Assessing the Relationship between Antigenecity and Immunogenecity of Human Rabies Vaccines: Results of a Meta-Analysis

Sudarshan, Mysore Kalappa; Mahendra, Bangalore Jayakrishnappa; Madhusudana, Shampur Narayan; Narayana, Doddabele Hanumanthaiah Ashwath; Sanjay, Thitamaranahalli V.; Gangaboraiah,; Anandagiri, M.S.

doi:10.4161/hv.1.5.2110

Cited by 18 publications

(3 citation statements)

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“…To our knowledge, these observations of a dose–response relationship for a rabies vaccine are novel; prior meta-analysis by Sudarshan et al explored historical data on the relationship between antigenicity and immunogenicity of ten cell culture human rabies vaccines administered at one center between 1993 and 2004 but not in a randomized controlled study. 26 In our study, high-dose PVRV-NG2 compared favorably with the HDCV vaccine in terms of immune response, with higher GMTs and GMTRs noted at each timepoint, a comparable proportion of participants displaying RVNA titers ≥0.5 IU/mL and fewer reports of ARs.…”

Section: Discussionmentioning

confidence: 56%

Safety and immunogenicity of three dose levels of an investigational, highly purified Vero cell rabies vaccine: A randomized, controlled, observer-blinded, Phase II study with a simulated post-exposure regimen in healthy adults

Pichon,

Guinet-Morlot,

Saleh

et al. 2023

Human Vaccines & Immunotherapeutics

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A serum-free, highly purified rabies vaccine produced in Vero cells is under development. The initial formulation, PVRV-NG, was evaluated in five Phase II studies and subsequently reformulated (PVRV-NG2). This multicenter, observer-blinded Phase II study investigated the safety and immune response of three different doses (antigen content) of PVRV-NG2 versus a licensed human diploid cell rabies vaccine (HDCV; Imovax rabies®). Healthy adults ( N = 320) were randomized to receive PVRV-NG2 (low, medium, or high dose), PVRV-NG, or HDCV (2:2:2:1:1 ratio), according to a five-dose Essen simulated post-exposure regimen (Days [D] 0, 3, 7, 14, and 28). All participants received human rabies immunoglobulin intramuscularly on D0. Immunogenicity was assessed at D0, 14, 28, 42, and 6 months after the final injection using the rapid fluorescent focus inhibition test. Seroconversion rates were calculated as the percentage of participants achieving rabies virus neutralizing antibody titers ≥0.5 IU/mL. All analyses were descriptive. At each timepoint, geometric mean titers (GMTs) increased with antigen content (measured using an enzyme-linked immunosorbent assay). High-dose PVRV-NG2 GMTs were the highest at all timepoints, medium-dose PVRV-NG2 GMTs were similar to those with HDCV, and low-dose PVRV-NG2 GMTs were similar to PVRV-NG. The safety profile of PVRV-NG2 was comparable to PVRV-NG; however, fewer injection site reactions were reported with PVRV-NG2 or PVRV-NG (range 36.7–47.5%) than with HDCV (61.5%). This study demonstrated a dose–effect of antigen content at all timepoints. As post-exposure prophylaxis, the safety and immunogenicity profiles of the high-dose PVRV-NG2 group compared favorably with HDCV. Clinicaltrials.gov number: NCT03145766.

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Section: Discussionmentioning

confidence: 56%

Safety and immunogenicity of three dose levels of an investigational, highly purified Vero cell rabies vaccine: A randomized, controlled, observer-blinded, Phase II study with a simulated post-exposure regimen in healthy adults

Pichon,

Guinet-Morlot,

Saleh

et al. 2023

Human Vaccines & Immunotherapeutics

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“…challenge ( S1 Table ), although mice that received mRNA vaccine stored at 5°C showed a transient drop in body weight ( Fig 1D ). In contrast, two out of five mice immunized with the licensed vaccine HDC stored at 4°C for 12 months had to be sacrificed due to critical weight loss and one of the three surviving mice had a body weight only slightly above the critical threshold, indicating compromised vaccine efficacy for the HDC vaccine, potentially reflecting the reported lower potency of HDC compared to Rabipur [ 16 ].…”

Section: Resultsmentioning

confidence: 99%

A thermostable messenger RNA based vaccine against rabies

Stitz¹,

Vogel²,

Schnee³

et al. 2017

PLoS Negl Trop Dis

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Although effective rabies virus vaccines have been existing for decades, each year, rabies virus infections still cause around 50.000 fatalities worldwide. Most of these cases occur in developing countries, where these vaccines are not available. The reasons for this are the prohibitive high costs of cell culture or egg grown rabies virus vaccines and the lack of a functional cold chain in many regions in which rabies virus is endemic. Here, we describe the excellent temperature resistance of a non-replicating mRNA based rabies virus vaccine encoding the rabies virus glycoprotein (RABV-G). Prolonged storage of the vaccine from -80°C to up to +70°C for several months did not impact the protective capacity of the mRNA vaccine. Efficacy after storage was demonstrated by the induction of rabies specific virus neutralizing antibodies and protection in mice against lethal rabies infection. Moreover, storing the vaccine at oscillating temperatures between +4° and +56°C for 20 cycles in order to simulate interruptions of the cold chain during vaccine transport, did not affect the vaccine’s immunogenicity and protective characteristics, indicating that maintenance of a cold chain is not essential for this vaccine.

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“…For this purpose, we used the data from a meta-analysis of the immunogenecity of selected vaccines that was reported recently by Sudrashan et al 11 We observed that the RVNA titers were comparable to those obtained with other commonly used vaccines such as PCEC, PVRV and HDCV.…”

Section: -7mentioning

confidence: 99%

Immunogenicity, safety and tolerance of a purified duck embryo vaccine (PDEV, VAXIRAB) for rabies post-exposure prophylaxis: Results of a multicentric study in India

Mahendra¹,

Madhusudana²,

Sampath³

et al. 2010

Human Vaccines

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Assessing the Relationship between Antigenecity and Immunogenecity of Human Rabies Vaccines: Results of a Meta-Analysis

Cited by 18 publications

References 0 publications

Safety and immunogenicity of three dose levels of an investigational, highly purified Vero cell rabies vaccine: A randomized, controlled, observer-blinded, Phase II study with a simulated post-exposure regimen in healthy adults

Safety and immunogenicity of three dose levels of an investigational, highly purified Vero cell rabies vaccine: A randomized, controlled, observer-blinded, Phase II study with a simulated post-exposure regimen in healthy adults

A thermostable messenger RNA based vaccine against rabies

Immunogenicity, safety and tolerance of a purified duck embryo vaccine (PDEV, VAXIRAB) for rabies post-exposure prophylaxis: Results of a multicentric study in India

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