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Virus Therapy

Oral HIV Vaccine Safety for HIV Prevention

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
Must not have
Active tuberculosis
History of suicide attempts, recent suicidal ideation, or psychosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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
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I do not have HIV.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have active tuberculosis.
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I have a history of suicide attempts or thoughts, or have experienced psychosis.
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I do not have active syphilis.
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I have a history of immune system problems or take medication that affects my immune system.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
All participants will receive oral vaccine at study entry, although dosage will vary

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
3,336 Previous Clinical Trials
5,382,796 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
~25 spots leftby Dec 2025
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