRNA-based vaccine candidate; COReNAPCIN ® , as dose in adults aged 18-50 who had previously received three doses inactivated vaccines. In study, 30 participants randomly (2:2:1) 25 μg, or 50 μg placebo. results indicated that was well tolerated vaccinated individuals both groups with no life-threatening other serious adverse events. most noticeable solicited events were pain at site injection, fatigue and myalgia. Regarding immunogenicity, given seroprevalence SARS-CoV-2 antibodies due to vaccination history all, previous infection some participants, recipients two weeks showed significant fold increases level anti-RBD (6.6 8.1 folds) anti-spike (11.5 21.7 folds), potent neutralizing (10.2 8.4 groups, respectively, while meaningful changes observed placebo group. Additionally, increase spike-specific IFN-γ T-cell response upon underscores activation cellular immunity. Altogether, favorable safety, tolerability, immunogenicity profile support its further development. Trial registration number IRCT20230131057293N1

Язык: Английский

Comparative efficacy and safety of COVID-19 vaccines in phase III trials: a network meta-analysis DOI Creative Commons
Xiaodi Wu, Ke Xu, Ping Zhan

и другие.

BMC Infectious Diseases, Год журнала: 2024, Номер 24(1)

Опубликована: Фев. 21, 2024

Abstract Background Over a dozen vaccines are in or have completed phase III trials at an unprecedented speed since the World Health Organization (WHO) declared COVID-19 pandemic. In this review, we aimed to compare and rank these indirectly terms of efficacy safety using network meta-analysis. Methods We searched Embase, MEDLINE, Cochrane Library for randomized controlled (RCTs) from their inception September 30, 2023. Two investigators independently selected articles, extracted data, assessed risk bias. Outcomes included preventing symptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection incidence serious adverse events (SAEs) according vaccine type individual adults elderly individuals. The ratio mean differences were calculated with 95% confidence intervals Bayesian Results A total 25 RCTs involving 22 study. None had higher SAEs than placebo. Inactivated virus might be safest, surface under cumulative ranking curve (SUCRA) value 0.16. BIV1-CovIran showed highest index (SUCRA value: 0.13), followed by BBV152, Soberana, Gam-COVID-Vac, ZF2001. There no significant among various types regarding SARS-CoV-2 infection, although there was trend toward mRNA 0.09). BNT162b2 0.02) vaccines, mRNA-1273, Abdala, NVX-CoV2373. 0.08) population, whereas CVnCoV, CoVLP + AS03, CoronaVac not significantly different Conclusions superior efficacy, while inferior other types. elderly, lowest adults.

Язык: Английский

Процитировано

15

COVID-19 Vaccines: Where Did We Stand at the End of 2023? DOI Creative Commons
Kenneth Lundström

Viruses, Год журнала: 2024, Номер 16(2), С. 203 - 203

Опубликована: Янв. 29, 2024

Vaccine development against SARS-CoV-2 has been highly successful in slowing down the COVID-19 pandemic. A wide spectrum of approaches including vaccines based on whole viruses, protein subunits and peptides, viral vectors, nucleic acids developed parallel. For all types vaccines, good safety efficacy have obtained both preclinical animal studies clinical trials humans. Moreover, emergency use authorization granted for major vaccines. Although high demonstrated, rare cases severe adverse events detected after global mass vaccinations. Emerging variants possessing enhanced infectivity affected vaccine protection requiring re-design re-engineering novel candidates. Furthermore, insight is given into preparedness emerging variants.

Язык: Английский

Процитировано

10

Assessment of long-term adverse events regarding different COVID-19 vaccine regimens within an 18-month follow-up study DOI

Mona Sadat Larijani,

Rahim Sorouri, Sana Eybpoosh

и другие.

Pathogens and Disease, Год журнала: 2023, Номер 81

Опубликована: Янв. 1, 2023

Abstract Early reports on coronavirus disease 2019 (COVID-19) vaccines presented the short-term adverse events (AEs). This follow-up study investigated a standard regimen based protein subunit vaccines, PastoCovac and Plus, combinational vaccine regimens including AstraZeneca/PastoCovac Plus Sinopharm/PastoCovac Plus. The participants were followed up to 6 months post booster shot. All AEs collected through in-depth interviews using valid researcher-made questionnaire evaluated regarding association with vaccines. Of 509 individuals, 6.2% of had late AEs, whom 3.3% suffered from cutaneous manifestations, by 1.1% arthralgia complaints, neurologic disorders, 0.3% ocular problems metabolic complications, no significant difference between regimens. For regimen, 2% individuals experienced as (1%), neurological disorders (0.3%), (0.3%) involvement joints (0.3%). Notably, 75% persistent end study. A low number captured in 18 12 improbable, 5 unclassifiable, 4 possible 3 probable associated benefits COVID-19 vaccination far exceed potential risks seem be uncommon.

Язык: Английский

Процитировано

19

Evaluation of PastoCovac plus vaccine as a booster dose on vaccinated individuals with inactivated COVID-19 vaccine DOI Creative Commons
Behrokh Farahmand, Mona Sadat Larijani, Fatemeh Fotouhi

и другие.

Heliyon, Год журнала: 2023, Номер 9(10), С. e20555 - e20555

Опубликована: Сен. 29, 2023

COVID-19 pandemic has been managed through global vaccination programs. However, the antibody waning in various types of vaccines came to notice. Hereby, PastoCovac Plus as a protein subunit vaccine was investigated immunized health care workers by COVAXIN (BBV152). The booster recommended at least three months post second dose COVAXIN. Sera collection done before and after each injection. SARS-CoV-2 PCR test monthly detect any asymptomatic symptomatic breakthrough. 47.9 24.3% participants were seronegative for anti-N anti-S antibodies COVAXIN, respectively. On average, fold-rises 70, 93, 8 mean-rises 23.32, 892.4, 5.59 recorded regarding neutralizing antibody, quantitative semi-quantitative anti-Spike Anti-Spike seroconversion seen 59.3% 45.7%, breakthrough assessment showed that all isolated samples belonged Delta variant. boosting is strongly combination with inactivated platforms against SARS-CoV-2.

Язык: Английский

Процитировано

11

Immunogenicity and safety of heterologous boost immunization with PastoCovac Plus against COVID-19 in ChAdOx1-S or BBIBP-CorV primed individuals DOI Creative Commons
Sana Eybpoosh,

Alireza Biglari,

Rahim Sorouri

и другие.

PLoS Pathogens, Год журнала: 2023, Номер 19(11), С. e1011744 - e1011744

Опубликована: Ноя. 1, 2023

Background This study aimed at evaluation and comparison of PastoCovac Plus protein-subunit vaccine in parallel with ChAdOx1-S (AstraZeneca) BBIBP-CorV (Sinopharm) primarily vaccinated volunteers two doses or BBIBP-CorV. Materials methods 194 enrolled the who were previously primed 2 vaccines. They divided into heterologous regimens receiving a third dose Plus, homologous groups ChAdOx1-S. Serum samples obtained just before 4 weeks after booster dose. Anti-spike IgG neutralizing antibodies quantified conventional live-virus neutralization titer, (cVNT50) assay was done against Omicron BA.5 variant. Moreover, adverse events data recorded doses. Results ChAdOx1-S/PastoCovac group reached 73.0 units increase anti-Spike rise compared to ChAdOx1-S/ ( P : 0.016). No significant difference observed between regarding antibody 0.256), indicating equivalency both types. Adjusting for baseline titers, BBIBP-CorV/PastoCovac showed 135.2 <0.0001) IgG, 3.1 0.008) unit mean group. Adjustment COVID-19 history, age, underlying diseases, titers increased odds fourfold (OR: 1.9; 0.199) BBIBP CorV 37.3; < 0.0001) their corresponding arms. The rise, adjustment same variables, 2.4 0.610) 5.4 0.286) groups. All types had potency neutralize variant no difference. highest rate event incidence Conclusions application individuals successfully specific antibodies’ levels without any serious events. could be administrated regimen effectively boost humoral immune responses.

Язык: Английский

Процитировано

11

Immunological effectiveness of the booster Soberana Plus vaccine (FINLAY-FR-1A) DOI Creative Commons
K. S. Korsak, Е. В. Воропаев, О. В. Осипкина

и другие.

Health and Ecology Issues, Год журнала: 2025, Номер 21(4), С. 26 - 36

Опубликована: Янв. 16, 2025

Objective . To assess the efficacy of immunogenicity Soberana Plus (FINLAY-FR-1A) vaccine in adults previously vaccinated against COVID-19. Materials and methods A total 98 participants participated study. The was studied by measuring IgG concentration to SARS-CoV-2 enzyme-linked immunosorbent assay (ELISA) at 4 study sites: day 0, 42 days, 90 days 180 after administration. Results Participants were divided into groups based on their primary immunization: 1) Sputnik V (Gam-COVID-Vac) / Light; 2) Sinopharm (BBIBP-CorV); 3) (BBIBP-CorV) + (Gam-COVIDVac) Light. highest level observed administration booster dose (p< 0,001). At “90 day” point, levels higher with Light (BBIBP-CorV), however, this group had before In vaccination, age “45 plus” level, compared “25-45 years old” (р=0,048). Conclusion is quite immunogenic. marked (р

Язык: Английский

Процитировано

0

Immunobiology and immunotherapy of COVID-19 DOI
Kenneth Lundström

Progress in molecular biology and translational science, Год журнала: 2025, Номер unknown

Опубликована: Янв. 1, 2025

Язык: Английский

Процитировано

0

Detecting the Seasonal and Spatial Patterns of COVID-19 Hospitalization and Deaths in Iran: Insights from a Spatiotemporal and Hotspot Analysis DOI Creative Commons
Leila Mounesan, Ebrahim Farhadi,

Sana Eybpoosh

и другие.

International Journal of Preventive Medicine, Год журнала: 2025, Номер 16

Опубликована: Апрель 1, 2025

Abstract Background: Understanding the seasonal and spatial patterns of COVID-19 hospitalization deaths is crucial for effective hospital management, resource allocation, public health interventions. The current study conducts a spatiotemporal hotspot analysis that explores geographical high-risk areas hospitalizations in Iran. Methods: Provincial-level data on laboratory-confirmed cases with acute respiratory symptoms Iran (February 2019–March 30, 2022) were collected. Hotspot analyses mapped incidence risks, Global Moran’s autocorrelation identified clusters. Results: Over 2 years, 26 hotspots 11 cold spots ( P < 0.05). Western central provinces showed highest hotspots, while west north had most death hotspots. South southeast exhibited low number spots. High-risk prevalent spring autumn, mainly west, north, regions. Conclusions: This research unveils clustering fatalities during severe pandemic. Spatial clusters dynamic varied across regions time. Prioritizing critical epidemic waves, devising care strategies, implementing preventive measures can significantly improve outcomes.

Язык: Английский

Процитировано

0

COVID-19 Vaccines: Where Do We Stand at the End of 2023? DOI Open Access
Kenneth Lundström

Опубликована: Янв. 5, 2024

Vaccine development against SARS-CoV-2 has been highly successful in slowing down the COVID-19 pandemic. A wide spectrum of approaches including vaccines based on whole viruses, protein subunits and peptides, viral vectors, nucleic acids have developed parallel. For all types vaccines, good safety efficacy obtained both preclinical animal studies clinical trials humans. Moreover, emergency use authorization granted for vaccines. Although high demonstrated, rare cases severe adverse events detected after global mass vaccinations. Emerging variants possessing enhanced infectivity affected vaccine protection requiring re-design re-engineering novel candidates. Furthermore, insight into preparedness emerging other future infections is given.

Язык: Английский

Процитировано

3

Safety and immunogenicity of COReNAPCIN, a SARS-CoV-2 mRNA vaccine, as a fourth heterologous booster in healthy Iranian adults: A double-blind, randomized, placebo-controlled, phase 1 clinical trial with a six-month follow-up DOI

Mohammadreza Salehi,

Ilad Alavi Darazam, Alireza Nematollahi

и другие.

International Immunopharmacology, Год журнала: 2024, Номер 134, С. 112192 - 112192

Опубликована: Май 17, 2024

Язык: Английский

Процитировано

3