CompletedPhase 4

Responses to Rabies Vaccine in Adults With or Without Antibiotics

United States37 participantsStarted 2018-07-05

Plain-language summary

The use of antibiotics changes micro-organisms in the intestines which may impact the body's vaccine immune response and alter the effectiveness of the rabies vaccine. There will be two randomized groups (1:1 randomization). Group A will start taking an antibiotic regimen by mouth 3 days prior to vaccination and continue taking antibiotics the day of rabies vaccination and one day after vaccination for a total of 5 days. Group B will only receive the rabies vaccination and will not take any antibiotics. The dosage of each antibiotic is taken from their respective package inserts and does not exceed the maximum dose allowed for each antibiotic. The purpose of the study is to look at immune response after rabies vaccination with or without the use of antibiotics from day of vaccination to 28 days post vaccination in both groups.

Who can participate

Age range

18 Years – 49 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: * Healthy individuals aged 18-49 years. * Able to understand and give informed consent. * Women of child-bearing potential (not surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who are not postmenopausal for ≥1 year) must agree to practice adequate contraception that may include, but is not limited to, abstinence, monogamous relationship with vasectomized partner, barrier methods such as condoms, diaphragms, spermicides, intrauterine devices, and licensed hormonal methods for 28 days before and 28 days after Rabies vaccination. Exclusion Criteria: * Receipt of the following: * Receipt of blood products 3 months prior to vaccination or expected receipt through 12 months after vaccination. * Receipt of any live virus vaccines within 28 days prior to vaccination or expected receipt within 28 days after vaccination. * Receipt of any inactivated vaccine within 14 days or expected receipt within 14 days after vaccination. * Receipt of any antibiotic 3 months prior to vaccination or expected receipt 28 days after vaccination. * Receipt of probiotics and prebiotics 3 months prior to vaccination or expected receipt 28 days after vaccination. * Receipt of proton pump inhibitors, H2 receptor blockers, or antacids 3 months prior to vaccination or expected receipt 28 days after vaccination. * Presence of co-morbidities or immunosuppressive states such as: * Chronic medical problems including (but not limited to) insuli…

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

Antibody Titers

Timeframe: Day 28

Proportion of Participants Achieving Seroprotection

Timeframe: Day 28

Trial details

NCT IDNCT03557008

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-02

Results submitted2023-05-15

View on ClinicalTrials.gov More Rabies Human trials