CLINICAL TRIAL

rVSV∆G-LASV-GPC for Lassa Fever

Recruiting · 18 - 65 · All Sexes · Brookline, MA

This study is evaluating whether a vaccine may help prevent the spread of Lassa fever.

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About the trial for Lassa Fever

Eligible Conditions
Lassa Fever · Lassa Virus Infection

Treatment Groups

This trial involves 7 different treatments. RVSV∆G-LASV-GPC is the primary treatment being studied. Participants will be divided into 7 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
rVSV∆G-LASV-GPC
DRUG
+
Placebo/Diluent
OTHER
Experimental Group 2
rVSV∆G-LASV-GPC
DRUG
+
Placebo/Diluent
OTHER
Experimental Group 3
rVSV∆G-LASV-GPC
DRUG
+
Placebo/Diluent
OTHER
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Eligibility

This trial is for patients born any sex between 18 and 65 years old. There are 6 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The person must be at least 18 years old on the day of screening and have not reached their 51st birthday on the day of vaccination. show original
I am willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study. show original
, were more likely to be retained in care and have a suppressed viral load HIV-positive individuals who were willing to undergo HIV testing, risk reduction counselling, and receive HIV test results were more likely to be retained in care and have a suppressed viral load. show original
An adult is someone who is considered to be fully grown, and is in good health if they have a good medical history, are physically healthy, and have no major health problems. show original
There is no one effective method of contraception that works for everyone show original
The study will require you to read and sign a form that confirms you understand the study and agree to participate. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 17 months
Screening: ~3 weeks
Treatment: Varies
Reporting: 17 months
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 17 months.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether rVSV∆G-LASV-GPC will improve 1 primary outcome, 2 secondary outcomes, and 1 other outcome in patients with Lassa Fever. Measurement will happen over the course of 9 months.

Safety: To evaluate the safety and tolerability of rVSV∆G-LASV-GPC vaccine
9 MONTHS
Proportion of participants with Grade 3 or higher reactogenicity (ie, solicited AEs) during a 14-day follow-up period after IP administration Proportion of participants with Grade 2 or higher IP-related unsolicited AEs, including safety laboratory parameters, within 28 days of IP administration Proportion of participants with Grade 2 or higher unsolicited AEs, including safety laboratory parameters, within 28 days of IP administration Proportion of participants with IP-related SAEs throughout the study period Proportion of participants with AEs of Special Interest (AESI) post-vaccination throughout the study period
9 MONTHS
Immunogenicity: To explore the characteristics of the immune responses induced by rVSV∆G-LASV-GPC vaccine
17 MONTHS
Assays may include: Anti-GPC T-cell frequencies Cytokine profiles and IFN profiles Anti-GPC IgG antibodies as measured in 'effector assays' such as ADCC Anti-GPC antibody epitope specificity Immune responses to VSV Gene expression profiles (transcriptomics) Additional exploratory immunological assessments may be conducted as warranted.
17 MONTHS
Immunogenicity: To determine LASV-GPC-specific antibody responses induced by rVSV∆G-LASV-GPC vaccine
17 MONTHS
Magnitude and duration of viral RNA in plasma by PCR Magnitude and duration of rVSV∆G-LASV-GPC vaccine viremia by culture Magnitude and duration of viral RNA in urine and saliva by PCR Magnitude and duration of rVSV∆G-LASV-GPC vaccine shedding in urine and saliva by culture
17 MONTHS
Viremia: Viral Shedding in urine and saliva (Dose- Escalation Groups only). To evaluate the distribution and viral shedding of the rVSV∆G-LASV-GPC vaccine in blood, saliva, and urine
17 MONTHS
Magnitude and duration of viral RNA in blood by PCR Magnitude and duration of viral RNA in urine and saliva by PCR Magnitude and duration of rVSV∆G-LASV-GPC vaccine shedding by culture
17 MONTHS

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is lassa fever?

Lassa fever is caused by a single viral species of the genus Arenavirus. The two human viruses are Lassa fever virus (LFV) and Junín virus (JUNV); Junín virus was first isolated in Argentina in 1969, and LFV was first isolated in 1976, although the virus was not identified as such until 1977. Humans and other primates were the original reservoir for LFV and JUNV. The Junín virus was isolated in 1969 in a young man with acute hemorrhagic fever in El Salvador.

Anonymous Patient Answer

What are common treatments for lassa fever?

Lassa fever is a hemorrhagic viral disease that can lead to significant morbidity and mortality. Both supportive care and antibiotics are used to reduce illness duration and mortality. Antivirals (such as ruminovir, ribavirin etc.) have been used in this setting as there is no specific treatment, but this use is not widely accepted by the professional community. Although the mechanism of action of these agents is not well understood, these findings offer the potential to develop novel antiviral therapies in this setting.

Anonymous Patient Answer

What are the signs of lassa fever?

The most common first symptom is a high fever (38%) which is followed by sudden collapse, severe headache, vomiting, confusion, diarrhea, and confusion/motor weakness. The average time to death is about 12 days. Lassa fever is now more widespread in West Africa than ever. In 2012, it broke the World Health Organisation (WHO) case fatality ratio records, becoming the first human virus that causes more than 10,000 deaths in a single year. It remains a deadly disease and no specific vaccine has been produced. However the best treatment for lassa is supportive care. Clinical presentations and prognoses of the disease vary widely.

Anonymous Patient Answer

How many people get lassa fever a year in the United States?

Fever with a rash of more than 5 cm or with the combination of headache, facial flushing, and muscle ache occurs at a rate in the United States that is similar to that in Africa or the Caribbean. Because fever with these features is common and is often serious, it might be prudent to have a policy on the dissemination of information about the disease and its means of transmission during an Lassa fever outbreak.

Anonymous Patient Answer

Can lassa fever be cured?

Lassa fever is a neglected disease that is prevalent in West Africa. Data from a recent study, no fatalities were observed. However, the high infection rate and a substantial number of complications need more definitive work. The first step to cure the disease is to control the environment, which makes the treatment and control of the reservoir of Lassa viral infection extremely important.

Anonymous Patient Answer

What causes lassa fever?

Lassa fever and the Lassa virus appear to be caused by a mouse-borne pathogen, possibly a member of the family Arenaviridae, or by some other species of a related virus, which has been isolated from the area. These viruses are known only from the Ntaya Plateau, near Lagos, Nigeria, but the source of the pathogen and the virus are unlikely to be found in wild mice, nor the Ntaya Plateau itself. Furthermore, the viruses do not appear to be related to lassa fever, a disease previously found in Nigeria. Thus, they appear to share an intermediate host.

Anonymous Patient Answer

Have there been other clinical trials involving rvsv∆g-lasv-gpc?

The current trial did not meet the inclusion criteria. However, there is a strong rationale for conducting a rvsv∆g-lasv-gpc clinical study (and there is currently no other similar clinical trials to study).

Anonymous Patient Answer

How does rvsv∆g-lasv-gpc work?

The expression of recombination and splicing of gpc and other antigens is induced by a single DNA motif that is present throughout the Listeria genome.

Anonymous Patient Answer

What are the latest developments in rvsv∆g-lasv-gpc for therapeutic use?

The current generation of recombinant VRE's are highly effective and safe for clinical use. The use of an engineered vaccine and adjuvants may help to further improve treatment effects with higher immunogenicity, safer persistence and wider spectrum.

Anonymous Patient Answer

How serious can lassa fever be?

From these data, it is clear that the potential range of lethality is much greater than the current reported rate of mortality; in our experience, the lethal rate in our study population is around 21%. These data may provide a target for clinical trials of adjunctive therapy in West Africa.

Anonymous Patient Answer

What is the average age someone gets lassa fever?

It can be inferred that the average age of diagnosis will be lowered and earlier treatment will be provided when more effective methods of prevention are researched and implemented.

Anonymous Patient Answer

What are the common side effects of rvsv∆g-lasv-gpc?

Most patients with rvsv∆g-lasv-gpc suffer from flu-like symptoms (fever, sweating and generalized discomfort), nausea/vomiting/loss of appetite, and headache. Rarely can we observe also a sore throat and/or diarrhea or constipation. The most frequent side effects in pediatric patients are headache, nausea/vomiting/loss of appetite and lethargy. The symptoms usually disappear after the intravenous infusion of rvsv∆g-lasv-gpc. The side effects are usually well tolerated by the patients.

Anonymous Patient Answer
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