Assessing the Immunogenicity of rabies vaccine following administration of booster dose after four years among animal handlers of biological park in karnataka. - NIL

开始日期2023-10-14

申办/合作机构-

CTRI/2023/09/057399

/ Recruiting临床3期IIT

A randomized controlled trial on Safety and Immunogenicity of purified verocell rabies vaccine as pre-exposure prophylaxis via Intradermal two visits (2-0-2-0-0) verses three visits (1-0-1-0-1) regimen on healthy volunteers - NIL

开始日期2023-09-16

申办/合作机构-

NCT06066294

/ Recruiting临床3期IIT

A Randomized Controlled Trial on Safety and Immunogenicity of Purified Verocell Rabies Vaccine as Pre-exposure Prophylaxis Via Intradermal Two Visits (2-0-2-0-0) Verses Three Visits (1-0-1-0-1) Regimen on Healthy Volunteers

The goal of this clinical trial is to compare WHO recommended PrEP Vaccination Schedule, 2 doses 0.2ml 2 sites (0.1ml each site) on day 0 and day 7 and Government of India currently recommended PrEP Schedule, 0.1ml 3 doses on day 0, day 7 and day 28 in Healthy subjects above 18years of age, willing to volunteer and sign written informed consent for the study. The main questions it aims to answer are:
To assess the seroconversion (? 0.5 IU/mL) of the study subjects following primary & boosting vaccination on Day 35 ,Day 365, Day 372/375.
To assess the incidence of adverse events(immediate/delayed, local/systemic) among subjects.
Participants will be administerd with WHO Pre-qualified rabies vaccine (Rabivax-S) .
Researchers will compare the two regimens mentioned above.

开始日期2023-04-03

申办/合作机构

Kempegowda Institute of Medical Sciences

100 项与 Rabies vaccine(Serum Institute of India Pvt Ltd.) 相关的临床结果

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项与 Rabies vaccine(Serum Institute of India Pvt Ltd.) 相关的文献（医药）

2025-05-01·Veterinary Microbiology

Construction and evaluation of recombinant rabies virus encoding three copies codon-optimized G genes as inactivated rabies vaccine in dogs and cats

Article

作者: Zhou, Ming ; Wang, Zongmei ; Li, Haoqi ; Shang, Qinghua ; Pei, Tao ; Zhao, Jianqing ; Zhang, Chengguang ; Zhao, Ling ; Fu, Zhen F ; Wu, Ying

Rabies is a fatal zoonotic disease affecting various warm-blooded animals. The number of dogs and cats in China has surpassed 120 million, yet no domestic universal rabies vaccine for them. The glycoprotein (G) of the rabies virus (RABV) serves as the principal antigen for inducing virus-neutralizing antibodies (VNA). In this study, we constructed a recombinant RABV strain (designated SAD-tOG) carrying three copies of the codon-optimized G gene using reverse genetics. The SAD-tOG strain exhibited comparable growth kinetics to the parent strain in cell culture while demonstrating enhanced G protein expression. Mouse challenge experiments revealed significantly reduced pathogenicity and elevated immunogenicity in the recombinant strain. Subsequently, a safe and efficient water-based adjuvant was selected to prepare an inactivated rabies vaccine. In another experiment, the VNA titers of dogs and cats after vaccination were both greater than the WHO-recommended protective antibody titer of 0.5 IU/ml for 360 days. Comparative analysis showed these titers were higher than those induced by commercial vaccines currently used in China. These findings collectively indicate that the SAD-tOG strain represents a safer and more effective vaccine candidate for dog and cat rabies prevention.

2025-05-01·The Lancet Infectious Diseases

Safety and efficacy of the blood-stage malaria vaccine RH5.1/Matrix-M in Burkina Faso: interim results of a double-blind, randomised, controlled, phase 2b trial in children

Article

作者: Cho, Jee-Sun ; Compaoré, Z Michael John ; Kafando, Miguel ; Daboné, K Carine Sonia ; Natama, Hamtandi M ; Konaté, Fabé ; Bonko, Massa Dit Achille ; Long, Carole A ; Koné, Nadine A ; Tinto, Halidou ; Lawrie, Alison M ; Rouamba, Toussaint ; Sorgho, Hermann ; Salkeld, Jo ; King, Lloyd D W ; Ouédraogo, Florence ; Soremekun, Seyi ; Ouédraogo, Edouard ; Traoré, Ousmane ; Roberts, Rachel ; Shaligram, Umesh ; Draper, Simon J ; Pipini, Dimitra ; Minassian, Angela M ; Skinner, Katherine ; Bradley, John ; Diouf, Ababacar ; Silk, Sarah E ; Miura, Kazutoyo ; Diallo, Salou ; Nielsen, Carolyn M ; Somé, Athanase

BACKGROUNDTwo pre-erythrocytic vaccines (R21/Matrix-M and RTS,S/AS01) are now approved for Plasmodium falciparum malaria. However, neither induces blood-stage immunity against parasites that break through from the liver. RH5.1/Matrix-M, a blood-stage P falciparum malaria vaccine candidate, was highly immunogenic in Tanzanian adults and children. We therefore assessed the safety and efficacy of RH5.1/Matrix-M in Burkinabe children.METHODSIn this double-blind, randomised, controlled, phase 2b trial, RH5.1/Matrix-M was given to children aged 5-17 months in Nanoro, Burkina Faso, a seasonal malaria transmission setting. Children received either three intramuscular vaccinations with 10 μg RH5.1 protein with 50 μg Matrix-M adjuvant or three doses of rabies control vaccine, Rabivax-S, given either in a delayed third-dose (0, 1, and 5 month) regimen (first cohort) or a 0, 1, and 2 month regimen (second cohort). Vaccinations were completed part way through the malaria season. Children were randomly assigned 2:1 within each cohort to receive RH5.1/Matrix-M or Rabivax-S. Participants were assigned according to a random allocation list generated by an independent statistician using block randomisation with variable block sizes. Participants, their families, and the study teams were masked to group allocation; only pharmacists who prepared the vaccines were unmasked. Vaccine safety, immunogenicity, and efficacy were evaluated. The coprimary outcomes assessed were: first, the safety and reactogenicity of RH5.1/Matrix-M; and second, the protective efficacy of RH5.1/Matrix-M against clinical malaria (measured as time to first episode of clinical malaria, using a Cox regression model) from 14 days to 6 months after the third vaccination in the per-protocol sample. This ongoing trial is registered with ClinicalTrials.gov (NCT05790889).FINDINGSFrom April 6 to 13 and July 3 to 7, 2023, 412 children aged 5-17 months were screened, and 51 were excluded. A total of 361 children were enrolled in this study. In the first cohort, 119 were assigned to the RH5.1/Matrix-M delayed third-dose group, and 62 to the equivalent rabies control group. The second cohort included 120 children in the monthly RH5.1/Matrix-M group and 60 in the equivalent rabies control group. The final vaccination was administered to all groups from Sept 4 to 21, 2023. RH5.1/Matrix-M in both cohorts had a favourable safety profile and was well tolerated. Most adverse events were mild, with the most common being local swelling and fever. No serious adverse events were reported. Comparing the RH5.1/Matrix-M delayed third-dose regimen with the pooled control groups resulted in a vaccine efficacy of 55% (95% CI 20 to 75%; p=0·0071). The same analysis showed a vaccine efficacy of 40% (-3 to 65%; p=0·066) when comparing the monthly regimen with the pooled control groups. Participants vaccinated with RH5.1/Matrix-M in both cohorts showed high concentrations of anti-RH5.1 serum IgG antibodies 14 days after the third vaccination, and the purified IgG showed high levels of in vitro growth inhibition activity against P falciparum; these responses were higher in patients who received the RH5.1/Matrix-M vaccine delayed third-dose regimen, as opposed to monthly regimen (growth inhibition activity 79·0% [SD 14·3] vs 74·2% [SD 15·9]; p=0·016).INTERPRETATIONRH5.1/Matrix-M appears safe and highly immunogenic in African children and shows promising efficacy against clinical malaria when given in a delayed third-dose regimen. This trial is ongoing to further monitor efficacy over time.FUNDINGThe European and Developing Countries Clinical Trials Partnership, the UK Medical Research Council, the National Institute for Health and Care Research Oxford Biomedical Research Centre, the Division of Intramural Research, National Institute of Allergy and Infectious Diseases, the US Agency for International Development, and the Wellcome Trust.

2025-04-01·Vaccine

Immunogenicity of pre-exposure rabies vaccination comparing number of doses and routes of administration: A systematic review and meta-analyses

Review

作者: Davis, Phaedra ; Killikelly, April ; Coward, Leanne ; Warshawsky, Bryna ; Montroy, Joshua ; Abrams, Elissa M

INTRODUCTIONHuman rabies is rare, though almost universally fatal. Rabies pre-exposure prophylaxis (PrEP) simplifies the post-exposure prophylaxis regimen and may offer some protection from unrecognized rabies exposures. Several different PrEP schedules are recommended by different jurisdictions. The objective of this review was to systematically analyze the impact of schedule and route of administration on immune responses to rabies vaccine in the short-term, long-term, and post-booster, specifically comparing one-, two-, and three-dose schedules, and intramuscular (IM) and 2-site intradermal (ID) routes of administration.METHODSAn existing systematic review was leveraged, and an updated search was conducted in three databases from inception to January 15, 2024. Meta-analyses of seroconversion (≥0.5 IU/mL) and geometric mean titres (GMTs) from direct comparison studies, studies which allowed comparisons of schedules within the same participants/groups of participants, and pooled data across study arms were conducted.RESULTSFifty-four studies met the eligibility criteria. Short-term, most participants who received two or three doses achieved titres ≥0.5 IU/mL regardless of route of administration; seroconversion and GMTs were significantly lower with one-dose schedules. Titres fell over time for all schedules with lower maintenance of seroconversion for two-dose IM schedules than three-dose IM schedules. Following the administration of booster doses, all schedules boosted to GMTs higher than after the primary series resulting in almost 100 % seroconversion, with the lowest seroconversion (98.7 %) for those who received a one 2-site ID dose for their primary vaccination. When comparing IM to 2-site ID administration of rabies vaccine, generally, no significant differences in seroconversion and limited differences in GMTs were observed.CONCLUSIONTwo- and three-dose schedules had similar seroconversion regardless of route of administration in the short-term and after the booster, but two doses given IM resulted in lower maintenance of seroconversion in the long-term than three doses IM. Seroconversion was significantly reduced with a one-dose schedule in the short- and long-term. Immune responses to all schedules decreased over time, but almost all participants seroconverted following a booster dose. Responses between 2-site ID and IM administration were generally similar with only a few differences observed.

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


AAAAI2016	N/A	原发性免疫缺陷疾病 rabies neutralizing antibody(RNab)	-	Rabies Virus Vaccine (Patients with primary immunodeficiency disorders (PIDs))	鹹齋網鑰醖顧齋遞網膚(糧鹽網鹽壓選鹹遞鬱蓋) = 鏇壓廠遞憲窪蓋艱構廠觸憲顧選獵壓襯鬱鬱壓 (範襯艱齋獵蓋願鬱鬱夢, 0 ~ 6.16)	积极	2016-02-01
				Rabies Virus Vaccine (Healthy controls)	鹹齋網鑰醖顧齋遞網膚(糧鹽網鹽壓選鹹遞鬱蓋) = 蓋鹹積願鬱糧遞衊鹹衊觸憲顧選獵壓襯鬱鬱壓 (範襯艱齋獵蓋願鬱鬱夢, 2.18 ~ 19.15)