Mix-and-Match COVID-19 Vaccinations (Heterologous Boost): A Review

Garg, Ishan; Sheikh, Abu Baker; Pal, Suman; Shekhar, Rahul

doi:10.3390/idr14040057

Cited by 33 publications

(18 citation statements)

References 54 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…However, due to limited vaccine availability, heterologous vaccine regimes were also approved by regulatory agencies [ 29 ]. Furthermore, heterologous vaccination provides a better immunogenicity compared to homologous vaccination [ 30 ]. We further investigated whether heterologous vaccination influenced the side effect frequency.…”

Section: Discussionmentioning

confidence: 99%

Vaccine Side Effects in Health Care Workers after Vaccination against SARS-CoV-2: Data from TüSeRe:exact Study

Bareiß¹,

Uzun²,

Mikus³

et al. 2022

Viruses

View full text Add to dashboard Cite

As the Corona Disease 2019 (COVID-19) caused by SARS-CoV-2 persists, vaccination is one of the key measures to contain the spread. Side effects (SE) from vaccination are one of the reasons for reluctance to vaccinate. We systematically investigated self-reported SE after the first, second, and booster vaccinations. The data were collected during the TüSeRe: exact study (Tübinger Monitoring Studie zur exakten Analyse der Immunantwort nach Vakzinierung). Employees of health and research institutions were invited to participate. Study participants were asked to fill out an online questionnaire and report their SE after each dose of SARS-CoV-2 vaccination. A total of 1046 participants (mean age: 44 ± 12.9 years; female, n = 815 (78%); male, n = 231 (22%)) were included in the analysis. Local and systemic SE were more frequent after receiving the vector-based vaccine ChAdOx1 nCoV-19 in the first vaccination. However, local and systemic SE were more common after receiving mRNA vaccines (BNT162b2, mRNA-1273) in the second vaccination. Compared to the BNT162b2 vaccine, more SE have been observed after receiving the mRNA-1273 vaccine in the booster vaccination. In multivariate analysis, local and systemic side effects were associated with vaccine type, age and gender. Local and systemic SE are common after SARS-CoV-2 vaccines. The frequency of self-reported local and systemic SE differ significantly between mRNA and vector-based vaccines.

show abstract

Section: Discussionmentioning

confidence: 99%

Vaccine Side Effects in Health Care Workers after Vaccination against SARS-CoV-2: Data from TüSeRe:exact Study

Bareiß¹,

Uzun²,

Mikus³

et al. 2022

Viruses

View full text Add to dashboard Cite

show abstract

“…[14][15][16][17] Several recent clinical studies indicate that heterologous schedules may, in fact, elicit a more robust immune response and higher antibody titres, with consequent higher effectiveness, supporting a mix-and-match approach. [18][19][20] These data suggest that there is a strong case for more vaccine platforms to broaden vaccination options worldwide.…”

Section: Introductionmentioning

confidence: 97%

Safety and immunogenicity of the protein-based PHH-1V compared to BNT162b2 as a heterologous SARS-CoV-2 booster vaccine in adults vaccinated against COVID-19: a multicentre, randomised, double-blind, non-inferiority phase IIb trial

Corominas

Garriga

Prenafeta

et al. 2022

Preprint

View full text Add to dashboard Cite

SummaryBackgroundA SARS-CoV-2 protein-based heterodimer vaccine, PHH-1V, has been shown to be safe and well-tolerated in healthy young adults in a first-in-human, Phase I/IIa study dose-escalation trial. Here, we report the interim results of the Phase IIb HH-2, where the immunogenicity and safety of a heterologous booster with PHH-1V is assessed versus a homologous booster with BNT162b2 at 14 and 98 days after vaccine administration.MethodsThe HH-2 study is an ongoing multicentre, randomised, active-controlled, double-blind, non-inferiority Phase IIb trial, where participants 18 years or older who had received two doses of BNT162b2 were randomly assigned in a 2:1 ratio to receive a booster dose of vaccine – either heterologous (PHH-1V group) or homologous (BNT162b2 group) – in 10 centres in Spain. Eligible subjects were allocated to treatment stratified by age group (18-64 versus ≥65 years) with approximately 10% of the sample enrolled in the older age group. The endpoints were humoral immunogenicity measured by changes in levels of neutralizing antibodies against the ancestral Wuhan-Hu-1 strain and different variants of SARS-CoV-2 after the PHH-1V or the BNT162b2 boost, the T-cell responses towards the SARS-CoV-2 spike glycoprotein peptides and the safety and tolerability of PHH-1V as a boost. This study is ongoing and is registered with ClinicalTrials.gov, NCT05142553.FindingsFrom 15 November 2021, 782 adults were randomly assigned to PHH-1V (n=522) or BNT162b2 (n=260) boost vaccine groups. The geometric mean titre (GMT) ratio of neutralizing antibodies on days 14 and 98, shown as BNT162b2 active control versus PHH-1V, was, respectively, 1·68 (p<0·0001) and 0·87 (p=0·43) for the ancestral Wuhan-Hu-1 strain; 0·61 (p<0·0001) and 0·57 (p=0·0064) for the beta variant; 1·01 (p=0·89) and 0·52 (p=0·0003) for the delta variant; and 0·59 (p=<0·0001) and 0·56 (p=0·0026) for the omicron variant. Additionally, PHH-1V as a booster dose induced a significant increase of CD4+ and CD8+ T-cells expressing IFN-γ on day 14. There were 458 participants who experienced at least one adverse event (89·3%) in the PHH-1V and 238 (94·4%) in the BNT162b2 group. The most frequent adverse events were injection site pain (79·7% and 89·3%), fatigue (27·5% and 42·1%) and headache (31·2 and 40·1%) for the PHH-1V and the BNT162b2 groups, respectively. A total of 52 COVID-19 cases occurred from day 14 post-vaccination (10·14%) for the PHH-1V group and 30 (11·90%) for the BNT162b2 group (p=0·45), and none of the subjects developed severe COVID-19.InterpretationOur interim results from the Phase IIb HH-2 trial show that PHH-1V as a heterologous booster vaccine, when compared to BNT162b2, elicits a strong and sustained neutralizing antibody response against Wuhan-Hu-1 strain, and a superior one concerning the previous circulating beta and delta SARS-CoV-2 variants, as well as the currently circulating omicron. Moreover, the PHH-1V boost also induces a strong and balanced T-cell response. Concerning the safety profile, subjects in the PHH-1V group report significantly fewer adverse events than those in the BNT162b2 group, most of mild intensity, and both vaccine groups present comparable COVID-19 breakthrough cases, none of them severe.FundingHIPRA SCIENTIFIC, S.L.U.

show abstract

“…The FDA approved and the CDC recommended a third is more likely to cause serious sickness in children with underlying medical issues than in children without such conditions [29,30].…”

Section: Immunocompromised Populationsmentioning

confidence: 99%

Covid-19 vaccines pharmacovigilance-a rapid review

Arackal¹,

Kalaparambath²,

Kidangeth³

et al. 2022

Asian Jour Hosp Phar

View full text Add to dashboard Cite

The rapid process of research and development and lack of follow-up time post-vaccination aroused greater public concern about the safety profile of COVID-19 vaccine candidates. Pharmacovigilance is critical for gathering, recognising, and monitoring adverse events, which is the primary goal. The reported adverse events should be evaluated to determine the causal relationship and avoid unnecessary consequences on the recipient. Many people are getting vaccines in a short period of time, putting a strain on pharmacovigilance facilities. The International Society of Pharmacovigilance (ISOP), the French National Agency for Medicines and Health Products Safety (ANSM), and many others worked together and took many initiatives to determine the safety and efficacy of vaccines, as well as to provide answers to the questions that were raised. Signals were discovered and several adverse occurrences were identified thanks to pharmacovigilance. BioNTech/Pfizer-m-RNA, Moderna-mRNA vaccine, Covishield, Johnson and Johnson, Vaxzervria, Sputnik V, and Convidicea pharmacovigilance is discussed. There were 12,249 ADRs reported with BioNTech/Pfizer-mRNA, 577 ADRs with Moderna-mRNA vaccine, 447 ADRs with Covishield, 653 ADRs with Johnson and Johnson, and 743 ADRs with Vaxzervria. As a result of these immunizations, Immune thrombocytopenic purpura, cerebrovascular events, thrombosis, thrombocytopenia, facial paralysis, fatalities, and a variety of other potentially lethal reactions have all been linked to these immunizations. However, the recorded incidents were minor in comparison to the patients' safety. The Uppsala monitoring centre kept track of all of these events. Uppsala monitoring centre, an initiative of WHO to detect various ADR relating to medications and preventing serious causalities associating with it have a greater role in minimizing the serious cases occurs with medicine dysfunction.

show abstract

Mix-and-Match COVID-19 Vaccinations (Heterologous Boost): A Review

Cited by 33 publications

References 54 publications

Vaccine Side Effects in Health Care Workers after Vaccination against SARS-CoV-2: Data from TüSeRe:exact Study

Vaccine Side Effects in Health Care Workers after Vaccination against SARS-CoV-2: Data from TüSeRe:exact Study

Safety and immunogenicity of the protein-based PHH-1V compared to BNT162b2 as a heterologous SARS-CoV-2 booster vaccine in adults vaccinated against COVID-19: a multicentre, randomised, double-blind, non-inferiority phase IIb trial

Covid-19 vaccines pharmacovigilance-a rapid review

Contact Info

Product

Resources

About