A Phase 1b Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of a Prime-Boost Regimen of Three Dose Levels of PHV02, a Nipah Virus Vaccine Candidate (rVSV-ΔG-EBOV GP-NiVG) in Healthy Adults

The goal of this clinical trial is to test the safety and immunogenicity of PHV02 live, attenuated recombinant vesicular stomatitis virus vaccine expressing the Nipah Virus glycoprotein in healthy adult subjects. The main questions it aims to answer are:
which doses of PHV02 are safe to administer to and well-tolerated by healthy adult subjects as a 2 dose regimen given 1 month apart?
what is the immunologic response (Nipah-specific IgG ELISA antibody and neutralizing antibodies) to each dose level after a 2-dose regimen given 1 month apart? Participants will receive 2 intramuscular injections of PHV02 (2x105, 2x106, and 2x107 plaque-forming units [pfu]) or placebo on Day 1 and Day 29 and will be followed for 197 days.

开始日期2024-01-26

申办/合作机构

Public Health Vaccines LLC

[+1]

NCT05178901 / Completed临床1期

A Phase 1 Randomized, Single Center, Double-Blind, Placebo-Controlled, Dose-Response and Open-Label or Single Blind Booster Study to Evaluate the Safety and Immunogenicity of RVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects

A Phase 1 Study to Evaluate the Safety and Immunogenicity of rVSV-Nipah Virus Vaccine Candidate PHV02 in Healthy Adult Subjects

开始日期2022-01-10

申办/合作机构

Public Health Vaccines LLC

[+1]

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2024-10-01·JOURNAL OF INFECTION

Replication, safety and immunogenicity of the vectored Ebola vaccine rVSV-ΔG-ZEBOV-GP in a sub-Saharan African paediatric population: A randomised controlled, open-label trial in children aged 1-12 years living in Lambaréné, Gabon

Article

作者: Kabwende, Anita L ; Siegrist, Claire-Anne ; Mahmoudou, Saidou ; Velavan, Thirumalaisamy P ; Musangomunei, Fungai P ; Kremsner, Peter G ; Harandi, Ali M ; Alabi, Ayodele ; Kavishna, Ranmali ; Medaglini, Donata ; Bie-Ondo, Juste C ; Engler, Olivier ; Agnandji, Selidji T ; Nakka, Sravya S ; Nakaya, Helder I ; Olubiyi, Bisola F ; Kokou, Kossiwa ; Rothenberger, Sylvia

BACKGROUND:

Unlike adults, children experienced stronger and longer vector replication in plasma and shedding in saliva following rVSVΔG-ZEBOV-GP vaccination. The resulting risks of immunosuppression or immune hyperactivation leading to increased Adverse Events (AEs) and altered antibody responses are concerns that have been addressed in the present manuscript.

METHODS:

Children aged 1-12 years living in Gabon received either rVSVΔG-ZEBOV-GP (ERVEBO®) vaccine or the varicella-zoster virus (VZV) vaccine (VZV). The concentration of rVSVΔG vector in blood and saliva, the occurrence of AEs up to day 28; the anti-rVSVΔG-ZEBOV-GP and anti-VZV IgG antibody titres, neutralising and avidity functions of anti-rVSVΔG-ZEBOV-GP by day 365; were assessed in serum. (PACTR202005733552021) FINDINGS: In the rVSVΔG-ZEBOV-GP group, 70% and 7% of children had > 0 copies/ml of rVSVΔG respectively in plasma by day 3 and in saliva by day 14 after vaccination, with no detection on day 28. Significantly higher but transient AEs occurred in the rVSVΔG-ZEBOV-GP group. Both vaccines induced seroconversion on day 28 and sustainable IgG antibody titres by day 365. Avidity and neutralisation functions of the anti-rVSVΔG-ZEBOV-GP antibodies peaked at day 28 and were maintained by day 365.

INTERPRETATION:

The replication and shedding do not affect the favourable risk-benefit balance of the rVSVΔG-ZEBOV-GP in children.

FUNDING:

This trial is funded by the Innovative Medicines Initiative 2 (IMI 2) Joint Undertaking (grant number: 116068). The Biomedicine and Social Sciences research team of CERMEL is funded by the European and Developing Countries Clinical Trials Partnership (EDCTP-TMA-SF-1946-VARSAF).

2024-05-01·Tropical medicine & international health : TM & IH

Current progress towards prevention of Nipah and Hendra disease in humans: A scoping review of vaccine and monoclonal antibody candidates being evaluated in clinical trials

Review

作者: Yao, Jacqueline ; Nafade, Vaidehi ; Basta, Nicole E ; Gravagna, Katie ; Rodrigue, Valerie

Abstract:

Objectives:

Nipah and Hendra are deadly zoonotic diseases with pandemic potential. To date, no human vaccine or monoclonal antibody (mAb) has been licensed to prevent disease caused by these pathogens. The aim of this scoping review was to identify and describe all Phase I, II, and III clinical trials of vaccine candidates or mAbs candidates designed to prevent Nipah and Hendra in humans and to compare the characteristics of the vaccine candidates to characteristics outlined in the Target Product Profile drafted by the World Health Organisation as part of the WHO Research & Development Blueprint for Action to Prevent Epidemics.

Methods:

We searched 23 clinical trial registries, the Cochrane Central Register of Clinical Trials, and grey literature up to June 2023 to identify vaccine and mAb candidates being evaluated in registered clinical trials. Vaccine candidate and trial characteristics were double‐extracted for evaluation and the vaccine candidate characteristics were compared with the preferred and critical criteria of the World Health Organisation's Target Product Profile for Nipah virus vaccine.

Results:

Three vaccine candidates (Hendra Virus Soluble Glycoprotein Vaccine [HeV‐sG‐V], PHV02, and mRNA‐1215) and one mAb (m102.4) had a registered human clinical trial by June 2023. All trials were phase 1, dose‐ranging trials taking place in the United States of America or Australia and enrolling healthy adults. Although all vaccine candidates meet the dose regimen and route of administration criteria of the Target Product Profile, other criteria such as measures of efficacy and reactogenicity will need to be evaluated in the future as evidence becomes available.

Conclusion:

Multiple vaccine candidates and one mAb candidate have reached the stage of human clinical trials and are reviewed here. Monitoring progress during evaluation of these candidates and candidates entering clinical trials in the future can help highlight many of the challenges that remain.

2024-04-10·Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

Immunogenicity and Vaccine Shedding After 1 or 2 Doses of rVSVΔG-ZEBOV-GP Ebola Vaccine (ERVEBO®): Results From a Phase 2, Randomized, Placebo-controlled Trial in Children and Adults

Article

Abstract:

Background:

The rVSVΔG-ZEBOV-GP vaccine (ERVEBO®) is a single-dose, live-attenuated, recombinant vesicular stomatitis virus vaccine indicated for the prevention of Ebola virus disease (EVD) caused by Zaire ebolavirus in individuals 12 months of age and older.

Methods:

The Partnership for Research on Ebola VACcination (PREVAC) is a multicenter, phase 2, randomized, double-blind, placebo-controlled trial of 3 vaccine strategies in healthy children (ages 1–17) and adults, with projected 5 years of follow-up (NCT02876328). Using validated assays (GP-ELISA and PRNT), we measured antibody responses after 1-dose rVSVΔG-ZEBOV-GP, 2-dose rVSVΔG-ZEBOV-GP (given on Day 0 and Day 56), or placebo. Furthermore, we quantified vaccine virus shedding in a subset of children's saliva using RT-PCR.

Results:

In total, 819 children and 783 adults were randomized to receive rVSVΔG-ZEBOV-GP (1 or 2 doses) or placebo. A single dose of rVSVΔG-ZEBOV-GP increased antibody responses by Day 28 that were sustained through Month 12. A second dose of rVSVΔG-ZEBOV-GP given on Day 56 transiently boosted antibody concentrations. In vaccinated children, GP-ELISA titers were superior to placebo and non-inferior to vaccinated adults. Vaccine virus shedding was observed in 31.7% of children, peaking by Day 7, with no shedding observed after Day 28 post-dose 1 or any time post-dose 2.

Conclusions:

A single dose of rVSVΔG-ZEBOV-GP induced robust antibody responses in children that was non-inferior to the responses induced in vaccinated adults. Vaccine virus shedding in children was time-limited and only observed after the first dose. Overall, these data support the use of rVSVΔG-ZEBOV-GP for the prevention of EVD in at-risk children.Clinical Trials Registration. The study is registered at ClinicalTrials.gov (NCT02876328), the Pan African Clinical Trials Registry (PACTR201712002760250), and the European Clinical Trials Register (EudraCT number: 2017-001798-18).

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