CompletedPhase 1

A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Experimental Rabies Vaccine in Healthy Adults

United States160 participantsStarted 2019-08-13

Plain-language summary

The purpose of this first time-in-human (FTiH) study is to evaluate the safety, reactogenicity and immunogenicity of different dose levels of an experimental rabies glycoprotein G (RG) vaccine (RG-SAM \[CNE\] vaccine), made using a new technology, when administered intramuscularly (IM) on a 0, 2, 6 \*-month schedule to healthy adults. \* There will be no vaccinations with the third dose of any of the study treatments.

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. participation in genetics research, completion of the electronic diary cards, return for follow-up visits). * Written informed consent obtained from the participant prior to performance of any study specific procedure. * Healthy participants as established by medical history and clinical examination before entering into the study. * A male or female participant between, and including, 18 and 40 years of age at the time of the first vaccination. * Body Mass Index \>18 Kg/m\^2 and \<35 Kg/m\^2. * Participants with following hematological/biochemical parameters: * White Blood Cells and differential, within the study designated laboratory normal range. Participants with FDA toxicity grade 1 differential cell counts and considered not clinically significant may be enrolled at the discretion of the investigator, and with the review and approval of the medical monitor. * Platelets = 125,000 - 500,000 cells/mm\^3 * Hemoglobin within normal range of the study designated laboratory * Alanine aminotransferase within the study designated laboratory normal range * Aspartate aminotransferase within the study designated laboratory normal range * Total bilirubin within the study designated laboratory normal range * Alkaline phosphatase within the study designated laboratory normal range * Serum creatinine less than or equal to 1.1 times…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants reporting solicited local adverse events (AEs) during the 7-day follow-up period after the first dose received in the Primary vaccination phase

Timeframe: During the 7-day follow-up period after the first dose (administered at Day 1)

Number of participants reporting solicited local adverse events (AEs) during the 7-day follow-up period after the second dose received in the Primary vaccination phase

Timeframe: During the 7-day follow-up period after the second dose (administered at Day 61)

Number of participants reporting solicited general AEs during the 7-day follow-up period after the first dose received in the Primary vaccination phase

Timeframe: During the 7-day follow-up period after the first dose (administered at Day 1)

Number of participants reporting solicited general AEs during the 7-day follow-up period after the second dose received in the Primary vaccination phase

Timeframe: During the 7-day follow-up period after the second dose (administered at Day 61)

Number of participants reporting unsolicited AEs during a 30-day follow-up period follow-up after the first dose received in the Primary vaccination phase

Timeframe: During the 30-day follow-up period after the first dose (administered at Day 1).

Trial details

NCT IDNCT04062669

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-07-28

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