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Virus Therapy

Vaccine A for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Emergent BioSolutions
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 months
Awards & highlights

Study Summary

The purpose of this study is to test experimental human immunodeficiency virus (HIV) vaccines that use an adenovirus vector. The adenovirus vector may help the vaccines stimulate an immune response. Researchers want to see how the immune system will respond to these vaccines as well as if they are safe to give to people. Participants cannot get HIV from these vaccines. However, researchers also want to see if the vaccine's adenovirus is contagious. Adenoviruses cause cold symptoms or mild eye infections, therefore household and intimate contacts will be asked to participate as well.

Eligible Conditions
  • Healthy Subjects
  • HIV Vaccine

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To evaluate the safety of the Ad4-mgag and Ad4-EnvC150 vaccines in humans when administered via the oral route in combination with an AIDSVAX® B/E boost.

Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Vaccine BExperimental Treatment2 Interventions
Receive Ad4-EnvC150 three times at 0,2,and 6 months with a boost at 8 months
Group II: Vaccine A & B (previously received study vaccine)Experimental Treatment3 Interventions
People who have previously had a study vaccine: Receive both Ad4-mgag and Ad4-EnvC150 three times at 0,2,and 6 months with a boost at 8 months
Group III: Vaccine A & BExperimental Treatment3 Interventions
Receive both Ad4-mgag and Ad4-EnvC150 three times at 0,2,and 6 months with a boost at 8 months
Group IV: Vaccine AExperimental Treatment2 Interventions
Receive Ad4-mgag three times at 0,2,and 6 months with a boost at 8months
Group V: PlaceboPlacebo Group2 Interventions
Receive placebo three times at 0,2,and 6 months with a boost at 8 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ad4-mgag
2013
Completed Phase 1
~70
Ad4-EnvC150
2013
Completed Phase 1
~70
AIDSVAX B/E
2014
Completed Phase 1
~280

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Emergent BioSolutionsLead Sponsor
61 Previous Clinical Trials
937,424 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,269 Previous Clinical Trials
5,481,449 Total Patients Enrolled
Sean Bennett, MDStudy DirectorEmergent BioSolutions

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate the Safety and Immunogenicity of an Oral HIV Vaccine in Healthy, HIV-uninfected Adults
2015. "Study to Evaluate the Safety and Immunogenicity of an Oral HIV Vaccine in Healthy, HIV-uninfected Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02771730.
~2 spots leftby Apr 2025
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