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Virus Therapy

Oral HIV Vaccine Safety for HIV Prevention

Q: Am I eligible to be a participant in this research study?

<p>Candidates for this research must be <a href="https://www.withpower.com/clinical-trials/hiv">HIV</a>-positive and of legal age (18 to 55 years old). Currently, the trial is aiming to enroll 38 participants.</p>

Phase 1

Waitlist Available

Led By George K. Lewis, PhD

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

HIV uninfected

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up throughout study

Awards & highlights

Study Summary

This trial will test a new oral HIV vaccine for safety and effectiveness. The vaccine uses a weakened form of Salmonella to deliver an HIV gene into the body, stimulating an immune response. The vaccine cannot cause HIV.

Who is the study for?

This trial is for HIV-negative individuals who don't have Hepatitis B or C, can commit to a 12-month follow-up, practice low-risk sexual behavior, and use effective contraception. It's not for those with immune deficiencies, chronic illnesses, autoimmune diseases, cancer histories (unless cured), high-risk behaviors for HIV infection, recent drug injections or certain vaccine receipts.Check my eligibility

What is being tested?

The study tests an oral HIV vaccine using a weakened Salmonella typhi bacterium to deliver an HIV gene that prompts the body to produce an anti-HIV protein and immune response. The vaccine cannot cause HIV/AIDS as it contains only one non-replicating component of the virus.See study design

What are the potential side effects?

Potential side effects are not detailed in the provided information but may include typical reactions to vaccines such as soreness at administration site, fever, fatigue or allergic responses due to components of the vaccine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I do not have HIV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~throughout study

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety, as judged by the lack of an immune response to CD4 epitopes or other significant adverse events as defined by the HVTN toxicity tables

Secondary outcome measures

Neutralizing antibody response against HIV-1

Trial Design

1Treatment groups

Experimental Treatment

Group I: 1Experimental Treatment1 Intervention

All participants will receive oral vaccine at study entry, although dosage will vary

0 / 1Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,272 Previous Clinical Trials

5,485,558 Total Patients Enrolled

George K. Lewis, PhDPrincipal InvestigatorUnivesity of Maryland

1 Previous Clinical Trials

33 Total Patients Enrolled

Media Library

SCBaL/M9 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00062530 — Phase 1

Human Immunodeficiency Virus Infection Research Study Groups: 1

Human Immunodeficiency Virus Infection Clinical Trial 2023: SCBaL/M9 Highlights & Side Effects. Trial Name: NCT00062530 — Phase 1

SCBaL/M9 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00062530 — Phase 1

Frequently Asked Questions

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

Is SCBaL/M9 a potentially hazardous substance to humans?

"Our experts at Power have provided a safety score of 1 for SCBaL/M9 as it is still in its initial Phase 1 trials, meaning there is little evidence to suggest robust efficacy or safety."

Answered by AI